1 #9_Attach 9B_IRB Policy Survey

Attachment 9B:

Survey to Determine IRB Policy Regarding NCI Action Letters

OMB No. 0925-0046-09

Expiry Date:

Public reporting burden for this collection of information is estimated to average 5 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0046-09). Do not return the completed form to this address.

1.      Does your IRB review Action Letters for NCI Cooperative Group

Phase 2 or 3 treatment trials? Yes ___ No ___ 

2. Please identify your role:

______ IRB Administrator/Director

______ IRB Chair

3.      Does your IRB allow expedited review for Action Letters?

___ Always ____ Sometimes ____ Never

4.      If your IRB does not allow Action Letters to receive expedited review, why not? (answer all that apply)

____Was not aware OHRP allows it

            ____OHRP written statement confusing

            ____IRB office wants to process all Action Letters the same way

regardless of level of risk

            ____Individuals who conduct expedited review do not have sufficient

oncology expertise

            ____Other, explain: _________________

5. To the best of your knowledge, are patients at your institution not enrolled on trials due Action Letters resulting in temporary suspension? ___ Yes ___ No