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An Assessment of the Human Subjects Protection Review Process for Exempt Research

Published online by Cambridge University Press:  01 January 2021

Jonathan D. Loe ,
D. Alex Winkelman  and
Christopher T. Robertson
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Abstract

Medical and public health research includes surveys, interviews, and biospecimens — techniques that do not present substantial risks to subjects. Consequently, this research is exempt from regulation under the Federal Common Rule. Nevertheless, at many institutions, exempt research is frequently subject to the same regulatory process that is required for non-exempt research, requiring the consumption of time and resources for review by Institutional Review Board members or staff. The federal government has indicated an intention to reform and centralize this system, but has not yet specified the form that it will use instead. By examining the policies of the top 50 research institutions, this article assesses institutional practices surrounding exempt research, quantifies the extent of exempt-research review requirements, documents a problem of “over-compliance,” and makes recommendations for reform.

Type
Independent Articles
Information
Journal of Law, Medicine & Ethics , Volume 44 , Issue 3: Contemporary Challenges in Informed Consent: Law, Research Practice, and Ethics , Fall 2016 , pp. 481 - 491
Copyright
Copyright © American Society of Law, Medicine and Ethics 2016

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References

45 C.F.R. § 46 (2015).Google Scholar
45 C.F.R. § 46.101(b)(1)-(6).Google Scholar
45 C.F.R. § 46.101(b)(2).Google Scholar
45 C.F.R. § 46.101(b)(4).Google Scholar
Federal Policy for the Protection of Human Subjects, 80 Federal Register 53931, 53966 (proposed September 8, 2015) (to be codified at 45 C.F.R. pt. 46); Grady, C., et al., “Broad Consent for Research with Biological Samples: Workshop Conclusions,” American Journal of Bioethics 15, no. 9 (2015): 34-42, at 34–35.Google Scholar
45 C.F.R. § 46.116.Google Scholar
45 C.F.R. § 46.109(e).Google Scholar
Dept. Health & Human Servs., “Frequently Asked Questions,” available at <http://www.hhs.gov/ohrp/policy/faq/exempt-research-determination/review-by-someone-other-than-investigator-before-research-study-is-exempt.html> (last visited June 22, 2016) (explaining additionally that regulatory flexibility permits institutions to make human subject protection determinations which minimally delay research).+(last+visited+June+22,+2016)+(explaining+additionally+that+regulatory+flexibility+permits+institutions+to+make+human+subject+protection+determinations+which+minimally+delay+research).>Google Scholar
Federal Policy for the Protection of Human Subjects, 80 Federal Register 53931.Google Scholar
Id.Google Scholar
42 U.S.C. § 289 (2012).Google Scholar
45 C.F.R. § 46.101(a).Google Scholar
Dept. of Health & Human Servs., Guidance on Extension of an FWA to Cover Collaborating Individual Investigators and Introduction of the Individual Investigator Agreement (2005); Dept. Health & Human Servs., Guidance on Research Involving Coded Private Information or Biological Specimens (2008).Google Scholar
Id.Google Scholar
45 C.F.R. § 46.103; See also Dept. of Health & Human Servs., “Frequently Asked Questions,” available at <http://www.hhs.gov/ohrp/policy/faq/45-cfr-46/hhs-ensures-regulatory-requirements.html> (last visited June 22, 2016).+(last+visited+June+22,+2016).>Google Scholar
45 C.F.R. § 46.101(b)(1)-(6).Google Scholar
45 C.F.R. § 46.101(a).Google Scholar
See supra note 8.Google Scholar
Wright, M. S. and Robertson, C. T., “Heterogeneity in IRB Policies with Regard to Disclosures about Payment for Participation in Recruitment Materials,” Journal of Law, Medicine & Ethics 42, no. 3 (2014): 375–382.Google Scholar
