Correspondence
The Office for Human Research Protections and the NIH
N Engl J Med 2003; 349:2076-2077November 20, 2003
- Article
To the Editor:
Steinbrook notes in his Perspective article (Aug. 14 issue)1 that in its review of the protocols for the trials of treatment for the acute respiratory distress syndrome (ARDS) conducted by the ARDS Network, the Office for Human Research Protections (OHRP) concluded that institutional review boards (IRBs) must use greater rigor in fulfilling their regulatory obligations.2 In multicenter trials, study subjects would be far better served by centralization of the responsibility for the protection of human subjects than by reliance on an inefficient and sometimes ineffective system in which multiple IRBs duplicate each other's efforts in performing this function. It is implausible to assume that each local IRB at an institution involved in a multicenter trial can amass the expertise and make the time commitment required to maximize the protection of human subjects in the way that a central IRB (or data and safety monitoring board) specifically constituted for this purpose can do. This is not to say that the local IRB should have no role; rather, its responsibility should relate to the conduct of the trial at its site, including consideration of the capabilities of the investigators and any potential conflicts. It is time for the OHRP to recognize that a better process is needed for the protection of human subjects in multicenter trials, rather than merely dictate that IRBs must carry out their regulatory obligations.
2 ReferencesRoy W. Beck, M.D., Ph.D.
Jaeb Center for Health Research, Tampa, FL 33647
rbeck@jaeb.org 1
Steinbrook R . Trial design and patient safety -- the debate continues. N Engl J Med 2003;349:629-630
Full Text | Web of Science | Medline2
Borror K, Carome MA. Human research subject protections under federalwide assurance (FWA) 3136, multiple project assurances (MPA) M-1331, M-1363, and M-1338 and the OHRP-approved assurances for all ARDS Network institutions. Letter to Ronald S. Newbower, Massachusetts General Hospital, Lee E. Limberd, Vanderbilt University, and Robert Kay, the Cleveland Clinic Foundation. Rockville, Md.: Office for Human Research Protections, July 3, 2003. (Accessed October 29, 2003, at http://ohrp.osophs.dhhs.gov/detrm_letrs/YR03/jul2003.htm.)
