1,079
Views
20
CrossRef citations to date
0
Altmetric
Target Article

IRBs and the Protection-Inclusion Dilemma: Finding a Balance

ORCID Icon, , , & ORCID Icon

REFERENCES

  • Angell, E. L., A. Bryman, R. E. Ashcroft, and M. Dixon-Woods. 2008. An analysis of decision letters by research ethics committees: The ethics/scientific quality boundary examined. Quality & Safety in Health Care 17 (2):131–6. doi:10.1136/qshc.2007.022756.
  • Assembly, WMA General. 1996. WMA Declaration of Helsinki—Ethical principles for medical research involving human subjects. Somerset West, South Africa: World Medical Association.
  • Baily, M. A. 2008. Harming through protection? The New England Journal of Medicine 358 (8):768–9. doi:10.1056/NEJMp0800372.
  • Bayer, A., and W. Tadd. 2000. Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval: Descriptive study. BMJ (Clinical Research ed.) 321 (7267):992–3. doi:10.1136/bmj.321.7267.992.
  • Baylis, F., and C. Kaposky. 2010. Wanted: Inclusive guidelines for research involving pregnant women. Journal of Obstetrics and Gynaecology Canada: JOGC = Journal D'obstetrique et Gynecologie du Canada: JOGC 32 (5):473–6. doi:10.1016/S1701-2163(16)34502-9.
  • Beauchamp, T. L. 2008. The Belmont report. In The Oxford textbook of clinical research ethics, ed. Ezekiel J. Emanuel, 149–55. Oxford: Oxford University Press.
  • Beecher, H. K. 1966. Ethics and clinical research. The New England Journal of Medicine 274 (24):1354–60. doi:10.1056/NEJM196606162742405.
  • Berry, S. H., D. Khodyakov, D. M. Grant, A. Mendoza-Graf, E. Bromley, G. Karimi, A. Barbara, K. Levitan, and S. J. Liu. 2019. Profile of institutional review board characteristics prior to the 2019 implementation of the revised common rule. Newberry: RAND.
  • Bierer, B. E., S. A. White, L. G. Meloney, H. R. Ahmed, D. H. Strauss, and L. T. Clark. 2020. Achieving diversity, inclusion, and equity in clinical research. Cambridge and Boston, MA: Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard (MRCT Center).
  • Bierer, B. E., A. Ne'eman, W. DeCormier Plosky, D. H. Strauss, B. C. Silverman, and M. A. Stein. 2021. Integrating supported decision-making into the clinical research process. The American Journal of Bioethics 21 (11):32–5. doi:10.1080/15265161.2021.1980141.
  • Blehar, M. C., C. Spong, C. Grady, S. F. Goldkind, L. Sahin, and J. A. Clayton. 2013. Enrolling pregnant women: Issues in clinical research. Women's Health Issues 23 (1):e39–45. doi:10.1016/j.whi.2012.10.003.
  • Caplan, A., and P. Friesen. 2017. Health disparities and clinical trial recruitment: Is there a duty to tweet? PLoS Biology 15 (3):e2002040. doi:10.1371/journal.pbio.2002040.
  • Charo, R. 1993. Protecting us to death: Women, pregnancy, and clinical research trials. Saint Louis University Law Journal 38:135–87.
  • Coleman, C. H. 2009. Vulnerability as a regulatory category in human subject research. Journal of Law, Medicine & Ethics. 37 (1):12–8. doi:10.1111/j.1748-720X.2009.00346.x.
  • Corbie-Smith, G. M., R. W. Durant, and D. M. M. St George. 2006. Investigators' assessment of NIH mandated inclusion of women and minorities in research. Contemporary Clinical Trials 27 (6):571–9. doi:10.1016/j.cct.2006.05.012.
  • Council for International Organizations of Medical Sciences. 2017. International ethical guidelines for health-related research involving humans. Geneva: CIOMS.
  • de Champlain, J., and J. Patenaude. 2006. Review of a mock research protocol in functional neuroimaging by Canadian research ethics boards. Journal of Medical Ethics 32 (9):530–4. doi:10.1136/jme.2005.012807.
