COMPLIANCE POLICIES

The Compliance Administrator at OSP serves as the administrator for committees established to ensure compliance in three areas of research: human subjects, animal care and use, and radiation safety. AU compliance policies in these areas and committee procedures and memberships are given below. Hazardous materials and controlled substances are also addressed.

The information in this handbook details policies and procedures for the AU compliance committees for which the Office of Sponsored Programs provides coordination services. For general information about the university’s risk management and safety services for hazardous materials and chemical hygiene go the website http://american.edu/finance/rmo/ehands.html.”

HUMAN SUBJECTS

Protection of human subjects in research at American University is overseen by the Institutional Review Board for the Protection of Human Subjects (IRB). AU adheres to 45 CFR 46, Protection of Human Subjects, as amended (made more stringent) by the IRB and approved by the Provost (see Attachment IV-A), for all federally-funded research. For this research, AU operates under the terms of its Federalwide Assurance (FWA) on file with the Department of Health and Human Services’ Office for Human Research Protections (OHRP) (see Attachment IV-B).

All research involving human subjects must receive prior approval from the IRB or appropriate Unit Designee. Review of all externally funded or high-risk research is done by the IRB, which meets monthly during the academic year and once during the summer. Non-funded and minimal risk studies are approved by the Unit Designees. For a decision tree chart regarding human subjects research at AU, see Attachment IV-C. Researchers should submit the Research Proposal Review form (Attachment IV-D), with all of the required documentation, to the IRB Administrator or the Unit Designee. Researchers may file a Claim of IRB Exemption (Attachment IV-E) if they believe that the project falls under one or more of the regulatory exemptions, but the determination of exemption can only be made by the IRB or Unit Designee.

A new condition for IRB approval, effective in the fall of 2002, is completion by all researchers involved in a project of an on-line educational training module at http://www.cc.nih.gov/researchers/training/crt.shtml or the completion of comparable documented training.

Questions and Answers about Human Subjects Protection at American University (Attachment IV-F) covers the basic policies and procedures. Further questions should be referred to the IRB Administrator or Unit Designee. Additional guidance is available at http://www.hhs.gov/ohrp/policy/index.html.

IRB members, 2005-6

Chair: Peter Jaszi, Washington College of Law

Members: Karen Froslid-Jones, Institutional Research and Assessment

James Gray, Psychology

Dolores Koenig, Anthropology

Renee Marlin-Bennett, School of International Service

Ruth Cernea, community member

Alternates: Joseph Eldridge, University Chaplain

Brian Yates, Psychology

Administrator: Catherine Kirby, OSP (x3440, ckirby@american.edu)

ANIMAL CARE AND USE

Research involving animals at American University is overseen by the Institutional Animal Care and Use Committee (IACUC). AU adheres to legislation such as the Animal Welfare Act of 1966 and the Health Research Extension Act of 1985, as well as the Public Health Service Policy on Humane Care and Use of Laboratory Animals and other relevant guidelines. Applicable regulations are available at the web site of the Office of Laboratory Animal Welfare (OLAW): http://grants.nih.gov/grants/olaw/olaw.htm. AU operates under the terms of its Animal Welfare Assurance with OLAW.

AU’s policies on animal care and use are described in detail at the IACUC web site. The site is password-protected; for a password, contact the IACUC Administrator. http://www.american.edu/academic.depts/provost/osp/iacuc/index.cfm

All research involving animals must receive prior approval from the IACUC. The IACUC meets twice a year but proposals can be reviewed at any time. Proposals should be submitted to theIACUC Administrator using the Protocol for the Use of Live Vertebrates for Research, Teaching, or Demonstration form (Attachment IV-G).

IACUC procedures include monthly inspections (announced and unannounced) by AU’s consulting veterinarian. The IACUC prepares semi-annual reports for the Provost.

Since 1995 AU has not been engaged in research using any animals whose use would require a license and annual inspection from the U.S. Department of Agriculture. Introduction of certain animals other than mice, rats, pigeons, and fish could trigger these new requirements.

IACUC members, 2005-6

Chair: Anthony Riley, Psychology

Members: Lynne Arneson, Biology

Bernard M. Flynn, consulting veterinarian

Michael Gross, community member

Craig Gruber, community member

Administrator: Catherine Kirby, OSP (x3440, ckirby@american.edu)

RADIATION SAFETY

AU is licensed by the Nuclear Regulatory Commission (NRC) and the District of Columbia to use specific radioactive isotopes for teaching, research, and training. NRC inspectors can and do conduct unannounced inspections to determine the University’s compliance with licensing requirements. Use of radioactive isotopes is overseen by the Radiation Safety Committee.

A researcher who proposes to use radioactive isotopes must:

have current training in radiation safety;
request inclusion on AU’s NRC license;
strictly follow all the requirements for ordering, use, and disposal of the isotopes (see Attachment IV-H for further information on ordering and receiving radioactive materials).

The names of all persons approved to use radioactive isotopes at AU must appear on the license, and their training in this area must be current. All isotopes and their locations must appear on AU’s inventory, and warning signs must be posted in each location. In addition, all orders for isotopes for use at AU must be signed by the teaching unit head and the Radiation Safety Officer. All isotopes that are ordered must include an approved plan for disposal.

For further information on federal and AU procedures regarding research with radioactive isotopes or specific licensing requirements, contact either the Radiation Safety Officer or the Compliance Administrator.

Radiation Safety Committee members, 2005-6

Chair: Albert Cheh, Chemistry (Radiation Safety Officer)

Members: Anthony Newman, Contract and Risk Management

Catherine Schaeff, Biology

Administrator: Catherine Kirby, OSP (x3440, ckirby@american.edu)

HAZARDOUS MATERIALS

American University conducts research and other activities that involve the use of hazardous materials. These materials, if not properly used, stored, transported, or disposed of, may pose a risk to persons or the environment. AU’s policy is to provide an environment free from recognized, significant hazards and comply with local and federal regulations regarding environmental and occupational safety and health, such as those promulgated by the Occupational Safety and Health Administration (OSHA) and the Environmental Protection Agency (EPA).

Accordingly, all projects involving the use of hazardous chemical or biological materials must adhere to the University’s Chemical Hygiene Plan, available from the Office of Contract and Risk Management. This policy serves as a guide for laboratory researchers, professors, students, and other AU personnel who generate hazardous waste.

Management questions should be addressed to Anthony Newman, Director of Risk Management, x2706, anewman@american.edu

CONTROLLED SUBSTANCES

Researchers cannot use controlled substances in research unless they have registered with the Drug Enforcement Agency (DEA). 21 CFR 1301 (and in particular 21 CFR 1301.18) covers requirements that must be met by any researcher anticipating the use of controlled substances listed under schedules one through five. The application (DEA form 225 or 225a) requires the submission of the research protocol, a description of the quantity and type of controlled substance proposed for use; and an explicit description of the safe, location of the safe, and controlled access to the safe in which the substances will be stored.

Since the researcher registers directly with the DEA for a license to obtain controlled substances, AU has no standing committee for this purpose. However, faculty members considering research that involved controlled substances may wish to contact OSP for guidance in contacting the proper authorities.

Attachment IV-A

American University Regulations

on the Protection of Human Subjects

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

American University regulations on the protection of human subjects follow 45 CFR 46 with the exception of articles 46.101(b)(3) and (4), which have been modified (made more stringent).

CODE OF FEDERAL REGULATIONS

TITLE 45
PUBLIC WELFARE

DEPARTMENT OF HEALTH AND HUMAN SERVICES
NATIONAL INSTITUTES OF HEALTH
OFFICE FOR PROTECTION FROM RESEARCH RISKS

PART 46
PROTECTION OF HUMAN SUBJECTS

* * *

Revised November 13, 2001
Effective December 13, 2001

* * *

Subpart A --	Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects)
Sec.
46.101	To what does this policy apply?
46.102	Definitions.
46.103	Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency.
46.104- 46.106	[Reserved]
46.107	IRB membership.
46.108	IRB functions and operations.
46.109	IRB review of research.
46.110	Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.
46.111	Criteria for IRB approval of research.
46.112	Review by institution.
46.113	Suspension or termination of IRB approval of research.
46.114	Cooperative research.
46.115	IRB records.
46.116	General requirements for informed consent.
46.117	Documentation of informed consent.
46.118	Applications and proposals lacking definite plans for involvement of human subjects.
46.119	Research undertaken without the intention of involving human subjects.
46.120	Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.
46.121	[Reserved]
46.122	Use of Federal funds.
46.123	Early termination of research support: Evaluation of applications and proposals.
46.124	Conditions.

Subpart B --		Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
Sec.
46.201	To what do these regulations apply?
46.202	Definitions.
46.203	Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.
46.204	Research involving pregnant women or fetuses.
46.205	Research involving neonates.
46.206	Research involving, after delivery, the placenta, the dead fetus or fetal material.
46.207	Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.
Subpart C --		Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
Sec.
46.301	Applicability.
46.302	Purpose.
46.303	Definitions.
46.304	Composition of Institutional Review Boards where prisoners are involved.
46.305	Additional duties of the Institutional Review Boards where prisoners are involved.
46.306	Permitted research involving prisoners.
Subpart D --		Additional DHHS Protections for Children Involved asSubjects in Research
Sec.
46.401	To what do these regulations apply?
46.402	Definitions.
46.403	IRB duties.
46.404	Research not involving greater than minimal risk.
46.405	Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.
46.406	Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.
46.407	Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.
46.408	Requirements for permission by parents or guardians and for assent by children.
46.409	Wards.

Authority: 5 U.S.C. 301; Sec. 474(a), 88 Stat. 352 (42 U.S.C. 2891-3(a)).

Note: As revised, Subpart A of the DHHS regulations incorporates the Common Rule (Federal Policy) for the Protection of Human Subjects (56 FR 28003). Subpart D of the HHS regulations has been amended at Section 46.401(b) to reference the revised Subpart A.

The Common Rule (Federal Policy) is also codified at

7 CFR Part 1c	Department of Agriculture
10 CFR Part 745	Department of Energy
14 CFR Part 1230	National Aeronautics and Space Administration
15 CFR Part 27	Department of Commerce
16 CFR Part 1028	Consumer Product Safety Commission
22 CFR Part 225	International Development Cooperation Agency, Agency for International Development
24 CFR Part 60	Department of Housing and Urban Development
28 CFR Part 46	Department of Justice
32 CFR Part 219	Department of Defense
34 CFR Part 97	Department of Education
38 CFR Part 16	Department of Veterans Affairs
40 CFR Part 26	Environmental Protection Agency
45 CFR Part 690	National Science Foundation
49 CFR Part 11	Department of Transportation

TITLE 45
CODE OF FEDERAL REGULATIONS
PART 46

PROTECTION OF HUMAN SUBJECTS

* * *

Revised June 18, 1991
Effective August 19, 1991

* * *

Subpart A	Federal Policy for the Protection of Human Subjects (Basic DHHS Policy for Protection of Human Research Subjects)
	Source: 56 FR 28003, June 18, 1991.

