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In Plain Sight: A Solution to a Fundamental Challenge in Human Research

Published online by Cambridge University Press:  01 January 2021

Lois Shepherd  and
Margaret Foster Riley
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Extract

The physician-researcher conflict of interest, a long-standing and widely recognized ethical challenge of clinical research, has thus far eluded satisfactory solution. The conflict is fairly straightforward. Medical research and medical therapy are distinct pursuits; the former is aimed at producing generalizable knowledge for the benefit of future patients, whereas the latter is aimed at addressing the individualized medical needs of a particular patient. When the physician-researcher combines these pursuits, he or she serves two masters and cannot — no matter how well-intentioned — avoid the risk of compromising the duties owed in one of the professional roles assumed. Because of the necessary rigidity of a research protocol, the more demanding of the two masters is frequently the research.

The problem of the physician-researcher conflict has been evident since the first attempts to regulate human research in the United States. Otto E. Guttentag, a physician at the University of California School of Medicine in San Francisco, addressed the conflict in a 1953 Science magazine article.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 40 , Issue 4 , Winter 2012 , pp. 970 - 989
Copyright
Copyright © American Society of Law, Medicine and Ethics 2012

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Model Rule of Professional Conduct, R. 1.7(b)(3) prohibits representation when it “involve[s] the assertion of a claim by one client against another client represented by the lawyer in the same litigation or other proceeding before a tribunal.” Certain types of representation may also be categorically prohibited by state or federal law, such as the prohibition in some states “that the same lawyer may not represent more than one defendant in a capital case, even with the consent of the clients.” Id., R. 1.7, cmt 16. While framed as ethical canons, the Model Rules of Professional Conduct create legal rather than merely aspirational obligations. See generally Bassett, D. L., “Three's a Crowd: A Proposal to Abolish Joint Representation,” Rutgers Law Journal 32, no. 2 (2011): 387–458, at 405.Google Scholar
Johnson, S. H., “Five Easy Pieces: Motifs of Health Law,” Health Matrix 14, no. 1 (2004): 131–140, at 131.Google Scholar
As Sandra Johnson has written, “[T]ell doctors that they have a ‘conflict of interest’ in relation to a proposed protocol for research with human subjects, and they believe that you have accused them of unethical behavior….[D]octors tend to assume that a conflict of interest exists only when they actually have made a ‘bad’ decision motivated by their financial interest in the sponsor of the research.” The medical profession in general tends to prefer calling Conflicts between primary obligations, such as medical care and research, “conflicts of obligation.” Id. See Institute of Medicine, Report on Conflict of Interest in Medical Research, Education, and Practice (2009), at 48. In fact, rather than describing medical practice and research as posing conflicting interests, the Report combines these two aims under the “goals of medicine” Id., at 44.Google Scholar
See Sage, , supra note 121.Google Scholar
Model Rule 1.8(h). Not all states have adopted Model Rule 1.8(h) in this form, and some are more restrictive in what they permit. A few states go so far as to proscribe all agreements that prospectively limit a lawyer's liability. See, e.g., New York Rules of Professional Conduct 1.8(h); Alabama Rules of Professional Conduct 1.8(h). New Jersey allows such agreements, but only when “the client fails to act in accordance with the lawyer's advice or refuses to permit the lawyer to act in accordance with the lawyer's advice.” New Jersey Rules of Professional Conduct 1.8(h). According to the Comments to the Model Rules, this independent lawyer requirement is imposed “because [such agreements] are likely to undermine competent and diligent representation.” Thus, there is a recognition and concern that the quality of the representation may be altered (like the “adviser's” advice in the psychological experiments about estimation, discussed above), not merely that the client will be unduly influenced into signing the waiver or misunderstand its import, although those, too, are a concern.Google Scholar
The analogy between the lawyer seeking to limit liability and the physician performing clinical research is not perfect. For one, the legal client is waiving the right to sue for negligence of the lawyer, but the physician-researcher could still be sued for negligence by the patient-subject, however that might be defined. In fact, researchers are prohibited by law from seeking waivers of liability for negligence. 45 C.F.R. § 46.116 (1994); 21 C.F.R. § 50.20 (1995) (prohibiting exculpatory agreements concerning negligence in clinical investigations regulated by the FDA); Vodopest v. MacGregor, 128 Wash. 2d 840, 913 P.2d 779 (1996) (preinjury agreement releasing medical researcher for liability for negligence conduct violates public policy). The point, however, is that almost certainly negligence on the part of the physician-researcher will not be judged in reference to a standard of care that requires exclusive pursuit of the best medical interests of the patient-subject. Second, the lawyer who obtains a waiver of liability from a client has not actually become subject to a different standard of care, but simply cannot be sued by that client for certain deviations from the ordinary standard of care. Others, including professional bar associations, can still hold the lawyer accountable for practicing law to the usual standards of competence and diligence. The point, though, is that this client cannot hold the lawyer legally accountable to such standards and therefore is entitled to another lawyer's guidance on the liability waiver.Google Scholar
