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Requiring a Single IRB for Cooperative Research in the Revised Common Rule: What Lessons Can Be Learned from the UK and Elsewhere?

Published online by Cambridge University Press:  01 January 2021

Edward S. Dove
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Abstract

This article argues in general support of the sIRB rule, but also draws on recent empirical research to highlight several residual weaknesses in the US regulatory structure for research ethics review, and suggests ways in which these weaknesses might be addressed in future regulatory reforms to improve upon the sIRB rule.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 2: Human Subject Protection , Summer 2019 , pp. 264 - 282
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

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References

Subpart A of 45 CFR 46. See DHHS, “Federal Policy for the Protection of Human Subjects,” 82 F.R. 7149, January 19, 2017 [hereinafter Common Rule – Final Rule], available at <https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects> (last visited April 2, 2019).+(last+visited+April+2,+2019).>Google Scholar
See generally Menikoff, J., “The Paradoxical Problem with Multiple-IRB Review,” New England Journal of Medicine 363, no. 17 (2010): 1591-1593; C.E. Schneider, The Censor's Hand: The Misregulation of Human-Subject Research (Cambridge: MIT Press, 2015); C.A. Heimer and J. Petty, “Bureaucratic Ethics: IRBs and the Legal Regulation of Human Subjects Research,” Annual Review of Law and Social Science 6 (2010): 601-626. See also R. McWilliams et al., “Problematic Variation in Local Institutional Review of a Multicenter Genetic Epidemiology Study,” Journal of the American Medi-cal Association 290, no. 3 (2003): 360-366; L. Abbott and C. Grady, “A Systematic Review of the Empirical Literature Evaluating IRBs: What We Know and What We Still Need to Learn,” Journal of Empirical Research on Human Research Ethics 6, no. 1 (2001): 3-19.CrossRefGoogle Scholar
Common Rule – Final Rule, supra note 1, at 7265.Google Scholar
Federally funded adult and pediatric cancer studies have had the option since 2001 of delegating review authority to the central IRB of the National Cancer Institute. Published research indicates it has had good success. See National Cancer Institute, Central Institutional Review Board for the National Cancer Institute, available at <https://www.ncicirb.org/> (last visited April 2, 2019). See also Wagner, T.H. et al., “Costs and Benefits of the National Cancer Institute Central Institutional Review Board,” Journal of Clinical Oncology 28, no. 4 (2010): 662–666.CrossRefGoogle Scholar
Townend, D. et al., “Streamlining Ethical Review of Data Intensive Research,” BMJ 354 (2016): i4181.Google Scholar
Stark, L., “IRBs and the Problem of ‘Local Precedents’,” in Cohen, I.G. and Lynch, H. Fernandez, eds., Human Subjects Research Regulation: Perspectives on the Future (Cambridge: MIT Press, 2014).Google Scholar
Common Rule – Final Rule, supra note 1, at 7154.Google Scholar
Dove, E.S. et al., “Ethics Review for International Data-Intensive Research,” Science 351, no. 6280 (2016): 1399-1400.CrossRefGoogle Scholar
NIH, “Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research,” Notice No. NOTOD-16-094 (June 21, 2016), available at <https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-094.html> (last visited April 2, 2019).+(last+visited+April+2,+2019).>Google Scholar
Uganda National Council for Science and Technology, “National Guidelines for Research involving Humans as Research Participants” (2014), s. 4.5.5, para. c.Google Scholar
Dove, E.S. and Garattini, C., “Expert Perspectives on Ethics Review of International Data-Intensive Research: Working towards Mutual Recognition,” Research Ethics 14, no. 1 (2018): 1-25. See also Clinical Trials Ontario, available at <http://www.ctontario.ca/> (last visited April 2, 2019) and Ontario Cancer Research Ethics Board, available at <https://ocreb.ca/> (last visited May 29, 2019).CrossRefGoogle Scholar
