Another Case for the Review of IRB Review

Jennifer M. Purcell, Ph.D.
Education Specialist
Academy of Medical Educators
Touro University College of Medicine
E-mail:  jennifer.purcell@touro.edu

Which of the following statements are true?

A linguist seeking to study language development in a preliterate tribe was instructed by the Institutional Review Board (IRB) to have the subjects read and sign a consent form before participating in the study.

A political scientist who had bought a list of appropriate names for a survey of voting behavior was required by the IRB to get written informed consent from the subjects before mailing the survey.

A Caucasian PhD student, seeking to study career expectations in relation to ethnicity, was told by IRB that African American PhD students could not be interviewed because it might be traumatic for them to be interviewed by the student.

A campus IRB attempted to deny an MA student her diploma because she did not obtain IRB approval for calling newspaper executives to ask for copies of printed material generally available to the public.

A PhD student in education planned to send an innocuous, anonymous survey to senior faculty at 80 institutions nationwide. She received IRB approval from her own institution, provided she contacted all 80 institutions to ensure compliance.

Is the answer a, b, c, d, or e? How about none or all of the above? At this point, the answer is pure speculation.  Rumor or not, however, they appear to be circling the literature over and over again. Thomson and colleagues (2006) compiled the first four options, and I add the fifth. If these anecdotes are even partially true, it is no wonder the amount of literature concerning IRB processes seems to be on the rise.

Critics of IRB mission creep have claimed that the system is strained and that the broad definitions of research and increased bureaucracy are causing high-risk issues to slip through the cracks (Illinois White Paper, 2005). Others have reported a negative impact on their ability to do research. Even members of institutional review boards have conducted empirical research, reporting that the length of time for IRB approval leads researchers to “go solo” without, or prior to, obtaining IRB approval (Ashcraft & Krause, 2007). Examples come from fields such as anthropology journalism English composition, oral history, and education (Bradburd, 2006; Church, Shopes, & Blanchard, 2002; Gunsalus, 2002; Hemmings, 2006; Hunt, et. al, 2002; Lederman, 2006).

The IRB has even become the target of jokes, with a comment by Malcolm Feeley, President of the Law & Society Association, reportedly “bringing down the house” during his presidential address at the annual conference (Stark, 2007). Feeley (2007) stated, “On my campus, the Committee for the Protection of Human Subjects is known to graduate students as the committee for the Prevention of Research on Human Subjects.” Doctoral student advisors at institutions nationwide have likely heard similar comments from their students.

How did this all begin? As we well know, human subject protection came about in response to the horrific studies we read in IRB training – the Nuremberg trials, the Tuskegee syphilis study, and the Beecher report. These issues, of course, resulted in the Belmont Report and the Common Rule. But over time, IRB oversight has infiltrated all almost areas of research with each IRB having its own interpretation of the Common Rule. Hemmings (2006) and Stark (2007) offer accounts of this transition over time and the causes of mission creep are highlighted by the authors of the Illinois White Paper (2005).

This is not to say the role of IRBs is unimportant –few if any authors would take that stand - but when multiple stakeholders in the academic community, including members of IRBs, are suggesting the need for review, it stands to reason that a review of IRB processes might be warranted. In addition to the critiques and recommendations by individual authors, a number of prominent national organizations are currently taking steps to influence change.

Late last year, the Office for Human Research Protections solicited feedback on categories of research which would fall under expedited review. Because of the gap between formal federal regulations and their local implementation, The American Educational Research Association (AERA), with support of ten professional societies, commented on the review categories, but emphasized the need to focus on the categories for exempt research and the importance of an expedited review process (AERA, 2008).

I propose an additional recommendation whereby the IRB approval from the home institution serves as an umbrella document for the study, specifically those utilizing anonymous surveys, even if members of another institution are being solicited for participation. Allow me to elaborate.

Over 45,000 students graduated from research doctoral programs across the United States in 2006 (Hoffer, Hess, Welch, & Williams, 2007) and most of these students had to endure the IRB indoctrination. Nearly half (46.6%) of graduates earned degrees in the fields at the forefront of the current debate - education, humanities, social sciences, and communications. Navigating the IRB process is a great learning experience and, some might say, a right of passage, but the process in and of itself might be hindering the quality of projects in which doctoral students choose to engage. Why wouldn’t an energetic, optimistic doctoral student attempt to design a national research study that can impact their field by being able to generalize to groups far beyond the students at a single institution? There are several anecdotal reasons: time, money, and frustration. Extended IRB processes can add to all three. Although this story applies directly to educational research, it can very well cross disciplines if a student is interested in conducting a study using schools nationwide.

I will present some empirical data. The data were originally collected as part of my dissertation for tracking purposes only. I discussed the need to seek IRB approval with our local IRB officer after being encouraged to look at the data more formally. Based on how the data were stored, it was deemed a secondary data analysis and did not require IRB approval. That being said, here is the story.

I was interested in surveying senior faculty at a stratified random sample of 80 research institutions around the nation for my dissertation research. Participation was voluntary, responses were anonymous, the questions posed no risk to participants, and faculty could quit at any time. If any group understands the research process and can make an informed decision to participate, it would be a member of the academy, right?

The IRB process at my home institution was actually completed without any major issues, and I was pleased to only go through one revision before receiving approval. What was surprising to me, however, was that a condition of the approval required that I contact the IRB office at every institution in my sample to be sure I was in compliance with their policies. Too late to back out at that point, I embarked on the tedious, time consuming, and almost comical task of contacting each school. This process took an additional seven weeks to complete. Seven weeks may not appear to be much in the grand scheme of things, but it was one of several unexpected hurdles that did delay my graduation.