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, Pub. No. 78-0012, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (1979), available at <http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html> (last visited December 12, 2012).+(last+visited+December+12,+2012).>Google Scholar
“Beneficence” is used in the Report to describe both negative obligations to do no harm and positive obligations to help others.Google Scholar
The Report appears to conflate the two conceptions of beneficence that physician-researchers might promote – the good for society and the good for individual subject-patients by telling us that “avoiding harm [presumably to individual patients] requires learning what is harmful [by doing research],” and although “the Hippocratic Oath requires physicians to benefit their patients ‘according to their best judgment’” (again, a patient-centered approach), “[l]earning what will in fact benefit may require exposing persons to risk” (research subjects).Google Scholar
Kolata, G. and Eichenwald, K., “Stopgap Medicine: A Special Report; For the Uninsured, Drug Trials Are Health Care,” New York Times, June 22, 1999.Google Scholar
As we are hopeful that eventually everyone in the United States will be insured for health care services, questions relating to the application of our proposal to the person seeking free medical care through research participation may be a temporary one. Unfortunately, however, even optimistic projections of current health care reform demonstrate that there will be a segment of the population still uninsured. Much of that group will truly be part of a vulnerable population. They are likely to be less well educated and many teetering on the edge of financial disaster. Some of them will be undocumented immigrants. This is even greater reason to give them additional support.Google Scholar
This list is based on the broad literature involving human subject protections. But some particulars come from the literature on DMCs which attempt, we believe unsuccessfully, to address some of these concerns. Haavi Morreim's work on patient advocates, supra note 105, was particularly helpful.Google Scholar
In using the word “vulnerable,” we intend to use it more broadly than the definition provided in the current regulations.Google Scholar
See Emanuel, and Emanuel, , supra note 28.Google Scholar
Chen, D. T. Miller, F. G., and Rosenstein, D. L., “Clinical Research and the Physician-Patient Relationship,” Annals of Internal Medicine 138, no. 8 (2003): 669–672 (describing physicians’ role in advising their patients who are considering volunteering for clinical research).CrossRefGoogle Scholar
Chen, D. T. and Shepherd, L. L., “Advising Patients about Obtaining Genomic Profiles,” Neurology Clinical Practice 1, no. 1 (2011): 5–12.CrossRefGoogle Scholar
See Chen, et al., supra note 137.Google Scholar
See Wilson, , supra note 103, at 229–30.Google Scholar
See, e.g., Employers’ Fire Ins. Co. v. Beals, 240 A.2d 397, 400 (R.I. 1968), overruled in part on other grounds, Peerless Ins. Co. v. Viegas, 667 A.2d 785 (R.I. 1995).Google Scholar
Fewer than 2% of adult cancer patients participate in clinical trials. Murthy, V. et al., “Participation in Cancer Clinical Trials,” JAMA 291, no. 8 (2004): 2720–2726.CrossRefGoogle Scholar
There are some reports that some oncologists do not tell their patients about available clinical trials because they would lose them as patients. Klabunde, C. N. et al., “A Population-Based Assessment of Specialty Physician Involvement in Cancer Clinical Trials,” Journal of National Cancer Institute 103, no. 5 (2011): 384–397.CrossRefGoogle Scholar
See, e.g., Comis, R. L. Miller, J. D. Aldige, C. R. Krebs, L., and Stoval, E., “Public Attitudes towards Participation in Cancer Clinical Trials,” Journal of Clinical Oncology 21, no. 5 (2003): 830–835, available at <http://www.harrisinteractive.com/news/allnewsbydate.asp?NewsID=941> (last visited December 6, 2012).CrossRefGoogle Scholar
Ford, F. G. Howerton, M. W., and Bolen, S. et al., Information on Recruitment of Underrepresented Populations to Cancer Clinical Trials. Evidence Report/Technology Assessment No. 122 AHRQ Publication No. 05-E019–2, Agency for Healthcare Research and Quality (June 2005), Rockville, MD; Kennedy, B. R. et al., “African Americans and their Distrust of the Health Care System: Healthcare for Diverse Populations,” Journal of Cultural Diversity 14, no. 2 (2007): 56–60.Google Scholar
In fact, experience with RSAs in studies involving minority populations has demonstrated that having a patient advocate can improve trust in the research and thus recruitment. See Easa, et al., supra note 110, at 3.Google Scholar