Friday, July 30, 2010

Smithsonian Frees Oral History, Journalism, and Folklore

The Smithsonian Institution has posted a document entitled "HUMAN SUBJECTS RESEARCH FAQs." Although undated, the document appears, from its metadata, to have been last modified on 11 June 2010.

The document makes the Smithsonian the latest in a growing number of prestigious research institutions to provide oral historians, journalists, and folklorists explicit permission to do their work without contacting the IRB. Here are the key questions and answers:

6. Are there any examples of activities that aren't considered Human Subjects Research?

The following are specifically excluded from the definition of Human Subject Research and do not need to be reviewed by the IRB:
• interviews used to provide quotes or illustrative statements, such as those used in journalism;
• collection(s) of oral histories and cultural expressions (e.g., stories, songs, customs, and traditions and accounts thereof) to document a specific historical event or the experience of individuals without intent to draw statistically or quantitatively-based conclusions or generalizations;
• gathering of information from a person to elucidate a particular item (or items) in a museum collection;
• gathering of information from a person to assess suitability for and/or supplement a public program, publication, or cultural performance; or
• survey procedures, interview procedures, or observations of public behavior that are conducted for Smithsonian internal purposes only, the results of which will not be published or presented in a public setting (e.g., at conferences or professional meetings).

7. I think my project is an "oral history" and doesn't need to be reviewed by the IRB. How can I be sure?

The hallmark of an oral history is that it stands alone as a unique perspective rather than an item of data that can be qualitatively analyzed to reach a general conclusion or explanation. If your intention is to interview people who have a unique perspective on a particular historical event or way of life, and you also intend to let the individuals' stories stand alone, with no further analysis, the research is most likely oral history and you do not need to have the research reviewed by the IRB. However, if the surveys or interviews are conducted with the intention of comparing, contrasting, or establishing commonalities between different segments or among members of the same segment, it is safe to say your research will be regular survey/interview procedures, because you will be generalizing the results and your research may need IRB review.

While it is welcome, I can't say this is the most elegant policy. It is hard to track a researcher's intentions and post-interview decisions, rather than his or her conduct of the interviews themselves. And wouldn't a journalist gathering reactions to an event be "comparing, contrasting, or establishing commonalities between different segments or among members of the same segment"?

By contrast, Princeton University distinguishes among types of interviews based on the likelihood that the people being interviewed will understand that they are speaking for the record.

Wednesday, July 28, 2010

Hospital IRB Forbids Interviews with Patients

The Yale Interdisciplinary Center for Bioethics offers an interview project as one of its Cases in Research Ethics, which describe choices faced by hospital IRBs in Connecticut.

Case 3 concerns a nurse who was also a divinity school student, and who gained approval from her hospital's IRB to interview fifteen "hospital patients who were suffering from a progressive and/or life-threatening disease such as cancer" about their religious beliefs and practices and the role of religion in their feelings about their illnesses. Patients agreed to participate after "a thorough review of the purpose of the study, the nature of the questions and the time involved for participation."

Eleven interviews went fine. Then the twelfth patient "became agitated and demanded the researcher leave immediately. The researcher spoke with the hospital nurses and was informed that this subject had 'fallen away' from her prior religious involvement and had wondered if her malignancy was divine retribution for her lapse."

The researcher dutifully reported this as an adverse event. The IRB then reconsidered the project and voted 10 to 1 to forbid the researcher from interviewing the three additional patients.

As described in the case study, the IRB recognized that, collectively, it knew little about this kind of research. "While this IRB was routinely accustomed to addressing the standard types of adverse medical events seen in oncology drug trials, it did not consider the possibly significant adverse psychological consequences of asking these same subjects about their religious and spiritual beliefs vis-à-vis their disease."

Yet the IRB's awareness of its ignorance did not prevent it from stopping the research project. The case study does not give the reason for this decision.

Monday, July 19, 2010

SACHRP to Discuss Internet Research

The July 21 meeting of the Secretary's Advisory Committee on Human Research Protections will sponsort a panel entitled "The Internet in Human Subjects Research," featuring Elizabeth Buchanan, Montana Miller, Michael Zimmer, and John Palfrey. It should be an interesting session. Unfortunately (and ironically), SACHRP has stopped posting transcripts of its meetings, so it's not clear how much of the content will be available to Internet researchers. I am told the meeting minutes will be posted at some point.

Friday, July 16, 2010

Librarian Urges Cooperation with IRBs

Maura Smale, information literacy librarian at the New York City College of Technology, suggests that librarians "embrace research involving human subjects" and seek IRB approval to do so.

