Office for Human Research Protections (OHRP)

Requests for Public Comment on OHRP’s viewpoint on conflicting interests for National Cancer Institute (NCI) Pediatric Central IRB (PedCIRB) members

Background: Over the past several months, OHRP has engaged in an in-depth discussion with NCI staff, PedCIRB members and staff, FDA staff, and Children’s Oncology Group (COG) investigators, among others, regarding circumstances under which a PedCIRB member who is also a COG investigator would have a conflicting interest for a particular protocol undergoing review by the PedCIRB. The links below provide (a) a copy of an OHRP letter to NCI describing the evolution of OHRP’s viewpoint on this issue; and (b) an NCI position paper on this issue. OHRP is posting these materials in order to make all IRBs that review COG protocols aware of OHRP’s viewpoint on this topic and to invite comments from the public on this issue. Comments should be submitted by 12/15/05 to OHRP by email at ohrp@osophs.dhhs.gov. Please include the term "PedCIRB" in the subject field. Alternatively, comments may be submitted by mail to:

CAPT Michael Carome, M.D.,
Office for Human Research Protections
1101 Wootton Parkway
Suite 200
Rockville, MD 20852

August 31, 2005 OHRP letter to NCI describing OHRP’s viewpoint on conflicting interests of PedCIRB members [HTML | PDF]

July 27, 2005 NCI position paper on PedCIRB conflicts of interest [HTML | PDF]