Law vs. Regulations in the Common Rule

By Jessica L. Roberts* & Valerie Gutmann Koch**, January 6, 2016

Inconsistencies in the Common Rule and the Law

Today marks the end of the comment period for the Notice of Proposed Rulemaking (“NPRM”) on the Federal Policy for the Protection of Human Subjects (“Common Rule”).[i] The Common Rule offers comprehensive, widespread protection for research subjects and the NPRM seeks to update and further strengthen its provisions. While ambitious, parts of the NPRM that presumably advance the ethical principles by which research should be conducted—respect for persons, beneficence, and justice—still lack corresponding legal protections. To be sure, the Common Rule has its own enforcement mechanism with significant financial penalties for researchers and institutions that run afoul of the regulations.[ii] However, research participants themselves are personally without legal remedies in two significant ways: (1) for violations of informed consent and (2) with respect to their potential commercial interests in research profits. Accordingly, we have urged the Department of Health and Human Services (“HHS”) to take further action on these important issues.

Research-Related Injuries

Research participants who experience harms as a result of their participation in research protocols have little, if any, recourse under the existing Common Rule or under the proposed changes in the NPRM.[iii] Currently, the United States does not require compensation for research-related injuries for research participants.[iv] And, in fact, the U.S. is an outlier in this respect in the international community. In 2013, it conspicuously refused to sign on to the seventh edition of the Declaration of Helsinki, which had added a new general principle: that “[a]ppropriate compensation and treatment for subjects who are harmed as a result of participating in research must be ensured.”[v] According to one study, only sixteen percent of academic medical centers in the United States make it a policy to pay for the care of injured subjects.[vi] Further, there is a robust literature focused on the absence of researcher liability, particularly with regard to a failure to provide informed consent.[vii]

The existing Common Rule relies on the autonomy principle in its informed consent requirements, and the NPRM, in summarizing the goals of the proposed changes to the Common Rule, states first its goal to “[i]ncrease subject autonomy by increasing human subjects’ ability and opportunity to make informed decisions.”[viii] However, despite the NPRM’s stated concerns regarding autonomy and public trust, research participants who are harmed due to their participation in a research protocol do not have the same recourse that patients do in the treatment context.  This distinction is based in historic artifact, and therefore even if this differential treatment was justifiable in the past, advances in research technology require a new approach

Current research poses a similar (or even greater) threat to participant autonomy as do medical interventions. First, as research evolves to focus more on human biological materials than on physical interventions, harmed research participants will be less able to rely on the traditional claim for battery. Second, as research on previously collected biological specimens proliferates, donors’ continued status as research participants becomes less certain,[ix] further implicating participants’ autonomy interests and privacy rights.[x]

Commercial Interests 

The commercial interests of research subjects are another place where the NPRM and the law diverge. With some exceptions,[xi] the NPRM would require investigators to provide, when appropriate, “[a] statement that the subject’s biospecimens may be used for commercial profit and whether the subject will or will not share in this commercial profit.”[xii]  This provision offers regulatory support for the well-known holding in the 1990 California Supreme Court case Moore v. Regents of the University of California that physicians must disclose their research and economic interests[xiii] to their patients and extends that rule beyond the treatment relationship to the contributors of biospecimens. However, in so doing, the NPRM creates a conflict between the law and the proposed regulations. One of the NPRM’s most significant proposed changes to the Common Rule was classifying any research done on biospecimens to be human subject research, regardless of whether the biospecimens are identifiable.[xiv] As a result, pursuant to the NPRM, most research on biospecimens requires informed consent. By contrast, at least one federal appellate court has held that researchers do not owe contributors of biospecimens—described as “donors” in contrast to research subjects and patients—any informed consent obligation.[xv] Like with informed consent, a violation of the Common Rule lacks a concomitant legal safeguard. Thus, failing to obtain an individual’s consent to do research on her biospecimen would violate her rights under the Common Rule yet could still leave her without her day in court.

Additionally, by requiring that investigators state whether the subject “will or will not share in this commercial profit,” the commercial disclosure provision implies that research subjects are capable of sharing in the financial proceeds of research. Allowing profit-sharing in research has certain benefits. It could empower research subjects by making them more active participants; it could create buy-in and increase the willingness to participate in research; and finally it could help to avoid potential feelings of exploitation, as research subjects will share in the profits of research. However, under the current law, individuals maintain no commercial interests in their excised tissue.[xvi] At this point in time, HHS has been glaringly silent as to whether the Common Rule—unlike the law—supports profit-sharing for the contributors of biospecimens.

