March 24, 2015 - March 25, 2015
Webcasts:
Agenda
Day 1 - Tuesday, March 24, 2015
| Time | Agenda Item | Speaker(s) |
|---|---|---|
| 8:30 a.m. – 8:45 a.m. |
Welcome: Opening Remarks |
Jeffrey R. Botkin, M.D. Jerry Menikoff, M.D., J.D. |
| 8:45 a.m.- 9:00 a.m. | Subpart A Subcommittee (SAS) Overview | David Borasky, M.P.H. Michele Russell-Einhorn, J.D. |
| 9:00 a.m.- 10:15 a.m. | Introduction to Newborn Bloodspot Issues and Discussion of H.R. 1281 | Jeffrey R. Botkin, M.D. Associate Vice President for Research Integrity Professor of Medical Ethics and Pediatrics University of Utah Michelle Huckaby Lewis, M.D., J.D. Research Scholar Berman Institute of Bioethics Johns Hopkins University |
| 10:15 a.m. - 10:30 a.m. | Break | |
| 10:30 a.m. - 12:00 p.m. | SAS Recommendation: Newborn Bloodspot Issues and H.R. 1281 | David Borasky, M.P.H. Michele Russell-Einhorn, J.D. |
| 12:00 p.m.- 1:00 p.m. | Lunch | |
| 1:00 p.m.- 3:00 p.m. | SAS Recommendation: Draft NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research | David Borasky, M.P.H. Michele Russell-Einhorn, J.D. |
| 3:00 p.m. – 4:30 p.m. | Subcommittee on Harmonization (SOH) Overview; SOH Recommendation: Big Data and the Impact on Human Subjects Research | David Forster, J.D. Mark Barnes, J.D. |
| 4:30 p.m. – 4:45 p.m. | Public Comment | |
| 4:45 p.m.- 5:00 p.m. | Summary and Adjournment | Jeffrey R. Botkin, M.D. |
Day 2 - Wednesday, March 25, 2015
| Time | Agenda Item | Speaker(s) |
|---|---|---|
| 8:30 a.m. – 8:45 a.m. | Opening Remarks | Jeffrey Botkin, M.D. SACHRP Chair Jerry Menikoff, M.D., J.D., Director, OHRP |
| 8:45 a.m.- 10:45 a.m. | SOH Recommendation: Return of Research Results and Emergent CLIA and HIPAA Issues | Mark Barnes, J.D. David Forster, J.D. CMS, FDA and OCR Representatives |
| 10:45 a.m.- 11:00 a.m. | Break | |
| 11:00 a.m.- 12:30 a.m. | SOH Recommendation: FDA draft guidance, "General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products" | David Forster, J.D. |
| 12:30 p.m.- 1:30 p.m. | LUNCH | |
| 1:30 p.m.- 3:15 p.m. | SOH Recommendation: Return of Individual Research Results | David Forster, J.D. |
|
3:00 p.m.- 4:00 p.m. 3:00 p.m - 3:15 p.m Remarks 3:15 p.m.- 4:00 p.m. Discussion |
Draft FDA Guidance, “Use of Electronic Informed Consent in Clinical Investigations” |
Cheryl A. Grandinetti, Pharm.D.
|
| 4:00 p.m.- 4:15 p.m. | Public Comment | |
| 4:15 p.m.- 4:30 p.m. | Wrap-up Discussion and Adjourn | Jeffrey R. Botkin, M.D. |