[Maura A. Smale, "Demystifying the IRB: Human Subjects Research in Academic Libraries," portal: Libraries and the Academy 10 (July 2010): 309-321, DOI: 10.1353/pla.0.0114]

Smale notes that librarians can interact with IRBs in two ways. First, they can serve as IRB members or consultants, helping researchers and reviewers inform themselves about a proposal. Better library research, she suggests, could have prevented the 2001 death of Ellen Roche, a volunteer in a Johns Hopkins University asthma study. Smale could also have mentioned that better library research might prevent unreasonable IRB demands.

Second, librarians can act as researchers. Smale offers as examples two of her own studies of student and faculty users of her library. She found value in the approval process:

While it was a lengthy and labor-intensive process, obtaining IRB approval was an experience with real value, not simply a bureaucratic hurdle to overcome. Applying to the IRB required us to think deeply and critically about the goals for our research project while still in the early planning stages of the study; navigating the IRB approval process helped us make our research project both stronger and more relevant. Additionally, because we created all of our materials for the IRB application, we were ready to get started on our project as soon as the IRB approval came through, which saved us time at the beginning of our study. (317)

Smale does note that approval took five months, leading the skeptic to ask whether the same deep thinking could have been achieved in less time by another form of review.

Most of Smale's article is less of an argument than an introduction to IRBs for librarians new to the concept. (309). While it serves reasonably well for this purpose, the article unfortunately includes some factual errors that deserve correction:

  • "Any study involving human subjects that meets the definition of research in the Belmont Report requires review by the IRB." (312) In fact, the Belmont Report has no legal force, and it is the definition of research in 45 CFR 46 that determines the need for IRB review. That this definition does not match the definition in the Belmont Report suggests the imprecision of the work of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (More on this in Ethical Imperialism.)

  • "There are three levels of IRB review—exempt, expedited, and full. The IRB evaluates each research project and determines the level of review required; researchers may not make this determination on their own." (312) Exempt means exempt; it is not a level of IRB review. The regulations do not forbid researchers from making the exempt determination. And not even OHRP's recommendations insist that an IRB be involved in that determination.

  • "Certain types of studies automatically meet the criteria for exemption set forth in the Common Rule, including research on 'normal educational practices' such as curriculum design, instruction, and assessment. Research involving use of previously collected data is also usually exempt. In both cases the subjects' anonymity must be preserved." (313) The "normal educational practices" exemption, 45 CFR 46.101(b)(1), imposes no requirement of anonymity. The existing data exemption, 45 CFR 46.101(b)(4), does not require anonymity if the data are publicly available.

  • "Library research projects that include procedures in which the researcher is in direct contact with the subject will usually be required to undergo expedited review by the IRB." (315) Perhaps this is the practice at Smale's institution, but the regulations exempt this kind of research unless "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." [45 CFR 46.101(b)(2)]. This would not seem the case in the kind of research Smale proposes concerning "the use of space in the library" or "collaboration between the library and the campus writing center." (318)

  • "It is worth noting that the underlying principles used by the IRB to evaluate projects involve ethical treatment of subjects and preservation of privacy and are similar to the recommendations of many discipline-specific professional organizations, including the Oral History Association and the American Anthropological Association." (316). For over a decade, the Oral History Association has been fighting IRB requirements and insisting on the differences between the ethics of medical research and the ethics of oral history. Smale does cite the CITI Program in support of this assertion, but she fails to notice that the CITI Program offers no support for its statement.
  • {See comments for a correction.]

I am grateful to Smale for sharing her experience and for her kind citations to this blog and to my scholarship. But I fear that she has too readily accepted the claims of IRB administrators and training programs, leading her to advise librarians to tolerate months of delay when they should be demanding swift exemption.

Monday, July 12, 2010

Social Work Research Gets Few Exemptions

Stephanie Valutis and Deborah Rubin, both of Chatham University, sought "to explore the attitudes toward, knowledge about, and practices of IRBs across colleges and universities as reported by BSW [bachelor of social work] and MSW [master of social work] program directors as they pertain to faculty and student research."

[Stephanie Valutis and Deborah Rubin, "IRBs and Social Work: A Survey of Program Directors’ Knowledge and Attitudes," Journal of Social Work Education 46 (Spring/Summer 2010): 195-212, DOI 10.5175/JSWE.2010.200800059.]

They sent a survey to social work programs around the country, receiving 201 responses. They asked both factual questions about the composition and operations of the IRBs, and questions about the program directors' attitudes.