§46.101 To what does this policy apply?

(a) Except as provided in paragraph (b) of this section, this policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any Federal Department or Agency which takes appropriate administrative action to make the policy applicable to such research. This includes research conducted by Federal civilian employees or military personnel, except that each Department or Agency head may adopt such procedural modifications as may be appropriate from an administrative standpoint. It also includes research conducted, supported, or otherwise subject to regulation by the Federal Government outside the United States.

(1) Research that is conducted or supported by a Federal Department or Agency, whether or not it is regulated as defined in §46.102(e), must comply with all sections of this policy.

(2) Research that is neither conducted nor supported by a Federal Department or Agency but is subject to regulation as defined in §46.102(e) must be reviewed and approved, in compliance with §46.101, §46.102, and §46.107 through §46.117 of this policy, by an Institutional Review Board (IRB) that operates in accordance with the pertinent requirements of this policy.

(b) Unless otherwise required by Department or Agency heads, research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from this policy:¹

(1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

*3) Research involving survey or interview procedures, except where responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, and (i) the subject’s responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability, or (ii) the research deals with sensitive aspects of the subject’s own behavior, attitudes or opinions.

*(4) Research involving the observation (including observations by participants) of public behavior, except where responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, and (i) the observations about the individual, if they become known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability, or (ii) the research deals with sensitive aspects of the subject’s own behavior, attitudes or opinions.

(5) Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

(6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

(d) Department or Agency heads may require that specific research activities or classes of research activities conducted, supported, or otherwise subject to regulation by the Department or Agency but not otherwise covered by this policy, comply with some or all of the requirements of this policy.

(e) Compliance with this policy requires compliance with pertinent Federal laws or regulations which provide additional protections for human subjects.

(f) This policy does not affect any State or local laws or regulations which may otherwise be applicable and which provide additional protections for human subjects.

(g) This policy does not affect any foreign laws or regulations which may otherwise be applicable and which provide additional protections to human subjects of research.

(h) When research covered by this policy takes place in foreign countries, procedures normally followed in the foreign countries to protect human subjects may differ from those set forth in this policy. [An example is a foreign institution which complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989) issued either by sovereign states or by an organization whose function for the protection of human research subjects is internationally recognized.] In these circumstances, if a Department or Agency head determines that the procedures prescribed by the institution afford protections that are at least equivalent to those provided in this policy, the Department or Agency head may approve the substitution of the foreign procedures in lieu of the procedural requirements provided in this policy. Except when otherwise required by statute, Executive Order, or the Department or Agency head, notices of these actions as they occur will be published in the Federal Register or will be otherwise published as provided in Department or Agency procedures.

(i) Unless otherwise required by law, Department or Agency heads may waive the applicability of some or all of the provisions of this policy to specific research activities or classes or research activities otherwise covered by this policy. Except when otherwise required by statute or Executive Order, the Department or Agency head shall forward advance notices of these actions to the Office for Protection from Research Risks, National Institutes of Health, Department of Health and Human Services (DHHS), and shall also publish them in the Federal Register or in such other manner as provided in Department or Agency procedures.[1]

§46.102 Definitions.

(a) Department or Agency head means the head of any Federal Department or Agency and any other officer or employee of any Department or Agency to whom authority has been delegated.

(b) Institution means any public or private entity or Agency (including Federal, State, and other agencies).

(c) Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

(d) Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

(e) Research subject to regulation, and similar terms are intended to encompass those research activities for which a Federal Department or Agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentallyregulated by a Federal Department or Agency solely as part of the Department's or Agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).

(f) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains

(1) data through intervention or interaction with the individual, or
(2) identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

(g) IRB means an Institutional Review Board established in accord with and for the purposes expressed in this policy.

(h) IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.

(i) Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

(j) Certification means the official notification by the institution to the supporting Department or Agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.

§46.103 Assuring compliance with this policy -- research conducted or supported by any Federal Department or Agency.

(a) Each institution engaged in research which is covered by this policy and which is conducted or supported by a Federal Department or Agency shall providewritten assurance satisfactory to the Department or Agency head that it will comply with the requirements set forth in this policy. In lieu of requiring submission of an assurance, individual Department or Agency heads shall accept the existence of a current assurance, appropriate for the research in question, on file with the Office for Protection from Research Risks, National Institutes Health, DHHS, and approved for Federalwide use by that office. When the existence of an DHHS-approved assurance is accepted in lieu of requiring submission of an assurance, reports (except certification) required by this policy to be made to Department and Agency heads shall also be made to the Office for Protection from Research Risks, National Institutes of Health, DHHS.

(b) Departments and agencies will conduct or support research covered by this policy only if the institution has an assurance approved as provided in this section, and only if the institution has certified to the Department or Agency head that the research has been reviewed and approved by an IRB provided for in the assurance, and will be subject to continuing review by the IRB. Assurances applicable to federally supported or conducted research shall at a minimum include:

(1) A statement of principles governing the institution in the discharge of its responsibilities for protecting the rights and welfare of human subjects of research conducted at or sponsored by the institution, regardless of whether the research is subject to Federal regulation. This may include an appropriate existing code, declaration, or statement of ethical principles, or a statement formulated by the institution itself. This requirement does not preempt provisions of this policy applicable to Department- or Agency-supported or regulated research and need not be applicable to any research exempted or waived under §46.101 (b) or (i).

(2) Designation of one or more IRBs established in accordance with the requirements of this policy, and for which provisions are made for meeting space and sufficient staff to support the IRB's review and recordkeeping duties.

(3) A list of IRB members identified by name; earned degrees; representative capacity; indications of experience such as board certifications, licenses, etc., sufficient to describe each member's chief anticipated contributions to IRB deliberations; and any employment or other relationship between each member and the institution; for example: full-time employee, part-time employee, member of governing panel or board, stockholder, paid or unpaid consultant. Changes in IRB membership shall be reported to the Department or Agency head, unless in accord with §46.103(a) of this policy, the existence of a DHHS-approved assurance is accepted. In this case, change in IRB membership shall be reported to the Office for Protection from Research Risks, National Institutes of Health, DHHS.

(4) Written procedures which the IRB will follow (i) for conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution; (ii) for determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous IRB review; and (iii) for ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject.

(5) Written procedures for ensuring prompt reporting to the IRB, appropriate institutional officials, and the Department or Agency head of (i) any unanticipated problems involving risks to subjects or others or any serious or continuing noncompliance with this policy or the requirements or determinations of the IRB; and (ii) any suspension or termination of IRB approval.

(c) The assurance shall be executed by an individual authorized to act for the institution and to assume on behalf of the institution the obligations imposed by this policy and shall be filed in such form and manner as the Department or Agency head prescribes.

(d) The Department or Agency head will evaluate all assurances submitted in accordance with this policy through such officers and employees of the Department or Agency and such experts or consultants engaged for this purpose as the Department or Agency head determines to be appropriate. The Department or Agency head's evaluation will take into consideration the adequacy of the proposed IRB in light of the anticipated scope of the institution's research activities and the types of subject populations likely to be involved, the appropriateness of the proposed initial and continuing review procedures in light of the probable risks, and the size and complexity of the institution.

(e) On the basis of this evaluation, the Department or Agency head may approve or disapprove the assurance, or enter into negotiations to develop an approvable one. The Department or Agency head may limit the period during which any particular approved assurance or class of approved assurances shall remain effective or otherwise condition or restrict approval.

(f) Certification is required when the research is supported by a Federal Department or Agency and not otherwise exempted or waived under §46.101 (b) or (i). An institution with an approved assurance shall certify that each application or proposal for research covered by the assurance and by §46.103 of this policy has been reviewed and approved by the IRB. Such certification must be submitted with the application or proposal or by such later date as may be prescribed by the Department or Agency to which the application or proposal is submitted. Under no condition shall research covered by §46.103 of the policy be supported prior to receipt of the certification that the research has been reviewed and approved by the IRB. Institutions without an approved assurance covering the research shall certify within 30 days after receipt of a request for such a certification from the Department or Agency, that the application or proposal has been approved by the IRB. If the certification is not submitted within these time limits, the application or proposal may be returned to the institution. (Approved by the Office of Management and Budget under Control Number 9999-0020.)

§§46.104--46.106 [Reserved]

§46.107 IRB membership.

(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members, including consideration of race, gender, and cultural backgrounds and sensitivity to such issues as community attitudes, to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects. In addition to possessing the professional competence necessary to review specific research activities, the IRB shall be able to ascertain the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. The IRB shall therefore include persons knowledgeable in these areas. If an IRB regularly reviews research that involves a vulnerable category of subjects, such as children, prisoners, pregnant women, or handicapped or mentally disabled persons, consideration shall be given to the inclusion of one or more individuals who are knowledgeable about and experienced in working with these subjects.

(b) Every nondiscriminatory effort will be made to ensure that no IRB consists entirely of men or entirely of women, including the institution's consideration of qualified persons of both sexes, so long as no selection is made to the IRB on the basis of gender. No IRB may consist entirely of members of one profession.

(c) Each IRB shall include at least one member whose primary concerns are in scientific areas and at least one member whose primary concerns are in nonscientific areas.

(d) Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

(e) No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB.

(f) An IRB may, in its discretion, invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the IRB. These individuals may not vote with the IRB

§46.108 IRB functions and operations.

In order to fulfill the requirements of this policy each IRB shall:

(a) Follow written procedures in the same detail as described in §46.103(b)(4) and to the extent required by §46.103(b)(5).

(b) Except when an expedited review procedure is used (see §46.110), review proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it shall receive the approval of a majority of those members present at the meeting

§46.109 IRB review of research.

(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities covered by this policy.

(b) An IRB shall require that information given to subjects as part of informed consent is in accordance with §46.116. The IRB may require that information, in addition to that specifically mentioned in §46.116, be given to the subjects when in the IRB's judgment the information would meaningfully add to the protection of the rights and welfare of subjects.

(d) An IRB shall notify investigators and the institution in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. If the IRB decides to disapprove a research activity, it shall include in its written notification a statement of the reasons for its decision and give the investigator an opportunity to respond in person or in writing.

(e) An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)

§46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

(a) The Secretary, HHS, has established, and published as a Notice in the Federal Register, a list of categories of research that may be reviewed by the IRB through an expedited review procedure. The list will be amended, as appropriate, after consultation with other departments and agencies, through periodic republication by the Secretary, HHS, in the Federal Register. A copy of the list is available from the Office for Protection from Research Risks, National Institutes of Health, DHHS, Bethesda, Maryland 20892.

