AKEN Lexi Hill: IRBs, Tribal Approvals, and Bears, Oh My!!

10 Mar 2014 9:00 AM | Anonymous
Over the last forty years, the federal government has issued and revised extensive regulations around the protection of human subjects involved in research; the need for such regulation was evident not just from the extreme abuses by Germany during the Nazi era, but also from abuses closer to home, such as the decision to study the progression of syphilis by withholding treatment from research subjects in Tuskeegee from the 1940s to the 1970s,and to study hepatitis by deliberately infecting children in the Willowbrook State School in New York in the 1950s and 60s. Key in that protection are Institutional Review Boards that review research plans for ethical challenges.  

While the regulations are directed at ‘research’ rather than ‘evaluation’, many of our studies as evaluators (especially those of us working in public health and post-secondary institutions) fall under the purview of one or more IRBs.  In addition, research may require one or more tribal approvals.  For example, if research is focused on Southcentral Foundation’s customer-owners (Alaska Native or American Indian people living in or near Anchorage), if recruitment occurs on the Alaska Native Medical Center campus or if Southcentral Foundation employees are engaged in the research, the researchers must obtain Southcentral Foundation approval; similarly, research in the Bethel area may require approval from the Yukon Kuskokwim Health Corporation.

Obtaining approvals, making all the required changes, and ensuring the final research protocol is the same across all the potentially different approvals can be time consuming and organizationally challenging.  However, the process isn’t just a bureaucratic exercise.  It can be series of valuable and useful reviews of your research plans by professionals who bring multiple different perspectives and make suggestions (and requirements) that improve your research design.

Hot tips:

Plan plenty of time.  A full board review by just one IRB can easily take two to four months to prepare and submit, and another month to make the required modifications and receive approval.  Projects that require multiple board and tribal reviews can take a year, even without significant delays or modifications, just because of the meeting schedules of different review levels.

Communicate, communicate, communicate!  The IRB administrators and sometimes the board members (when they have time) can be valuable resources to guide your efforts, to understand how the reviews take place, and to clarify required modifications, if there are any.

Be compulsively organized.  If your institution uses IRBNet (or a similar software package) to manage IRB submissions, it may have tools for tracking document revisions, as well as on-line instructions and forms that you’ll need for your submissions. You’ll also want your own copies of everything submitted, organized so that you can easily tell what’s been submitted, modified, or approved through the process.

Rad Resources:

For a quick overview of human subjects protection issues, see the AEA365 blog post by Judy Savageau on “The IRB Process in Human Subject Research” (http://aea365.org/blog/judy-savageau-on-the-irb-process-in-human-subject-research/)  

Everyone should read the Belmont Report sometime:http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html

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