Among the key findings:

  • Familiarity improves attitudes. "Respondents who reported higher levels of knowledge about their IRBs had more positive responses to several attitude questions." (201)

  • IRBs grant few exemptions for three types of social work research: closed case files (28 percent of IRBs consider them exempt from review), satisfaction surveys (23 percent), and staff interviews (16 percent). The article does not go into depth about what each type of research entails, why an IRB might choose to require review, or whether social work program directors believe such research should be exempt. (205)

  • IRBs take a long time to approve research. While about half of program directors reported that the exempt and expedited reviews took less than two weeks, 17 percent reported exempt reviews taking one month or longer, and 11 percent reported expedited reviews taking that long. Thirty-seven percent reported full reviews taking one month or longer. And this question produced many "Do not know" responses, so the true level of delay may be much higher. (205)

  • Some students aren't allowed to do research with human subjects. Seven percent of program directors reported that "social work students were not permitted to do research that required IRB approval." (206)

I have my doubts about the usefulness of this survey, for two reasons. First, the survey posed factual questions (e.g., "How long does it take for initial review of an expedited submission?") to program directors who had no easy way of finding out this information. The authors rightly note that "the many 'don't know' responses" suggest a lack of transparency in IRB operations. But a better survey would have reached IRB administrators or chairs as well, allowing for some comparison. [For an example of this type of survey, see Robert E. Cleary, "The Impact of IRBs on Political Science Research,"IRB: Ethics and Human Research 9 (May-June 1987): 6-10.]

As for the attitudinal questions, they only allowed respondents to agree or disagree with positive statements about IRBs, e.g., "The IRB process helps students learn research ethics." I can't credit the conclusion that "We did not find the frustration with the process and scope of IRB reviews discussed in the broader social science literature," when the survey offered no opportunity to register such frustration. In his pioneering IRB survey of 1976, Bradford Gray understood the need to give respondents a chance to react to more critical statements, e.g., "The review procedure is an unwarranted intrusion on an investigator's autonomy--at least to some extent." [Bradford H. Gray, Robert A. Cooke, and Arnold S. Tannenbaum, "Research Involving Human Subjects," Science, new series, 201 (22 September 1978): 1094-1101] This survey should have done the same.

Indeed, while Valutis and Rubin cite a fair amount of IRB-related scholarship, it is not clear that they read any previous surveys of this sort before designing their own. Rather, they report concerns about the use of "a new survey instrument." (209)

The article also shows some confusion about federal regulations. It states that "Calling research 'exempt' by federal guidelines means that the research poses no risk to human subjects." While it is true that the 1981 Federal Register announcement of the exemptions describes them as exempting "broad categories of research which normally present little or no risk of harm to subjects," little risk is not the same as "no risk." And the regulations themselves exempt some research, e.g., interviews with public officials, regardless of risk. Later, the article claims that "an example of criteria for exemption by federal guidelines is research that does not pose more than minimal risk to human subjects." Actually, that's the criterion for expedited review, not exemption. Finally, the article claims that "Federal regulations require that IRBs make IRB membership available by name, role on the board, and earned degrees, but this information may not be widely disseminated." Indeed, that information is included on federal assurances, but those assurances are rarely made public.

Valutis and Rubin have raised important questions about how IRB oversight affects the education of social work students. But complete answers will require further research.

Friday, July 2, 2010

Librarians Ponder IRB Resolution

On June 29, at the American Library Association's Annual Conference, Melora Ranney Norman proposed a "Resolution on Institutional Review Boards and Intellectual Freedom."

Norman, a former chair of the ALA's Intellectual Freedom Round Table, noted that

Despite the fact that walking down the street is more dangerous than any conversation could ever be, on some college and university campuses, assertions of liability or vague, unproven risk are allowed to trump any actual proof of risk or danger, to the detriment of the preservation of knowledge and the human record.

Libraries are all about preserving and providing access to the human record with all its pimples, bumps, and bruises. Many of us have heard a quote attributed to Jo Godwin asserting that "A truly great library contains something in it to offend everyone." If the human record is not created to begin, how can we collect, preserve, and provide access to it?

She then called for the ALA to "[support] the American Historical Association in its position on oral history Institutional Review Board exemption, and [join] with the American Association of University Professors in recommending that 'research on autonomous adults whose methodology consists entirely in collecting data by surveys [or] conducting interviews . . . be exempt from the requirement of IRB review—straightforwardly exempt, with no provisos, and no requirement of IRB approval of the exemption.'"

The ALA Council voted to refer the resolution to the Intellectual Freedom Committee, the Library Research Roundtable, the Library History Roundtable, and the Committee on Professional Ethics. The American Historical Association hopes "they will reconsider the decision and support our efforts after further review."

Norman has also posted a Q & A, IRBs and Intellectual Freedom.

Hat tip: Rob Townsend.