(b) An IRB may use the expedited review procedure to review either or both of the following:

(1) some or all of the research appearing on the list and found by the reviewer(s) to involve no more than minimal risk,

(2) minor changes in previously approved research during the period (of one year or less) for which approval is authorized.

Under an expedited review procedure, the review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB. In reviewing the research, the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review in accordance with the non-expedited procedure set forth in §46.108(b).

(c) Each IRB which uses an expedited review procedure shall adopt a method for keeping all members advised of research proposals which have been approved under the procedure.

(d) The Department or Agency head may restrict, suspend, terminate, or choose not to authorize an institution's or IRB's use of the expedited review procedure.

§46.111 Criteria for IRB approval of research.

(a) In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:

(1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.

(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.

(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.

(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.

(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.

(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.

(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.

(b) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

§46.112 Review by institution.

Research covered by this policy that has been approved by an IRB may be subject to further appropriate review and approval or disapproval by officials of the institution. However, those officials may not approve the research if it has not been approved by an IRB.

§46.113 Suspension or termination of IRB approval of research.

An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination or approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the investigator, appropriate institutional officials, and the Department or Agency head.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)

§46.114 Cooperative research.

Cooperative research projects are those projects covered by this policy which involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with this policy. With the approval of the Department or Agency head, an institution participating in a cooperative project may enter into a joint review arrangement, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort.

§46.115 IRB records.

(a) An institution, or when appropriate an IRB, shall prepare and maintain adequate documentation of IRB activities, including the following:

(1) Copies of all research proposals reviewed, scientific evaluations, if any, that accompany the proposals, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to subjects.

(2) Minutes of IRB meetings which shall be in sufficient detail to show attendance at the meetings; actions taken by the IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controverted issues and their resolution.

(3) Records of continuing review activities.

(4) Copies of all correspondence between the IRB and the investigators.

(5) A list of IRB members in the same detail as described in §46.103(b)(3).

(6) Written procedures for the IRB in the same detail as described in §46.103(b)(4) and §46.103(b)(5).

(7) Statements of significant new findings provided to subjects, as required by §46.116(b)(5).

(b) The records required by this policy shall be retained for at least 3 years, and records relating to research which is conducted shall be retained for at least 3 years after completion of the research. All records shall be accessible for inspection and copying by authorized representatives of the Department or Agency at reasonable times and in a reasonable manner.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)

§46.116 General requirements for informed consent.

Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

(a) Basic elements of informed consent. Except as provided in paragraph (c) or (d) of this section, in seeking informed consent the following information shall be provided to each subject:

(1) a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;

(2) a description of any reasonably foreseeable risks or discomforts to the subject;

(3) a description of any benefits to the subject or to others which may reasonably be expected from the research;

(4) a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;

(5) a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;

(6) for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;

(7) an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and

(8) a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

(b) additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:

(1) a statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;

(2) anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;

(3) any additional costs to the subject that may result from participation in the research;

(4) the consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;

(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and

(6) the approximate number of subjects involved in the study.

(c) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:

(1) the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and

(2) the research could not practicably be carried out without the waiver or alteration.

(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that:

(1) the research involves no more than minimal risk to the subjects;

(2) the waiver or alteration will not adversely affect the rights and welfare of the subjects;

(3) the research could not practicably be carried out without the waiver or alteration; and

(4) whenever appropriate, the subjects will be provided with additional pertinent information after participation.

(e) The informed consent requirements in this policy are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.

(f) Nothing in this policy is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, State, or local law.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)

§46.117 Documentation of informed consent.

(a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

(b) Except as provided in paragraph (c) of this section, the consent form may be either of the following:

(1) A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; or

(2) A short form written consent document stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

(c) An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:

(1) That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

(2) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.

In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.
(Approved by the Office of Management and Budget under Control Number 9999-0020.)

§46.118 Applications and proposals lacking definite plans for involvement of human subjects.

Certain types of applications for grants, cooperative agreements, or contracts are submitted to departments or agencies with the knowledge that subjects may be involved within the period of support, but definite plans would not normally be set forth in the application or proposal. These include activities such as institutional type grants when selection of specific projects is the institution's responsibility; research training grants in which the activities involving subjects remain to be selected; and projects in which human subjects' involvement will depend upon completion of instruments, prior animal studies, or purification of compounds. These applications need not be reviewed by an IRB before an award may be made. However, except for research exempted or waived under §46.101 (b) or (i), no human subjects may be involved in any project supported by these awards until the project has been reviewed and approved by the IRB, as provided in this policy, and certification submitted, by the institution, to the Department or Agency.

§46.119 Research undertaken without the intention of involving human subjects.

In the event research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects in the research, the research shall first be reviewed and approved by an IRB, as provided in this policy, a certification submitted, by the institution, to the Department or Agency, and final approval given to the proposed change by the Department or Agency.

§46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency.

(a) The Department or Agency head will evaluate all applications and proposals involving human subjects submitted to the Department or Agency through such officers and employees of the Department or Agency and such experts and consultants as the Department or Agency head determines to be appropriate. This evaluation will take into consideration the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained.

(b) On the basis of this evaluation, the Department or Agency head may approve or disapprove the application or proposal, or enter into negotiations to develop an approvable one.

§46.121 [Reserved]

§46.122 Use of Federal funds.

Federal funds administered by a Department or Agency may not be expended for research involving human subjects unless the requirements of this policy have been satisfied.

§46.123 Early termination of research support: Evaluation of applications and proposals.

(a) The Department or Agency head may require that Department or Agency support for any project be terminated or suspended in the manner prescribed in applicable program requirements, when the Department or Agency head finds an institution has materially failed to comply with the terms of this policy.

(b) In making decisions about supporting or approving applications or proposals covered by this policy the Department or Agency head may take into account, in addition to all other eligibility requirements and program criteria, factors such as whether the applicant has been subject to a termination or suspension under paragraph (a) of this section and whether the applicant or the person or persons who would direct or has/have directed the scientific and technical aspects of an activity has/have, in the judgment of the Department or Agency head, materially failed to discharge responsibility for the protection of the rights and welfare of human subjects (whether or not the research was subject to Federal regulation).

§46.124 Conditions.

With respect to any research project or any class of research projects the Department or Agency head may impose additional conditions prior to or at the time of approval when in the judgment of the Department or Agency head additional conditions are necessary for the protection of human subjects.

Subpart B	Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research
	Source: Federal Register: November 13, 2001 (Volume 66, Number 219), Rules and Regulations, Page 56775-56780, from the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr13no01-9].

§46.201 To what do these regulations apply?

(a) Except as provided in paragraph (b) of this section, this subpart applies to all research involving pregnant women, human fetuses, neonates of uncertain viability, or nonviable neonates conducted or supported by the Department of Health and Human Services (DHHS). This includes all research conducted in DHHS facilities by any person and all research conducted in any facility by DHHS employees.

(b) The exemptions at Sec. 46.101(b)(1) through (6) are applicable to this subpart.

(c) The provisions of Sec. 46.101(c) through (i) are applicable to this subpart. Reference to State or local laws in this subpart and in Sec. 46.101(f) is intended to include the laws of federally recognized American Indian and Alaska Native Tribal Governments.

(d) The requirements of this subpart are in addition to those imposed under the other subparts of this part.

§46.202 Definitions.

The definitions in Sec. 46.102 shall be applicable to this subpart as well. In addition, as used in this subpart:

(a) Dead fetus means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

(b) Delivery means complete separation of the fetus from the woman by expulsion or extraction or any other means.

(d) Neonate means a newborn.

(e) Nonviable neonate means a neonate after delivery that, although living, is not viable.

(f) Pregnancy encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.

(g) Secretary means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.

(h) Viable, as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. The Secretary may from time to time, taking into account medical advances, publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of this subpart. If a neonate is viable then it may be included in research only to the extent permitted and in accordance with the requirements of subparts A and D of this part.

§46.203 Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.

In addition to other responsibilities assigned to IRBs under this part, each IRB shall review research covered by this subpart and approve only research which satisfies the conditions of all applicable sections of this subpart and the other subparts of this part.

§46.204 Research involving pregnant women or fetuses.

Pregnant women or fetuses may be involved in research if all of the following conditions are met:

(a) Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses;

(b) The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means;

(d) If the research holds out the prospect of direct benefit to the pregnant woman, the prospect of a direct benefit both to the pregnant woman and the fetus, or no prospect of benefit for the woman nor the fetus when risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be obtained by any other means, her consent is obtained in accord with the informed consent provisions of subpart A of this part;

(e) If the research holds out the prospect of direct benefit solely to the fetus then the consent of the pregnant woman and the father is obtained in accord with the informed consent provisions of subpart A of this part, except that the father's consent need not be obtained if he is unable to consent because of unavailability, incompetence, or temporary incapacity or the pregnancy resulted from rape or incest.

(f) Each individual providing consent under paragraph (d) or (e) of this section is fully informed regarding the reasonably foreseeable impact of the research on the fetus or neonate;

(g) For children as defined in Sec. 46.402(a) who are pregnant, assent and permission are obtained in accord with the provisions of subpart D of this part;

(h) No inducements, monetary or otherwise, will be offered to terminate a pregnancy;

(i) Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy; and

(j) Individuals engaged in the research will have no part in determining the viability of a neonate

§46.205 Research involving neonates.

(a) Neonates of uncertain viability and nonviable neonates may be involved in research if all of the following conditions are met:

(1) Where scientifically appropriate, preclinical and clinical studies have been conducted and provide data for assessing potential risks to neonates.

(2) Each individual providing consent under paragraph (b)(2) or (c)(5) of this section is fully informed regarding the reasonably foreseeable impact of the research on the neonate.

(3) Individuals engaged in the research will have no part in determining the viability of a neonate.

(4) The requirements of paragraph (b) or (c) of this section have been met as applicable.

(b)Neonates of uncertain viability. Until it has been ascertained whether or not a neonate is viable, a neonate may not be involved in research covered by this subpart unless the following additional conditions have been met:

(1) The IRB determines that:

(i) The research holds out the prospect of enhancing the probability of survival of the neonate to the point of viability, and any risk is the least possible for achieving that objective, or

(ii) The purpose of the research is the development of important biomedical knowledge which cannot be obtained by other means and there will be no added risk to the neonate resulting from the research; and

(2) The legally effective informed consent of either parent of the neonate or, if neither parent is able to consent because of unavailability, incompetence, or temporary incapacity, the legally effective informed consent of either parent's legally authorized representative is obtained in accord with subpart A of this part, except that the consent of the father or his legally authorized representative need not be obtained if the pregnancy resulted from rape or incest.

