PMI-IRB_responses_to_Questions-.docx

Responses to Questions for Support Services NIH PMI

RFPNIHOD2016764J

1. Will the research involve sites (with investigators at the sites), or just one investigator and open to the community? Or will it vary by study and if so, what is the estimated number of trials with sites and how many sites per protocol on average? Answer: Multiple investigators, multiple sites and open to the community. There are no estimations regarding number of trials and sites. The PMI website provides pertinent background on current awardees and also on future expansion.

2. Are the panel members shown online the panel members anticipated under this contract? Answer: Yes

a. Can we add panel members to support it, especially for review via the expedited procedure or determinations of exemption or determinations of human vs. non-human research? Answer: Only NIH will add panel members.

b. Can we assign a chair from our organization or is the chair pre-determined? Answer: No, the Chair is already assigned.

c. If these are the panel members, have they agreed to an assessment of their understanding of their regulatory obligations (e.g. the regulatory criteria for approval) and to further training on a set of SOPs with which that they’re not yet familiar? Answer: Yes, we had planned to address training and SOPs as soon as we have a contract on board.

3. Does the NIH anticipate that the IRB will convene for all research, even research that does not require convened review, such as minimal-risk studies? Answer: For the moment yes. We have been conducting teleconferences and email exchange for review. We only anticipate meeting in person twice year.

4. Does the NIH anticipate that the IRB would be accredited by AAHRPP as a separate entity, or could it be accredited under the umbrella of a currently-accredited organization? Answer: Accredited under the umbrella of a currently-accredited organization.

5. The RFP references processes such as votes to approve minutes and chair signatures on approval documents. There are no regulatory or AAHRPP requirements for these. Similarly, the RFP mentions an established minutes template, which are presumably part of set of SOPs and policies that have not been approved by AAHRPP. The RFP also references review and advice related to extant SOPs and policies for the PMI IRB, and the development of new SOPs. Is the NIH wedded to the improvement of existing SOPs, to the development of SOPs de novo, or can the PMI IRB simply adopt a set of policies, processes, worksheets, checklists, etc, which have already passed muster with AAHRPP for many IRBs. Answer: We are open to adopting a set of policies, processes, worksheets, and checklists etc which have already passed muster.

6. The RFP suggests that the budget will be based strictly on hourly work performed. Is this correct or are there alternatives? Answer: There are alternatives. For example, we are now reimbursing the IRB Chair at a flat monthly rate.

7. Is NIH wedded to their file-sharing site, or can an alternative IT system be deployed? Answer: We are open to alternative.

8. Does the phrase “payments to participants” refer to panel members or study subjects? Answer: IRB members.

9. Regarding section 5A and 5B, it appears that the expectation is to have convened meetings with public access, similar to a FACA committee like SACHRP. Is this the intent? Answer: No this isn’t the intent. This is an error.

10. Past Performance states “the offeror must have experience with the NIH Office of the Director” this is an error and is not a requirement. Offeror’s must however demonstrate some prior experience performing the work outlined in the SOW.