The new language added to the AHA's "Statement on Interviewing for Historical Documentation," which is part of its Statement on Standards of Professional Conduct, is intended to alert historians that they must follow federal regulations for conducting interviews using human subjects in their research. The modifications incorporate proposals that were made last fall and winter by the National Institutes of Health's Office for Protection from Research Risks (OPRR) and the Oral History Association (OHA), and that were adopted by the AHA's Professional Division on March 1, 1997, and by the AHA Council on June 7, 1997.

Many historians who plan to conduct oral or written interviews may be alarmed to learn that they must obtain approval to do so from an Institutional Review Board (IRB) at their college or university. Even if they knew about regulations governing human subjects in research, they may have assumed that the rules applied only to studies in the medical and behavioral sciences. The prospect of learning that their own projects may also be scrutinized by IRBs that have the authority to delay, alter, or prohibit their work unless certain conditions are met may raise questions about academic freedom—as well as gastric distress at the thought of having to slog through yet another bureaucratic swamp.1

Although such concerns are valid, my own experience with IRBs suggests that historians who agree with the Statement on Standards of Professional Conduct should have no fundamental reservations about the review process and should easily obtain approval for their interviews. Federal regulations regarding the protection of human subjects in research are reasonable. Their rationale and procedures actually reinforce the OHA's exceptionally strong Principles and Standards of the Oral History Association and its Evaluation Guidelines,2 as well as key tenets of the AHA's Standards of Professional Conduct, regarding the need to inform people who are interviewed about the nature of a project and their rights as participants in it. The problems associated with having to file lengthy IRB forms and with haggling over wording on informed consent forms can be minimized by working closely with IRBs to develop procedures that work for one project and can easily be adapted to others. It is possible that some IRBs overstep their authority legally and ethically. But I have found that IRB members at my university—many of whom also conduct research involving human subjects—have helped me to construct forms and procedures that protect academic freedom and the rights of interviewees. I hope that the information here, based on my own IRB experiences, will help ease both the concerns and the review process of other historians who conduct oral history interviews.

Origins of the Institutional Review Board

Protection of human subjects lies at the core of the concerns of the IRBs as well as those of the interview guidelines contained in the AHA's "Statement on Interviewing for Historical Documentation." The first AHA guideline states that "interviews should be recorded on tape but only after the person to be interviewed has been informed of the mutual rights and responsibilities involved in oral history, such as editing, confidentiality, disposition, and dissemination of all forms of the record." Another guideline provides that "the interviewer should guard against possible social injury to or exploitation of interviewees and should conduct interviews with respect for human dignity."3

The ethical principles embodied in these policies and especially those of the OHA evolved first from deeper concerns that were codified in the Nuremberg Code after World War II, and later from biomedical research conducted in the 1950s and 1960s in the United States that involved human beings who were not fully informed about the nature of the research and who did not always voluntarily consent to the procedures. Such concerns led to regulations governing the protection of human subjects that were issued by the OPRR and administered by the Department of Health and Human Services (DHHS). In 1974, the National Research Act (Public Law 93-348) expanded federal authority in this area in two ways: it required that IRBs be established in all institutions receiving federal funding that conduct research involving human beings; and it created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The IRBs were to enforce the DHHS regulations for human subject research. The 11-person commission was charged with developing an ethical code for conducting research with human subjects, and with recommending ways to strengthen existing regulations. The commission issued its findings in the 1979 Belmont Report, named for the commission's intensive 1976 conference on research ethics at the Smithsonian Institution's Belmont Conference Center. The current regulations, which embody principles of The Belmont Report, were codified in 1981 (with updates in 1983 and 1991) in Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects (or 45 CFR 46). The Belmont Report and 45 CFR 46 are available from local IRBs, and also can be downloaded from the "Human Subjects—Document Library" link in the OPRR's Human and Animal Protection web site at http://www.nih.gov/grants.oprr.html, which has many other relevant and useful documents.4

Principles and Procedures of IRBs

Belmont and 45 CFR 46 embrace fundamental ethical principles that have been widely accepted tenets of our culture. Belmont identified these principles as (1) the need to respect and protect the autonomy of all people, especially "those with diminished autonomy"; (2) the obligation inherent in the term "beneficence" not to harm people and to maximize possible benefits to them; and (3) the imperative to apply principles of justice and fairness in conceptualizing research projects, in selecting participants, and in distributing the benefits of research results. Belmont suggested three broad requirements that would incorporate these general principles into research conduct. Researchers should (1) fully inform their subjects about their projects in understandable language and obtain their voluntary consent for their participation; (2) carefully assess the possible risks and benefits of their projects and convey this assessment to their subjects; and (3) establish fair procedures for selecting research participants and distributing the outcomes of their research.5

These are the general principles and procedures that have been codified in 45 CFR 46. They clearly apply to historians who conduct interviews for their research. Parts of Section 46.101 and 102 state that the policies cover "all research involving human subjects," consider research as "a systematic investigation ... designed to develop or contribute to generalizable knowledge," and define a human subject as "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."