(c) Nonviable neonates. After delivery nonviable neonate may not be involved in research covered by this subpart unless all of the following additional conditions are met:

(1) Vital functions of the neonate will not be artificially maintained;

(2) The research will not terminate the heartbeat or respiration of the neonate;

(3) There will be no added risk to the neonate resulting from the research;

(4) The purpose of the research is the development of important biomedical knowledge that cannot be obtained by other means; and

(5) The legally effective informed consent of both parents of the neonate is obtained in accord with subpart A of this part, except that the waiver and alteration provisions of Sec. 46.116(c) and (d) do not apply. However, if either parent is unable to consent because of unavailability, incompetence, or temporary incapacity, the informed consent of one parent of a nonviable neonate will suffice to meet the requirements of this paragraph (c)(5), except that the consent of the father need not be obtained if the pregnancy resulted from rape or incest. The consent of a legally authorized representative of either or both of the parents of a nonviable neonate will not suffice to meet the requirements of this paragraph (c)(5).

(d) Viable neonates. A neonate, after delivery, that has been determined to be viable may be included in research only to the extent permitted by and in accord with the requirements of subparts A and D of this part.

§46.206 Research involving, after delivery, the placenta, the dead fetus or fetal material.

(a) Research involving, after delivery, the placenta; the dead fetus; macerated fetal material; or cells, tissue, or organs excised from a dead fetus, shall be conducted only in accord with any applicable Federal, State, or local laws and regulations regarding such activities.

(b) If information associated with material described in paragraph (a) of this section is recorded for research purposes in a manner that living individuals can be identified, directly or through identifiers linked to those individuals, those individuals are research subjects and all pertinent subparts of this part are applicable.

§46.207 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses, or neonates.

The Secretary will conduct or fund research that the IRB does not believe meets the requirements of Sec. 46.204 or Sec. 46.205 only if:

(a) The IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates; and

(b) The Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, ethics, law) and following opportunity for public review and comment, including a public meeting announced in the Federal Register, has determined either:

(1) That the research in fact satisfies the conditions of Sec. 46.204, as applicable; or

(2) The following:

(i) The research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of pregnant women, fetuses or neonates;

(ii) The research will be conducted in accord with sound ethical principles; and

(iii) Informed consent will be obtained in accord with the informed consent provisions of subpart A and other applicable subparts of this part.

Subpart C	Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects
	Source: 43 FR 53655, Nov. 16, 1978.

§46.301 Applicability.

(a) The regulations in this subpart are applicable to all biomedical and behavioral research conducted or supported by the Department of Health and Human Services involving prisoners as subjects.

(b) Nothing in this subpart shall be construed as indicating that compliance with the procedures set forth herein will authorize research involving prisoners as subjects, to the extent such research is limited or barred by applicable State or local law.

§46.302 Purpose.

Inasmuch as prisoners may be under constraints because of their incarceration which could affect their ability to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, it is the purpose of this subpart to provide additional safeguards for the protection of prisoners involved in activities to which this subpart is applicable.

§46.303 Definitions.

As used in this subpart:

(a) "Secretary" means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.

(b) "DHHS" means the Department of Health and Human Services.

(c) "Prisoner" means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which providealternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

(d) "Minimal risk" is the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

§46.304 Composition of Institutional Review Boards where prisoners are involved.

In addition to satisfying the requirements in §46.107 of this part, an Institutional Review Board, carrying out responsibilities under this part with respect to research covered by this subpart, shall also meet the following specific requirements:

(a) A majority of the Board (exclusive of prisoner members) shall have no association with the prison(s) involved, apart from their membership on the Board.

(b) At least one member of the Board shall be a prisoner, or a prisoner representative with appropriate background and experience to serve in that capacity, except that where a particular research project is reviewed by more than one Board only one Board need satisfy this requirement.

§46.305 Additional duties of the Institutional Review Boards where prisoners are involved.

(a) In addition to all other responsibilities prescribed for Institutional Review Boards under this part, the Board shall review research covered by this subpart and approve such research only if it finds that:

(1) the research under review represents one of the categories of research permissible under §46.306(a)(2);

(2) any possible advantages accruing to the prisoner through his or her participation in the research, when compared to the general living conditions, medical care, quality of food, amenities and opportunity for earnings in the prison, are not of such a magnitude that his or her ability to weigh the risks of the research against the value of such advantages in the limited choice environment of the prison is impaired;

(3) the risks involved in the research are commensurate with risks that would be accepted by nonprisoner volunteers;

(4) procedures for the selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners. Unless the principal investigator provides to the Board justification in writing for following some other procedures, control subjects must be selected randomly from the group of available prisoners who meet the characteristics needed for that particular research project;

(5) the information is presented in language which is understandable to the subject population;

(6) adequate assurance exists that parole boards will not take into account a prisoner's participation in the research in making decisions regarding parole, and each prisoner is clearly informed in advance that participation in the research will have no effect on his or her parole; and

(7) where the Board finds there may be a need for follow-up examination or care of participants after the end of their participation, adequate provision has been made for such examination or care, taking into account the varying lengths of individual prisoners' sentences, and for informing participants of this fact.

(b) The Board shall carry out such other duties as may be assigned by the Secretary.

(c) The institution shall certify to the Secretary, in such form and manner as the Secretary may require, that the duties of the Board under this section have been fulfilled.

§46.306 Permitted research involving prisoners.

(a) Biomedical or behavioral research conducted or supported by DHHS may involve prisoners as subjects only if:

(1) the institution responsible for the conduct of the research has certified to the Secretary that the Institutional Review Board has approved the research under §46.305 of this subpart; and

(2) in the judgment of the Secretary the proposed research involves solely the following:

(A) study of the possible causes, effects, and processes of incarceration, and of criminal behavior, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;

(B) study of prisons as institutional structures or of prisoners asincarcerated persons, provided that the study presents no more than minimal risk and no more than inconvenience to the subjects;

(C) research on conditions particularly affecting prisoners as a class (for example, vaccine trials and other research on hepatitis which is much more prevalent in prisons than elsewhere; and research on social and psychological problems such as alcoholism, drug addiction, and sexual assaults) provided that the study may proceed only after the Secretary has consulted with appropriate experts including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of his intent to approve such research; or

(D) research on practices, both innovative and accepted, which have the intent and reasonable probability of improving the health or well-being of the subject. In cases in which those studies require the assignment of prisoners in a manner consistent with protocols approved by the IRB to control groups which may not benefit from the research, the study may proceed only after the Secretary has consulted with appropriate experts, including experts in penology, medicine, and ethics, and published notice, in the Federal Register, of the intent to approve such research.

(b) Except as provided in paragraph (a) of this section, biomedical or behavioral research conducted or supported by DHHS shall not involve prisoners as subjects.

Subpart D	Additional DHHS Protections for Children Involved as Subjects in Research
	Source: 48 FR 9818, March 8, 1983; 56 FR 28032, June 18, 1991.

§46.401 To what do these regulations apply?

(a) This subpart applies to all research involving children as subjects, conducted or supported by the Department of Health and Human Services.

(1) This includes research conducted by Department employees, except that each head of an Operating Division of the Department may adopt such nonsubstantive, procedural modifications as may be appropriate from an administrative standpoint.

(2) It also includes research conducted or supported by the Department of Health and Human Services outside the United States, but in appropriate circumstances, the Secretary may, under paragraph (i) of §46.101 of Subpart A, waive the applicability of some or all of the requirements of these regulations for research of this type.

(b) Exemptions at §46.101(b)(1) and (b)(3) through (b)(6) are applicable to this subpart. The exemption at §46.101(b)(2) regarding educational tests is also applicable to this subpart. However, the exemption at §46.101(b)(2) for research involving survey or interview procedures or observations of public behavior does not apply to research covered by this subpart, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed.

(c) The exceptions, additions, and provisions for waiver as they appear in paragraphs (c) through (i) of §46.101 of Subpart A are applicable to this subpart.

§46.402 Definitions.

The definitions in §46.102 of Subpart A shall be applicable to this subpart as well. In addition, as used in this subpart:

(a) "Children" are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

(b) "Assent" means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

(d) "Parent" means a child's biological or adoptive parent.

(e) "Guardian" means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

§46.403 IRB duties.

§46.404 Research not involving greater than minimal risk.

DHHS will conduct or fund research in which the IRB finds that no greater than minimal risk to children is presented, only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in §46.408.

§46.405 Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

DHHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that holds out the prospect of direct benefit for the individual subject, or by a monitoring procedure that is likely to contribute to the subject's well-being, only if the IRB finds that:

(a) the risk is justified by the anticipated benefit to the subjects;

(b) the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches; and

(c) adequate provisions are made for soliciting the assent of the children and permission of their parents or guardians, as set forth in §46.408.

§46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition.

DHHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring procedure which is not likely to contribute to the well-being of the subject, only if the IRB finds that:

(a) the risk represents a minor increase over minimal risk;

(b) the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations;

(c) the intervention or procedure is likely to yield generalizable knowledge about the subjects' disorder or condition which is of vital importance for the understanding or amelioration of the subjects' disorder or condition; and

(d) adequate provisions are made for soliciting assent of the children and permission of their parents or guardians, as set forth in §46.408.

§46.407 Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

DHHS will conduct or fund research that the IRB does not believe meets the requirements of §46.404, §46.405, or §46.406 only if:

(a) the IRB finds that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children; and

(b) the Secretary, after consultation with a panel of experts in pertinent disciplines (for example: science, medicine, education, ethics, law) and following opportunity for public review and comment, has determined either:

(1) that the research in fact satisfies the conditions of §46.404, §46.405, or §46.406, as applicable, or (2) the following:

(i) the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children;

(ii) the research will be conducted in accordance with sound ethical principles;

(iii) adequate provisions are made for soliciting the assent of children and the permission of their parents or guardians, as set forth in §46.408.

§46.408 Requirements for permission by parents or guardians and for assent by children.

(a) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in the judgment of the IRB the children are capable of providing assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances in which consent may be waived in accord with §46.116 of Subpart A.

(b) In addition to the determinations required under other applicable sections of this subpart, the IRB shall determine, in accordance with and to the extent that consent is required by §46.116 of Subpart A, that adequate provisions are made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404 or §46.405. Where research is covered by §46.406 and §46.407 and permission is to be obtained from parents, both parents must give their permission unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.

(c) In addition to the provisions for waiver contained in §46.116 of Subpart A, if the IRB determines that a research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements in Subpart A of this part and paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, State, or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

(d) Permission by parents or guardians shall be documented in accordance with and to the extent required by §46.117 of Subpart A.

(e) When the IRB determines that assent is required, it shall also determine whether and how assent must be documented.

§46.409 Wards.

(a) Children who are wards of the State or any other agency, institution, or entity can be included in research approved under §46.406 or §46.407 only if such research is:

(1) related to their status as wards; or

(2) conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.

