Creation of a Facility-Research-Focused Institutional Review Board (IRB) within the Military Health System (MHS)
Debajyoti Pati (PI) and Tom Harvey
U.S. Department of Defense, Medical Facilities Center of Expertise and Standardization, and U.S. Army Corps of Engineers
Military Health System, US Department of Defense
What was the aim
The specific aim of the study was to examine the following issues:
- Avenues available for speedy IRB approval of facility design studies within MHS, with minimal risk to human subjects. This is important since numerous MHS studies are carried out to inform ongoing facility projects.
- Whether instituting an IRB in MHS FIRM is the appropriate solution.
- Regulations guiding the creation of an IRB.
Why is it important
In efforts to conduct two research studies to validate a newly developed Research Framework for the Military Health System Facility Innovation and Research Model (MHS FIRM), two significant delays were experienced in securing approvals from relevant Institutional Review Boards (IRBs) for the proposed study sites. From this experience, the Project Development Team for the MHS FIRM began to discuss the merits of establishing an IRB within the MHS FIRM – one focused on the type of studies most likely conducted or supported by this entity. Such an IRB would still be required to meet all Federal regulatory requirements of 24 CFR 46 as do all other IRBs. However, it would be attuned to the nature of environmental design research which deals more with behavioral and human factor considerations that are affected by and hence should influence design decisions, and in most studies pose "minimal risk" to human subjects.
WHAT DID WE DO | HOW DID WE DO IT
A semi-structured telephone interview method was adopted for the study. In addition to an introduction, a list of questions was developed to guide the interviews. The introduction included description of the team's experience in two IRBs, where study proposals were submitted for review under the MHS contract. The introduction was intended to provide a foundation for the subsequent discussions. The questions included:
- How does the IRB in your institution deal with facility design and minimal risk study proposals?
- What avenues does the MHS FIRM have to ensure speedy approval of facility design studies?
- Do you feel that setting up an IRB within MHS is a viable option and an appropriate solution?
- What guidelines dictate structure and function of IRBs in the United States?
Seven telephone interviews were conducted between December 5th and 11th, 2013, and one additional interview was conducted by e-mail during the same time. Key observations, ideas, and recommendations originating from each interview were captured in meeting notes. The meeting notes were subsequently sent to the interviewee to check for accuracy and missing information. Responses on accuracy and missing information were incorporated in the analysis.
What did we find
The nature of research to be supported or conducted by the MHS FIRM is “environmental”, falling within the domains of the behavioral sciences. These are the areas most affected by facility design. Research in all these areas tends to rely extensively on tools of observation, interviews, and surveys. The use of such tools with human subjects generally pose minimal risk to human subjects. Data gathering to inform architectural programming or design regularly occurs without an IRB review. However, as our industry focuses more and more on research, these types of interactions with human subjects the facilities auger for a better definition of what constitutes research which may need IRB oversight.
If IRB review and approval is deemed necessary due to use of human subjects, every measure should be taken in the design of the research protocol to ensure an exempt or expedited approval process. Exempt designation by the IRB would likely be the faster trip through the IRB process. However, an Expedited Review can also yield a much faster approval. Working closely as needed with a representative from the subject IRB was noted as a beneficial measure.
There is clear precedent for setting up an IRB specifically for review of environmental, social and behavioral studies where personal and particularly clinical data is not typical gathered. There are many instances where multiple IRBS exist (academic and medical as one institution. With the right research study design, some sites, may offer alternatives to a review by their IRB. An example would be an Ethics Committee or similar type of special training and review committees with an oversight charge to protect human subjects. These entities may help avoid the IRB review entirely, but more often, their review will simply pave the way for faster processing by the IRB. Another approach is to propose the research as a quality improvement study which sometimes can circumvent an IRB review.
If the MHS FRIM elects to establish its own IRB, the composition and charge for this entity is defined by 45 CFR 46 (Code of Federal Regulations) with respect to representation of backgrounds and experience on the Board. Whether setting up a dedicated IRB, or choosing to work with external IRBs, the creation of a position of IRB Coordinator within its staff should be considered as an important resource to smoothing the IRB review experience