IRB (Institutional Review Board) “Common Rule” (45 CFR part 46)

the boys are swallowing a hundred million infant stars, while the rest of us, unwilling or unable to hold them, trip and stumble through the elements with our note books.


"No Data = No Problem."

Securing the type of research data that secures the release of funding that secures the best interests of sexually abused & exploited boys, is largely dependent today on “the amount of overnight tossing-and-turning that a researcher can tolerate" and the amount of support he/she receives from friends and colleagues across disciplines.

Research guidelines and financial constraints, play a significant role in the collection & visibility of the 'type' of research data that serves as a catalyst for the creation of appropriate legislation and release of funding for safe houses, medical care, legal representation & counsel, that serve the best interests of sexually exploited boys.

Federal and state laws require that a person’s HIV status be kept confidential. The confidentiality of a person’s HIV status is important because people with HIV and AIDS face discrimination when other people find out they have HIV. People will only get tested and treated for HIV, if they know their HIV status will be kept private.

Sexually Exploited boys are more at risk for HIV infection, & the devastating consequences of stigma, than any other group of youth in the USA today. The stigmatizing process is perpetuated by the derogatory & highly misleading cultural names that many adults call Sexually Abused & Sexually Exploited kids. For instance, "child prostitutes" and/or "child sex workers" and/or "child whores" and/or "addicts" and/or "delinquents" and/or "status offenders"...

Journalism & IRB Reviews:

Most activities considered journalism (e.g., investigations and interviews that focus on specific events, views, etc., and that lead to newspaper/news publication, documentary production, or are part of training that is explicitly linked to journalism) are not research, and do not require IRB review. When journalists conduct activities normally considered scientific research intended to produce generalizable knowledge (e.g., systematic research, surveys, and/or interviews that are intended to test theories or develop models), some of these activities may be subject to IRB review. In such cases investigators should consult with the IRB.

Data Collection:

Journalists are careful about what they print because if it can be established there were crimes involved around data hacking, they can be prosecuted under the law.

Institutional Review Board (IRB) : The Common Rule.

There is significant debate concerning the appropriate purview of the IRB; indeed the Office of Human Research Protection (OHRP) is currently seeking public comment on a series of proposed changes to the regulations [The Common Rule]. Some argue that federal regulation of human subject research has largely derived from the ethical concerns emerging out of the biomedical field and are ill-suited to the research methodologies routinely employed in the social sciences. Some argue that IRBs have so expanded their scope that research has been seriously constrained.

Oral histories that describe or document particular lives or historical events are exempt from IRB review. Oral histories and similar investigations that are intended to produce generalizable knowledge (e.g., that are designed to draw conclusions, inform policy, or collect data to test economic, sociological, or anthropological models and/or theories) do require IRB review.

The Breath of Life...

The animated figures stand

Adorning every public street

And seem to breathe in stone, or

move their marble feet.

- Pindar -

Pygmalion byJean-Baptiste Regnault

“By making the projects visible, we are bringing the problem to the surface. By giving victims a voice, by talking about it, we are breaking through the taboo”, said Meinie Nicolai, MSF operational director. (SHATTERED LIVES: Immediate medical care vital for sexual violence victims. A report by Médecins Sans Frontières. March 2009).


According to the Common Rule (section 46.101(b)), research
that may be exempt from the Common Rule includes:

  • research "conducted in established or commonly accepted educational settings, involving normal educational practices."
  • research "involving the use of educational tests... survey procedures, interview procedures or observation of public behavior" unless the information recorded is individually identifiable and such research poses a risk to participants.
  • research "involving the use of educational tests... surveys procedures, interview procedures or observation of public behavior" where the participants are elected or appointed public officials or candidates for public office, or federal statute requires confidentiality of identifiable information.
  • research "involving the collection or study of existing data, documents, records" if these sources are public or information is recorded by the investigator in such a manner that the participants cannot be identified, directly or through identifiers linked to the subjects."

