Secretary's Advisory Committee on Human Research Protections (SACHRP)

SACHRP March 29 - 30, 2007 Meeting Presentations

March 29, 2007 - Presentations/Charges

• Subpart A Subcommittee (SAS) Update
  By: Felix Gyi, Pharm.D, M.B.A., CIP, and Daniel K. Nelson, M.S., CIP

• Understanding and Applying Minimal Risk for Subpart A
  By: David A. Strauss, M.D.

• Report of Subcommittee on Inclusion of Individuals with Impaired Decision- Making in Research (SIIIDR)
  By: David A. Strauss, M.D.

• Charge to the Panel on Issues Impacting Those with Impaired Decision-Making Capacity

  Human Experimentation and Informed Consent: The Legacy of Willowbrook
  By: David Rothman, Ph.D.

  Promoting Ethical Clinical Research Involving Critically Ill Patients in the United States
  By: John M. Luce, M.D.

  Research with Adults Lacking Decision-Making Capacity: Ethics and Policy
  By: Scott Kim, M.D., Ph.D.

  "Legally Authorized Representative" - 45 CFR part 46
  By: Laura Odwazny, Senior Attorney

March 30, 2007 - Presentations/Charges

• Charge on the Discussion of Conflict of Interest Among IRB Members

  Conflict of Interest in Research: How IRBs Address Their Own
  By: Leslie E. Wolf, J.D., M.P.H.

  Conflict of Interest of IRB Members and Consultants
  By: Marjorie A. Speers, Ph.D.

  SACHRP - UNMC Management of Conflict of Interest (COI) of IRB Members
  By: Ernest D. Prentice, Ph.D.

• Charge to the Panel on Investigator Responsibilities/Training and Certification

  Investigators' Responsibilities and Educational Requirements under 45 CFR part 46
  By: Ivor Pritchard, Ph.D.

  Academy of Pharmaceutical Physicians and Investigators (APPI)
  By: Ronald E. Keeney, M.D., FAAP, FFPM/RCP, CPI

  SoCRA - Society of Clinical Research Associates
  By: Erich Lukas, BS, MBA

  Secretary's Advisory Committee on Human Research Protections - Investigator Responsibilities Training and Certification
  By: Christine Pierre, RN

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