Introduction: Partnering with rural primary care in practice-based research allows researchers access to a vital segment of the health care sector and a window into some of the most vulnerable, high-risk, high-need patient populations. The readiness for rural primary care to fully embrace research partnerships, however, is often tempered by ethical questions in conducting research in close-knit settings. This research provides practices with a refined decision support tool for evaluating the fit of research opportunities for their unique practices.
Materials and Methods: A two-phase effort was conducted to glean insight from currently available literature on ethical considerations in practice-based research and augment this information by consulting with state-based subject matter experts. Qualitative data were gathered through semi-structured interviews with key stakeholders at each of the West Virginia medical schools.
Results: The literature clearly acknowledges the need to ensure ethical standards in practice-based research – from the standpoints of the clinician and the researcher. The need to ensure comprehensive, culturally appropriate institutional review board approval is essential in developing and safeguarding participants. From discussions with subject matter experts, we find complementary guidance. However, tempering this sentiment is an overall caution of the unique role of rural primary care in representing and protecting the needs of the community. Five fundamental cautions regarding the conduct of practice-based research in rural settings are here identified, spanning the protection of individual patients, their communities, and clinicians.
Discussion: Findings from this study can support and empower primary care clinicians and practices, especially those in rural and close-knit communities, to address essential considerations in practice-based research. Results allow for framing of a refined decision support tool for primary care practices and clinicians to use in evaluating the fit of research opportunities for their unique practices, instilling a sense of shared power in the research process by better equipping primary care to proactively engage in substantive dialogue with research partners.
Conflict(s) of Interest
References with DOI
1. State Health Facts [Internet]. West Virginia: Providers and Service Use. 2015 [cited 2017 Jan 1]. p. 1. Available from: https://www.kff.org/state-category/providers-service-use/?state=WV
2. Rural Health Information Hub [Internet]. West Virginia. 2017 [cited 2017 Jan 1]. Available from: https://www.ruralhealthinfo.org/states/west-virginia
3. Federally Qualified Health Center (FQHC) and Rural Health Clinic (RHC) Services. Vol. 522, Bureau for Medical Services Provider Manual. 2015.
4. US Department of Health and Human Services B of PHC. 2016 Health Center Profile [Internet]. 2016 Health Center Profile. 2016. Available from: https://bphc.hrsa.gov/uds/datacenter.aspx?q=d
5. Mold JW, Peterson KA. Primary care practice-based research networks: working at the interface between research and quality improvement. Ann Fam Med [Internet]. 2005 [cited 2017 Nov 27];3 Suppl 1(Suppl 1):S12-20. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15928213
6. Lindbloom E, Ewigman B, Hickner J. Practice-based research networks: the laboratories of primary care research. Med Care. 2004;22(4 suppl):III-45-III-49. https://doi.org/10.1097/01.mlr.0000119397.65643.d4
7. Peterson KA, Lipman PD, Lange CJ, Cohen RA, Durako S. Supporting better science in primary care: a description of practice-based research networks (PBRNs) in 2011. J Am Board Fam Med [Internet]. 2012 Sep 1 [cited 2017 Nov 27];25(5):565–71. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22956691
8. Warner TD, Monaghan-Geernaert P, Battaglia J, Brems C, Johnson ME, Roberts LW. Ethical considerations in rural health care: a pilot study of clinicians in Alaska and New Mexico. Community Ment Health J [Internet]. 2005 Feb [cited 2018 Sep 20];41(1):21–33. Available from: http://www.ncbi.nlm.nih.gov/pubmed/15934173
9. Shore N, Brazauskas R, Drew E, Wong KA, Moy L, Baden AC, et al. Understanding community-based processes for research ethics review: a national study. Am J Public Health [Internet]. 2011 Dec 28 [cited 2017 Nov 18];101 Suppl(S1):S359-64. Available from: http://ajph.aphapublications.org/doi/10.2105/AJPH.2010.194340
10. West Virginia Alliance for Creative Health Solutions [Internet]. 2017 [cited 2017 Jan 1]. Available from: https://www.wvalliance.com/
11. Strauss A, Corbin J. Grounded theory methodology learning objectives. In: Strategies of qualitative inquiry [Internet]. Sage Publications; 1998 [cited 2018 Sep 23]. p. 158–83. Available from: https://www.mheducation.co.uk/openup/chapters/9780335244492.pdf
12. Hsieh H-F, Shannon SE. Three approaches to qualitative content analysis. Qual Health Res [Internet]. 2005 Nov [cited 2018 Jul 11];15(9):1277–88. Available from: http://www.ncbi.nlm.nih.gov/pubmed/16204405
13. Lemaire F. Patient care versus research: Does clinical research provide individual benefit to patients enrolled in trials? Curr Opin Crit Care. 2004;10(6):565. https://doi.org/10.1097/01.ccx.0000144764.96410.e1
14. Mikesell L, Bromley E, Khodyakov D. Ethical community-engaged research: a literature review. Am J Public Health [Internet]. 2013 Dec [cited 2017 Nov 18];103(12):e7–14. Available from: http://www.ncbi.nlm.nih.gov/pubmed/24134352
15. Michener L, Cook J, Ahmed S, Yonas M, Coyne-Beasley T, Aguilar-Gaxiola S. Aligning the goals of community-engaged research: why and how academic health centers can successfully engage with communities to improve health. Community-Engaged Res. 2012;87(3):285–91. https://doi.org/10.1097/acm.0b013e3182441680
16. Shore N, Drew E, Brazauskas R, Seifer SD. Relationships between community-based processes for Research Ethics Review and Institution-Based IRBs: A National Study. J Empir Res Hum Res Ethics [Internet]. 2011 Jun [cited 2017 Nov 18];6(2):13–21. Available from: http://journals.sagepub.com/doi/10.1525/jer.2011.6.2.13
17. Chen DT, Worrall BB. Practice-Based Clinical Research and Ethical Decision Making-Part I: Deciding whether to incorporate practice-based research into your clinical practice. Semin Neurol [Internet]. 2006 Feb 15 [cited 2017 Nov 17];26(01):131–9. Available from: http://www.thieme-connect.de/DOI/DOI?10.1055/s2006-933317
18. Chen DT, Worrall BB. Practice-Based Clinical Research and Ethical Decision Making-Part II: Deciding whether to host a particular research study in your practice. Semin Neurol [Internet]. 2006 Feb 15 [cited 2017 Nov 18];26(01):140–7. https://doi.org/10.1055/s-2006-933318
19. Dolor RJ, Campbell-Voytal K, Daly J, Nagykaldi ZJ, O’Beirne M, Sterling P, et al. Practice-based Research Network Research Good Practices (PRGPs): Summary of recommendations. Clin Transl Sci [Internet]. 2015 Dec 1;8(6):638–46. https://doi.org/10.1111/cts.12317
20. Largent E, Joffe S, Franklin M. Can research and care be ethically integrated? Hastings Center Report. 2011;41(4):37–46. https://doi.org/10.1002/j.1552-146x.2011.tb00123.x
21. Miller F. Research on medical records without informed consent. The Journal of Law, Medicine & Ethics. 2008;36(3):560. https://doi.org/10.1111/j.1748-720x.2008.304.x
22. Crowden A. Distinct rural ethics. Am J Bioeth. 2008;8(4):65–7. https://doi.org/10.1080/15265160802147207
Baus, Adam D.; Hendershot, Tracy L.; Cook Carter, Martha; and Boone, Laura K.
"Applying a research ethics review processes in rural practice-based research,"
Marshall Journal of Medicine:
4, Article 7.
Available at: https://mds.marshall.edu/mjm/vol4/iss4/7