I recently obtained a copy of that report. While it has not previously been posted on the web, a University of Texas official assured me that a final policy report like this is public information under Texas law. So to make this important public document freely available, I have posted a copy on my website. (See link above.)
The report offers an exceptionally thorough and thoughtful consideration of how IRBs should work at great research universities. While some of its recommendations may be inapplicable to univerisities that are not part of larger systems or do not operate a medical campus, many of the task force's procedures and recommendations offer a model for others. I salute all those who were involved in the report's preparation.
In particular, I commend the following elements of the UT task force and its report.
The UT system carefully set up the task force in a way that would build respect for its findings. In particular, it managed to:
1. Represent Multiple Disciplines
UT included task force members "representing a variety of academic disciplines," among them SACRHP member Lisa Leiden. (3, 24) It also sought help from a range of consultants, including such "national experts" Tina Gunsalus; John Heldens, Moira Keene, Dan Nelson, Ivor Pritchard, and Marjorie Speers. (8)
2. Include Stakeholders
At each UT campus, the task force solicited comments from university officials, IRB chairs, investigators, and other interested parties. (8)
3. Allow Adequate Time
The UT task force completed its deliberations over the course of a year, from February 2008 to February 2009, then released its report in April 2009. A report with so broad a scope cannot be rushed.
Careful investigation led to thoughtful recommendations. The report suggests that the UT system:
1. Employ Faculty Expertise
The UT report recognizes that researchers are often expert in a particular area of human subjects research, and it recommends that faculty experts be identified to prepare standards for specific types of research (e.g., research involving subjects with impaired capacity, internet research) and to consult on individual projects as needed. (10)
2. Utilize Flexibility and Empirical Evidence
The report recommends that the university encourage IRB staff to provide "an efficient level of regulatory review compatible with adequate protection of human subjects," rather than the most stringent level of review. In particular, it suggests that IRB staff and members employ empirical evidence when determining risk, by consulting experts or scholarly literature. (11) The report also suggests that IRBs rely strongly on experts when determining the scientific soundness of a proposal. (14)
3. Uncheck the Box
The UT report notes that, according to Speers, fewer than 50 percent of AAHRP accredited institutions check all the box on their federal-wide assurances, and that it is "primarily the major research universities that are considering unchecking the box," thus maximizing their flexibility in handling projects not directly funded by a Common Rule agency. (12) (More on this in an upcoming post.)
4. Diversify the IRB
The UT report recommends that "Institutional Officials should ensure that the institution's disciplines are well represented in the IRB." (18)
5. Provide IRB Oversight
The UT report recommends that institutions "consider the implementation of a research ombudsperson to increase the opportunity for rapid resolution of issues involving human subjects research." (21) It also suggests an ongoing "IRB Advisory Group" to implement recommendations and assist with human subject policy issues. (23)
6. Define Key Terms
The UT Report includes definitions of key terms. Among other things, these definitions make clear that information-gathering interviews, service surveys, and classroom activities may not meet the definition of human subjects research, and that biography and oral history interviews do not meet that definition. (27) As I mentioned earlier, this recommendation has already led to the deregulation of oral history at the University of Texas at Austin.
7. Explore Alternatives
The report include an appendix on "alternative IRB models," based on the November 2006 "National Conference on Alternative IRB Models." While it is promising that the task force is willing to consider such alternatives, I would have liked it to pick up on that conference's call for "further exploration" of models for social and behavioral research. The University of Pennsylvania policy on research in the sociobehavioral sciences might be such a model.
Most importantly, the UT task force understood the IRB problem as something larger than an administrative challenge. While it explored ways to increase IRB "effectiveness, efficiency, and productivity," it went beyond such managerial concerns to probe big questions about "IRB authority, mission, and functions," the "unnecessary obstruction of research and lapses of effective human subject protection," and best practices from the available literature. (8)
The task force hoped to foster a "culture of conscience" rather than a "culture of compliance," and it understood that conscience cannot be dictated from above. (20) If other universities also seek to promote a culture of conscience, they must give a voice to all those involved with human subjects research.