Hostname: page-component-586b7cd67f-dsjbd Total loading time: 0 Render date: 2024-11-30T17:14:46.711Z Has data issue: false hasContentIssue false
  • English
  • Français

Key Information in the New Common Rule: Can It Save Research Consent?

Published online by Cambridge University Press:  01 January 2021

Nancy M. P. King
Get access Rights & Permissions [Opens in a new window]

Abstract

Informed consent in clinical research is widely regarded as broken, but essential nonetheless. The most recent attempt to reform it comes as part of the first revisions to the Common Rule since it became truly “common” in 1991. This change, the addition of a “key information” requirement for most consent forms, is intended to support and promote a reasoned decision-making process by potential subjects. The key information requirement is both promising and problematic. It is promising because it encourages clarity and honesty about research participation, creativity in information disclosure, and mutual learning through the investigator-subject relationship. It is problematic because those goals — which have remained aspirational since the beginning — may be difficult to achieve in what has become an excessively compliance-oriented regulatory regime.

Type
Symposium Articles
Information
Journal of Law, Medicine & Ethics , Volume 47 , Issue 2: Human Subject Protection , Summer 2019 , pp. 203 - 212
Copyright
Copyright © American Society of Law, Medicine and Ethics 2019

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Department of Homeland Security et al., “Federal Policy for the Protection of Human Subjects,” Federal Register 82, no. 12 (2017): 7149-7274. The DHHS Office of Human Research Protections orchestrated the revision process; the revisions themselves were jointly issued by all the Common Rule agencies. For a useful historical perspective, see A. M. Capron, “At Last! Aye, and There's the Rub,” American Journal of Bioethics 17, no. 7 (2017): 4-7.Google Scholar
Department of Homeland Security et al., Id. at 7265.Google Scholar
Id.Google Scholar
Department of Homeland Security et al., supra note 1, at 7211 (footnotes omitted).Google Scholar
Id. at 7213.Google Scholar
Id. at 7214.Google Scholar
Id.Google Scholar
Id.Google Scholar
Supra note 2 at 7213.Google Scholar
Id.Google Scholar
Id.Google Scholar
See, e.g., Katz, J., “Statement by Committee Member Jay Katz,” in Final Report, Advisory Committee on Human Radiation Experiments, US Government Printing Office 1995, pp. 848-856, available at <https://bioethicsarchive.georgetown.edu/achre/final/report.html> (last visited March 20, 2019) and Dr. Katz's statement, available at <https://bioethicsarchive.georgetown.edu/achre/final/jay_katz.html> (last visited March 20, 2019).Google Scholar
Department of Homeland Security et al., supra note 1.Google Scholar
This history is described far more thoroughly and eloquently in Capron, A. M., “Where Did Informed Consent for Research Come From?” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 12-29. See also R. Dresser, “The Reasonable Person Standard for Research Disclosure: A Reasonable Addition to the Common Rule,” Journal of Law, Medicine & Ethics 47, no. 2 (2019): 194-202, for a perspective on the reasonable person standard that is complementary to and more complete than my own.CrossRefGoogle Scholar
See King, N. M. P., “The Reasonable Patient and the Healer,” Wake Forest Law Review 50 (2015): 343-361.Google Scholar
Dresser, R., Silent Partners: Human Subjects and Research Ethics (New York: Oxford University Press 2017). See also S. A. Kraft et al., “Comprehension and Choice Under the Revised Common Rule: Improving Informed Consent by Offering Reasons Why Some Enroll in Research and Others Do Not,” American Journal of Bioethics 17, no. 7 (2017): 53-55, and J. Sugarman, “Examining Provisions Related to Consent in the Revised Common Rule,” American Journal of Bioethics 17, no. 7 (2017): 22-26.Google Scholar
I've drawn this formulation from Powers, M. and R. Faden's discussion of a range of justice theories in Social Justice: The Moral Foundations of Public Health and Health Policy (New York: Oxford University Press 2006), e.g., p. 191. The analogy is based on thinking about justice beyond questions of distribution, focusing instead on substantive determinations of what societies owe their members — and, in this context, on what information the research enterprise owes potential subjects as reasonable persons.Google Scholar