Ethnographic research

The American Anthropological Association Statement on Ethnography and Institutional Review Boards provides the following definitions and guidance:

Ethnography involves the researcher's study of human behavior in the natural settings in which people live. Specifically, ethnography refers to the description of cultural systems or an aspect of culture based on fieldwork in which the investigator is immersed in the ongoing everyday activities of the designated community for the purpose of describing the social context, relationships and processes relevant to the topic under consideration. Ethnographic inquiry focuses attention on beliefs, values, rituals, customs, and behaviors of individuals interacting within socioeconomic, religious, political and geographic environments. Ethnographic analysis is inductive and builds upon the perspectives of the people studied. Ethnography emphasizes the study of persons and communities, in both international and domestic arenas, and involves short or long-term relationships between the researcher and research participants.

Multiple methods are used in ethnographic research. These include but are not limited to the following: unobtrusive direct observation, participant observation, structured and unstructured interviewing, focused discussions with individuals and community members, analysis of texts, and audio-visual records. Ethnographic methods can be employed in non-traditional ways in interdisciplinary projects that bridge the sciences and humanities.

The complexity and length of ethnographic research engenders an approach to ethics that is both dynamic and flexible. The process of obtaining informed consent may be continuous and incremental throughout the course of the research, and review of consent obtained may be periodic.

Ethnographic research is subject to the Common Rule [….] because it involves "a systematic investigation...designed to develop or contribute to generalizable knowledge." Although ethnographic research takes place in natural settings and differs significantly from clinical research, ethnographic research projects are subject to review by an Institutional Review Board (IRB) to ensure that the participants in the proposed research are not harmed. Because of its complexity, variable contexts, and duration of different ethnographic research projects, ethnographic research should be reviewed on a case-by-case basis.

See further : Institutional Review Boards and Anthropology

Research on Educational Practices and Programs

If the research examines the effectiveness of educational practices, techniques, or programs, even in settings that include minors as ‘participants,’ it does not require IRB review, as long as the research examines educational practices or strategies that take place in commonly accepted educational settings and involve normal educational practices (regular or special education). Thus research on the effectiveness of instructional programs or techniques (e.g., strategies, assignments, computer exercises, content units, etc.) does not require IRB review.


ORAL HISTORY EXCLUDED FROM IRB REVIEW by Donald A. Ritchie (Oral History Association) & Linda Shopes (American Historical Association).  2003.

The U.S. Office for Human Research Protection (OHRP), part of the Department of Health and Human Services (HHS), working in conjunction with the American Historical Association and the Oral History Association, has determined that oral history interviewing projects in general do not involve the type of research defined by HHS regulations and are therefore excluded from Institutional Review Board oversight.

At the October 2003 meeting of the Oral History Association in Bethesda, Maryland, George Pospisil of the OHRP’s Division of Education and Development, explained the OHRP decision regarding the application of the “Common Rule” (45 CFR part 46), which sets regulations governing research involving human subjects.  These federal regulations define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The type of research encompassed by the regulations involves standard questionnaires with a large sample of individuals who often remain anonymous, not the open-ended interviews with identifiable individuals who give their interviews with “informed consent”that characterizes oral history. Only those oral history projects that conform to the regulatory definition of research will now need to submit their research protocols for IRB review.

Following is the text of a policy statement that was developed by the Oral History Association and the American Historical Association in consultation with the Office of Human Research Protection.  This policy applies to oral history that takes place within an institution that has filed a multiple project assurance with OHRP.  As one of the seventeen federal agencies that have signed on to the Common Rule, the  Department of Health and Human Services deals most directly with the type of clinical research that the federal regulations were originally intended to cover, and its concurrence with the policy statement should set the way for a uniform interpretation by other federal agencies.  Oral historians should make this statement available to department chairs, directors of graduate study, deans, and other officers concerned with institutional compliance with federal regulations.

Application of the Department of Health and Human Services Regulations for the Protection of Human Subjects at 45 CFR Part 46, Subpart A to Oral History Interviewing.