Our Recommendations

While we acknowledge that HHS on its own cannot change the current state of the law, we nonetheless encourage the agency to take action regarding the current inconsistencies between the NPRM and the governing law.[xvii]

Statutory Private Right of Action for the Common Rule

Extending a private right of action to the research setting may provide necessary protection against the serious threat to participant autonomy that modern research poses.[xviii] In other words, research participants should have access to a meaningful remedy for harms that occur as a result of participating in research, similar to the access patients have to a remedy for harms that occur in the treatment context. Informed consent in the research context relies on the same operative principles of autonomy and respect for persons and the same duty of disclosure as informed consent in the treatment context. Importantly, both duties—the duty of the doctor to the patient to disclose relevant risks and benefits of a proposed intervention and the duty of the investigator to the participant to disclose the relevant risks and benefits of a proposed research protocol—are premised on the principle of autonomy. Further, provision of a remedy for research-related harms would not “chill medical research,”[xix] because the Common Rule already has a sufficient deterrent effect: the penalty for violation of the regulations governing human subjects research is loss of federal funding or suspension of research.[xx] Finally, allowing research participants a remedy for harms may increase public trust in the research enterprise.

Clarification Regarding the Commercial Interests of Research Subjects

Additionally, HHS should consider being more explicit when it comes to the potential financial interests of subjects in the research conducted on their biospecimens. A clear statement regarding whether a researcher-subject profit-sharing relationship is acceptable under the Common Rule is even more important given the lack of an independent legal entitlement. Consequently, HHS should make its position on the possibility of profit-sharing for the contributors of biospecimens explicit. Once the regulations are clear, perhaps the law will also follow suit. In the meantime, regulatory protection of research subjects’ commercial interests absent a legal entitlement is better than no protection at all.

Conclusion

The NPRM cites beneficence, respect for persons, and justice as guiding principles.[xxi] Yet HHS cannot simply espouse these lofty principles without providing for meaningful enforcement and clarity. Extending a statutory private right of action for the Common Rule would protect research subjects who voluntarily participate in research protocols that are intended to contribute to generalizable medical knowledge and to promote the public good. Additionally, explicitly acknowledging the potential commercial interests of research subjects in biomedical research may increase research participation and public support. The Common Rule can be a powerful means of safeguarding the rights of research participants. However, until the law and the Common Rule align, research subjects may continue to find themselves vulnerable, without access to appropriate recourse. Thus, HHS should do its part in ensuring the law moves in the right direction by advocating for a statutory private right of action and clarifying its position on profit-sharing in research.

 


* Associate Professor, Director, Health Law & Policy Institute University of Houston Law Center; 2018 Greenwall Faculty Scholar in Bioethics.

** Visiting Assistant Professor of Law Chicago-Kent College of Law; Lecturer, MacLean Center for Clinical Medical Ethics, University of Chicago.

[i] 80 Fed. Reg. 53933 (proposed Sept. 8, 2015).

[ii] Agencies may terminate funding for noncompliance. See 45 C.F.R. § 46.123.

[iii] Valerie Gutmann Koch, A Private Right of Action for Informed Consent in Research, 45 Seton Hall L. Rev. 173 (2015).

[iv] In 2011, the Presidential Commission for the Study of Bioethical Issues called for the federal government to study the issue of research-related injuries to determine if there is a need for a national system of compensation or treatment for research-related injuries. The Commission identified the fact that “previous presidentially appointed bioethics commissions and other duly appointed advisory bodies have made similar recommendations regarding compensation or treatment for research-related injuries; yet no clear response by the federal government has been issued.” Presidential Commission for the Study of Bioethical Issues, Moral Science: Protecting Participants in Human Subjects Research (2011), at 8, http://bioethics.gov/sites/default/files/Moral%20Science%20June%202012.pdf [http://perma.cc/TB85-QBT3].

[v] WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects, http://www.wma.net/en/30publications/10policies/b3/ [http://perma.cc/UP58-UM4Q].

