Conference Theme - Thinking outside the box: Addressing the challenges of human subject research in 2008 Save the date: February 8, 2007

The Office for Human Research Protections (OHRP) in conjunction with the University of California Davis will be sponsoring a National Research Community Forum entitled, “Thinking Outside the Box: Addressing the Challenges of Human Subject Research in 2008,” on Friday, February 8, 2008, at the Doubletree Hotel Sacramento in Sacramento, California. Co-sponsors for this forum are the Northern California IRB Consortium Forum, the California State University Chancellor’s Office, California State University Long Beach, the San Jose State University, and the California State University San Marcos.

This forum will focus on specific applications and interpretations of the regulations entitled, “Protecting Human Subjects” for conducting biomedical and behavioral research that is funded by the Department of Health and Human Services. The program will showcase experts from academia and the federal and state governments who will address unique aspects for balancing the principles of The Belmont Report in conjunction with federal and state laws and ensuring that the protection of human subjects in clinical trials is maximized. Representatives from the OHRP, U.S. Food and Drug Administration, National Institutes of Health, Department of Education, and the Department of Defense will provide federal regulatory updates and clarification of key policy issues.

The forum will provide a Keynote Address, Plenary Session, Panel Discussions, and Breakout Sessions. The forum provides information for the novice researcher as well as the experienced IRB chair. Topics during this one day forum will offer a wide variety of learning opportunities for all those interested in the protection of human research subjects, such as:

  • Alternative Models of IRB Review
  • Data Security for SB13
  • Deception in Research
  • Human Subjects Protections: Regulations & OHRP Guidance
  • IRB Review in Clinical and Translational Awards (CTSAs)
  • Research vs. Program Evaluation
  • Research in Community Settings
  • Roles of IRB and Staff
  • Stem Cell Research
  • Student Research
  • Research in School Settings
  • Unanticipated Problems & Adverse Events

This forum should be of special interest to those persons currently serving or about to begin serving as a member of an IRB as well as institutional officials and administrators, principal investigators, legal counsel, research staff, patient advocates, research sponsors, public health officials, privacy officials, compliance officers, laypersons and sponsors and contract research professionals.

Make plans now to join us in sunny Sacramento - the beautiful capital of California!

Agenda, Registration Forms, and Additional Information will soon be available online.

Visit the OHRP website at: http://www.hhs.gov/ohrp/ or contact Connie Koog at UC Davis.