(b) If the research is approved under paragraph (a) of this section, the IRB shall require appointment of an advocate for each child who is a ward, in addition to any other individual acting on behalf of the child as guardian or in loco parentis. One individual may serve as advocate for more than one child. The advocate shall be an individual who has the background and experience to act in, and agrees to act in, the best interests of the child for the duration of the child's participation in the research and who is not associated in any way (except in the role as advocate or member of the IRB) with the research, the investigator(s), or the guardian organization.

Version Date 03/20/2002

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Attachment IV-B

U. S. Department of Health and Human Services (DHHS)
Office for Human Research Protections (OHRP)

FEDERALWIDE ASSURANCE OF PROTECTION FOR HUMAN SUBJECTS

A. TERMS OF THE FEDERALWIDE ASSURANCE FOR INSTITUTIONS WITHIN THE UNITED STATES

1. Human Subject Research Must be Guided by Ethical Principles

All of the Institution's human subject activities and all activities of the Institutional Review Boards (IRBs) designated under the Assurance, regardless of funding source, will be guided by the ethical principles in: (a) The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, or (b) other appropriate ethical standards recognized by Federal Departments and Agencies that have adopted the Federal Policy for the Protection of Human Subjects.

2. Applicability

These terms apply whenever the Institution becomes engaged in federally-supported* (i.e., conducted or supported) human subject research, which is not otherwise exempt from the Federal Policy for the Protection of Human Subjects. The Institution becomes so engaged whenever (a) the Institution's employees or agents intervene or interact with human subjects for purposes of federally-supported research; (b) the Institution's employees or agents obtain individually identifiable private information about human subjects for purposes of federally-supported research; or (c) the Institution receives a direct federal award to conduct human subject research, even where all activities involving human subjects are carried out by a subcontractor or collaborator.

[*Federally-supported is defined throughout the FWA and the Terms of Assurance as the U.S. Government providing any funding or other support (including, but not limited to, providing supplies, products, drugs, and identifiable private information collected for research purposes) and/or the conduct of the research involves U.S. Government employees.]

3. Compliance with the Federal Policy for the Protection of Human Subjects

Institutions conducting federally-supported human subject research and the IRB(s) designated under the Institution's Assurance will comply with the Federal Policy for the Protection of Human Subjects, known as the Common Rule. All federally-supported human subject research will also comply with any additional human subject regulations and policies of the supporting Department or Agency. All human subject research conducted or supported by the Department of Health and Human Services (DHHS) will comply with all Subparts of DHHS regulations at Title 45 Code of Federal Regulations Part 46 (45 CFR 46 and its Subparts A, B, C, and D).

The reference in the Code of Federal Regulations is shown below for each Agency which has adopted the Common Rule:

7CFR 1c	Department of Agriculture
10 CFR 745	Department of Energy
14 CFR 123	National Aeronautics and Space Administration
15 CFR 27	Department of Commerce
16 CFR 1028	Consumer Product Safety Commission
22 CFR 225	Agency for International Development
24 CFR 60	Department of Housing and Urban Development
28 CFR 46	Department of Justice
32 CFR 219	Department of Defense
34 CFR 97	Department of Education
38 CFR 16	Department of Veterans Affairs
40 CFR 26	Environmental Protection Agency
45 CFR 46	Department of Health & Human Services
45 CFR 690	National Science Foundation
49 CFR 11	Department of Energy
By Executive Order	Central Intelligence Agency
By Statue	Social Security Administration

4. Written Procedures

a) The Institution should establish, and should provide a copy to OHRP upon request, written procedures for:

1) ensuring prompt reporting to the IRB, appropriate institutional officials, the relevant Department or Agency Head, any applicable regulatory body, and OHRP of any: (i) unanticipated problems involving risks to subjects or others, (ii) serious or continuing noncompliance with the Federal Regulations or IRB requirements, and (iii) suspension or termination of IRB approval.

2) Verifying, by a qualified person or persons other than the investigator or research team, whether proposed human subject research activities qualify for exemption from the requirements of the Common Rule;

b) The designated IRB(s) has established, and will provide a copy to OHRP upon request, written procedures for:
1) Conducting IRB initial and continuing review (not less than once per year), approving research, and reporting IRB findings to the investigator and the Institution;

2) Determining which projects require review more often than annually and which projects need verification from sources other than the investigator that no material changes have occurred since the previous IRB review;

3) Ensuring that changes in approved research protocols are reported promptly and are not initiated without IRB review and approval, except when necessary to eliminate apparent immediate hazards to the subject.

5. Responsibilities and Scope of IRB(s)

Except for research exempted or waived in accordance with Sections 101(b) or 101(i) of the Common Rule, all human subject research will be reviewed, prospectively approved, and subject to continuing oversight and review at least annually by the designated IRB(s). The IRB(s) will have authority to approve, require modifications in, or disapprove the covered human subject research.

6. Informed Consent Requirements

Except for research exempted or waived in accordance with Sections 101(b) or 101(i) of the Common Rule, informed consent will be:

a) sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by Section 116 of the Common Rule;

b) appropriately documented, in accordance with, and to the extent required by Section 117 of the Common Rule.

7. Requirement for Assurances for Collaborating Institutions/Investigators

The Institution is responsible for ensuring that all institutions and investigators engaged in its U.S. federally-supported human subject research operate under an appropriate OHRP or other federally-approved Assurance for the protection of human subjects. In some cases, one institution may operate under an Assurance issued to another institution with the approval of the supporting Department or Agency and the institution holding the Assurance.

8. Written Agreements with Non-Affiliated Investigators

The engagement in human research activities of each independent investigators who is not an employee or agent of the Institution may be covered under the FWA only in accordance with a formal, written agreement of commitment to relevant human subject protection policies and IRB oversight. OHRP's sample Unaffiliated Investigator Agreement may be used or adapted for this purpose, or the Institution may develop its own commitment agreement. Institutions must maintain commitment agreements on file and provide copies to OHRP upon request.

9. Institutional Support for the IRB(s)

The Institution will provide the IRB(s) that it operates with resources and professional and support staff sufficient to carry out their responsibilities under the Assurance effectively.

10. Compliance with the Terms of Assurance

The Institution accepts and will follow items 1-9 above and is responsible for ensuring that (a) the IRB(s) designated under the Assurance agree to comply with these terms; and (b) the IRB(s) possesses appropriate knowledge of the local research context for all research covered under the Assurance (please refer to the OHRP guidance on IRB Knowledge of Local Research Context on the OHRP website).

Any designation under this Assurance of another Institution's IRB or an independent IRB must be documented by a written agreement between the Institution and the IRB organization outlining their relationship and include a commitment that the designated IRB will adhere to the requirements of this Assurance. OHRP's sample IRB Authorization Agreement may be used for such purpose or the two organizations may develop their own agreement. This agreement should be kept on file at both organizations and made available to OHRP upon request.

11. Assurance Training

The OHRP Assurance Training Modules describe the major responsibilities of the Institutional Signatory Official, the Human Protection Administrator, and the IRB Chair(s) that must be fulfilled under the Assurance. OHRP strongly recommends that the Institutional Signatory Official, the Human Protections Administrator (e.g., Human Subjects Administrator or Human Subjects Contact Person), and the IRB Chair(s) personally complete the relevant OHRP Assurance Training Modules, or comparable training that includes the content of these modules, prior to submitting the Assurance.

12. Educational Training

OHRP strongly recommends that the Institution and the designated IRB(s) establish educational training and oversight mechanisms (appropriate to the nature and volume of its research) to ensure that research investigators, IRB members and staff, and other appropriate personnel maintain continuing knowledge of, and comply with, relevant ethical principles, relevant Federal Regulations, OHRP guidance, other applicable guidance, state and local laws, and institutional policies for the protection of human subjects. Furthermore, OHRP recommends that a) IRB members and staff complete relevant educational training before reviewing human subject research; and b) research investigators complete appropriate institutional educational training before conducting human subject research.

13. Renewal of Assurance

All information provided under this Assurance must be updated at least every 36 months (3 years), even if no changes have occurred, in order to maintain an active Assurance. Failure to update this information may result in restriction, suspension, or termination of the Institution's FWA for the protection of human subjects.

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Attachment IV-C prepared by the Institutional Review Board, August 2002

Human Subjects Research at AU

All research on human subjects, as defined below, must receive prior approval by AU’s Institutional Review Board for the Protection of Human Subjects (IRB) or its designee. Research that might need review includes: survey research, interviews, questionnaires, focus groups, and observation projects. This chart helps to identify the steps needed to secure IRB approval.

flow chart

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Attachment IV-D

IRB Application Form

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Attachment IV-E

Claim of IRB Exemption

Many research projects involve studying people but are exempt from IRB review. In some cases, these projects are exempt because the interview subjects – as human beings – are not the subject of the inquiry. Instead, the project deals with the public role of these individuals. In other cases, the questions being asked are simply not sensitive, and we can reasonably claim that the research does not pose a risk of harm to subjects. If you believe that your research project is exempt from IRB review, please elaborate on your claim below.

In submitting this form, you asking the appropriate IRB representative to grant your project an exemption from IRB review. The researcher can not make the determination herself or himself.

Principal Investigator:

Title of Project:

Brief Summary of Project Research Question:

Brief Summary of Research Design:

Justification for Exemption. Federal law lists the following forms of research as exempt from IRB review (indicate all that apply):

Research is on educational methods or evaluation in a normal educational setting.

Research involves tests, surveys, or observations of public behavior without collecting any information to identify the subjects.

Research involves no sensitive information (i.e., no physical, psychological, or social harm would come to the subject if he or she were identified with the information collected).

Research involves public (elected or appointed) officials in their public roles.

Research involves publicly available information or documents.

Research involves the collection or study of existing data, documents, records AND the information is recorded by the investigator in such a manner that the subjects cannot be identified, directly or through identifiers linked to the subjects.

Research or demonstration projects evaluate, or otherwise examine public benefit or service programs.

Research involves taste and food quality consumer acceptance studies of wholesome food.

All the human subjects components of the research design fall into at least one of the above exempt categories.
Yes No

Unit Designee, IRB Chair, or other IRB representative:

The proposed research is/is not exempt from IRB review.

Signature:

Name:

Date:

Examples:

Research is on educational methods or evaluation in a normal educational setting.

You might introduce a “pre-test” teaching methodology in one section and compare the final exam test scores of students in and not in the pre-test section.

Research involves tests, surveys, or observations of public behavior without collecting any information to identify the subjects.

You can observe and record how people passing a homeless person on a Washington street react to him or her.

Research involves no sensitive information (i.e., no physical, psychological, or social harm would come to the subject if he or she were identified with the information collected).

You can ask people which brand of toothpaste they prefer and why.

Research involves public (elected or appointed) officials in their public roles.

You can ask President Clinton how the Lewinsky issue is affecting his ability to govern.

Research involves publicly available information or documents.

