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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.

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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).

See generally

Menikoff

, “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.

Common Rule – Final Rule, supra note 1, at 7265.

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

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11.

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Garattini , “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).

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14.

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15.

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16.

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17.

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18.

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19.

Common Rule – Final Rule, supra note 1, at 7149.

20.

Id. at 7151.

21.

Id. at 7150.

22.

Id.

23.

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.

24.

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.

25.

Care Act 2014, s. 110(2) (emphasis added).

26.

Care Act 2014, s. 112(1) (emphasis added).

27.

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).

28.

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29.

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30.

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].

31.

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.

32.

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).

33.

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).

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E.S.

Dove , and

B.M.

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Supra note 43.

46.

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Schneider, supra note 2, at 78, 83.

49.

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50.

Trace and

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Id.

52.

Dove and Garattini, supra note 11.

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Id.

54.

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55.

Id. at 7209.

56.

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.

57.

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.

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64.

Schneider, supra note 2, at xxvii.

65.

Baldwin ,

Cave , and

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66.

H. Fernandez

Lynch

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67.

Id. at 153.

68.

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).

69.

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70.

Health Research Authority, “Standard Operating Procedures for Research Ethics Committees,” Version 7.3, (2018), at para. 8.1.

71.

Id. at para. 8.5.

72.

Dove and Garattini, supra note 11.

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

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