Recent lawsuit suggests IRBs need a formal appeals process
Recent lawsuit suggests IRBs need a formal appeals process
Researcher sues Brown University
A recent lawsuit against Brown University in Providence, RI, is an important sign that it's time for research institutions to create formal appeals processes in the event of contested IRB review decisions.
When a university professor's social-behavioral study was grounded by an IRB's decline of some requested revisions, the investigator filed a lawsuit with some broad allegations against the university. Experts say this episode highlights why research institutions need to have a formal appeals process for IRB decisions.
"The Brown case will have fairly large implications," says Monika Markowitz, PhD, MA, RN, MSN, director of the Office of Research Compliance and Education in the Vice President's Office for Research at Virginia Commonwealth University in Richmond, VA.
Virginia Commonwealth University recently developed a formal appeals process, which Markowitz and co-author Elizabeth Ripley, MD, MS, described in a poster presented at the 2010 Advancing Ethical Research Conference by the Public Responsibility in Medicine & Research (PRIM&R), held Dec. 6-8, in San Diego, CA.
When Ripley and Markowitz worked on creating an appeals process they discovered that this was not on most IRBs' radar screens.
"We have not been able to find another institution that has a formal appeals process," says Ripley, who is a professor of medicine, Division of Nephrology at Virginia Commonwealth University.
The Brown case is proof that times are changing, and investigators might not accept a "no" decision from an IRB.
Jin Li, a Brown University associate professor of education, filed a lawsuit in the U.S. District Court for the District of Rhode Island on Feb. 25, 2011, alleging that Brown University has deprived her of an opportunity for review of the actions of its IRB.
Li's study involved educational testing of Chinese American children and interviews with their parents. It was funded through private foundations, and Li's IRB application stated that each family would receive $600 for three years of participation in the study, according to court documents. The IRB approved the study.
As the investigation was underway, Li observed that the lower-income subjects were spending more time completing surveys and interviews than the middle and upper-middle income families, so she decided the lower-income families should receive $600 for three years, but the other families should receive a rate of $300. She included the different payment rates in informed consent documents signed by subjects. When she submitted a request for modification of the study to the IRB, the IRB denied the request and said she could not use any data collected from families that were paid $300 unless she made arrangements to make additional payments to those families. The lawsuit states that she did not have the funds available to make retroactive payments.
"Should the IRB ruling stand, Plaintiff would be deprived of the fruits of years of research, and the educational community would be deprived of the results of the same," the court document says.
The lawsuit also alleges:
- "The limitations imposed by Brown's IRB on the Plaintiff's investigation has impeded the progress of the investigation and has interfered with Plaintiff's ability to complete her investigation in a timely, efficient, and effective manner," the court document says.
- Brown's IRB has interfered with the relationship between the Plaintiff and the foundation that awarded her the grant to conduct the investigation.
- The research is exempt from IRB review because it does not involve federal employees, federal funds, or regulation by any federal agency and it poses no threat to any human subject.
- Brown's IRB contains no minority members and fails to comply with the requirements of 45 CFR 46.107.
"One of the pieces we thought was important in having an appeals process was the idea of due process," Markowitz says. "Investigators could have a way to legitimately and fairly have their case heard."
Virginia Commonwealth University had its own event that led Markowitz and Ripley to come up with the idea of developing a formal appeals process.
"Basically it involved a study that had been approved, and it included recruitment from a clinic that was not associated with VCU," Ripley explains. "The IRB panel did not approve direct contact of individuals who would not have any reason to think we'd be contacting them, and this became a heated exchange with both the investigator and IRB panel firmly believing their position was correct."
There were many discussions and attempts to resolve the conflict, but the IRB panel did not think they should change their decision, she notes.
"At that point the university opted to bring in consultants," Ripley says. "The consultants' decision matched what the IRB panel said."
Also, the institution changed one of its policies about contacting people from outside the institution, and the case eventually was resolved, she adds.
The institution formed its appeal process two years ago, and the hope is that investigators will have confidence that there is an alternative pathway they can follow when a dispute seems intractable, Markowitz says.
Markowitz and Ripley wrote the appeal process written policy and procedure (WPP) and had it reviewed by IRB chairs, investigators, and other interested parties. The WPP was edited, and they included a flow chart, but a consensus on the wording quickly was met.
The result is a two-page WPP document that is available as a resource for VCU staff and other IRBs or research institutions on the VCU website at www.research.vcu.edu/irb/wpp/flash/VII-9.htm.
"Since we've put this appeals process in place it has not been utilized," Ripley says. "It's the kind of thing that you hope will not need to be utilized and that you can collegially deal with issues in the usual pathways."
VCU's IRB Leadership and Enhancement Committee was involved in developing the appeals process. This committee has members representing each IRB panel, investigators, a non-affiliate IRB member, and leaders of the IRB administration and education. The appeals committee is derived from this group. The appeals committee is comprised of at least six individuals, including IRB chairs and vice chairs, a nonaffiliated IRB member, a patient advocate, the director of the Office of Research Subject Protection, one person selected by the investigator, and it's chaired by the director of the Office of Research Compliance and Education.
When an appeals committee is called, it does not consist of IRB members affiliated with the IRB decision that's in dispute.
Also, if the appeals committee disagrees with the IRB's decision, then it will send the study back to a different IRB for review and approval per the appeals decision.
"Out of fairness for everyone, we don't want to bring it back to the original panel," Markowitz says.
A recent lawsuit against Brown University in Providence, RI, is an important sign that it's time for research institutions to create formal appeals processes in the event of contested IRB review decisions.Subscribe Now for Access
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