You can use Washington Post reports of leaks from the Kenneth Starr investigation.

You have access to data someone else has collected, and all demographics that would provide unique identifiers have been stripped.

Research or demonstration projects evaluate, or otherwise examine public benefit or service programs.

You can accept a contract from the USDA to set up a demonstration project to test a new model for delivering WIC benefits.

Research involves taste and food quality consumer acceptance studies of wholesome food.

You can have people take the “Pepsi Challenge.”

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Attachment IV-F

Questions and Answers

About

Human Subject Protection

At

American University

The Institutional Review Board

for the

Protection of Human Subjects

American University

This copyright does not extend to material quoted from HHS 4-5 CFR 46.

Revised 1991

TABLE OF CONTENTS

Introduction …………………………………………………………….........………… 36

Basic Questions about the Institutional Review Board for

the Protection of Human Subjects ………………………………………………………….. 37

What is the IRB? ………………………………………………………………………. 37

What are the Objectives of the IRB? …………………………………………………. 37

Who are the Members of the IRB? ……………………………………………………. 38

How Often Does the IRB Meet? ………………………………………………………. 38

Definitions ……………………………………………………………………………….… 39

How is "Research with Human Subjects" Defined? ………………………..………… 39

Do the HHS Regulations Define Additional Protections? ……………………………. 39

General Procedures …………………………………………………………………….……. 40

When do Research Proposals have to be Reviewed by the University IRB;
When do they have to be Reviewed by the Departmental or School IRB?   .……………     40
What is the Process for an Exemption?   ……………………………………………….     40
How do the University's Regulations Vary from 45 CFR 46?   …………….....………….    40
What about Questionnaires which go out from the University?   ……………………….     41
Can the IRB or the Departmental Designee Suspend or Terminate Approval of Research? 41
How can the Human Subjects Designee or the IRB Require an Informed Consent if
the Research Plan is not Specific at the Time of Submission?   …………………….……… 41
What about Research in Cooperation with Another Institution?   ………………………… 42
What are the Procedures for Approval for Research Using Media/Photography?   ………   42
What Human Subjects’ Standards do we Use for Research Being Done Overseas?   ……… 43

TABLE OF CONTENTS (Continued)

Departmental Human Subjects Procedures ………………………………………………… 43

Functioning as a Department/Unit Human Subject's Designee   …….....…………………   43
Classroom/Intern Projects Requiring Review   …………………………………..................   44
Graduate Student Research   ……………………………………………………………......45
Forms for Use in Research Review   ………………………………………………..……....45
Reporting on Research which has been Reviewed   ………………………………………....45

Informed Consent …………………………………………………………………………….. 46

What is an Informed Consent?   …………………………………………………………   46
Where is Informed Consent Needed?   ……………………………….…………….……. 46
What Should be Contained in anInformed Consent?   …………………....………………. 46
Are There Examples of Informed Consent?   ……………………………....……….…… 47
What Procedures Should be Used for Informed Consent for Minors?   ……..…………...   47

Risks and Safeguards …………………………………………………………………………. 48

Risks Defined   ………………………………………………………………….... 48
Assurance of Anonymity   ………………………………………………………     48
Case Study Research and Anonymity   …………………………………………… 48
Safeguard for Data Saved for Follow-up Research   …………………………………… 49

Computerized Data …………………………………………………………………….. 49

Questions and Answers About Human Subject Protection at American University was compiled by

the AU IRB. This publication is based on 45 CFR 46, “Protection of Human Subjects” and

American University revisions to 45 CFR 46.

August 1991 revision

INTRODUCTION

All research involving human subjects that is done at American University or on behalf of the University is subject to review. The review of this research is based on 45 CFR 46,

Protection of Human Subjects, as amended by American University. Each teaching unit and pertinent administrative unit has copies of this regulation, as amended. In general, proposals for funded research involving human subjects, for university research questionnaires, and for all research involving a “fee for service” component is reviewed by the University Institutional Review Board. Proposals for unfunded research are reviewed at the teaching or administrative unit level.

This booklet is designed to help faculty and staff comply with the human subject research regulations and, in particular, to assist personnel at the teaching unit or administrative unit level who will be taking responsibility for human subject review for nonfunded research. The information in the booklet will help answer the following basic questions:

What is the University Institutional Review Board; who serves on the Board?

How is “Research with Human Subjects” defined?

When are research proposals involving human subjects reviewed by the University Institutional Review Board, and when are they reviewed by the Unit Designee?

What is an exemption from IRB review; who decides?

How can the Unit IRB Designee function effectively?

Where can the Unit IRB Designee get assistance?

Do classroom projects involving human subjects need to be reviewed; under what conditions?

Who reviews questionnaires which will use a campus-wide population as subjects; who reviews research in which there is a “fee for service” component?

How can I help researchers determine what constitutes risks and safeguard?

What is an informed consent; when is it needed; and what type of information should be in an informed consent?

How can I assure maximum confidentiality of sensitive data involving human subjects?

In the age of computerization, how can I be sure that research data entered about human subjects can be protected?

BASIC QUESTIONS ABOUT THE INSTITUTIONAL REVIEW BOARD FOR THE PROTECTION OF HUMAN SUBJECTS

1. WHAT IS THE IRB?

The Institutional Review Board (IRB) has the responsibility within our University to carry out the regulations (45 CFR 46) which the Department of Health and Human Services (HHS) has developed to protect human subjects involved in research conducted by persons affiliated with American University (staff, students, or faculty), but apply to all research done under the auspices of any federal agency. In addition, American University has adopted 45 CFR 46, with amendments, for use in assisting human subject protection in all research done under the auspices of the University. In doing this, AU is among approximately 70% of the U.S. colleges and universities which use these regulations as amended as a guide to AU review of research involving human subjects.

2. OBJECTIVES?

In general, the IRB:

* Reviews proposed research at convened meetings at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas.

* In order for the research to be approved, it must be accepted by a majority of those members present at the meeting.

* Reviews and has the authority to approve, require modifications in, or disapprove all research activities covered by regulations on Protection of Human Subjects.

* Requires that information given subjects as part of the informed consent is in compliance with the regulations and may require that additional information be included in order to assure the protection of subjects.

* Notifies investigators and the institutions/agencies in writing of its decision to approve or disapprove the proposed research activity, or of modifications required to secure IRB approval of the research activity. In the case of disapproval, reasons for this disapproval must be given to the investigator in writing and the investigator must be given an opportunity to respond in writing or in person.

* Conducts continuing reviews (not less than once per year), and has the authority to observe or have a third party observe the consent process and the research.

* Is responsible for reporting to institutional officials and sponsoring agencies any serious or continuing noncompliance by investigators with the requirements and determinations made by the IRB.

3. WHO ARE THE MEMBERS OF THE IRB? HOW IS IT CONSTITUTED?

* IRB membership is specified in 45 CFR 46, Protection of Human Subjects.

* Each IRB must have at least five members with varying backgrounds to promote complete and adequate review of research activities conducted by the institution.

* No IRB may be composed entirely of men or entirely of women, or entirely of members of one profession.

* Each IRB must have one member whose primary concerns are nonscientific; for example, lawyers, members of the clergy, ethicist.

* Each IRB must include at least one member who is not affiliated with the institution (a community member). This member cannot be related to a person who is affiliated with the institution. The presence of the community member is a prerequisite for certain Board actions.

* An IRB may invite individuals with specific expertise to assist in the review of complex proposals which require special knowledge beyond that represented on the Board; however, this person(s) cannot participate in the voting.

* The IRB operates within the Office of Sponsored Programs (OSP), Nebraska Hall, Room 105, x3440. A list of current IRB members and a list of Unit Designees can be obtained by contacting the University Compliance Administrator in OSP. Information can also be obtained through the department chairs or directors of the various units.

* All members are appointed by the University Provost. Members of the University faculty who have interest in serving on the IRB should notify the Provost.

4. HOW OFTEN DOES THE IRB MEET?

The University IRB meets at least once per month and often twice monthly during the academic year. In addition, if there are unexpected proposal deadlines, the IRB tries to accommodate the research with emergency meetings.

DEFINITIONS

1. HOW IS “RESEARCH WITH HUMAN SUBJECTS” DEFINED?

Two definitions contained in the regulations, augmented by some examples, should help answer this question.

RESEARCH means a systematic investigation designed to develop or contribute to generalized knowledge. Activities that meet this definition constitute “research” for the purpose of these regulations, whether or not they are supported or funded under a program which is considered research for other purposes. The definition in the regulations is a very broad definition and includes, for example, classical experiments, work involving questionnaires and field observations, and classroom demonstrations and experiments where students are used as subjects. In the case of surveys in classroom teaching, whether informal or formal, coverage can depend on the degree of sensitivity of the question(s) and whether responding is optional. For example, a professor might ask a question such as, “How many of you are Republicans?” Students can abstain from answering. However, if the professor asks each student individually about his/her political affiliation in the class setting, each student might feel pressure to respond. This type of survey might be used in teaching statistics’ students how to construct frequency tables.

HUMAN SUBJECT means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. “Intervention” includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes. “Interaction” includes communication or interpersonal contact between investigator and subject. “Private information” includes information about behavior that occur in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public. Examples of human subjects

include the classic subject who receives a fee or services for participation, the person to whom a questionnaire is administered, the living person about whom historical research is undertaken, and the student in the classroom where experiments with new technology are taking place.

2. DO THE HHS REGULATIONS DEFINE ADDITIONAL PROTECTIONS? DO THEY APPLY TO OUR UNIVERSITY?

* Yes, there are additional protections defined and explained in the January 26, 1981 and the March 8, 1983 revisions of the regulations. They are as follows:

* Subpart B concerns additional protection for research, development and related activities involving fetuses, pregnant women, and human in vitro fertilization.

* Subpart C concerns additional protections applicable to biomedical and behavioral research involving prisoners as subjects.

* Subpart D concerns additional protections for children involved as subjects of research.

Any research proposed by person affiliated with American University involving pregnant women, fetuses, prisoners, and minor children must comply with these regulations in order to receive IRB approval.

GENERAL PROCEDURES

1. WHEN DO RESEARCH PROPOSALS HAVE TO BE REVIEWED BY THE UNIVERSITY IRB; WHEN DO THEY HAVE TO BE REVIEWED BY THE DEPARTMENTAL OR SCHOOL IRB?

All research involving human subjects must be reviewed at the departmental or university level. Proposals for funded research, including “fee for service” research, involving human subjects are reviewed by the University Institutional Review Board. Proposals for nonfunded research are reviewed at the unit level. If the departmental reviewer and/or committee have questions about the protection of human subjects in a specific proposal or, if for any reason, the departmental designee feels he/she cannot handle a specific research project, that person can consult with the IRB or refer the proposal to the IRB.

