October 16-17, 2018 - SACHRP Meeting

October 16, 2018 - October 17, 2018

6700B Rockledge Drive, Suite 1102
Bethesda, MD 20892

Webcasts:

Meeting Materials

Agenda

Day 1 - Tuesday, October 16, 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. - 9:15 a.m.

Draft Recommendations
Focus on Transition to the Revised Common Rule:  Issues Surrounding Informed Consent under HHS or FDA Jurisdiction

Mark Barnes, J.D.
SOH Co-chair
9:15 a.m. - 10:30 a.m

Panel Discussion

1. Albert J. Allen, M.D., Ph.D.
    Senior Medical Fellow, Medicines
    Development Unit
    Eli Lilly and Company

2. Parthena G. Psyllos, J.D.
    Senior Corporate Counsel,
    Clinical Development Legal,
    Pfizer Inc.

3. Megan Kasimatis Singleton, J.D.,
    MBE
    Assistant Dean, Office of Human
    Subjects Research
    John Hopkins University School
    of Medicine

4. Barbara E. Bierer, M.D.
    Professor of Medicine, Harvard
    Medical School Faculty Director,
    Multi-Regional Clinical Trials
    Center of Brigham and Women's
    Hospital and Harvard

5. Tim Chulindra, PharmD, CIPM,
    CIPP E/US, FIP
    Vice President Chief Privacy
    Officer
    PRA Health Sciences

6. Heather H. Pierce, J.D., M.P.H.
    Senior Director for Science Policy
    and Regulatory Counsel
    Association of American Medical
    Colleges

7. Philip Desjardins, J.D.
    Vice President, Global Regulatory
    Affairs Policy & Intelligence,
    Johnson &  Johnson

 Mark Barnes, J.D.,
Moderator
10:30 a.m. - 10:45 a.m. BREAK

 
10:45 a.m. - 11:45 p.m.

Panel Discussion

Mark Barnes, J.D.
Moderator
11:45 p.m. - 12:30 p.m.

SACHRP Discussion

Stephen Rosenfeld, M.D.
SACHRP Chair
12:30 p.m. - 1:15 p.m.

LUNCH

  
1:15 p.m. - 2:30 p.m.

"Key Information" in Informed Consent Interpretation and Application of Section 116 (a)(5)

 David Borasky, M.P.H.
SAS Co-chair
2:30 p.m. - 3:45 p.m. When is a Parent or Guardian "Reasonably Available" for Purposes of  §46.408 (b) Michele Russell-Einhorn, J.D.
SOH Co-chair
3:45 p.m - 4:30 p.m.

Draft Recommendations, Revised
Focus on Transition to the Revised Common Rule:  Issues Surrounding Informed Consent under HHS or FDA Jurisdiction

 Mark Barnes, J.D.
SOH Co-chair
4:30 p.m. - 4:45 p.m. Public Comment  
4:45 p.m. - 5:00 p.m. Wrap-up and Adjourn Stephen Rosenfeld, M.D.
SACHRP Chair

 

Day 2 - Wednesday, October 17, 2018

Time Agenda Item Speaker(s)
8:30 a.m. - 8:45 a.m. Opening Remarks Stephen Rosenfeld, M.D.
SACHRP Chair
 
8:45 a.m. - 10:300 a.m. Discussion and Recommendation:
Office of Inspector General Report, July 7, 2017:  "OHRP Generally Conducted Its Compliance Activities Independtly, But Changes Would Strengthen Its Independence"		 Stephen Rosenfeld, M.D.
SACHRP Chair
10:30 a.m. - 10:45 a.m. BREAK

 
10:45 a.m. - 12:15 p.m. Ethical Concerns Regarding Offer of Payment to Research Participants

David Borasky, M.P.H.
SAS Co-chair
12:15 p.m. - 1:15 p.m. LUNCH  
1:15 p.m. - 2:15 p.m. Interpreation of Revised Common Rule Exemptions  §46.101 (b)(1) and (2)

David Borasky, M.P.H.
SAS Co-chair
2:15 p.m. - 2:30 p.m. Public Comment  
2:30 p.m. - 2:45 p.m. Wrap-up and Adjourn Stephen Rosenfeld, M.D.
SACHRP Chair
Content created by Office for Human Research Protections (OHRP)
Content last reviewed