The remainder of 45 CFR 46 establishes the procedures that IRBs use for reviewing three types of research projects. Research that is considered exempt from full IRB review includes educational testing, research and demonstration projects, and other studies involving human subjects that are "conducted in established or commonly accepted educational settings" and which usually do not include historical research. Exempt projects can be reviewed by an authorized department or college representative who forwards the results to an IRB staff member for final approval. Projects that are classified as minimal risk are those in which human subjects are not likely to encounter any greater physical or psychological risk than they would ordinarily encounter in daily life. And projects are considered as involving risk or deception if there is a substantial physical or psychological risk or if they employ deception. Scholars whose research involves minimal risk, risk, or deception, must submit a formal protocol, appear at an IRB meeting to discuss their projects, and revise their protocols to comply with their IRB's instructions. Title 45 CFR 46 provides that no research involving human subjects that is undertaken in any of the three categories can begin without an IRB's approval.

Historians who interview people for their studies most likely will submit minimal risk protocols. Protocols for minimal risk projects usually include the following: a one-page coversheet; a one-page project abstract; three to four pages of required detailed information about the social characteristics of the people who will interviewed, how they will be recruited and compensated (if applicable), what risks they may encounter, how their identities will be kept confidential if they so desire, and how their informed consent will be obtained; an informed consent form; and samples of question sets used in the interviews.

Assembling all of this information the first time through may take a day or two, but the following suggestions for preparing the most important and difficult document—the informed consent form—should help cut the time considerably. Wording in this form can also be used at appropriate places in the abstract and the description of procedures, so Perspectives readers are invited to adapt as much of the following wording (approved by my own IRB) to their own needs. (The project described below is fictitious.)

Historians must present and explain Informed Consent Forms to persons they are interviewing, and also obtain interviewees' consent signatures on the forms, before the interviews actually occur. The forms have nine required components. They must begin with a brief introduction that explains the purpose of the research. An introduction might read as follows:

Professor Clio Jones of the Department of History at Local University is conducting an oral history project about the Neighborhood Development Commission (NDC) for an article about the history of the NDC and of your neighborhood. She will appreciate your participation in this study because it will shed light on important changes in the NDC over the last 25 years. She believes that it is important to obtain information about these changes through oral history interviews because few printed sources are available which do so, and which document the experiences, concerns, and activities of a variety of NDC members. Her objective is to obtain information and perceptions that will help deepen an understanding of the forces and events that have shaped your neighborhood's history, and the various ways neighborhood residents and NDC members have reacted to these developments.

Part two of the form requires an explanation of procedures, including details about the time, place, and length of the interviews, and the approximate number of interviewees. This can be accomplished quickly:

Professor Jones plans to interview about 20 people for this project. All participants will be at least 18 years of age, but most will be between 40 and 70 years of age. She would like to interview you sometime soon about your own experiences. She will interview you in your own home or in the history department conference room on the Local University campus. The interview will last about two hours.

Part three, a discussion of alternative procedures, is not applicable to oral history interviews, but the fourth section—an explanation of the risks and benefits (including possible compensation) is. This part can also be covered quickly:

Professor Jones is required by state and federal regulations to explain the possible risks and benefits that you may incur by participating in this project. She does not anticipate that the interview will cause any physical risks, but it is possible that recalling sensitive or divisive issues, if there were any, may result in temporary discomfort. Moreover, there is a minimal risk that perceptions and details that you provide in the interview could adversely affect your employment status (if applicable) and your reputation in the community. You will not be paid money for doing the interview. Professor Jones does believe that your remembrances will contribute much to the history of your neighborhood and the NDC. As you know, this community has faced significant challenges in housing, education, economic vitality, and safety. The NDC has been an important voice and advocate for area residents. Scholars and the media have occasionally devoted some attention to the NDC and your neighborhood, but much more remains to be known about how ordinary people and NDC leaders and others viewed changes over the years. Students and other researchers may consult your interview in preparing scholarly articles and community publications on your neighborhood and community development.

