OBA Review Process

OBA Review Process

1.  In making a determination whether a study presents characteristics warranting public RAC review and discussion, reviewers will examine the scientific rationale, scientific content, whether the preliminary in vitro and in vivo safety data were obtained in appropriate models and are sufficient, and whether questions related to relevant social and ethical issues have been resolved.

2.  Other factors that may warrant public review and discussion of a human gene transfer study by the RAC include:

·  A new vector/new gene delivery system

·  A new clinical application

·  A unique application of gene transfer

·  Other issues considered requiring further public discussion

3.  Initial RAC review will be completed within 15 working days of receipt of a complete submission.

4.  At the end of the 15-day review period, OBA will notify the Principal Investigators (PI) in writing about the results of the RAC's initial review.

5.  Two outcomes are possible:

·  The study does not present characteristics that warrant further review and discussion and is therefore exempt from public RAC review and discussion

·  The study presents characteristics that warrant public RAC review and discussion

6.  Completion of the RAC review process is defined as:

·  Receipt by the PIs of a letter from OBA indicating that the submission does not present characteristics that warrant public RAC review and discussion

·  Receipt by the PIs of a letter from OBA after public RAC review that summarizes the committee's key comments and recommendations (if any).

7.  If a human gene transfer protocol is submitted less than eight weeks before a scheduled RAC meeting and is subsequently recommended for public RAC review and discussion, the review of the protocol by the RAC will be deferred until the next scheduled RAC meeting.

8.  In the case of clinical study proposals that are reviewed publicly and lead to specific recommendations from the RAC with regard to the protocol, OBA will send written RAC recommendations to the PI and the IBC and the IRB within 10 working days of public RAC review and discussion.

9.  OBA will send a letter within 10 working days to the NIH Director, the PI, the sponsoring institution, and other Federal components, as appropriate, which summarizes the RAC recommendations.