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Institutional Review Board Questions

May 27, 2009

The following email arrived in our office recently:

Hello,
One of the questions on your grant application form asks if the project is IRB (Institutional Review Board) approved. I have a few questions about this:

    1) Our intended research project seeks to simply measure progress and outcome variables between EAP and office-based therapy. The ONLY manipulation/intrusion that is experienced by the clients is filling out measures when asked (done in between sessions) and the fact that they will be randomly assigned to either the EAP or the office-based therapy group. Other than this, therapy proceeds as usual. Having said this, the anticipated risk to participants is nominal. Considering this, would HHRF still require our project to be IRB approved? (e.g. does HHRF require all proposed projects to be IRB approved?)

    2) If HHRF does indeed require IRB approval, then I’m wondering about the timing of the approval. Several sections of the IRB initial review submission form require information about the sponsor of the research. If our project were to be approved, that sponsor would of course be HHRF. However, unless and until our research project is approved by HHRF, I cannot provide the IRB this information. As incomplete IRB forms are not accepted, this means that I cannot submit the forms, and therefore obtain approval, until after HHRF sponsorship is confirmed. What is procedure for this?

Our answers to this researcher’s questions, and to others who are wondering:

1) This group should have the research approved by the IRB, and this should be very straightforward since, as they’ve noted, there is minimal intervention. Any research that requires subjects to provide information – especially health information – that can be linked to them should be approved. Patient privacy rules and release of information are very sensitive areas, and the IRB should be aware of this research. If they don’t have a local IRB, Western IRB would likely approve this in about a month or less from time of submission.

2) Despite funding coming from HHRF, the group conducting the research is the Sponsor. Thus, this group could submit immediately. If, however, the research will not be performed without HHRF funding, we suggest they wait to submit to the IRB until they hear if they are awarded a grant. We would be satisfied, and give a good review score for the IRB portion, if they had identified an IRB that they plan to submit to and have the application prepared.

-KC Henry, HHRF ED

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