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.Google Scholar
Id.Google Scholar
Schneider, C. E., The Censor's Hand (Cambridge: MIT Press, 2015): at 71–105.Google Scholar
Id.Google Scholar
National Institutes of Health, “NIH Awards by Location and Organization,” available at <http://www.report.nih.gov/award/index.cfm> (last visited June 22, 2016). List was sorted by funding amount, based on the information reported on May 19, 2015.+(last+visited+June+22,+2016).+List+was+sorted+by+funding+amount,+based+on+the+information+reported+on+May+19,+2015.>Google Scholar
It is possible this number is inflated. Many institutions lacked a clearly stated policy regarding exempt review. Because, by its very nature, exempt research is not subject to further IRB 490 journal of law, medicine & ethics Loe, Winkelman, and Robertson review, IRBs should not be reviewing changes that do not affect the exempt status.Google Scholar
44 U.S.C. §§ 3501-21. One purpose of the law is to “minimize the paperwork burden for individuals, small businesses, educational and nonprofit institutions, Federal contractors, State, local and tribal governments, and other persons resulting from the collection of information by or for the Federal Government.” Id., at § 3501.Google Scholar
Dept. of Health & Human Servs., “IRB Knowledge of Local Research Context,” available at <http://www.hhs.gov/ohrp/policy/local.html> (last visited December 7, 2015); Federal Policy for the Protection of Human Subjects, 80 Federal Register at 53983.+(last+visited+December+7,+2015);+Federal+Policy+for+the+Protection+of+Human+Subjects,+80+Federal+Register+at+53983.>Google Scholar
Arora, S. and Gangopadhyay, S., “Toward a Theoretical Model of Voluntary Overcompliance,” Journal of Economic Behavior & Organization 28, no. 3 (1995): 289-309; S. Arora and T. N. Cason, “Why Do Firms Volunteer to Exceed Environmental Regulations? Understanding Participation in EPA's 33/50 Program,” Land Economics 72, no. 4 (1996): 413–432.Google Scholar
Id., at 291.Google Scholar
Shimshack, J. P. and Ward, M. B., “Enforcement and Over-Compliance,” Journal of Environmental Economics and Management 55, no. 1 (2008): 90–105.Google Scholar
Id., at 96–100.Google Scholar
Steinbrook, R., “Protecting Research Subjects — the Crisis at Johns Hopkins,” New England Journal of Medicine 346, no. 9 (2002): 716–720.Google Scholar
Lightfoot, S. R., “Emerging International Indigenous Rights Norms and ‘Over-Compliance’ in New Zealand and Canada,” Political Science 62, no. 1 (2010): 84–104.Google Scholar
Id.Google Scholar
See Schneider, supra note 22, at 107–120.Google Scholar
Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators, 76 Federal Register 44512 (proposed July 26, 2011).Google Scholar
Federal Policy for the Protection of Human Subjects, 80 Federal Register 53931.Google Scholar
Hudson, K. L. and Collins, F. S., “Bringing the Common Rule into the 21st Century,” New England Journal of Medicine 373, no. 24 (2015): 2293–2296.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Federal Policy for the Protection of Human Subjects, Federal Register at 53956.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Dept. of Health & Human Servs., “Transcript of October 20 Town Hall Meeting on Common Rule NPRM,” available at <http://www.hhs.gov/ohrp/humansubjects/regulations/transcriptoct20townhall.html> (last visited June 22, 2016).+(last+visited+June+22,+2016).>Google Scholar
Federal Policy for the Protection of Human Subjects, 80 Federal Register at 53955.Google Scholar
Welcome to NYU's Decision Engine, Federal Demonstration Partnership, available at <http://nsprmd.org/fdp/> (last visited June 22, 2016). (last visited June 22, 2016).' href=https://scholar.google.com/scholar?q=Welcome+to+NYU's+Decision+Engine,+Federal+Demonstration+Partnership,+available+at++(last+visited+June+22,+2016).>Google Scholar