  • Diekema, D. S. 2006. Conducting ethical research in pediatrics: A brief historical overview and review of pediatric regulations. The Journal of Pediatrics 149 (1 Suppl):S3–S11. doi:10.1016/j.jpeds.2006.04.043.
  • Epstein, S. 2008. Inclusion: The politics of difference in medical research. Chicago, IL: University of Chicago Press.
  • Fineman, M. A. 2010. The vulnerable subject: Anchoring equality in the human condition. In Transcending the boundaries of law, ed. M. A. Fineman, 177–91. New York: Routledge-Cavendish.
  • Fisher, J. A., and C. A. Kalbaugh. 2011. Challenging assumptions about minority participation in US clinical research. American Journal of Public Health 101 (12):2217–22. doi:10.2105/AJPH.2011.300279.
  • Food and Drug Administration. 1977. General considerations for the clinical evaluation of drugs. Rockville, MD: Food and Drug Administration.
  • Food and Drug Administration. 1993. Guideline for the study and evaluation for gender differences in the clinical evaluation of drugs. Federal Register 1993:39406–16.
  • Food and Drug Administration. 2018. The pediatric exclusivity provision. Rockville, MD: Food and Drug Administration.
  • Food and Drug Administration. 2020. Enhancing the diversity of clinical trial populations—Eligibility criteria, enrollment practices, and trial designs guidance for industry. Rockville, MD: Food and Drug Administration.
  • Freedman, B. 1987. Scientific value and validity as ethical requirements for research: A proposed explication. Irb 9 (6):7–10.
  • Friesen, P., A. Yusof, and M. Sheehan. 2019. Should the decisions of institutional review boards be consistent? Ethics & Human Research 41 (4):2–14. doi:10.1002/eahr.500022.
  • Friesen, P., L. Kearns, B. Redman, and A. L. Caplan. 2017. Rethinking the Belmont report? The American Journal of Bioethics 17 (7):15–21. doi:10.1080/15265161.2017.1329482.
  • Geisser, M. E., K. N. Alschuler, and R. Hutchinson. 2011. A Delphi study to establish important aspects of ethics review. Journal of Empirical Research on Human Research Ethics 6 (1):21–4. doi:10.1525/jer.2011.6.1.21.
  • Geller, S. E., A. Koch, B. Pellettieri, and M. Carnes. 2011. Inclusion, analysis, and reporting of sex and race/ethnicity in clinical trials: Have we made progress? Journal of Women's Health 20 (3):315–20. doi:10.1089/jwh.2010.2469.
  • Gennet, É., R. Andorno, and B. Elger. 2015. Does the new EU Regulation on clinical trials adequately protect vulnerable research participants? Health Policy 119 (7):925–31. doi:10.1016/j.healthpol.2015.04.007.
  • Glickman, S. W., A. Ndubuizu, K. P. Weinfurt, C. D. Hamilton, L. T. Glickman, K. A. Schulman, and C. B. Cairns. 2011. Perspective: The case for research justice: Inclusion of patients with limited English proficiency in clinical research. Academic Medicine 86 (3):389–93.
  • Holdcroft, A. 2007. Gender bias in research: How does it affect evidence based medicine? Journal of the Royal Society of Medicine 100 (1):2–3. doi:10.1177/014107680710000102.
  • Hurst, S. A. 2008. Vulnerability in research and health care; describing the elephant in the room? Bioethics 22 (4):191–202. doi:10.1111/j.1467-8519.2008.00631.x.
  • Johnson, J. L., and A. Beaudet. 2013. Sex and gender reporting in health research: Why Canada should be a leader. Canadian Journal of Public Health 104 (1):e80–1. doi:10.1007/BF03405660.
  • Johnson, J., Z. Sharman, B. Vissandjée, and D. E. Stewart. 2014. Does a change in health research funding policy related to the integration of sex and gender have an impact? PLoS ONE 9 (6):e99900. doi:10.1371/journal.pone.0099900.
  • King, P. A. 2005. Justice beyond Belmont. In Belmont revisited: Ethical principles for research with human subjects, ed. James F. Childress, Eric Mark Meslin, and Harold T. Shapiro, 136–47. Washington, DC: Georgetown University Press.
  • Kipnis, K. 2001. Vulnerability in research subjects: A bioethical taxonomy. Ethical and Policy Issues in Research Involving Human Participants 2: G1–G13.
