Friday, November 20, 2009

Draft TCPS Allows Critical Inquiry of Aboriginal Governments

In 2006, Canadian historian Nancy Janovicek complained that ethics polices designed to protect Aboriginal peoples could allow Aboriginal governments to silence their critics by denying researchers permission to speak with them.

A new draft revised version of Chapter 9 of the Tri-Council Policy Statement addresses that problem. While it calls for researchers to secure the permission of Aboriginal governments for most types of research, it recognizes that this may be inappropriate when those governments themselves are being critically examined:

Article 9.7.   Research that critically examines the conduct of public institutions or persons in authority may do so ethically, notwithstanding the usual requirement, in research involving Aboriginal peoples, of engaging representative leaders.

As I have written before, the draft TCPS is inconsistent in its respect for critical inquiry, and ethics committees may not give sufficient weight to the disclaimers like this one. But such statements do give researchers a foothold in arguing for the freedom of inquiry.

Wednesday, November 18, 2009

Brown Pledges IRB Reform

The Brown Daily Herald reports "a series of reforms" at Brown University, intended to "streamline Institutional Review Board procedures." (Sydney Ember, "Reform in the Works for Research Review Board," 13 November 2009.)

The process started in 2007, when Brown faculty complained that IRB operations were inhibiting research, especially by undergraduates. Brown's Research Advisory Board convened a four-person, ad hoc subcommittee to investigate. That subcommittee released a draft report, "Undergraduate Research in the Social Sciences and the Institutional Review Board at Brown" in January 2009.

The January 2009 Report

The draft report found:

Many faculty members from the social sciences report some aspect of the IRB to be or to have been a burden, and a significant fraction feel that IRB practices are having or have had some dampening effect on the quality or availability of undergraduate research opportunities. There is the widely held belief that many social science projects typically consisting of interviews or surveys, have a low intrinsic risk. Most faculty members, however, do recognize the existence of some risk, depending on the nature of the activity, and the need for some type of oversight. Many faculty members believe that the formal and rigidly structured IRB process is not an optimal way to oversee and regulate undergraduate work, due to variable levels of organization, knowledge, and professionalism among the undergraduates, and the special time constraints associated with the undergraduate senior year.

The subcommittee offered three policy options:

A. "Brown adopts IRB review as the standard procedure for undergraduate theses and non-classroom projects dealing with human subjects."

B. "Continue the current system, but clarify several points and communicate the policy more explicitly to avoid faculty and student confusion."

C. "Adopt and communicate a policy in which non-federally-funded undergraduate work is not subject to IRB review, but rather to some other educational and oversight system tailored for undergraduates, to be defined."

It recommended Option B "as the best near-term solution," while keeping C open as a longer-term option.

Brown's Faculty Executive Committee (FEC) received the draft report at its January 2009 meeting. According to the minutes of that meeting, "The FEC was disappointed that the report did not address some of the larger issues. It appears that the definition of research is getting broader so that the IRB has their hand in every aspect of research." As far as I can tell, the report has still not been finalized.

Changes Since January 2009

According to the Daily Herald story, the university's Research Protections Office (RPO) claims that it has implemented many of the recommendations in the report, primarily by updating its website. Since many of the pages on that website are undated, it's hard to know how many have been changed since the release of the draft report in January.

Some of the report's recommendations do seem to have been implemented. For example, the report called for the prominent placement of the information that faculty advisors get to decide whether an undergraduate project needs IRB review. That information is now indeed prominently displayed.

In contrast, the report specifically objected to the assertion that "obvious examples of dissemination [and therefore generalizability] are publication in a scholarly journal, presentation at a professional conference, or placement of a report in a library." It recommended the deletion of the references to conferences and libraries, but as of today, they remain on the RPO website. Given that this was one of the most concrete, immediate proposals of the subcommittee, I suggest that the Daily Herald may have been premature in its announcement of reform.

Erroneous Assertions

Not mentioned in the faculty report are three significant misstatements about federal regulations in the RPO's document, Frequently Asked Questions.

1. "Federal Regulations are clear that it is not up to the investigator alone to determine if a project is exempt."

Federal regulations specify no such thing, as recently reiterated by OHRP.

2. "In certain situations, all involving no more than minimal risk, the IRB can waive the requirement that you obtain the participant's signature on the consent form."

In fact, 45 CFR 46.117(c)(1) also allows IRBs to waive the signature requirement when "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." This is true even when the risk is greater than minimal.

3. "As long as your research involves collecting data or information from or about living individuals, you need to have it reviewed by the IRB."

This would put reading a newspaper under the jurisdiction the IRB. Brown's RPO doesn't really believe this, but it hasn't been careful with its explanations.

Unfinished Business

It's great that a Brown faculty committee has taken a look at IRB operations, and that the administration has made some changes in response. But the report indeed failed to address some of the big issues at stake, and the administration has failed to implement some of the minor reforms suggested ten months ago. This case suggests the difficulty of restoring the principle of faculty governance when it comes to social science research.

Tuesday, November 10, 2009

Princeton IRB Delays Student Research

The Daily Princetonian reports a sociology major's difficulties getting IRB approval for her senior thesis on Brazilian immigrants' changing perceptions of gender roles.

"It's such a long process that it thwarts your field work efforts," [Christine] Vidmar said, noting that the review board does not meet to approve proposals during the summer. "I've been waiting since I got back to school. The first deadline that I could apply for was in October. It's November now, and I still can't officially go do my interviews."

. . .

Vidmar noted that a well-researched thesis may require up to a year of field work, adding that review board hurdles make it more challenging to complete sufficient research. "If you're a senior and you don't have a thesis chosen by the spring of junior year then you can't start field research until November or December of senior year, which is really late," she said. "You need to be in the field in order to know what questions you're going to ask, but in order to be in the field you need to have given the IRB your questions ahead of time."

As horror stories go, this one is mild. But consider the following:

  • While details are lacking, Vidmar's proposed research sounds to be exempt under federal regulations; she's just interviewing adults about their perceptions of gender.
  • Princeton demands full board review for "almost all proposals," offering expedited review only on "an exception basis."
  • The IRB does not meet for three and a half months in the summer and requires proposals to be submitted two weeks in advance of the meeting. Hence, a student who misses the late-May deadline must wait almost four months until late September for review.

Put these together, and it seems that Princeton has built a substantial impediment to students who would like to interact with people as a capstone to their undergraduate training but are unable to write detailed research protocols six months in advance.

This is not to say that undergraduates should be sent into the field without training or supervision. But review by at the department level, as suggested by Felice Levine and Paula Skedsvold; subcommittee review, as practiced at Macquarie University; or researcher certification as permitted at the University of Pennsylvania, might well achieve the same or better levels of oversight as full-board review without delaying the work and discouraging the curiosity of a student researcher.

Friday, November 6, 2009

Former IRB Chair Decries Inconsistency

Jim Vander Putten, Associate Professor of Higher Education at the University of Arkansas-Little Rock, kindly alerted me to his essay, "Wanted: Consistency in Social and Behavioral Science Institutional Review Board Practices," Teachers College Record, 14 September 2009.

Vander Putten, who chaired his university's IRB for six years, complains that IRBs fail to make decisions consistently. He accuses them of both under- and over-protection, and then offers two suggestions for reform.