2. WHAT IS THE PROCESS FOR AN EXEMPTION? DO INDIVIDUAL RESEARCHERS DECIDE? OR, MUST THE DECISION COME FROM THE DEPARTMENTAL DESIGNEE OR THE UNIVERSITY IRB?

The most important fact to remember in this series of questions is that the decision is not made by the individual researcher. Research proposals must be evaluated by either the unit process or the University IRB in order to reach a decision as to whether the research can be categorized as exempt. If the research is categorized as exempt, it may not have to go through a detailed review and may not be subject to the use of consent forms.

3. HOW DO THE UNIVERSITY'S REGULATIONS VARY FROM 45 CFR 46? WHY

DID THE UNIVERSITY DECIDE TO USE MORE STRINGENT REGULATIONS?

The difference is in section 46.101(b)(3) and 46.101(b)(4) and American University's amendments are somewhat more stringent. Copies of 45 CFR 46 distributed by the IRB contain these revisions.

The University administration determined that although the 1981 regulations were generally an improvement, they went too far in providing large-scale exemptions from human subject protection and review. Therefore, the above revisions in those regulations were adopted to govern American University research. Over 75 percent of U.S. universities and colleges also adopted the more stringent regulations. These revisions are particularly pertinent for survey and participant observer studies.

4. WHAT ABOUT QUESTIONNAIRES WHICH GO OUT FROM THE UNIVERSITY

(OR WITHIN THE UNIVERSITY)? HOW ARE THEY REVIEWED? SHOULD THEY BE REVIEWED? ARE THEY COVERED UNDER THE UNIVERSITY'S REGULATIONS ON HUMAN SUBJECTS RESEARCH?

All research within the University is reviewable. This includes survey research such as questionnaires sent to faculty and staff, as well as questionnaires eliciting information from enrolled students, accepted students who chose not to attend the University, alumni, and the like. The University IRB should review these questionnaires. It is expected that some survey research will be exempt from detailed review under the regulations adopted by the University in 1983; however, in order to determine whether a particular proposal for survey research can be classified as exempt, the IRB or the Unit Designee must consider the characteristics of that research. The exemption decision is not made by the researcher.

Surveys which involve students of the University are also provided to the Office of the Student Services for review.

5. CAN THE IRB OR THE DEPARTMENTAL DESIGNEE SUSPEND OR TERMINATE APPROVAL OF RESEARCH?

Yes, that is one of their main functions. Section 46.108© states that the IRB shall “be responsible for reporting to the appropriate institutional officials and the Secretary any serious or continuing noncompliance by investigators with the requirements and determinations of the IRB.”

Furthermore, section 46.113, “Suspension or Termination of IRB Approval of Research,” states, “An IRB shall have authority to suspend or terminate approval of research that is not being conducted in accordance with the IRB's requirements, or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the IRB's action and shall be reported promptly to the Investigator, appropriate institutional officials, and the Secretary.”

The IRB has a procedure for follow-up on research projects, and it is suggested the departmental designees also have some type of system to follow research in order to determine whether the conditions of the review are being met. One way of accomplishing this is to ask that the researcher submit a brief report in writing during the process of research.

6. HOW CAN THE HUMAN SUBJECTS DESIGNEE OR THE IRB REQUIRE AN INFORMED CONSENT IF THE RESEARCH PLAN IS NOT SPECIFIC AT THE TIME OF THE PROPOSAL SUBMISSION? DOES THE RESEARCHER HAVE TO

PRESENT HIS/HER PROPOSAL FOR INFORMED CONSENT AT A LATER DATE?

The IRB or its unit counterpart can (1) require that the research plan be more fully developed to

the extent that approval can be granted, or (2) a “first-phase” approval can be given with the

condition that no research which involves human subjects be started until the research plan

(including the experimental design) is completed, questionnaires and informed consent are developed, and specific terms of informed consent and any other information needed is submitted

to the Board or designee.

If Option 2 is used, the researcher should be informed, in writing, that no research with human subjects can proceed until full approval is granted.

7. IF THE RESEARCHER IS WORKING THROUGH ANOTHER INSTITUTION (FOR EXAMPLE, THE D.C. SCHOOLS), IS THAT RESEARCHER STILL REQUIRED TO SUBMIT RESEARCH PROPOSALS TO THE APPROPRIATE PERSON OR COMMITTEE AT THE UNIVERSITY?

Yes, however, there can be different arrangements. For example:

(1) Cooperative research. “Cooperative research projects involve institutions in addition to the grantee or prime contractor. In such instances, the grantee or prime contractor remains responsible for safeguarding the rights and welfare of human subjects. Also, when cooperating institutions conduct some or all of the research involving some or all of these subjects, each cooperating institution shall comply with these regulations ... In complying with these regulations institutions may use joint review, reliance upon the review of another qualified IRB, or similar arrangements aimed at avoidance of duplication of effort.”

(2) Research where the investigator is using subjects within another institutional setting; e.g., a doctoral student is doing a survey with students in the District of Columbia Public Schools, or a researcher is working with subjects who are employed by the Montgomery County government. Each of these institutions usually has a procedure for research approval and informed consent. This approval should be obtained and submitted to the IRB or the unit designee.

8. WHAT ARE THE PROCEDURES FOR GETTING APPROVAL FOR USING HUMAN SUBJECTS IN RESEARCH INVOLVING MEDIA, PHOTOGRAPHY, AND THE LIKE?

The procedure is the same as in studies involving other types of research tools. If there is something about the nature of what is being photographed, for example, which is potentially controversial and if the subjects are identifiable, then there is a problem and there ought to be consent obtained if any intention exists to make use of the material. The mere taking of photographs in connection with a public activity is not a matter of concern so long as those photographs are being taken in public places. Of concern, however are the various uses to which those photographs may be put and where they may be published or publicized. In cases where photographs or other media records are to be redisseminated, potential human subjects problems may arise. The designee should review the project to see if the subject might be put at risk. If so, the informed consent procedure should be used. It is a good idea to think ahead when using photography or other forms of media; if publication is a possibility, then it would be a good idea to get an informed consent at the time for the photography. Of course, if a researcher is using photography or other media in a private setting, then the situation calls for review.

WHAT HUMAN SUBJECTS’ STANDARDS DO WE USE FOR RESEARCH WHICH IS BEING DONE OVERSEAS - OUR STANDARDS, THE COUNTRYS’ STANDARDS, OR BOTH?

The Department of Defense in 32 CPR Part 219, “Protection of Human Subjects in Department of Defense Supported Research,” states in 219.4(1) (4) (1), “In research conducted outside the United States involving non-U.S. citizens as human subjects, the laws, customs, and the practices of the country in which the research is conducted, or those required by this rule, whichever is more stringent, shall take precedence. The research shall meet the same standards of ethics and safety that apply to research conducted within the Untied States involving U.S. citizens.” It is the position of the IRB that this regulation should be used at American University. One implication of this procedure for anyone who is anticipating doing research overseas, especially in non-western cultural settings, is that the researcher has to ascertain whether members of that culture have any group sensitivities in respect to the proposed research activities. These should be discussed in the human subjects section of this proposal.

DEPARTMENTAL HUMAN SUBJECTS PROCEDURES

1. HOW DO YOU SUGGEST THAT I FUNCTION AS A DEPARTMENTAL HUMAN SUBJECTS’ DESIGNEE? HOW DO I DETERMINE COMPLIANCE WITH THE REGUIATIONS; I.E., WHAT SHOULD I DO IF KNOW THAT SOMEONE IS DOING RESEARCH INVOLVING HUMAN SUBJECTS, BUT THE PROPOSAL HAS NOT BEEN REVIEWED? ARE THERE UNIVERSITY RESOURCES TO HELP ME WITH THIS TASK? WHEN SHOULD I REFER PROPOSALS TO THE UNIVERSITY IRB?

* You may find that you can be more effective as a Unit Human Subject’s designee by using some of the following suggestions:

* Be sure that it is officially announced, in writing, that you are the human subjects designee for your unit.

* Explain your function at your department/school/unit's next meeting.

* Use handouts to further explain the responsibilities which researchers whose studies involve human subjects have for review of their research proposals.

* Have handouts available that further explain specifics, such as the contents and informed consent, etc.

* Routinely inform persons in your unit who supervise graduate student theses/dissertations about the requirements for human subjects review.

What do I do if I know that someone is doing research involving human subjects, but the proposal has not been reviewed? The University has a policy which states that all research involving human subjects must be reviewed at either the departmental or University level. With that in mind, probably the first step is discussing this policy with the person doing the research and hoping that the person will then go through the human subjects procedure. Secondly, if this does not work, discussing next steps with the unit chairperson, or with the University IRB would be advisable.

Are there University resources to help me with this task? Yes, human and material. The Compliance Administrator in OSP has the forms which are needed to review research. In addition, copies of the regulation, 45 CFR 46, are also available from OSP. Members of the University IRB and the Compliance Administrator are also willing to help unit designees with problems or interpretations of parts of the 45CFR 46 regulations.

In addition, periodic training sessions are provided for new unit designees and experienced designees who would like to review their responsibilities.

When should I refer proposals to the University IRB? When the funding for the research is from a source external to the University, or, if the project is of such a complex nature that the unit designee feels that an additional opinion is necessary.

2. ARE THERE CLASSROOM PROJECTS WHICH MIGHT REQUIRE REVIEW BY THE DEPARTMENTAL DESIGNEE? INTERN PROJECTS?

Classroom Projects: The issue is whether students are at risk. Routine experiments with new forms of classroom teaching are usually exempt, but there may be other situations where students could be at risk in connection with classroom activities. Some examples are:

* When demonstration experiments are performed in the classroom using students as subjects.

* When survey information is collected from students in a classroom setting.

* When students are subjected to any form of non-educational testing in the classroom such as psychological testing or blood testing.

If these activities are occurring in your area, it would be appropriate for the unit designee to conduct a review to determine whether and to what extent students will be at risk.

Intern or Cooperative Education Projects: These projects are subject to review if they involve student-initiated research involving human subjects. Student involvement in these projects is usually in one of the following two situations. One would be when the student is placed in a setting where there is basically no ongoing research, but the student performs research of his/her own, for example, survey research. That type of research, if it involves human subjects, is reviewable at the student’s department. The other situation is where a student is an intern or a cooperating student and is placed in an agency where there is ongoing research. That type of research should be reviewed by the institution employing the student. The department interacting with that institution should determine whether a proper review has taken place. For example, one inquiry per year to ascertain whether there is adequate human subject protection ought to be enough when a department has continuing relationship with an institution or agency. This is especially important when a student is working under a college credit arrangement.

3. WHAT ABOUT GRADUATE STUDENT RESEARCH OR DISSERTATION RESEARCH? IS THERE A PROCESS THROUGH WHICH EACH STUDENT GOES TO DETERMINE WHETHER OR NOT THAT STUDENT HAS SATISFIED THE HUMAN SUBJECT REVIEW PROCESS?