  • Klitzman, R. 2015. The ethics police?: The struggle to make human research safe. Oxford: Oxford University Press.
  • Knepper, T. C., and H. L. McLeod. 2018. When will clinical trials finally reflect diversity? New York: Nature Publishing Group. doi:10.1038/d41586-018-05049-5.
  • Koski, G. 2014. Getting past protectionism: Is it time to take off the training wheels. In Human Subjects Research Regulation: Perspectives on the Future. Cambridge, MA: MIT Press.
  • Kottow, M. H. 2003. The vulnerable and the susceptible. Bioethics 17 (5–6):460–71. doi:10.1111/1467-8519.00361.
  • Lai, R., D. Elliott, and H. Ouellette‐Kuntz. 2006. Attitudes of research ethics committee members toward individuals with intellectual disabilities: The need for more research. Journal of Policy and Practice in Intellectual Disabilities 3 (2):114–8. doi:10.1111/j.1741-1130.2006.00062.x.
  • Lange, M. M., W. Rogers, and S. Dodds. 2013. Vulnerability in research ethics: A way forward. Bioethics 27 (6):333–40. doi:10.1111/bioe.12032.
  • Lau, C.-Y., M. Cardinali, P. A. Sato, A. Fix, and J. Flores. 2008. Broadening inclusion of vulnerable populations in HIV vaccine trials. Expert Review of Vaccines 7 (2):259–68. doi:10.1586/14760584.7.2.259.
  • Levine, C., R. Faden, C. Grady, D. Hammerschmidt, L. Eckenwiler, and J. Sugarman. 2004. The limitations of "vulnerability" as a protection for human research participants. The American Journal of Bioethics 4 (3):44–9. doi:10.1080/15265160490497083.
  • Levine, R. J. 2010. IRB perspective on inclusion of pregnant women in clinical research. Enrolling Pregnant Women 37. https://orwh.od.nih.gov/sites/orwh/files/docs/ORWH-EPW-Report-2010.pdf
  • Light, K. P., A. T. Lovell, H. Butt, N. J. Fauvel, and A. Holdcroft. 2006. Adverse effects of neuromuscular blocking agents based on yellow card reporting in the UK: Are there differences between males and females? Pharmacoepidemiology and Drug Safety 15 (3):151–60. doi:10.1002/pds.1196.
  • Lim, K. S., P. Kwan, and C. T. Tan. 2008. Association of HLA-B* 1502 allele and carbamazepine-induced severe adverse cutaneous drug reaction among Asians, a review. Neurology Asia 13 (6):15–21.
  • Luna, F. 2009. Elucidating the concept of vulnerability: Layers not labels. International Journal of Feminist Approaches to Bioethics 2 (1):121–39. doi:10.3138/ijfab.2.1.121.
  • Lyerly, A. D., M. O. Little, and R. Faden. 2008. The second wave: Toward responsible inclusion of pregnant women in research. International Journal of Feminist Approaches to Bioethics 1 (2):5–22. doi:10.3138/ijfab.1.2.5.
  • Macklin, R. 2010. Enrolling pregnant women in biomedical research. The Lancet 375 (9715):632–3. doi:10.1016/S0140-6736(10)60257-7.
  • Martin del Campo, F., J. Casado, P. Spencer, and H. Strelnick. 2013. The development of the Bronx Community Research Review Board: A pilot feasibility project for a model of community consultation. Progress in Community Health Partnerships: Research, Education, and Action 7 (3):341–52. doi:10.1353/cpr.2013.0037.
  • Mazure, C. M., and D. P. Jones. 2015. Twenty years and still counting: Including women as participants and studying sex and gender in biomedical research. BMC Women's Health 15 (1):94 doi:10.1186/s12905-015-0251-9.
  • McDermott, B. E. 2013. Coercion in research: Are prisoners the only vulnerable population? The Journal of the American Academy of Psychiatry and the Law 41 (1): 8–13.
  • Mehta, T. Y., L. M. Prajapati, B. Mittal, C. G. Joshi, J. J. Sheth, D. B. Patel, D. M. Dave, and R. K. Goyal. 2009. Association of HLA-B*1502 allele and carbamazepine-induced Stevens-Johnson syndrome among Indians. Indian Journal of Dermatology, Venereology and Leprology 75 (6):579–82. doi:10.4103/0378-6323.57718.