In general, responses from the IRB offices fell into five categories. The first came from the group of institutions who viewed their faculty as participants in a study who where capable of choosing whether or not to participate, rather than being “engaged” in the research. My hope was that most institutions would hold this view. The second group simply wanted a copy of my home institution’s IRB approval. The third group was comprised of schools asking to review the protocol, but accepted my home institution’s forms, whereas the fourth group (which, unfortunately, was removed from my sample) expected me to complete their IRB process using their specific forms. In fact, there was even a subset of the fourth group that required one of their faculty members serve as a member of my committee! The fifth and final group represented those IRB offices that did not respond after two contact attempts.

When I realized the potential impact this would have on my sample size, with only 34% falling within groups one and two, and the time that would be required to wait for responses from group three, I randomly selected an additional 42 institutions and began the same contact procedure. Table 1 lists the final number and percentage of institutions falling within each group. Of course, if an institution requested a modification, the change was made, but only after having the modification approved by my home IRB office. One school rejected my request and wished me luck with obtaining other approvals. Another school told me to contact the Provost’s Office, and yet another stated that I need only seek the approval of the departments. After two rounds of contacts, applications, and waiting for approvals, I finally settled on a total of 69 schools.

Table 1:  Responses of IRB Offices to Request for Data Collection at Institution (n = 122)

Note. * Two institutions did not render a decision prior to the collection of data and were removed from the sample. One institution did not approve the request. ** Three schools additionally required one of their faculty members to serve on the committee.

Even though less than 10% of institutions had to be deleted due to the extended process, I found one result to be quite surprising. Almost one-third of the IRB offices did not respond to the initial or second request and the reasons for this are unknown. They could have very well agreed with the first group, seeing no role for their IRB. On the other hand, they could have felt overburdened by a request from an external researcher when there were already an unwieldy number of internal applications to process. Or, even worse, they saw no value in responding to a doctoral student from another institution. I certainly hope that the latter is not the case, but given the current requirements of some local IRBs and the goal of conducting rigorous research at a national level, IRB offices across the nation must be willing and able to respond to researchers who are external to their organizations. This alone should encourage institutional IRBs to examine their local policies regarding external research.

Of course, not all IRBs contributed to the problem. Recall that 29% of the institutions said there was no further action that I needed to take? One IRB officer even questioned why I had contacted her. After I responded to her email, she picked up the phone, called me, and we shared some laughs and some tears.

The dissertation process that followed was relatively smooth, and I was thrilled to still have completed the process in just over a year and a half as a full-time student. But, it wasn’t until after graduation that I realized things were not over. Each institution that reviewed the documents to grant approval contacted me for a final report. I am just now trying to figure out if they will accept a copy of my home institution’s final report, or if I will need to fill out additional forms. So far, it doesn’t look good.

In wrapping up, I’d like to reiterate a few points. First, IRB processes are extremely important, but they require review at the institutional levels. Second, in addition to the recommendations of other authors, I would strongly encourage that the approval of the home institution IRB serve as an umbrella document for research falling in the exempt, or even expedited, categories even if members of another institution are being solicited for participation. This might encourage more doctoral students in education – and possibly other disciplines as well – to design studies that reach beyond the walls of their own institutions. Finally, although they were not a laughing matter to the researchers involved, the stories at the beginning of this commentary should be shared and remembered. Not as a warning or to scare doctoral students away from following through on the research they wish to conduct, but as the Association of Law & Society members demonstrated at their annual conference, a reminder to keep a good sense of humor.

References

American Educational Research Association (2008). AERA leads effort to comment on expedited review categories: Concerns expressed about institutional review board practices. Educational Researcher, 37(1), 53-55.

Ashcraft, M. H., & Krause, J. A. (2007). Social and behavioral researchers’ experiences with their IRBs. Ethics & Behavior, 17(1), 1-17.

Bradburd, D. (2006). Fuzzy boundaries and hard rules: Unfunded research and the IRB. American Ethnologist, 33(4), 492-498.

Church, J. T., Shopes, L., & Blanchard, M. A. (2002). Should all disciplines be subject to the common rule? Academe Online, 88(3). Retrieved March 13, 2008, from http://aaup.org/AAUP/pubsres/academe/2002/MJ.

Feeley, M. M. (2007). Legality, social research, and the challenges of institutional review boards. Law & Society Review, 41(4), 757-776.

Gunsalus, C. K. (2002). Rethinking protections for human subjects. The Chronicle of Higher Education, 49(12), B24.

Hemmings, A. (2006). Great ethical divides: Bridging the gap between institutional review boards and researchers. Educational Researcher, 35(4), 12-18.

Hoffer, T.B., M. Hess, V. Welch, Jr., and K. Williams. 2007. Doctorate Recipients from United States Universities:Summary Report 2006. Chicago: National Opinion Research Center. (The report gives the results of data collected in the Survey of Earned Doctorates, conducted for six federal agencies, NSF, NIH, USED, NEH, USDA, and NASA by NORC.)

Hunt, B., Yekel, C.A., Blanchard, M. A., Elliott, D., & Youm, K. H. (2002). Symposium: compliance or concern? Institutional review boards in journalism and mass communication education. Journalism and Mass Communication Educator, 57(2), 92-112.

Illinois White Paper (2005). Improving the system for protecting human subjects: Counteracting IRB “Mission Creep”. Retrieved March 3, 2008 from http://www.law.uiuc.edu/conferences/whitepaper/.

Lederman, R. (2006). The perils of working at home: IRB “mission creep” as context and content for an ethnography of disciplinary knowledges. American Ethnologist, 33(4), 482-491.

Stark, L. (2007). Victims in our own minds? IRBs in myth and practice. Law & Society Review, 41(4), 777-786.

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