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.

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.

AAHRPP Retreats from "Objective Data"

In July I posted my comments on AAHRPP's Proposed Revised Standards. At the time, I applauded Element I.5.B for insisting that "based on objective data, the Organization identifies strengths and weaknesses of the Human Research Protection Program, makes improvements, when necessary, and monitors the effectiveness of the improvements."

How disappointing, then, to find that the Final Revised Accreditation Standards omit the phrase about objective data. Are we to infer that AAHRPP considers objective data too difficult a standard, and wants institutions to base their programs on subjective impressions? Of course, most of the IRB regime is based on such guesswork, but I had thought that AAHRPP seeks to raise the level of IRB review.

AAHRPP Policy on FWAs Remains Blurry

Back in July, I reported on the AAHRPP's ambiguous position on whether the institutions it accredits may "uncheck the box" on their federalwide assurances.

AAHRPP's new Final Revised Accreditation Standards fail to resolve this ambiguity. They require that an accredited organization apply "its HRPP [Human Research Protection Program] to all research regardless of funding source, type of research, or place of conduct of the research," but do not state not whether that HRPP must track federal regulations in all cases.

Interviewed for the October 2009 Report on Research Compliance, AAHRPP President Marjorie Speers had this to say:

We believe an organization must protect participants in all of the human research it conducts, whether or not it receives federal funding . . . As an accrediting organization, we don't have an opinion on whether or not an institution should 'check the box,' on their FWAs to OHRP. If an institution 'checks the box,' then we hold the institution to follow the regulations to all research to which 'the box' applies. If the boxes are unchecked, we hold the organization to have equivalent protections in place for all research.

This does little to clarify matters. What are "equivalent protections" to those specified in federal regulations? Were AAHRPP site visitors correct to tell the University of California "that in order for a human research protection program to be accredited, it must apply the Common Rule and its subparts to all human research at the institution, irrespective of funding"? Or can a university add new categories for exemption and expedited review, as advocated by Lisa Leiden, and consider those equivalent to the federal categories?

Unchecking the box is one of the leading proposed remedies for IRB overreach. It is a pity that AAHRPP has missed this opportunity to address this movement more directly.

OHRP Grudgingly Okays Self-Exemption

In his May 14 speech, "The Legal Assault on the Common Rule," OHRP director Jerry Menikoff pledged that his office would issue new guidance on the Common Rule exemptions. While OHRP would still recommend that investigators not be empowered to decide for themselves whether their research is exempt, it would also emphasize that "it's just a recommendation. You don't have to follow it."

Five months later, OHRP has kept that promise, issuing a new document entitled FAQs: Exempt Research Determination. While the new guidance continues to recommend that "because of the potential for conflict of interest, investigators not be given the authority to make an independent determination," it makes clear that this is not a regulatory requirement. It even goes further, offering a somewhat detailed scenario that would satisfy regulatory requirements:

For example, an institution might craft a checklist for certain exemption categories, with questions that are easily answered "yes" or "no" by an investigator, with certain answers leading to a clear conclusion that the study is exempt. The institution might allow a researcher to immediately begin a study after having completed such a checklist and filed it, together with accompanying documents, with an appropriate institutional office, without waiting for or requiring any prior review of that filing. Similarly, a web-based form might be created that served the same purpose, allowing the researcher to begin the research immediately after submitting the required information using the web form. In both instances, the key issue would be whether these procedures lead to correct determinations that studies are exempt.

While this is certainly a step in the right direction, it leaves unanswered the question of why OHRP still deprecates such a system of "independent determination." In particular, the new guidance claims that "an institutional policy that allowed investigators to make their own exemption determinations, without additional protections, would likely risk inaccurate determinations." What is the basis of this claim? Has anyone done a study showing that investigators make poor determinations? What does it even mean to make an inaccurate determination, when federal officials themselves appear unable to apply the exemptions to hypothetical projects?

The truth is that OPRR's 1995 guidance was less a response to any misapplication of the exemptions than part of a larger effort to look busy amid national concern about human radiation experiments conducted decades before OPRR's creation. Rather than reconsidering its panicked advice from that period, OHRP has merely acknowledged that its recommendation has no basis in the regulations.