[vi] Renuka Munshi and Urmila Thatte, Compensation for Research Related Injuries, 4 Perspectives in Clin. Research 61 (2013).

[vii] See, e.g.,Jessica W. Berg et al., Informed Consent: Legal Theory and Clinical Practice (Oxford Univ. Press, 2001); E. Haavi Morreim, Medical Research Litigation and Malpractice Tort Doctrines: Courts on a Learning Curve, 4 Hous. J. Health L. & Pol’y 1,63 (2003); Michelle M. Mello, David M. Studdert, & Troyen A. Brennan, The Rise of Litigation in Human Subjects Research, 139 Ann. Intern. Med. 40, 40 (2003); Roger L. Jansson, Researcher Liability for Negligence in Human Subject Research: Informed Consent and Researcher Malpractice Actions, 78 Wash. L. Rev. 229 (2003); Elizabeth R. Pike, Recovering from Research: a No-Fault Proposal to Compensate Injured Research Participants, 38 Am. J. L. & Med. 7 (2012); Leslie Meltzer Henry, Megan E. Larkin, & Elizabeth R. Pike, Just Compensation: a No-Fault Proposal for Research-Related Injuries, J. L. Biosciences (2015) (“The absence of a federal policy to address research-related injuries means that many injured research participants are abandoned at their most vulnerable moment by the very regulations designed to protect them.”).

[viii] 80 Fed. Reg.at 53941.

[ix] We recognize the NPRM’s efforts to clarify whether biospecimens would be considered human subjects.

[x] David Magnus & Mildred K. Cho, Issues in Oocyte Donation for Stem Cell Research, 308(5729) Science 1747 (2005); Geoff Lomax & Steve Peckman, Stem Cell Policy Exceptionalism: Proceed with Caution, 8 Stem Cell Rev. and Rep. 299 (2011).

[xi] See 80 Fed. Reg at 54053 (to be codified in 45 C.F.R. § 46.116(b).

[xii] Id. § 46.116(b)(7).

[xiii] Moore v. Regents of the Univ. Cal., 793 P.2d 479 (Cal. 1990).

[xiv] 80 Fed. Reg. at 54047; see also id. at 54042 (describing the proposal to expand the definition of human subject research to include non-identified biospecimens and referring to that proposed change as a “Major Proposal to Modernize the Common Rule”).

[xv] See, e.g.,Greenberg v. Miami Children’s Hosp., 264 F. Supp. 2d 1064 (S.D. Fla. 2003).

[xvi] See Moore, 793 P.2d. (holding that the plaintiff had no property rights in his excised tissue and affirming the lower court’s dismissal of his claim for conversion); see also Greenberg, 264 F. Supp. 2d (dismissing plaintiffs’ conversion claim and citing Moore). More recently, a federal court found that an informed consent document, which permitted the contributors of biospecimens to have their samples destroyed, did not likewise give them the authority to have their samples moved. See Washington University v. Catalona, 437 F. Supp. 2d 985 (E.D. Mo. 2006). While we take no position on whether such a commercial interest is desirable here, we nonetheless urge HHS to provide much needed clarity on this issue.

[xvii] Only Congress can create new rights enforceable under § 1983 of the Civil Rights Act; “agency regulations cannot give rise to a private right of action where the authorizing statute does not confer such a right.” Wright v. Fred Hutchinson Cancer Research Center, 269 F. Supp. 2d 1286, 1290.

[xviii] We acknowledge that Congress had “contemplated, but ultimately rejected, a statutory mechanism for the compensation of individuals and their families for injuries resulting from their participation in human subjects research.” Id. at 1290 n.1 (citing S. Rep. No. 93-381, at 197390). We believe it is time to revisit a statutory private right of action for the Common Rule.

[xix] Greenberg v. Miami Children’s Hosp. Research Inst., 264 F. Supp. 2d 1064, 1070 (S.D. Fla. 2003).

[xx] Office for Human Research Protections (OHRP), Department of Health and Services, OHRP’s Compliance Oversight Procedures for Evaluating Institutions (October 14, 2009), http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf [http://perma.cc/TP76-67BH]. 45 C.F.R. § 46.123(a) (2003); 21 C.F.R. § 56.121 (2003).

[xxi] See 80 Fed. Reg.at 53940-41.

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