Appelbaum, P. S., Roth, L. R., and Lidz, C., “The Therapeutic Misconception: Informed Consent in Psychiatric Research,” International Journal of Law and Psychiatry 5, no. 3-4 (1982): 319-329; P. S. Appelbaum et al., “False Hopes and Best Data: Consent to Research and the Therapeutic Misconception,” Hastings Center Report 17, no. 2 (1987): 20-24; P. S. Appelbaum, “Commentary: Examining the Ethics of Human Subjects Research,” Kennedy Institute of Ethics Journal 6, no. 3 (1996): 283-287.CrossRefGoogle Scholar
King, N. M. P, “Defining and Describing Benefit Appropriately in Clinical Trials,” Journal of Law, Medicine & Ethics 28, no. 4 (2000): 332-343.CrossRefGoogle Scholar
King, N. M. P, Henderson, G. E., Churchill, L. R., et al., “Consent Forms and the Therapeutic Misconception: The Example of Gene Transfer Research,” IRB: Ethics and Human Research 27, no. 1 (2005): 1-8; S. Horng and C. Grady, “Misunderstanding in Clinical Research: Distinguishing Therapeutic Misconception, Therapeutic Misestimation, and Therapeutic Optimism,” IRB: Ethics and Human Research 25, no. 1 (2003): 11-16. Even though the distinction between research and treatment has always been far more nuanced than the sharp dichotomy that is often posited (see, e.g., T. L. Beauchamp and Y. Saghai, “The Historical Foundations of the Research-Practice Distinction in Bioethics,” Theoretical Medicine and Bioethics 33, no. 1, (2012): 45-56), the value of distinguishing between research and treatment, based not primarily on risks of harm but on information provision and mutual education, remains vital.CrossRefGoogle Scholar
Koyfman, S. A., McCabe, M. S., Emanuel, E., and Grady, C., “A Consent Form Template for Phase I Oncology Trials,” IRB: Ethics in Human Research 31, no. 4 (2009): 1-8.Google Scholar
King, N. M. P and Cohen-Haguenauer, O., “En Route to Ethical Recommendations for Gene Transfer Clinical Trials,” Molecular Therapy 16, no. 3 (2008): 432-438.CrossRefGoogle Scholar
Knowing what a particular hospital or practice would recommend outside the context of a comparative effectiveness trial is site-specific information that could be very useful to patients who are potential subjects, especially if the points of comparison are described. See, e.g., Feudtner, C., Schreiner, M., and Lantos, J. D., “Risks (and Benefits) in Comparative Effectiveness Research,” New England Journal of Medicine 369, no. 10 (2013): 892-894. The differences between participating in comparative effectiveness research and receiving treatment outside the research context thus may not be measurable as changes in risks of harm, but they are readily describable nonetheless.CrossRefGoogle Scholar
“Charlie Gard: The Story of His Parents' Legal Fight,” BBC News, July 27, 2017, available at <https://www.bbc.com/news/health-40554462> (last visited March 20, 2019); S. Begley, “Trump Tweeted About a Dying Boy. Here's What You Need to Know About His Rare Disease,” STAT News, July 3, 2017, available at <https://www.statnews.com/2017/07/03/trump-tweet-dying-boy/> (last visited March 20, 2019); “Parents of Charlie Gard Raise £1.2m for Pioneering Treatment,” BBC News, April 2, 2017, available at <https://www.bbc.co.uk/news/uk-england-london-39471712> (last visited March 20, 2019).+(last+visited+March+20,+2019);+S.+Begley,+“Trump+Tweeted+About+a+Dying+Boy.+Here's+What+You+Need+to+Know+About+His+Rare+Disease,”+STAT+News,+July+3,+2017,+available+at++(last+visited+March+20,+2019);+“Parents+of+Charlie+Gard+Raise+£1.2m+for+Pioneering+Treatment,”+BBC+News,+April+2,+2017,+available+at++(last+visited+March+20,+2019).>Google Scholar
