title: The challenges of IRB review and human subjects protections in practice-based research.
abstract: Practice-based research raises unique challenges with respect to human subjects protections and institutional review board (IRB) review. In this paper, three challenges posed by practice-based research are analyzed: (1) IRB review for clinician investigators who are not affiliated with an institution that has an IRB; (2) multiple IRB review; and (3) required human subjects protection training of key personnel. Investigators should be proactive in addressing required IRB review in practice-based research. In particular, they need to ensure that appropriate IRB review is obtained for all performance sites and plan for review for unaffiliated investigators. Practice-based research investigators and professional societies should educate IRB members and policy makers and publish articles regarding how IRBs might best address human subjects concerns in practice-based research. Furthermore, practice-based research investigators and professional societies should work with IRBs and the Office for Human Research Protections to facilitate centralized or cooperative review of practice-based research. Finally, practice-based research investigators need to ensure that their clinician investigators receive appropriate training in human subjects protection. Practice-based research investigators and professional societies can facilitate this process by helping to define and implement the appropriate training for busy practice-based research clinicians and office staff.
authors.affiliation: Program in Medical Ethics, the Center for AIDS Prevention Studies, and the Division of General Internal Medicine, San Francisco, California 94143-0903, USA. lwolf@medicine.ucsf.edu
authors.forename: Leslie E
authors.initials: LE
authors.lastname: Wolf
authors.forename: Mary
authors.initials: M
authors.lastname: Croughan
authors.forename: Bernard
authors.initials: B
authors.lastname: Lo
mesh_terms: D004989:Ethics; D028744:Ethics Committees, Research; D006805:Human Experimentation / Q000331:legislation & jurisprudence*; D006801:Humans; D017712:Peer Review, Research / Q000379:methods*; D012106:Research / Q000191:economics / Q000193:education / Q000592:standards; D014481:United States