IRBs Unfamiliar With Internet Research Ethics

Two experts in Internet research ethics find "that IRBs generally do not know what . . . protections apply strictly to online research, and such boards often ignore the complexities of such research and thereby risk harming subjects while also violating federal regulations, or, they apply such restrictive models that inhibit researchers from pursuing important online endeavors."

[Elizabeth A. Buchanan and Charles M. Ess, "Internet Research Ethics and the Institutional Review Board: Current Practices and Issues," ACM SIGCAS Computers and Society 39 (December 2009): 43-49.]

In 2006, the authors sent surveys to more than 700 US-based IRBs, of which they received responses from 334. The learned that

Few boards were aware of extant guidelines such as the Association of Internet Researchers Ethical Decision Making document, and 74% did not provide specific training around Internet research issues, and that less than half (42%) felt the Office [for] Human Research Protections or other regulatory documents were useful in Internet research reviews. These data suggest that ethics boards may not be fully informed when reviewing such research. We must consider on what bases are review boards making decisions around [Internet research ethics]? Of particular concern, our qualitative data provided indications that many boards were "unsure of who to ask," "we don't even know what questions to ask of the researcher," and, "we rely on the IT department to advise us on such IT related issues."

This is typical of an IRB system that rewards members and, especially, staffers who can recite the Common Rule from memory but imposes no real incentive to read the ethics literature of the disciplines over which they claim power.

See also: The Dormant Right to Expertise
and In Search of Expertise.

Research Ethics--Now with Academic Freedom?

Canada's Panel on Research Ethics has released a new (December 2009) draft of the Second Editon of the Tri-Council Policy Statement (TCPS). It is accepting comments until March 1. Below are mine.

To the Panel on Research Ethics,

Thank you for the opportunity to comment on the Revised Draft 2nd Edition of the TCPS (December 2009). As with my March 2009 comments on the first draft, I offer the following comments as an American, a historian, and as a scholar who has written extensively about the history of the regulation of social science, primarily in the United States but with attention to Canada and other nations.

Improvements

The revised draft makes some progress addressing the concerns of scholars in the social sciences and humanities. Particularly welcome is its new endorsement of academic freedom in chapter 1:

A fundamental premise of this Policy is that research can benefit human society. In order to maximize the benefits of research, researchers must have certain freedoms. These freedoms include freedom of inquiry and the right to disseminate the results of that inquiry, freedom to challenge conventional thought and freedom from institutional censorship. Collectively, these are generally referred to as "academic freedom."

Such a recognition of research as both a freedom and a right is notably absent in many comparable documents, including the famed Belmont Report.

I also appreciate the revision of the support for critical inquiry in Article 2.8, which states that

REBs should also be aware that some research, particularly in the social sciences, when conducting critical assessments of, for example, political or corporate institutions, may be legitimately critical and/or opposed to the welfare of those who are the focus of the research, and may cause them some harm. Such research should be carried out according to professional standards of the relevant discipline(s) or field(s) of research, but it should not be blocked through the use of risk-benefit analysis. In such cases, the balance of risks to those who are the focus of the research is mainly weighed against the potential benefit of new knowledge to society and the indirect benefits to the population to which the participant belongs.

This is an improvement over the 2008 language which, as I noted in my earlier comments, described "harm to reputation is an unavoidable risk of certain types of social science inquiry" rather than a desired outcome of much research.

Chapter 2's "Approach to REB Review" now suggests that "An assessment of [risk] may be based on the researcher’s past experience conducting such studies, or the review of existing publications that provide rates of the relevant harms in similar issues."

While this is a step in the right direction, I would suggest that stronger language--that risk-assessment must be based on empirical evidence--would better guard against REBs' documented tendency toward guesswork.

Finally, I m heartened by the requirement that "Institutions should support their researchers in maintaining promises of confidentiality." (Article 5.1) As Ted Palys and John Lowman of Simon Fraser University noted in their comments on the previous draft, Canadian institutions have a poor record in this regard.

New Concerns

I am concerned, however, that the revised draft weakens protections for social scientists, scholars in the humanities, and journalists in at least four ways.

First, the new draft appears to require IRB review for any photography or filming of people in public places. (Article 2.3, 10.4) This would seem to outlaw the standard practices of photojournalists, television crews, and documentary film crews.

Second, the new draft weakens the protection for critical inquiry by deleting the 2008 draft's provision (Article 2.3) that "Research ethics board review is usually not required for research involving public policy issues, the writing of modern history, or literary or artistic criticism."

Third, the new draft (Article 4.6) states that "Individuals or groups whose circumstances may make them especially convenient for researchers to recruit into research projects shall not be included in research solely on the basis of these convenient circumstances."