Most oral history interviewing projects are not subject to the requirements of the Department of Health and Human Services (HHS) regulations for the protection of human subjects at 45 CFR part 46, subpart A, and can be excluded from institutional review board (IRB) oversight because they do not involve research as defined by the HHS regulations.  HHS regulations at 45 CFR 46.102(D) define research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” The Oral History Association defines oral history as “a method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life.”

It is primarily on the grounds that oral history interviews, in general, are not designed to contribute to “generalizable knowledge” that they are not subject to the requirements of the HHS regulations at 45 CFR part 46 and, therefore, can be excluded from IRB review.  Although the HHS regulations do not define “generalizable knowledge,” it is reasonable to assume that they term does not simply mean knowledge that lends itself to generalizations, which characterizes every form of scholarly inquiry and human communication.  While historians reach for meaning that goes beyond the specific subject of their inquiry, unlike researchers in the biomedical and behavioral sciences they do not reach for generalizable principles of historical or social development, nor do they seek underlying principles or laws of nature that have predictive value and can be applied to other circumstances for the purpose of controlling outcomes.  Historians explain a particular past; they do not create general explanations about all that has happened in the past, nor do they predict the future.

Moreover, oral history narrators are not anonymous individuals, selected as part of a random sample for the purposes of a survey.  Nor are they asked to respond to a standard questionnaire administered to a broad swath of the population.  Those interviewed are specific individuals selected because of their often unique relationship to the topic at hand.  Open-ended questions are tailored to the experiences of the individual narrator.  Although interviews are guided by professional protocols, the way any individual interview unfolds simply cannot be predicted. An interview gives a unique perspective on the topic at hand; a series of interviews offer up not similar “generalizable” information but a variety of particular perspectives on the topic.

For these reasons, then, oral history interviewing, in general, does not meet the regulatory definition of research as articulated in 45 CFR part 46.  The Office for Human Research Protections concurs with this policy statement, and it is essential that such an interpretation be made available to the many IRBs currently grappling with issues of human subject research.

An Update on the Exclusion of Oral History from IRB Review by Donald A. Ritchie (Oral History Association) & Linda Shopes (American Historical Association). March 15, 2004.

Since August 26, 2003, when the Office for Human Research Protection concurred in a policy statement developed jointly by the American Historical Association and the Oral History Association regarding the application of federal regulations governing research on human subjects to oral history, most campus-based oral history projects have been able to proceed with their interviews without submitting protocols for review by an Institutional Review Board.  The policy statement can be found on the OHA’s website: 

Some IRBs, however, have raised questions about the policy statement and have circulated memoranda that suggest hypothetical cases in which oral history would still be subject to review.  The memos purport to reflect the views of the Office for Human Research Protection, but in fact they seriously misinterpret the OHRP’s position.

As representatives of the OHA and AHA, we participated in a conference call with Dr. Michael Carome on January 7, 2004, the OHRP’s associate director for regulatory affairs, who reaffirmed his agency’s continued concurrence in the policy statement “that oral history interviewing activities, in general, are not designed to contribute to generalizable knowledge and therefore do not involve research as defined by Department of Health and Human Services (HHS) regulations at 45 CFR 46.102 (d) and do not need to be reviewed by an institutional review board (IRB).  OHRP has tried consistently to confirm this concurrence whenever it receives inquiries about this matter from representatives of IRBs or other institutional officers.”

Some of the confusion seems to have arisen around the concepts of “research” and “generalizable knowledge.”  While oral history clearly involves historical research and interviews can lend themselves to generalizations, oral historians’ standard operating procedures do not fit the type of research defined by federal regulations: “A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”  Individually-tailored interviews with a narrators’ informed consent do not meet this definition of “research.”  Nor do they contribute to “generalizable knowledge,” even if conducted with people identified with a common group, theme or event, and whether or not the interviewer or other researchers might draw some historical generalizations from multiple interviews.  The interviews must be designed specifically to produce generalizable knowledge in the scientific sense.

Interview projects that meet the above federal definition should be submitted for IRB review.  Those that do not are not subject to review.

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