National Health and Medical Research Council, “National Approach to Single Ethical Review,” Australian Government (2018), available at <https://www.nhmrc.gov.au/health-ethics/national-approach-single-ethical-review-multi-centre-research> (last visited April 2, 2019).+(last+visited+April+2,+2019).>Google Scholar
Rahimzadeh, V. and Knoppers, B.M., “How Mutually Recognizable is Mutual Recognition? An International Terminology Index of Research Ethics Review Policies in the USA, Canada, UK and Australia,” Personalized Medicine 13, no. 2 (2016): 101-105.Google Scholar
Lidz, C.W. et al., “Reliance Agreements and Single IRB review of Multisite Research: Concerns of IRB Members and Staff,” AJOB Empirical Bioethics 9, no. 3 (2018): 164-172.Google Scholar
Taylor, H.A., Ehrhardt, S., and Ervin, A.-M., “Public Comments on the Proposed Common Rule Mandate for Single-IRB Review of Multisite Research,” Ethics & Human Research 41, no. 1 (2019): 15-21.CrossRefGoogle Scholar
DHHS, “Federal Policy for the Protection of Human Subjects,” 80 F.R. 53931 (September 8, 2015), available at <https://www.federalregister.gov/documents/2015/09/08/2015-21756/federal-policy-for-the-protection-of-human-subjects> (last visited April 2, 2019). DHHS initially proposed the sIRB rule in its Advance Notice of Proposed Rulemaking (76 F.R. 44512) in July 2011.+(last+visited+April+2,+2019).+DHHS+initially+proposed+the+sIRB+rule+in+its+Advance+Notice+of+Proposed+Rulemaking+(76+F.R.+44512)+in+July+2011.>Google Scholar
Common Rule – Final Rule, supra note 1, at 7208.Google Scholar
Klitzman, R. et al., “Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions,” Ethics & Human Research 41, no. 1 (2019): 22-31.CrossRefGoogle Scholar
Common Rule – Final Rule, supra note 1, at 7149.Google Scholar
Id. at 7151.Google Scholar
Id. at 7150.Google Scholar
Id.Google Scholar
The UK also has a hybrid, and one might say uncoordinated, system of RECs. Several different types of RECs exist. They can be split into two main categories of non-NHS RECs (e.g. institution-based higher education RECs) and NHS RECs, the latter of which are primarily charged with reviewing health-related research.Google Scholar
An exception to this rule is the requirement that all non-clinical trials research involving adults lacking capacity in Scotland be reviewed by a specific REC known as the Scotland A REC. See Adults with Incapacity (Scotland) Act 2000, s. 51 and Adults with Incapacity (Ethics Committee) (Scotland) Regulations 2002.Google Scholar
Care Act 2014, s. 110(2) (emphasis added).Google Scholar
Care Act 2014, s. 112(1) (emphasis added).Google Scholar
Health Research Authority, “Information for Potential Research Ethics Service Committee Members,” available at <https://www.hra.nhs.uk/documents/1025/standard-application-pack-rec-members.pdf> (last visited April 2, 2019) (emphasis added).+(last+visited+April+2,+2019)+(emphasis+added).>Google Scholar
Chief Scientist Office, “Research Ethics Structure in Scotland,” available at <http://www.nhsresearchscotland.org.uk/services/research-ethics> (last visited April 2, 2019)(emphasis added).+(last+visited+April+2,+2019)(emphasis+added).>Google Scholar
Office for Research Ethics Committees Northern Ireland (ORECNI), “HSC REC A & HSC REC B Executive Summary Annual Report 2015-2016,” available at <http://www.hscbusiness.hscni.net/images/HSC_REC_A_and_HSC_REC_B_Executive_Summary_Annual_Report_2015-2016.doc> (last visited April 2, 2019).+(last+visited+April+2,+2019).>Google Scholar
Directive 2001/20/EC of the European Parliament and of the Council of April 4, 2001 on the approximation of the laws, regulations, and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use [hereinafter Clinical Trials Directive].Google Scholar