  • Miller, F. G., and A. Wertheimer. 2007. Facing up to paternalism in research ethics. The Hastings Center Report 37 (3):24–34. doi:10.1353/hcr.2007.0044.
  • Muthukumar, A., W. Morrell, and B. E. Bierer. 2021. Evaluating the frequency of English language requirements in clinical trial eligibility criteria: A systematic analysis using ClinicalTrials.gov. PLoS Medicine 18 (9):e1003758. doi:10.1371/journal.pmed.1003758.
  • National Institutes of Health. 2008. Inclusion of women and minorities as participants in research involving human subjects. Bethesda: National Institutes of Health.
  • National Institutes of Health. 2017. Amendment: NIH policy and guidelines on the inclusion of women and minorities as subjects in clinical research. Bethesda: National Institutes of Health.
  • Neufeld, S. D., J. Chapman, N. Crier, S. Marsh, J. McLeod, and L. A. Deane. 2019. Research 101: A process for developing local guidelines for ethical research in heavily researched communities. Harm Reduction Journal 16 (1):41. doi:10.1186/s12954-019-0315-5.
  • Nickel, P. J. 2006. Vulnerable populations in research: The case of the seriously ill. Theoretical Medicine and Bioethics 27 (3):245–64. doi:10.1007/s11017-006-9000-2.
  • Oberman, M., and J. Frader. 2003. Dying children and medical research: Access to clinical trials as benefit and burden. American Journal of Law & Medicine 29 (2–3):301–17. doi:10.1017/S0098858800002859.
  • Office for Human Research Protections. 2021. Consideration of the Principle of Justice 45 CFR part 46. Secretary’s Advisory Committee on Human Research Protections.
  • Oh, S. S., J. Galanter, N. Thakur, M. Pino-Yanes, N. E. Barcelo, M. J. White, D. M. de Bruin, R. M. Greenblatt, K. Bibbins-Domingo, A. H. B. Wu, et al. 2015. Diversity in clinical and biomedical research: A promise yet to be fulfilled. PLoS Medicine 12 (12):e1001918. doi:10.1371/journal.pmed.1001918.
  • Peter, E., and J. Friedland. 2017. Recognizing risk and vulnerability in research ethics: Imagining the "what ifs?" Journal of Empirical Research on Human Research Ethics 12 (2):107–16. doi:10.1177/1556264617696920.
  • Pope, A., C. Vanchieri, and L. O. Gostin. 2007. Ethical considerations for research involving prisoners. Washington, DC: National Academies Press.
  • Racine, E., and D. Bracken-Roche. 2019. Enriching the concept of vulnerability in research ethics: An integrative and functional account. Bioethics 33 (1):19–34. doi:10.1111/bioe.12471.
  • Ranganathan, M., and R. Bhopal. 2006. Exclusion and inclusion of nonwhite ethnic minority groups in 72 North American and European cardiovascular cohort studies. PLoS Medicine 3 (3):e44. doi:10.1371/journal.pmed.0030044.
  • Reardon, J., and K. TallBear. 2012. “Your DNA is our history”: Genomics, anthropology, and the construction of whiteness as property. Current Anthropology 53 (S5):S233–S45. doi:10.1086/662629.
  • Rhodes, R. 2010. Rethinking research ethics…This article originally appeared in The American Journal of Bioethics 5(1): 7–28. The American Journal of Bioethics 10 (10):19–36. doi:10.1080/15265161.2010.519233.
  • Rogers, W., and M. M. Lange. 2013. Rethinking the vulnerability of minority populations in research. American Journal of Public Health 103 (12):2141–6. doi:10.2105/AJPH.2012.301200.
  • Rogers, W., C. Mackenzie, and S. Dodds. 2012. Why bioethics needs a concept of vulnerability. International Journal of Feminist Approaches to Bioethics 5 (2):11–38. doi:10.2979/intjfemappbio.5.2.11.