Taken literally, this would seem to preclude researchers from choosing to study the communities in which they reside as a means of avoiding travel. Such choice of topics has been a staple of social science since Mayhew ventured among the London poor.

My most serious concern about the new draft concerns the "Key Definitions and Principles" section of Chapter 5.

The 2008 draft stated that "Privacy concerns also vary with the sensitivity of the information and the extent to which access, use or disclosure may harm an individual by exposing them to embarrassment, stigma, discrimination or other detriments."

The 2009 draft replaces this statement with the following language:

Ethical concerns regarding privacy decrease as it becomes more difficult or impossible to associate information with a particular individual. These concerns also vary with the sensitivity of the information and the extent to which access, use or disclosure may harm an individual or group by exposing them to embarrassment, stigmatization, discrimination or other detriments. (My emphasis.)

This change is of enormous potential significance, for it suggests that REBs be allowed to block projects not because they threaten to harm any identifiable individuals, but because of the much vaguer concern that they may stigmatize whole groups.

Before implementing this change, the PRE may want to consider the U.S. experience. In 1972, the chancellor of the University of California, Berkeley, proposed an ethics policy that stated that

Even when research does not impinge directly on it, a group may be derogated or its reputation injured. Likewise, an institution, such as a church, a university, or a prison, must be guarded against derogation, for many people may be affiliated with, or employed by, the institution, and pejorative information about it would injure their reputations and self-esteem.

Scholars at Berkeley and elsewhere immediately realized that such a policy would prohibit social scientists from reporting their findings if those findings might offend anyone. After a national outcry, the policy was withdrawn. The PRE should likewise understand that forcing researchers to protect groups as well as individuals would violate the TCPS's broader commitments to academic freedom and critical inquiry.

[See Edward Shils, "Muting the Social Sciences at Berkeley," Minerva 11 (July 1973): 290-295.]

Old Concerns

Finally, please let me reiterate my concern that this draft of the TCPS, like its predecessors, fails to answer the biggest questions surrounding the ethical review of research in the social sciences and humanities: what ethical errors do researchers in these fields commonly commit, and what structures might reduce those errors? Without substantial empirical investigation of the problems posed by research and a wide range of solutions, PRE cannot claim that ethics-board review is either necessary or sufficient to ensure ethical research.

Thank you for consideration of these issues.

AAHRPP Urges Extra Care When Talking to Pregnant Women

As I mentioned in October, Marjorie Speers, president of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), has stated that her organization permits institutions it accredits to submit Federalwide Assurances (FWAs) that do not pledge to impose federal regulations on all research not directly funded by the federal government. In otherwords, institutions may "uncheck the box" without losing accreditation.

At the same time, Speers insisted that "if the boxes are unchecked, we hold the organization to have equivalent protections in place for all research." In my earlier post, I asked what an equivalent exemption might look like.

AAHRPP takes a stab at answering this in the Winter 2010 issue of AAHRPP Advance.

"To Check or Uncheck the FWA Boxes" (p. 6) notes that "The regulations that come into play when the FWA boxes are checked were written primarily with clinical research in mind. Thus, if an organization checks Subpart B of the FWA, for example, it will not be allowed to conduct SBER studies that involve pregnant women, because any study involving pregnant women is required to advance biomedical knowledge."

To give institutions more flexibility, the article claims,

AAHRPP has designed its standards to apply as much to protecting participants in SBER as they apply to protecting those in biomedical research. When organizations have unchecked the boxes, AAHRPP allows them to provide protections that are appropriate to the level and nature of the risk involved in the study and meaningful to the type of research. Under the accreditation standards, an organization could require that the results of a SBER study that includes pregnant women, for example, must contribute to general knowledge or knowledge that is beneficial to society, rather than to biomedical knowledge.

While any concession is welcome, this one is unimpressive. The regulation in question, 45 CFR 46.204 states that "pregnant women or fetuses may be involved in research" only if the research holds out the prospect of direct benefit to the pregnant women or fetus or if "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."

Changing "biomedical" to "general" here yields a requirement that researchers meet a higher standard if they want to interview, survey, or observe pregnant women than if they want to interview, survey, or observe non-pregnant women, prospective fathers, or other autonomous adults. Such a requirement violates the rights of both researchers and women.

While I appreciate AAHRPP's understanding that much of the Common Rule is inappropriate when applied to non-biomedical research, the example it has chosen suggests that as an organization, AAHRPP still lacks a basic grasp of some of the issues surrounding IRB review of social science research. What is needed is not mere tinkering with the Common Rule, but wholesale reconsideration of the rights and responsibilities of social scientists.

I thank Rob Townsend for bringing this to my attention.