The reason why the EU did not mandate a single ethics opinion across the entire EU for a multi-site, multi-country clinical trial is that it lacks competence to regulate in research ethics, which is seen as an exclusive competence of the Member States.Google Scholar
The Medicines for Human Use (Clinical Trials) Regulations 2004, as amended by the Medicines for Human Use (Clinical Trials) Amendment 2006, SI 2006/1928. The amended Regulations were intended to give domestic effect to the EU's Good Practice Directive (2005/28/EC).Google Scholar
This is currently reflected in Health Research Authority, “Standard Operating Procedures for Research Ethics Committees,” Version 7.3 (2018), s. 5.2, available at <https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/research-ethics-committee-standard-operating-procedures/> (last visited April 2, 2019).+(last+visited+April+2,+2019).>Google Scholar
Alberti, K.G. M.M., “Local Research Ethics Committees: Time to Grab Several Bulls by the Horns,” BMJ 311, no. 7006 (1995): 639-640; K. Jamrozik, “The Case for a New System for Oversight of Research on Human Subjects,” Journal of Medical Ethics 26, no. 5 (2000): 334-339; C. Warlow, “Clinical Research Under the Cosh Again,” BMJ 329, no. 7460 (2004): 241-242.CrossRefGoogle Scholar
Health Research Authority, “REC Directory,” available at <https://www.hra.nhs.uk/about-us/committees-and-services/res-and-recs/search-research-ethics-committees/> (last visited April 2, 2019).+(last+visited+April+2,+2019).>Google Scholar
Rahimzadeh, V., Dove, E.S., and Knoppers, B.M., “The sIRB System: A Single Beacon of Progress in the Revised Common Rule?” American Journal of Bioethics 17, no. 7 (2017): 43-46, at 43-44.CrossRefGoogle Scholar
Common Rule – Final Rule, supra note 1, at 7234.Google Scholar
Dove, E.S., Regulatory Stewardship of Health Research: Navigating Participant Protection and Research Promotion (Cheltenham: Edward Elgar, forthcoming).CrossRefGoogle Scholar
Klitzman et al., supra note 18.Google Scholar
Common Rule – Final Rule, supra note 1, at 7208.Google Scholar
Common Rule – Final Rule, supra note 1, at 7208.Google Scholar
U.S. Congress, House Committee on Government Operations, Research and Technical Programs Subcommittee, The Use of Social Research in Federal Domestic Programs: Part IV — Current Issues in the Administration of Federal Social Research (90th Cong., 1st. sess., 1967), at 221.Google Scholar
Department of Health, Education, and Welfare, “Institutional Review Boards: Report and Recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,” Federal Register 43 (November 30, 1978), at 56176-56178.Google Scholar
Gladue, B.A., “Gender Identity Politics, Human Subjects Issues, and the ‘Law of Unintended Consequences,’” Archives of Sexual Behavior 37, no. 3 (2008): 448-450, at 449.CrossRefGoogle Scholar
Supra note 43.Google Scholar
Council for International Organizations of Medical Sciences (CIOMS), International Ethical Guidelines for Health-related Research Involving Humans (2016), available at <https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf> (last visited April 2, 2019).+(last+visited+April+2,+2019).>Google Scholar
World Health Organization (WHO), Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants, available at <http://ec.europa.eu/research/participants/data/ref/fp7/89857/research-human-participants_en.pdf> (last visited April 2, 2019).+(last+visited+April+2,+2019).>Google Scholar
Schneider, supra note 2, at 78, 83.Google Scholar
See e.g. Green, L.A. et al., “Impact of Institutional Review Board Practice Variation on Observational Health Services Research,” Health Services Research 41, no. 1 (2006): 214-230.CrossRefGoogle Scholar
Trace, S. and Kolstoe, S., “Reviewing Code Consistency is Important, but Research Ethics Committees Must Also Make a Judgement on Scientific Justification, Methodological Approach and Competency of the Research Team,” Journal of Medical Ethics 44, no. 12 (2018): 874-875, at 874. See also S. Trace and S. Kolstoe, “Measuring Inconsistency in Research Ethics Committee Review,” BMC Medical Ethics 18 (2017): 65 (1-10).CrossRefGoogle Scholar
