Enabling Rapid and Sustainable Public Health Research During Disasters Summary of a Joint Workshop by the Institute of Medicine and the U.S. Department of Health and Human Services (2015) / Chapter Skim
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4 Addressing Institutional Review Board Barriers to Health Research Implementation
4 Addressing Institutional Review Board Barriers to Health Research Implementation
Pages 41-50
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From page 41... ...
THE PUBLIC HEALTH EMERGENCY RESEARCH REVIEW BOARD In 2011, the National Preparedness and Research Science Board (NPRSB) 1 at ASPR produced a report on science preparedness disaster research, discussing what would be needed to bring the ongoing efforts by NIH, CDC, ASPR, and others together in a more cohesive and organized way.2 Among its recommendations, the NPRSB called for the creation of a PHERRB, an IRB that would be able to rapidly convene to assess research protocols while maintaining very robust protections for human subjects.
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From page 42... ...
As host of the PHERRB, NIH provides staff, develops operating procedures, and maintains operations. The PHERRB is a central IRB and serves as the single IRB for human subjects protections review of HHS-conducted, -supported, or -regulated research studies addressing public health emergencies (e.g., natural disasters, biohazards including anthrax, chemical and radiological emergencies, oil spills, pandemic influenza or other infectious diseases, and other mass casualty events)
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From page 43... ...
STATE HEALTH DEPARTMENT IRB PERSPECTIVE Nell Allbritton, the IRB director for the Louisiana Department of Health and Hospitals, said her experience shows that a state agency has a set of concerns that are very different from those of researchers and universities. A key issue for a state health department is patient privacy.
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From page 44... ...
The health department learned of the study prior to publication and would not let its publication proceed until the IRB had reviewed the manuscript. (She clarified that while it is possible that the study was approved by the university IRB, the state IRB is the IRB of record because a state mental health services population was the study population.)
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From page 45... ...
While there is not a separate or unique application process for disaster protocol IRB review, there are extra questions that the IRB for the Louisiana Department of Health and Hospitals recommends researchers consider in developing their protocol and methodology (see Box 4-1)
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From page 46... ...
The research component of the department, unfortunately, does not take priority in times of crisis, but it is important not to discourage or prevent this kind of work from being done. Therefore, Allbritton said, the state IRB must employ additional measures to ensure proper protections for public health consumers participating in postdisaster research and safeguard the ability of the department to maintain the standard operating level during catastrophic events.
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From page 47... ...
She noted that the IRBs managed reviews of disaster research in many ways. In some cases, a unique committee or the IRB subcommittee was created to review the study prior to the IRB review, and it appeared to look at issues unrelated to human subjects research.
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From page 48... ...
The number of medical service providers, social service providers, agency staff, and other research teams in the field created confusion for the subjects. Taylor explained that this became a problem for one research team when they were mistaken for a different research team that had apparently made promises they did not fulfill.
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From page 49... ...
was suggested that the absence of coordination could lead to survey fatigue in affected populations, with many different investigators approaching the same people or populations for different study protocols. During the discussion, a participant suggested that the central IRB could maintain a list of all disaster-related protocols and make the list available to all researchers and the IRB reviewers.
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From page 50... ...
Taylor suggested looking at how the IRBs handle international collaborations for lessons that could be applied to working with investigators from outside the disasteraffected area (e.g., requiring documentation that researchers are collaborating with a particular local organization and have the IRB review from the local level)
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