Note: As of this posting (18 October 2009), the bottom of the page with the new guidance reads "Last revised: April 20, 2009." An OHRP representative tells me this is an error, and that the new guidance was in fact posted on 14 October 2009.

Oral History Association Considers Guideline Revisions

At its annual meeting next week, members of the Oral History Association will vote on a set of General Principles for Oral History and Best Practices for Oral History.

The most striking feature of the new guidelines is that they avoid the confusing format of the existing Evaluation Guidelines, which pose dozens of questions without offering the proper answers or explaining whether answers might vary by project. Instead, the new guidelines present clear, declarative statements about how best to conduct oral history.

A more substantive change concerns harm. The existing guidelines state that "interviewers should guard against possible exploitation of interviewees and be sensitive to the ways in which their interviews might be used," and they suggest that interviewers must endeavor "to prevent any exploitation of or harm to interviewees." While the new guidelines offer many specific protections to narrators, they eliminate this vague language of exploitation and harm. And they caution that interviewers cannot guarantee control over the interpretation and presentation of interviews.

More generally, while the guidelines reflect historians' concerns with informed consent, they show the irrelevance to historical research of the biomedical concerns of risk/benefit analysis and equitable selection of subjects. There is more to research ethics than what is contained in the Belmont Report.

Internet Survey Sparks Outrage

Two newly PhD'd "cognitive neuroscientists"--Ogi Ogas and Sai Gaddam--got a book contract (rumored to be quite lucrative) with a popular press to write a book called "Rule 34: What Netporn Teaches Us About The Brain."

As part of their work, they launched an online survey aimed at authors of sexually explicit, online fan fiction. Many people who read the survey found it to be poorly designed and offensive, and anger grew as fan authors came to fear that the book would present erroneous information about their community.

The study was not IRB approved. Because the researchers had graduated from Boston University by the time they launched the survey, BU's IRB has disclaimed any authority over the matter, though it may have asked the researchers to stop using presenting themselves as being affiliated with the university. While some of the commentary on the event has included discussions about what the IRB might have done had it been presented the protocol, we can only speculate about whether IRB review would have changed the project for better, worse, or not at all.

Moreover, the chief concern of critics seems not to be that individual survey respondents would be harmed, but that their community as a whole would be harmed by a mass-market book written by inept, ignorant authors. Since the National Commission, policy makers have generally agreed that IRBs should not try to defend whole communities against mischaracterization by scholars.

Still, readers of this blog may be interested in a case where researchers' lack of preparation irreparably alienated the very people whom they wished to study.

For a good introduction, see Alison Macleod's human element blog. Many links follow.

Survey Seeks Ethnographers' Experiences with Ethics Oversight

Lisa Wynn of Macquarie University has posted an online survey asking for ethnographers' "subjective experience of ethics oversight – their memories of when and how they first became aware of ethics oversight, what they think and feel about it, whether and how they comply with it, and whether they think it makes ethnographic research more ethical or not."

Since I will publish Wynn's findings in the special issue of the Journal of Policy History I am editing, I naturally hope that researchers embrace this opportunity to help us understand the evolving role of IRBs and other ethics oversight bodies in the social sciences.

Note that Wynn defines ethnography broadly to include "any discipline that uses ethnographic research methods, including, but not limited to, anthropology, sociology, political science, history, geography, linguistics, Indigenous studies and area studies."

Psychologist Blasts "Taxonomic Chaos"

John J. Furedy, Emeritus Professor of Psychology, University of Toronto, has posted, "Implications for Australian Research of the Taxonomic Chaos in the Canadian Bioethics Industry: Après Moi le Deluge," originally presented at a June 2009 ethics conference in Australia. Though Furedy's expertise is in experimental psychology--a field outside the scope of this blog--his paper is relevant to the social sciences and humanities as well.

Furedy, who himself served for decades on ethics committees, argues that Canadian research ethics boards worked pretty well until the early 1990s. But since then bioethicists "have created taxonomic chaos by conflating such distinctions as the distinction between ethical and epistemological issues, or the differences among medical drug evaluation studies, psychological experiments, and sociological surveys."