Part five of the Informed Consent Form must include a full explanation of safeguards that will be used to protect the identity of the persons who are interviewed if they want this protection. The wording below describes the procedures I use to protect confidentiality. It also mentions a Legal Release Form that interviewees must sign after the interviews are completed. This form is not required by 45 CFR 46. However, because United States copyright law maintains that interviewees own the right to the contents of their interviews, historians must have interviewees transfer these rights on a Legal Release Form in order to use the interviews for their research.6 The rights can be transferred to the historian who conducts the interview or to an institution. The section on safeguards is necessarily long:

If you approve, your name will be attached to the cassette copies of the interview and to the printed transcripts of it. The tape-recorded interview will be the property of the Local University Board of Regents, and will be deposited in the university archives, which is located in the library. After the interview, as a legal requirement, Professor Jones will ask you to sign a Legal Release Form which transfers your rights to the contents of the interview to the Local University Board of Regents. Signing this form will make it possible for researchers to consult your interview and use its contents for research purposes. Professor Jones will ask you to read this form carefully, and will explain it fully to you, before you sign the form. This Legal Release Form will provide you with an opportunity to keep your identity and/or some of your comments confidential. The Local University Archives will be responsible for safeguarding your rights to privacy. The following is an explanation of how the archives will do this technically. The steps described below may seem complicated, but they are routine for Archives personnel. Please keep in mind that these procedures ensure that, if you desire, your identity will remain confidential and that some of your comments on the tape will not be made public. Here is how the procedures work:

1. The archives will make a duplicate copy of the tape-recorded interview. The original copy, called the "Master Copy," will be kept in a locked cabinet in the archives. The duplicate copy, called the "User Copy," will be available to researchers in the archives.
2. The original copies of the Legal Release Forms will be kept in a project file marked "Neighborhood Development Commission Project Legal Release Forms."
3. The Legal Release Forms of people who wish to keep their identities confidential will be kept in a separate project file marked "Neighborhood Development Commission Project Legal Release Forms—Confidential." A user copy of a Legal Release Form for each confidential interviewee will be placed in the file accessible by the public, but it will be identified only by a number which corresponds to a number on the User Cassette Copy. Hence, tape labels for people who do not wish to remain confidential will include complete names, but labels for confidential interviewees will be marked "Confidential" and followed by a number.
4. A separate file, labeled "Neighborhood Development Commission Project Legal Release Forms—Restricted," will be used for people who are willing to make their identities known but want to keep only part of the interview confidential.

In order to further guard your identity, you also may prohibit researchers from listening to the recorded conversation so that no one could determine your identity by hearing your voice. This restriction also will be listed on the Legal Release Form. In such cases, researchers will have access only to the User Transcript. Again, the transcript of confidential interviews will be identified by number only (corresponding to the number on the User Cassette Copy). All personal information that could be used to identify you will be deleted from the User Transcript. If you do not wish to keep your identity confidential, researchers will have complete access to the cassette tapes and the transcript. If you believe something you say is sensitive and should not be released to the public, you can place a restriction on the sensitive portion of the interview either permanently or for a reasonable period of time. The restriction can be made at the appropriate place on the Legal Release Form. We will erase the restricted portion on the User Copy, and delete the restricted information from the transcript that are available to researchers.

Parts six through nine of the Informed Consent Form are less complicated. Section six must indicate that interviewees' participation is voluntary and that they can withdraw from the project at any time and request that their tape-recorded conversation and transcripts be destroyed. Section seven must offer to provide interviewees with the results of the study and list the historian's address and phone number. Section eight must tell interviewees whom to contact if they have complaints about their treatment. Finally, interviewees must sign a statement attesting that they give their informed consent to participate.

None of the requirements in 45 CFR 46 should prevent historians from interviewing anyone. Some additional precautions to protect confidentiality may be necessary if historians use questionnaires to help identify potential interviewees, or if the interviews include questions about issues that are especially sensitive for political or other reasons. Moreover, historians and historical organizations occasionally may need to challenge IRB rulings. But 45 CFR 46 regulations appear to safeguard historians' freedom to conduct unfettered research that involves living human beings as long as scholars respect accepted ethical principles and legal standards.

Notes

1. For useful discussions of these subjects, see Kenneth R. Howe and Katherine Cutts Dougherty, "Ethics, Institutional Review Boards, and the Changing Face of Educational Research," Educational Researcher 22 (December 1993), 16–21; and Michael D. Murphy and Aqueta Johannsen, "Ethical Obligations and Federal Regulations in Ethnographic Research and Anthropological Education," Human Organization 49 (1990), 127–134.

2. Available from the Oral History Association, Baylor University, P.O. Box 97234, Waco, TX 76798-7234. E-mail: OHA_support@baylor.edu.

3. American Historical Association, "Statement on Interviewing for Historical Documentation," adopted May 1989 and amended June 1997, in Statement on Standards of Professional Conduct (Washington: AHA, 1997), 13, 14.

4. The direct address for The Belmont Report is http://www.nih.gov/grants/oprr/belmont.html. For 45 CFR 46 see http://www.med.umich.edu/irbmed/FederalDocuments/hhs/HHS45CFR46.html.

5. The Belmont Report, pp. 3–8.

6. On this and other legal points, see John A. Neuenschwander, Oral History and the Law, 2nd rev. ed. (1993), available from the Oral History Association.