Practice-based research network studies and institutional review boards: Two new issues

Journal of the American Board of Family Medicine

Volumn 22, Issue 4, 2009, Pages 453-460

  Yawn, Barbara P ^a   Graham, Deborah G ^b   Bertram, Susan L ^a   Kurland, Marge J ^d   Dietrich, Allen J ^c   Wollan, Peter C ^a   Brandt, Elias C ^b   Huff, Jessica M ^d   Pace, Wilson D ^b  

^a OLMSTED MEDICAL CENTER   (United States)

^b AMERICAN ACADEMY OF FAMILY PHYSICIANS   (United States)

^c DARTMOUTH MEDICAL SCHOOL   (United States)

^d NONE

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONTROLLED STUDY; HEALTH CARE ORGANIZATION; HEALTH PRACTITIONER; HUMAN; MEDICAL LITERATURE; MEDICAL PRACTICE; MEDICAL RESEARCH; PUERPERAL DEPRESSION;

EFFICIENCY, ORGANIZATIONAL; ETHICS COMMITTEES, RESEARCH; FORMS AND RECORDS CONTROL; HEALTH SERVICES RESEARCH; HUMANS; INSERVICE TRAINING; PRIMARY HEALTH CARE; UNITED STATES;

EID: 67650886079     PISSN: 15572625     EISSN: 15587118     Source Type: Journal    
DOI: 10.3122/jabfm.2009.04.080168     Document Type: Article

References (26)

1. Wolf L, Croughan M, Lo B. The challenges of IRB review and human subjects protections in practice-based research. Med Care 2002;40:521-529
2. Graham D, Spano M, Stewart T, Staton E, Meers A, Pace W. Strategies for planning and launching PBRN research studies: a project of the American Academy of Family Physicians National Research Network (AAFP NRN). JABFM 2007;20:220-228 (Pubitemid 46597100)
3. Graham D, Pace W, Kappus J, et al. The challenges and successes of institutional review board review and approval of practice-based research network studies. In: Henriksen K, ed. Advances in patient safety: from research to implementation. Rockville (MD): Agency for Healthcare Research and Quality; 2005.
4. Carey T, Kinsinger L, Keyserling R, Harris R. Research in the community: recruiting and retaining practices. J Community Health 1996;21:315-327 (Pubitemid 26327923)
5. Graham D, Spano M, Manning B. The IRB challenge for practice-based research: strategies of the American Academy of Family Physicians National Research Network (AAFP NRN). JABFM 2007;20:181-187 (Pubitemid 46597096)
6. Burman WJ, Reves RR, Cohn DL, Schooley RT. Breaking the camel's back: multicenter clinical trials and local institutional review boards. Ann Intern Med 2001;134:152-157
7. Gold JL, Dewa CS. Institutional review boards and multisite studies in health services research: is there a better way? Health Serv Res 2005;40:291-307.
8. Green LA, Lowery JC, Kowalski CP, Wyszewianski L. Impact of institutional review board practice variation on observational health services research. Health Serv Res 2006;41:214-230
9. Dietrich AJ, O'Connor G, Keller A, et al. Will community physicians participate in rigorous studies of cancer control? The methodology and recruitment of a randomized trial of physician practices. Prog Clin Biol Res 1990;339:373-381
10. Wolf LE, Waldren JF, Lo B. Human subjects issues and IRB review in practice-based research. Ann Fam Med 2005;3(Suppl 11):S30-7. (Pubitemid 44609608)
11. Yawn B, Pace W, Wollan P. Concordance of EPDS and PHQ-9 to assess increased risk of depression among postpartum women. J Am Board Fam Med In press 2009.
12. National Institutes of Health. Required education in the protection of human research participants. June 5, 2000, revised August 25, 2000. Available at: http://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html. Accessed July 21, 2008.
13. US Department of Health and Human Services, Office for Human Research Protections. Institutional Review Board (IRB)/Independent Ethics Committee (IEC) authorization agreement. Available at: http://www.hhs.gov/ohrp/humansubjects/ assurance/iprotsup.rtf. Accessed September 16, 2004.
14. Levin RJ, Lasagna L. Demystifying central review boards: current options and future directions. IRB 2000;22:1-9.
15. Pace WD, Staton EW, Holcomb S. Practice-based research network studies in the age of HIPPA. Ann Fam Med 2005;3(Suppl 1):S38-S45. (Pubitemid 44609609)
16. Wolf LE, Lo B. Final report: IRB review and practice based research networks. Rockville (MD): Agency for Healthcare Quality and Research; 2001.
17. National Institutes of Health Office of Extramural Research. Protecting human research participants user login/registration. Available at: http://phrp.nihtraining.com/users/login.php.Accessed May 3, 2009.
18. US Department of Health and Human Services, Office for Human Research Protections. Belmont report. November 13, 2008. Available at: www.hhs. gov/ohrp/belmontArchive.html. Accessed May 3, 2009.
19. Code of Federal Regulations, Title 45 Public Welfare, Department of Health and Human Services, Part 46 - Protection of Human Subjects. Available at: www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm. Accessed May 15, 2009.
20. Office for Human Research Protections (OHRP), Assurances, Requirements for Federal Wide Assurance. Available at: www.hhs.gov/ohrp/assurances/ assurances-index.html. Accessed May 15, 2009.
21. Department of Health and Human Services, Office of Public Health and Science, Office for Human Research and Protections. Request for information and comments on the implementation of human subjects protection training and education programs. Federal Register 2008;73(127). Available at: http://edocket.access.gpo.gov/2008/E8-14917.htm. Accessed May 3, 2009.
22. US Department of Health & Human Services, Office of Extramural Research. Frequently asked questions for the requirement for education on the protection of human subjects. Updated September 10, 2008. Available at: http://grants.nih.gov/grants/policy/hs-educ-faq.htm. Accessed May 3, 2009.
23. PHS Policy on Instruction in the Responsible Conduct of Research. Available at: www.lasalle.edu/academ/irb/training.pdf. Accessed April 2, 2002.
24. Westfall JM, Mold J, Fagnan L. Practice-based research - " Blue Highways" on the NIH roadmap. JAMA 2007;297:403-406
25. Ryan CM, Swanson DP. Clinical research, innovative practice and IRB review: identifying and respecting boundaries. Am J Transplant 2007;7:748-750
26. National Institutes of Health, US Department of Health and Human Services. NIH roadmap for medical research. April 17, 2009. Available at: www.nihroadmap.nih.gov. Accessed May 3, 2009.