July 10-11, 2018 - SACHRP Meeting

July 10, 2018 - July 11, 2018

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. - 10:45 a.m.	"Key Information" in Informed Consent: Interpretation and Application of Section 116 (a)(5)	David Forster, J.D. SOH Co-chair
10:45 a.m. - 11:00 a.m	BREAK
11:00 a.m. - 12:00 p.m.	When is a Parent or Guardian "Reasonably Available" for Purposes of 46.408 (b)	Michele Russell-Einhorn, J.D. SAS Co-chair
12:00 p.m. - 12:15 p.m.	Update from Division of Education Development	Yvonne Lau, MBBS, MBHL, Ph.D. Director, Division of Education and Developement, OHRP
12:15 p.m. - 1:15 p.m.	LUNCH
1:15 p.m. - 2:15 p.m.	Payment for Subject Participation	David Borasky, M.P.H. SAS Co-chair
2:15 p.m. - 2:30 p.m.	Office of Inspector General Report, July 7, 2017: "OHRP Generally Conducted its Compliance Activities Independently, but Changes Would Strengthen its Independence"	Jerry Menikoff, M.D., J.D. Director, OHRP
2:30 p.m. - 3:30 p.m.	Discussion and Recommendation, Office of Inspector General Report	Stephen Rosenfeld, M.D. SACHRP Chair
3:30 p.m - 4:00 p.m.	Discussion of Possible Modification to SACHRP Recommendation for Revised Expedited Review List	David Borasky, M.P.H. SAS Co-chair
4:00 p.m. - 4:15 p.m.	Public Comment
4:15 p.m. - 4:30 p.m.	Wrap-up and Adjourn	Stephen Rosenfeld, M.D. SACHRP Chair

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.	Implementaton of Transition Provision to the Revised Common Rule (Presentation followed by discussion)	Lauren Hartsmith, J..D. OHRP
10:15 a.m. - 10:30 a.m.	BREAK
10:30 a.m. - 10:45 a.m.	Draft Guidance Relating to Burden-Reducing Provisions of the Revised Common Rule	Irene Stith-Coleman, Ph.D. Director, Division of Policy and Assurances, OHRP
10:45 a.m. - 12:30 p.m.	Discussion of Draft Guidance Relating to Burden-Reducing Provisions of the Revised Common Rule 1. Scholarly and Journalistic Activities 2. Elimination of Continuing Review 3. Elimination of Grant Review	David Forster, J.D. and Mark Barnes, J.D. SOH Co-chairs Michele Russell-Einhorn, J.D. and David Borasky, M.P.H. SAS Co-chairs
12:30 p.m. - 1:15 p.m.	LUNCH
1:15 p.m. - 3:00 p.m.	Update on EU General Data Protection Regulation	Mark Barnes, J.D. SOH Co-chair
3:00 p.m. - 3:15 p.m.	Public Comment
3:15 p.m. - 3:45 p.m.	Reserved
3:45 p.m. - 4:00 p.m.	Wrap-up and Adjourn	Stephen Rosenfeld, M.D. SACHRP Chair