Id.Google Scholar
Dove and Garattini, supra note 11.Google Scholar
Id.Google Scholar
Common Rule – Final Rule, supra note 1, at 7265.Google Scholar
Id. at 7209.Google Scholar
Equivalent guidance was published in Wales and Scotland: DGM 98/25 and MEL 97/8, respectively. According to the original Governance Arrangements for NHS Research Ethics Committees (GAfREC), MRECs “undertake the review of the ethics of the research protocol, including the content of the patient information sheet and consent form. No further ethical review of these items shall be undertaken by other RECs (except in the process of a ‘second review’ […]).” See Department of Health, “Governance Arrangements for NHS Research Ethics Committees (Department of Health, 2001), at para. 8.7. Locality issues undertaken by LRECs were “limited to”: “the suitability of the local researcher; the appropriateness of the local research environment and facilities; specific issues relating to the local community, including the need for provision of information in languages other than English.” Id. at para. 8.8.Google Scholar
Department of Health, “Review of Ethics of Multi-centre Trials,” February 1995, CMO's Consultative Group on Research Ethics, RE/95/1, NPA, as quoted in A. Hedgecoe, “Scandals, Ethics, and Regulatory Change in Biomedical Research,” Science, Technology, & Human Values 42, no. 4 (2017): 577-599, at 586.Google Scholar
Al, R.-Shahi and Warlow, C., “Ethical Review of a Multicentre Study in Scotland: A Weighty Problem,” Journal of the Royal College of Physicians of London 33, no. 6 (1999): 549-552; I. Larcombe and M. Mott, “Multicentre Research Ethics Committees: Have They Helped?” Journal of the Royal Society of Medicine 92, no. 10 (1999): 500-501; N. Dunn, A. Arscott, and R. Mann, “Costs of Seeking Ethics Approval Before and After the Introduction of Multicentre Research Ethics Committees,” Journal of the Royal Society of Medicine 93, no. 10 (2000): 511-512.Google Scholar
Collett, C., “Setting the Strategic Landscape for the HRA – Ethics Governance” (2013) (unpublished internal Health Research Authority paper provided to the author), at 4 (emphasis in original).Google Scholar
Diamond, M.P. et al., “The Efficiency of Single Institutional Review Board Review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated Clinical Trials,” Clinical Trials 16, no. 1 (2019): 3-10.CrossRefGoogle Scholar
Health Insurance Portability and Accountability Act of 1996 (HIPAA), Pub. L. 104–191, 110 Stat. 1936.Google Scholar
Coleman, C., “Rationalizing Risk Assessment in Human Subject Research,” Arizona Law Review 46, no. 1 (2004): 1-51, at 17.Google Scholar
Townend, D. and Dove, E.S., “Approaching Ethics Review Equivalency Through Natural Justice and a ‘Sounding Board’ Model for Research Ethics Committees,” Medicine and Law 36, no. 1 (2017): 61-86, at 74.Google Scholar
Schneider, supra note 2, at xxvii.Google Scholar
Baldwin, R., Cave, M., and Lodge, M., Understanding Regulation: Theory, Strategy, and Practice (2nd ed., Oxford: OUP, 2012), at 29.Google Scholar
Lynch, H. Fernandez, “Opening Closed Doors: Promoting IRB Transparency,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 145-158, at 155.CrossRefGoogle Scholar
Id. at 153.Google Scholar
On this point, see also Global Alliance for Genomics and Health, “Ethics Review Recognition Policy” (2017), available at <https://www.ga4gh.org/wp-content/uploads/GA4GH-Ethics-Review-Recognition-Policy.pdf> (last visited April 2, 2019).+(last+visited+April+2,+2019).>Google Scholar
Townend and Dove, supra note 52, at 77-78.Google Scholar
Health Research Authority, “Standard Operating Procedures for Research Ethics Committees,” Version 7.3, (2018), at para. 8.1.Google Scholar
Id. at para. 8.5.Google Scholar
Dove and Garattini, supra note 11.Google Scholar