E.g., Petition: “Dear Biogen Company,” Change.org, available at <https://www.change.org/p/biogen-idec-dear-biogen-company-please-gift-kiana-compassionate-use-of-spinraza-she-deserves-treatment?j=377479&sfmc_sub=416434023&l=32_HTML&u=64606725&mid=7233053&jb=1713&utm_medium=email&utm_source=aa_sign_human&utm_campaign=377479&utm_content=&sfmc_tk=Wz7V9pgtrCGuxMfvFP8fnFSrHVGTui6r0JrDBSXnH8NZsECw8Wo3GdxvEsAzcuiu&j=377479&sfmc_sub=416434023&l=32_HTML&u=64606725&mid=7233053&jb=1713> (last accessed Jan. 8, 2019). See also, e.g., N. M. P. King and C. E. Bishop, “New Treatments for Serious Conditions: Ethical Implications,” Gene Therapy 24, no. 9 (2017): 534-538; K. Tay-Teo, A. Ilbawi, and S. R. Hill, “Comparison of Sales Income and Research and Development Costs for FDA-Approved Cancer Drugs Sold by Originator Drug Companies,” JAMA Network Open 2, no. 1 (2019): e186875, doi: 10.1001/jamanetworkopen.2018.6875, at 7/11; C. Klugman, “Cute with a Good Story: How Social Media Selects Experimental Subjects,” April 1, 2014, available at <http://www.bioethics.net/2014/04/CUTE-WITH-A-GOOD-STORY-SOCIAL-MEDIA-SELECTS-EXPERIMENTAL-SUBJECTS/> (last accessed Jan. 8, 2019).+(last+accessed+Jan.+8,+2019).+See+also,+e.g.,+N.+M.+P.+King+and+C.+E.+Bishop,+“New+Treatments+for+Serious+Conditions:+Ethical+Implications,”+Gene+Therapy+24,+no.+9+(2017):+534-538;+K.+Tay-Teo,+A.+Ilbawi,+and+S.+R.+Hill,+“Comparison+of+Sales+Income+and+Research+and+Development+Costs+for+FDA-Approved+Cancer+Drugs+Sold+by+Originator+Drug+Companies,”+JAMA+Network+Open+2,+no.+1+(2019):+e186875,+doi:+10.1001/jamanetworkopen.2018.6875,+at+7/11;+C.+Klugman,+“Cute+with+a+Good+Story:+How+Social+Media+Selects+Experimental+Subjects,”+April+1,+2014,+available+at++(last+accessed+Jan.+8,+2019).>Google Scholar
Snyder, J., Turner, L., and Crooks, V. A, “Crowdfunding for Unproven Stem Cell-Based Interventions,” Journal of the American Medical Association 319, no. 18 (2018): 1935-1936; L. Turner and P. Knoepfler, “Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry,” Cell Stem Cell 19, no. 2 (2016): 154-157.CrossRefGoogle Scholar
Henderson, G. E., Davis, A. M., King, N. M. P, et al., “Uncertain Benefit: Investigators' Views and Communications in Early Phase Gene Transfer Trials,” Molecular Therapy 10, no. 2 (2004): 225-231, at 229.CrossRefGoogle Scholar
Capron, A. M., “Informed Consent in Catastrophic Disease Research and Treatment,” University of Pennsylvania Law Review 123, no. 2 (1974): 341-438 at 371-374.CrossRefGoogle Scholar
King, N. M. P, “Research with Human Subjects: Humility and Deception,” IRB: Ethics & Human Research 40, no. 2 (2018): 12-14.CrossRefGoogle Scholar
Kost, R. G., Lee, L. M., Yessis, J., et al., “Assessing Research Participants' Perceptions of Their Research Experiences,” Clinical and Translational Science 4, no. 6 (2011): 403-413, 409; R. G. Kost, L. N. Lee, J. L. Yessis, et al., “Research Participant Centered Outcomes at NIH-Supported Clinical Research Centers,” Clinical & Translational Science 7, no. 6 (2014): 430–440; I. J. Kelly-Pumarol, P. Q. Henderson, J.T. Rushing, et al., “Delivery of the Research Participant Perception Survey Through the Patient Portal,” Journal of Clinical and Translational Science 2, no. 3 (2018): 163-168.CrossRefGoogle Scholar
DHHS, OHRP, SACHRP Recommendations, Nov. 13, 2018 Letter to the HHS Secretary, “Attachment C, SACHRP Commentary on the New ‘Key Information’ Informed Consent Requirements, October 17, 2018,” available at <https://www.hhs.gov/ohrp/sachrp-committee/recommendations/attachment-c-november-13-2018/index.html> (last visited March 20, 2019).+(last+visited+March+20,+2019).>Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Capron, supra note 14, at 25-26 and 18.CrossRefGoogle Scholar
Kimmelman, J., Gene Transfer and the Ethics of First-in-Human Research: Lost in Translation (New York, NY: Cambridge University Press, 2009). Recent controversy about the so-called Chinese CRISPR babies has only reinforced the need to change that popular and dangerous view of research progress. See, e.g., two summaries of these claims and responses to it that provide an overview: S. Begley and A. Joseph, “The “CRISPR Shocker: How Genome Editing Scientist He Jiankui Rose from Obscurity to Stun the World,” STAT, Dec. 17, 2018, available at <https://www.statnews.com/2018/12/17/crispr-shocker-genome-editing-scientist-he-jiankui/> (last accessed December 26, 2018); E. Yong, “The CRISPR Baby Scandal Gets Worse by the Day,” The Atlantic, Dec. 4, 2018, available at <https://www.theatlantic.com/science/archive/2018/12/15-worrying-things-about-crispr-babies-scandal/577234/> (last accessed December 27, 2018).CrossRefGoogle Scholar
Wilbanks, J., “Design Issues in E-Consent,” Journal of Law, Medicine & Ethics 46, no. 1 (2018): 110-118.CrossRefGoogle Scholar
Capron, supra note 14, at 26.Google Scholar
See Capron, supra note 28, at 374-376.Google Scholar
Supra note 31.Google Scholar