He offers three specific complaints:

1. "REBs have taken it upon themselves to judge not only whether the proposed research is ethical, but also whether it is scientifically valid. But research-design issues for a particular piece of research require a specific sort of epistemological expertise which most REB members do not possess."

2. "The Tri-Council committee has succeeded in persuading governments and universities to treat a sociological opinion survey and a drug evaluation study, as if they were all part of 'human subject research,' that can be evaluated by the same all-knowing REB, using criteria that may apply to medical treatment-evaluation studies, but that do not apply to most social science research."

3. Though the Tri-Council agreed to drop the term "code" (with its suggestion of mandatory rules), "it was made clear to REBs, that if a researcher did not follow the so-called "statement", the right to apply for funding would be denied, because the REB would refuse to accept the proposed research."

Furedy stresses that all of this is relatively new, but that new scholars may not understand that. He writes,

senior investigators are likely to be able get their research proposals through, even though they know, in their heart of hearts, the significance of distinctions such as the one between ethical and epistemological or research-design issues. But for younger researchers, and especially those who are currently students, the distinction between ethical and epistemological issues has been conflated, and so they lack a memory of how research used to be conducted. So researchers of the future are likely to succumb to the bioethics industry. They will, in the epistemological sense, be corrupted by these developments. Current senior researchers, then, who are in control to-day, are acting like France's Louis XV, who was said to have said "Après moi, le deluge."

As a historian, I applaud both the reference to the Bourbon monarchy and Furedy's emphasis on the need for historical consicousness. If younger researchers understand that scholars did not always operate under today's restrictive conditions, they are more likely to imagine alternatives.

UT Knoxville's IRB Joins "Collective Mobbing"

Over at Counterpunch, anthropologist David Price reports on the case of Janice Harper, an anthropologist recently dismissed from the University of Tennesee Knoxville.

According to Price, Harper's troubles began in 2007, when she reported sexual harassment by a colleague. Despite a unanimous vote from her college's tenure and promotion committee and strong outside letters of support, her associate dean opposed her bid for tenure. Worse still, she was accused of mental instability. As Price reports, "like a textbook discussion of collective mobbing behavior, the act of investigation brought more accusations," including student allegations that Harper planned to build a hydrogen bomb. This led to an FBI investigation, which found no criminal activity.

All of this would be bad enough, but then the IRB decided to make it worse. As Price explains,

Dr. Harper says that in early June, the University of Tennessee’s Institutional Review Board (IRB) revoked her standing research clearance on the grounds that the police and FBI investigations and the seizure of her research materials exposed her informants to risks. She was told that she "could not use my data until I had assurance from the FBI and university that I was no longer under surveillance." As these investigations continued, however, they found nothing to indicate that she had made threats or was somehow building a hydrogen bomb. Yet, Dr. Harper was caught in a classic double-bind. Although the FBI did not find that she had done anything wrong, she could not complete her work simply because this investigation had opened her private research records up to FBI scrutiny. This, of course, seriously imperiled her professional activity and development. Last fall, Dr. Harper learned that the faculty in her department voted to deny her tenure application.

Price suggests that the IRB's action was a major element in the collapse of Harper's career. He writes that "the loss of a scholar’s IRB clearance because of an FBI investigation that found no wrong doing ought to be an issue of central importance to such professional organizations, and I would hope that the AAUP, AAA and SFAA would recognize the need for them to weigh-in on this and other procedural aspects of her case. This is a case that impacts us all."

Price complains about the heavy hand of the "National Security State," and he titles his post "Trial by FBI Investigation." But in his account, the FBI was not Harper's biggest problem; it investigated a threat of nuclear terrorism and closed the case with reasonable efficiency. The IRB, by contrast, apparently offered no such resolution. Perhaps Price needs to worry less about the National Security State and more about the Human Subjects Protection State.

[Editor's Note: The Institutional Review Blog opposes letting anthropologists acquire thermonuclear weapons.]