Appendix B: Non-FAC Open Panel Model Guidelines

  1. Only OHRP screened applications which meet the requirements for review under the 4-07 process are forwarded for review by the panel of expert consultants.
  2. Relevant protocol and IRB documents are posted on the OHRP website for public review and a Federal Register notice is prepared that:
    1. Invites public review and comment on the proposed research; and
    2. Announces the date on which the panel of expert consultants will be convened and invites members of the public to attend.
  3.  Expert consultants selected from a standing pool of experts, supplemented with appropriate protocol specific experts, receive protocol materials and public comments for review.
  4. Experts new to the expert panel consultation review process receive an appropriate orientation by OHRP staff.
  5. A face-to-face meeting of the expert consultants is convened, with the public present for a portion of the meeting.
  6. All experts are given an opportunity to express their opinions, review all materials, and listen to public comments.
  7. After their convened meeting and consideration of public comments, each expert consultant writes an independent recommendation regarding the proposed research.
  8. The individual reports from the expert consultants are posted on the OHRP website.
  9. OHRP develops recommendations based upon all materials and forwards its recommendations and materials to the Secretary (or designee).
  10. The Secretary (or designee) approves or disapproves the request for HHS to support the research.
  11. OHRP notifies the referring institution in writing of the Secretary's (or designee's) decision.
  12. At the Secretary's (or designee's) discretion, the HHS decision, detailed rationale for the decision, and supporting materials are posted on the OHRP website.
  13. If the Secretary (or designee) approves the proposed research with stipulations, the investigator must modify the research proposal and submit it to the local referring IRB for review and approval.
  14. The IRB submits the approved revised protocol to OHRP for final concurrence.
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