On Tuesday, the Subpart A Subcommittee (SAS) will present their recommendations regarding the revised Common Rule’s expedited review requirements. This will be followed by a discussion of the meaning of “context” when considering requirement for single IRB review. This will be followed by a discussion of SOH 3 recommendations on the revised Common Rule’s HIPAA exemption, section 104(d) (4) (iii), and a panel discussion with a representative of the Office for Civil Rights. The day will conclude with a presentation by OHRP staff on a new public outreach website,
On Wednesday, the meeting will begin with a presentation and discussion led by FDA staff on a recent FDA experience with IRB review under 21 CFR 50.54, and the lessons learned.