The University catalog and the graduate student guide both contain sections about review requirements for research involving human subjects. Any graduate research involving human subjects must be reviewed by the departmental/school unit designee and approved before there can be any involvement with human subjects.

4. IS THERE A STANDARD UNIVERSITY FORM FOR USE IN REVIEWING RESEARCH INVOLVING HUMAN SUBJECTS?

Yes, The IRB “Research Proposal Review” form. Some departments have developed their own human subjects' review form. If you have a large quantity of research involving human subjects, your unit might want to do this also.

5. TO WHOM DOES THE UNIT DESIGNEE REPORT RESEARCH WHICH HAS BEEN REVIEWED AND THE ACTIONS TAKEN ON IT?

The person who will be doing the research with human subjects should complete the form and submit it to the IRB or the unit designee with a copy of the proposed research. When the proposal is approved by the unit designee, copies should be provided to the IRB office in OSP, Nebraska Hall; the researcher; and the unit's administrative office; and one should be retained by the unit designee's office.

INFORMED CONSENT

1. WHAT IS INFORMED CONSENT?

Informed consent means the “knowing” consent of an individual or that individual’s legally authorized representative. Informed consent embodies the following concepts:

* This consent must be sought only under circumstances where the individual has sufficient opportunity to consider participation.

* There should be no undue coercion, force, or influence.

* The informed consent must be in language that can be understood by the subject.

* The informed consent can contain no language through which the subject is made to waive or appears to waive any legal rights and no language that releases the investigator, sponsor, or institution from liability for negligence.

Additional information regarding the informed consent process can be obtained from the University Compliance Administrator or the unit designees.

2. WHERE IS INFORMED CONSENT NEEDED? ARE THERE EXCEPTIONS?

Informed consent is needed in all research with human subjects unless there is a waiver by the IRB or the unit designee under 46.117 © (1) (2). The situations under which informed consent may be waive able are (1) when the risk is minimal, and (2) when the informed consent would do more harm than good. Although most of the time the informed consent is in written form, there is also a possibility of oral informed consent in some research studies. See sections 46.116 and 46.117 for additional information.

Minimal risk means that the “risks of harm anticipated in the proposed research are not greater... than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

3. WHAT SHOULD BE CONTAINED IN AN INFORMED CONSENT?

Some basic components of an informed consent follow; additional information can be obtained by reading section 46.116 of the 45 CFR 46 Regulation, Protection of Human Subjects.

1. A statement that the study involves research, an explanation of the purposes of the research, length of the subject's participation, description of the procedures to be followed, and identification of any procedures which are experimental.

2. A description of any reasonable foreseeable risks or discomforts to the subject.

3. A description of any benefits to the subject or to others as a result of this research.

4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject. (This is particularly relevant for biomedical research)

5. A statement describing the safeguards which will be used to minimize risks disclosed, including, where relevant, a statement describing the extent to which confidentiality or records which have the potential for subject identification will be maintained.

6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs, and, if so, what they consist of, or where further information may be obtained. (Again, this is especially appropriate for biomedical research.)

7. Names, addresses, telephone numbers of persons who the subject may contact for answers to pertinent questions about the research and the research subject’s rights, and whom to contact in the event of a research-related injury. This could be to departmental or unit chairperson, the departmental human subjects designee, the IRB chairperson, or, in the case of a graduate student, his/her thesis advisor.

8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

4. ARE THERE EXAMPLES OF INFORMED CONSENT THAT I COULD USE?

Yes, the University Compliance Administrator and the unit designees have examples.

5. WHAT PROCEDURES SHOULD RESEARCHERS USE FOR INFORMED CONSENT FOR MINORS?

The March 8, 1983, revisions of 45 CFR 46, Protection of Human Subjects, add to the requirement of permission by parents and guardians, the requirement of assent by the child who will be involved in the research. “The IRB shall determine that adequate provisions are made for soliciting the assent to the child (children) when in the judgment of the IRB the children are capable of providing assent.” The IRB shall take into account the children’s:

* Ages

* Maturity

* Psychological state

RISKS AND SAFEGUARDS

1. HOW IS RISK DEFINED? WHAT ARE THE CLASSIFICATIONS OF RISK? HOW CAN WE BEST DEAL WITH THESE RISKS?

There are three major kinds of risk: (1) the risk of physical harm, (2) the risk of psychological harm in connection with either the process of the experiment or the results of the experiment, and (3) the possibility of various types of environmental harm ranging from economics, such as loss of job or job prospects, to social, such as ostracism from a group, as well as other harms which are peculiar to the subject's particular situation. The subject of risk must be defined broadly rather than in a narrow fashion. Even if the probability of risk occurring is low, it does not mean that it can be excluded from consideration and hence from human subject’s review.

The best way to deal with risk is by carefully defining each risk and developing appropriate safeguards to minimize them.

2. HOW DOES ONE BEST GO ABOUT ASSURING ANONYMITY?

An example of a possible risk which is often noted in research reviewed at American University

is the potential for breach of confidentiality. Therefore, it is important to be able to develop safeguards that minimize this risk. One of the best ways of minimizing this risk is by developing safeguards that will help anonymity.

The assurance of anonymity can be handled in three ways, (1) by gathering as little identifying information as possible, consistent with the research methodology, (2) by keeping the information secure, and (3) by destroying the raw data which includes the information traceable to individuals, at the earliest possible time consistent with the methodology. If for any reason it is necessary to store the raw data for any longer period of time, then it will be necessary to use a form of maximum security for the data such as a safe or safety deposit box. In assuring security of data, the researcher should keep the number of persons handling the information to a minimum, code data to the greatest degree possible, and keep coding keys and master lists under lock and key.

It is important to remember that anonymity is not just a concern when one is collecting names. Anonymity is an obvious problem in any situation where the names of subjects are known and the information being collected about them is sensitive. However, anonymity can also be a problem in a study where no names are collected if the demographic data being collected is significantly detailed and the group from whom it is being collected is relatively small.

3. CAN CASE STUDY RESEARCH BE USED AND STILL HAVE ANONYMITY ASSURED?

It is important to note that the regulations do not rule out any type of methodology. If sufficient numbers of transformations are performed with the nonsignificant demographic indicators relating to the subjects, case study research can probably be used. This always involves judgment on the part of the researcher in determining what degree of transformation is required. Of course the name of the subject should never be used. In addition, the more sensitive the information, the more one may wish to make such transformations; e.g., change the geographic area, change the economic level, change the physical description, etc.

4. WHAT SAFEGUARDS SHOULD BE USED FOR RESPONDENT CONFIDENTIALITY WHEN SOME TYPE OF FOLLOW-UP MAY BE NECESSARY OR IN THE REALM OF POSSIBILITY?

The essential data and the codes must be kept in a highly secure place. This would not be just a locked file cabinet; it would require a safety deposit box or safe. In cases of extremely sensitive data that must be retained for longitudinal study purposes, the IRB can petition to use secure storage in the Bender University Archives.

5. ARE THERE ADDITIONAL RISKS WHEN RESPONSES AND/OR DATA FROM HUMAN SUBJECTS ARE COMPUTERIZED? SHOULD ADDITIONAL SAFEGUARDS BE EMPLOYED?

The use of computerized data banks to store data and the use of computer programs to analyze data gathered about human subjects pose some special risks, but also present some special opportunities for creating new safeguards. The risks exist mainly because the computer can be used not only to store data, but also to recover information about the demographic characteristics of the individual respondents and the sensitive information that the individual respondents may have provided the researcher. There may be a risk of unauthorized person gaining access to these files unless precautions are carefully followed.

The following can help to minimize the risks:

Under no circumstances should any master code list which contains names of subjects be entered into the computers.

Researchers should be careful not to collect irrelevant demographic information which could be sensitive and could be retrieved.

Researchers should check out the possibility of use of a random number generator which can serve to provide further assurance of anonymity, and they should always use a password which is known only to them and is changed regularly.

Other suggestions for safeguards can be obtained from specialists at American University's computer center.

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Attachment IV-G

PROTOCOL FORM for use at American University

INSTRUCTIONS FOR COMPLETING

"PROTOCOL FOR USE OF LIVE VERTEBRATES"

(Submit completed Protocol Form to the Office of Sponsored Programs,Nebraska Hall - Room 105, x3440)

Federal regulations require that all uses of living vertebrates within the university be reviewed for their appropriateness by the Institutional Animal Care and Use Committee (IACUC).

An additional application of these protocols is to permit identification of each individual animal with its proper protocol at the request of an inspector. Similar procedures conducted on different species associated with the same study may be listed on one protocol provided all animal species are documented; however, if completely different procedures are to be conducted on groups of animals in a related study, then a separate explanation should be submitted for each procedureThese separate explanations can be paragraphs attached to the original protocol.

The information provided via this Protocol Form will be reviewed by the IACUC, including a non-scientist; every attempt should be made to use terminology understandable to a lay person. The completed Protocol Form will be held on file as a current protocol until the project is terminated, the course is discontinued, or the use is revised and new approval is obtained. The effective time period is for the ensuing twelve months.

Protocols must stand on their own merit. Protocols once submitted are public documents and available through the Freedom of Information Act. In order to project an image of competence and knowledge, it is essential the document be well written from both a scientific and grammatical standpoint. Many items are taken out of context by the media. It is wise to carefully read and edit the document to remove or replace verbiage that may be confusing, contradicting, or troublesome when read by the nonscientific general public.

Experiments Involving Pain and/or Distress

A major concern of the reviewers of these protocols is the degree of pain and/or distress imposed on the animals in the studies, and the methods the investigators will use to prevent, relieve, or minimize any suffering.

* As modified (made more stringent) by American University.

[1] Institutions with DHHS-approved assurances on file will abide by provisions of Title 45 CFR Part 46 Subparts A-D. Some of the other departments and agencies have incorporated all provisions of Title 45 CFR Part 46 into their policies and procedures as well. However, the exemptions at 45 CFR 46.101(b) do not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization, Subparts B and C. The exemption at 45 CFR 46.101(b)(2), for research involving survey or interview procedures or observation of public behavior, does not apply to research with children, Subpart D, except for research involving observations of public behavior when the investigator(s) do not participate in the activities being observed.

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American University Regulations

The Common Rule (Federal Policy) is also codified at

Attachment IV-C prepared by the Institutional Review Board, August 2002

Questions and Answers

At

August 1991 revision

INTRODUCTION

DEFINITIONS

GENERAL PROCEDURES

DEPARTMENTAL HUMAN SUBJECTS PROCEDURES

INFORMED CONSENT

RISKS AND SAFEGUARDS

Attachment IV-G

Attachment IV-H

PROCEDURES FOR ORDERING AND RECEIVING