Skip to page content  Home  Recombinant DNA  Genetics, Health, and Society  Dual Use Research  Clinical Research Policy
  About CRpac
  News and Events
  Issues and Activities
  Conferences and Meetings
  Key Policies and Resources
  Tools and Useful Links
  Trans-NIH Bioethics Committee (TNBC)
Conferences and Meetings
Past Events  
  National Conference on Alternative IRB Models: Optimizing Human Subjects Protections   
  November 20-21, 2006  
  This conference was sponsored by the Office for Human Research Protections (OHRP), the National Institutes of Health (NIH), the Association of American Medical Colleges (AAMC), the American Society of Clinical Oncology (ASCO), and the Department of Veterans Affairs (VA); it was cosponsored by the Association of American Universities (AAU), the Council on Government Relations (COGR), the Consortium of Social Science Associations (COSSA), the Department of Defense (DOD), the National Association of College and University Attorneys (NACUA), and Public Responsibility in Medicine and Research (PRIM&R). Its aim was to explore ways to enhance the protection of human subjects of research by examining the use of innovative IRB models as alternatives to local IRBs under appropriate circumstances.  
  Specific attention was given to:  
   Optimizing and facilitating institutions' access to appropriate ethical and scientific expertise for reviewing increasingly sophisticated projects, and  
   Optimizing institutions' resources to review such projects.  
  The changing nature of research involving human subjects, particularly as it relates to investigations involving multi-institutional trials, has created the need to be more innovative in selecting IRB models. The use of alternative IRB models to enhance the safety of research subjects and the efficiency of the research process is important for all types of research, including biomedical, social, behavioral science, and health services research.  
  A November 2005 workshop on alternatives to local IRBs, sponsored by OHRP, NIH, AAMC, and ASCO served as a precursor to this national conference. The 2005 workshop participants found that the greatest challenges for selecting an IRB model include liability, definition of shared authorities and responsibilities, costs and timeliness of various models, quality of review, and consideration of local context. The 2006 conference attendees discussed the extent to which these challenges are barriers to the use of alternative models of IRB review and suggest ways to minimize their impact to allow maximum flexibility in the selection of IRB models. A report of the conference will be available on this site in early in 2007.  
  Considering Usual Medical Care in Clinical Trial Design: Scientific and Ethical Issues  
  November 14-15, 2005  
  This meeting was held to discuss scientific and ethical principles pertaining to the use of "usual care" comparison arms in clinical trials. In particular, the meeting addressed situations in which it is unclear whether a usual care comparison arm should be used at all, as well as cases where there is a lack of consensus about exactly what interventions should be provided to a usual care comparison group. Participants discussed a series of case studies derived from actual clinical trials. Products of this meeting include a CD of key presentations and a proceedings report.  Under development are a DVD of the conference presentations and a "Points to Consider" document for the research community on ethical and scientific issues in considering usual medical care in the design of comparison arms in clinical trials. These will be posted to this Web site as soon as they are available. The full agenda can be viewed at the original conference Web site. Visit this site again in the future for more information about obtaining the products under development.  

Top of Page
Disclaimer | Privacy Policy | FOIA | Accessibility | Directions to OBA
HHS - Home Page Department of Health and Human Services   National Institutes of Health - Home Page National Institutes of Health   N I H - Office of Science Policy Office of Science Policy - government made easy
N I H - Office of Biotechnology Activities N I H - Office of Science Policy National Institutes of Health, DHHS