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

SACHRP July 30 – 31, 2007 Meeting Presentations

July 30, 2007 – Presentations/Charges

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

• SIIIDR - Summary of Discussions and Deliberations

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

• SAS – Recommendations Regarding the Provisions for Waiver or Alteration of the Informed Consent Requirements Under HHS Regulations 45 CFR 46, part 46.116(d)

July 31, 2007 – Presentations/Charges

• Briefing on Final Report of the National Conference on IRBs
  By: Bernard A. Schwetz, D.V.M., Ph.D., Director, OHRP

• Charge to the Panel on Informed Consent Issues
  

  Creating Informed Consent Documents That are Approachable, Readable, and Brief
  By: Howard B. Dickler, M.D.

  Informed Consent from the Subject's Perspective
  By: Gigi McMillan, Executive Director, We Can, Pediatric Brain Tumor Network

  Theoretical Issues and Concerns in the Informed Consent Process and Form
  By: Jonathan D. Moreno, Ph.D.

  The National Children's Study: A bold Approach to Informed Consent
  By: Alan R. Fleischman, M.D.

• Charge to the Panel on Diversity in Clinical Trials

  Diversity in Clinical Research: Ethical and Practical Considerations
  By: Giselle Corbie-Smith, M.D., MSc

  OVERVIEW: NIH Policy on the Recruitment and Retention of Women & Minorities as Subjects in Clinical Research
  By: Vivian W. Pinn, M.D.

  EDICT – Eliminating Disparities in Clinical Trials
  By: Barbara C. Pence, Ph.D.

  Racial/Ethic Diversity in Clinical Trials
  By: Leonard Sacks, M.D.

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