October 17-18, 2017 - SACHRP Meeting

October 17, 2017 - October 18, 2017

Time	Agenda Item	Speaker(s)
8:30 a.m. - 8:45 a.m.	Welcome	Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
8:45 a.m. - 9:15 a.m.	Introducing OHRP's Public Outreach Website About Research Participation	Yvonne Lau, M.D. OHRP
9:15 a.m. - 10:30 a.m	Subcommittee on Harmonization Topic: HIPAA and Exemption §104 (d) (4) (iii)	Mark Barnes, J.D. SOH Co-chair
10:30 a.m. - 10:45 a.m.	BREAK
10:45 a.m. - 12:15 p.m.	Subcommittee on Harmonization Topic: HIPAA and Exemption §104 (d) (4) (iii)	Mark Barnes, J.D. SOH Co-chair
12:15 p.m. - 1:15 p.m.	LUNCH
1:15 p.m. - 3:00 p.m.	Subpart A Subcommittee Topic: "Context" in Single IRB Review	Michele Russell-Einhorn, J.D. SAS Co-chair David Borasky, M.P.H. SAS Co-chair
3:00 p.m. - 4:30 p.m.	Subpart A Subcommitte Topic: Expedited Review List, §__ .110	Michele Russell-Einhorn, J.D. SAS Co-chair David Borasky, M.P.H. SAS Co-chair
4:30 p.m - 4:45 p.m.	Public Comment
4:45 p.m. - 5:00 p.m.	Wrap-up and Adjourn

Time	Agenda Item	Speaker(s)
8:30 a.m. - 8:45 a.m.	Opening Remarks	Stephen Rosenfeld, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D. Director, OHRP
8:45 a.m. - 10:15 a.m.	Recent FDA Experience with Review under 21 CFR 50.54; Lessons Learned	Robert "Skip" Nelson, M.D., Ph.D. Deputy Director and Senior Pediatric Ethicist Donna Snyder, M.D. Pediatric Ethicist / Team Lead Office of Pediatric Therapeutics, FDA
10:15 a.m. - 10:30 a.m.	BREAK
10:30 a.m. - 11:45 a.m.	Changes to NIH Certificate of Confidentiality	Taunton Paine, M.A. Science Policy Analyst Clinical and Healthcare Research Policy Division Office of Science Policy National Institutes of Health
11:45 a.m. - 12:45 p.m.	LUNCH
12:45 p.m. - 1:30 p.m.	Reserved. HIPAA and Exemption §104 (d)(4)(iii)
1:30 p.m. - 2:30 p.m.	Reserved, other
2:30 p.m. - 2:45 p.m.	Public Comment
2:45 p.m. - 3:00 p.m.	Wrap-up and Adjourn