  • Ryan, K. J., J. V. Brady, R. E. Cooke, D. I. Height, A. R. Jonsen, P. King, K. Lebacqz, D. W. Louisell, D. W. Seldin, E. Stellar, et al. 1979. The Belmont Report: Ethical principles and guidelines for the protection of human subjects of research. Washington, DC: United States National Commission for the Protection of Human Subjects of Biomedical and and Behavioral Research.
  • Schonfeld, T. 2013. The perils of protection: Vulnerability and women in clinical research. Theoretical Medicine and Bioethics 34 (3):189–206. doi:10.1007/s11017-013-9258-0.
  • Shah, S., A. Whittle, B. Wilfond, G. Gensler, and D. Wendler. 2004. How do institutional review boards apply the federal risk and benefit standards for pediatric research? JAMA 291 (4):476–82. doi:10.1001/jama.291.4.476.
  • Sherwin, S. 2005. Belmont revisited through a feminist lens. In Belmont revisited: Ethical principles for research with human subjects, ed. James F. Childress, Eric Mark Meslin, and Harold T. Shapiro, 148–64. Washington, DC: Georgetown University Press.
  • Shimabukuro, T. T., S. Y. Kim, T. R. Myers, P. L. Moro, T. Oduyebo, L. Panagiotakopoulos, P. L. Marquez, C. K. Olson, R. Liu, K. T. Chang, et al. 2021. Preliminary findings of mRNA Covid-19 vaccine safety in pregnant persons. The New England Journal of Medicine 384 (24):2273–82. doi:10.1056/NEJMoa2104983.
  • Simon, V. 2005. Wanted: Women in clinical trials. Science 308 (5728):1517. doi:10.1126/science.1115616.
  • Spencer, Q. N. J. 2018. A racial classification for medical genetics. Philosophical Studies 175 (5):1013–37. doi:10.1007/s11098-018-1072-0.
  • Strauss, David H. 2021. Anticipating and mitigating risk in research on mental illness. In Institutional review board: Management and function, ed. E. A. Bankert, B. G. Gordon, E. A. Hurley, and S. P. Shriver, 3rd ed. Sudbury, MA: Jones and Bartlett.
  • Strauss, D. H., S. A. White, and B. E. Bierer. 2021. Justice, diversity, and research ethics review. Science 371 (6535):1209–11. doi:10.1126/science.abf2170.
  • Stroup, T. S., and P. S. Appelbaum. 2006. Evaluation of “subject advocate” procedures in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study. Schizophrenia Bulletin 32 (1):147–52.
  • Taljaard, M., J. C. Brehaut, C. Weijer, R. Boruch, A. Donner, M. P. Eccles, A. D. McRae, R. Saginur, M. Zwarenstein, and J. M. Grimshaw. 2014. Variability in research ethics review of cluster randomized trials: A scenario-based survey in three countries. Trials 15:48. doi:10.1186/1745-6215-15-48.
  • TallBear, K. 2013. Native American DNA: Tribal belonging and the false promise of genetic science. Minneapolis: University of Minnesota Press.
  • Taylor, H. A. 2009. Inclusion of Women, minorities, and children in clinical trials: Opinions of research ethics board administrators. Journal of Empirical Research on Human Research Ethics 4 (2):65–73. doi:10.1525/jer.2009.4.2.65.
  • Tri-Council Policy Statement. 2018. Ethical conduct for research involving humans – TCPS 2 2018. Ottawa: Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada.
  • Tufford, L., P. A. Newman, D. J. Brennan, S. L. Craig, and M. R. Woodford. 2012. Conducting research with lesbian, gay, and bisexual populations: Navigating research ethics board reviews. Journal of Gay & Lesbian Social Services 24 (3):221–40. doi:10.1080/10538720.2012.697039.
  • US Department of Health and Human Services. 2014. Federal policy for the protection of human subjects (‘common rule’). DHHS version 45. Washington, DC: US Department of Health and Human Services.
  • Welch, M. J., R. Lally, J. E. Miller, S. Pittman, L. Brodsky, A. L. Caplan, G. Uhlenbrauck, D. M. Louzao, J. H. Fischer, and B. Wilfond. 2015. The ethics and regulatory landscape of including vulnerable populations in pragmatic clinical trials. Clinical Trials 12 (5):503–10. doi:10.1177/1740774515597701.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.