The Challenges of IRB Review and Human Subjects Protections in Practice-Based Research
Bibliographic Data
| ID | 14338409 |
|---|---|
| Authors | Leslie E Wolf (0000-0002-4660-8383, San Francisco AIDS Foundation, corresponding author), Mary Croughan, Mary S Croughan, Bernard Lo (0000-0001-6210-9667, corresponding author) |
| Year | 2002 |
| Volume | 40 |
| Issue | 6 |
| Pages | 521-529 |
| Publication date | 2002-06-01 |
| Open Access | No |
| Type | ARTICLE |
| Venue | Medical Care (JOURNAL) |
| Journal identifiers | ISSN: 0025-7079 • E-ISSN: 1537-1948 |
| Publisher | Ovid Technologies (Wolters Kluwer Health) (PUBLISHER) |
| DOI | 10.1097/00005650-200206000-00009 |
| PMID | 12021678 |
| OpenAlex | W2022093061 |
| Language | EN |
| Citations received | 5 |
| References cited | 7 |
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
Best practice · Clinical Practice · Engineering ethics · Family medicine · Human research · Institutional review board · Medical education · Political science · Psychiatry · Publication · Health Policy Implementation Science · Health Systems, Economic Evaluations, Quality of Life · Healthcare cost, quality, practices · Law · Medicine
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| Citations per year | 0.21 |
|---|---|
| Citation span | 2002 - 2016 (15) |
| Highly cited | No |