A Policy in Flux: New York State's Evolving Approach to Human Subjects Research Involving Individuals Who Lack Consent Capacity

See, e.g., Bristol N. , “US Reviews Human Trial Participant Protections,” The Lancet 376, no. 9757 (2010): 1975–76, at 1975.

Beecher H.K. , “Ethics and Clinical Research,” New England Journal of Medicine 274, no. 24 (1966): 1354–1360.

N.Y. Pub. Health Law Art. 24-A.

Where research is both federally and state funded, only the federal rules apply.

T.D. v. N.Y. State Office of Mental Health, 228 A.2d 95 (1st Dept. -) (citing 4 N.Y.C.R.R. § 527.10(b)).

Id.

T.D. v. N.Y. State Office of Mental Health, 650 N.Y.S.2d 175, 177 (App. Div. 1996).

T.D. v. N.Y. State Office of Mental Health, 690 N.E.2d 1259 (Ct. App. N.Y. 1997).

See Department of Health Advisory Work Group on Human Subject Research Involving Protected Classes, Recommendations on the Oversight of Human Subject Research Involving Protected Classes (1998): At 16, available at <http://www.nysl.nysed.gov/scandoclinks/ocm49377072.htm>(last visited July 30, 2014).

Hoffmann D. E. Schwartz J. DeRenzo E. G. , “Regulating Research with Decisionally Impaired Individuals: Are We Making Progress?” DePaul Journal of Health Care Law 3, no. 3–4 (2000): 547–608, at 591.

Birnbaum G. , “Hosps Fight for Freedom to Experiment,” N.Y. Post, March 21, 1999: At 20.

See Hoffmann , supra note 10 (citing a “series of articles that appeared in the New York Post on the … recommendations in early 1999.”). “According to one article, John Cardinal O'Connor, ‘evoking Nazi Germany, warned … that the recommendations were dangerous’ and ‘[a]dvocates for the mentally ill vowed to go to court if necessary to block them.’ A subsequent article stated that ‘hundreds of advocates for the mentally ill protested at the Capitol’ against what they viewed as recommendations supporting ‘state-sponsored drug experiments using vulnerable people as ‘human guinea pigs.’ ‘The article further recounted that Cardinal O'Connor, prior to a meeting on this issue with Governor Pataki, said that ‘to allow experiments with some risk – and no benefit to the subject – on adults who are too ill to consent on their own … could be a potentially horrifying thing.”’ Id. See Birnbaum G. , “O'Connor Boosts Drug-Test Protesters,” N.Y. Post, March 10, 1999: At 12 (stating that “[t]he department has not yet acted on the recommendations … and is still analyzing the complex proposals after seeking public comment on them.”);

Birnbaum G. , “Hosps Fight for Freedom to Experiment,” N.Y. Post, March 21, 1999: At 20.

See also Dresser R. , “Dementia Research: Ethics and Policy for the Twenty-First Century,” Georgia Law Review 35, no. 2 (2001): 661–90, at 689 (“politics and the bureaucracy have kept the … New York recommendations from being enacted into policy.”).

The New York State Task Force on Life and the Law, Report and Recommendations for Research with Human Subjects Who Lack Consent Capacity (2014), available at <http://www.health.ny.gov/regulations/task_force/reports_publications/>(last visited July 30, 2014). See also Koch V. G. Han S. A. , “‘Of Vital Importance’ The New York State Task Force on Life and the Law's Report and Recommendations for Research with Human Subjects Who Lack Consent Capacity,” New York State Bar Association Health Law Journal 19, no. 1 (2014): 27–37.

Pursuant to Public Health Law 24-A, the Department of Health may promulgate rules and regulations only for protocols that are not federally funded or otherwise federally regulated.

Roxland B. Zoubul C. , “The Family Health Care Decisions Act and Human Subjects Research in New York State,” New York State Bar Association Health Law Journal 16, no. 1 (2011): 84–89.

The Task Force recognized that for research that is categorized as offering no prospect of direct benefit, it may nevertheless be unclear whether the study has more than a negligible prospect of direct benefit or, if more than negligible, how much more; clarity (or its absence) often depends on the current state of available scientific knowledge. In order to clarify this statement, the Task Force offers the example of deep brain stimulation: Prospectively, the desired (and achieved) benefit in cases where deep brain stimulation has been administered to patients who have experienced traumatic brain injury and are in minimally conscious states is uncertain. Although the surgical procedure involves more than a minor increase over minimal risk, there are no other known clinical or research interventions that may improve the condition of these patients. Because deep brain stimulation is an innovative and risky procedure, with little data available, it would be arguably improper to suggest that the study holds out a prospect of direct benefit. However, in the few instances in which the procedure has been performed, remarkable progress has been shown and such knowledge may be invaluable for future studies.

This special review panel is based on the Common Rule's section 407 Review Children's Panels, which examines research protocols involving children that are otherwise not approvable because of their risk level.

45 C.F.R. § 46.111.

Coleman C. H. , “Research with Decisionally Incapacitated Human Subjects: An Argument for a Systemic Approach to Risk-Benefit Assessment,” Indiana Law Journal 83, no. 3 (2008): 743–89, at 765.

Saks E. R. , “Proxy Consent to Research: The Legal Landscape,” Yale Journal of Health Policy, Law, & Ethics 8, no. 1 (2008): 37–92, at 46. Twenty-seven had an explicit statute on proxy consent to research in general. And federal law defers to the states to establish who may serve as an LAR, looking to their formulations of LAR to determine who may consent to research conducted in that state. Thus, states with an explicit health care/treatment surrogate hierarchy may rely on that list to appoint an LAR to research.

See Hoffmann , supra note 10, at 591;.

Coleman , supra note 19, at 745.

Id., at 764.

Id., at 765 (citing Cal. Health & Safety Code § 24178 (2007);

Kan. Stat. Ann. § 65–4974 (2006);

N.J. Stat. § 26:14–1 (2008);

Va. Code Ann. § 32.1–162.18(B) (2008), 12 Va. Admin. Code § 5-20-40 (2007);

Okla. Stat. Ann. tit. 63, § 3102A (2007);

Wyo. Stat. Ann. § 25-5-132(d)(iii) (2007)). Some states have statutes authorizing surrogate consent to “experimental treatment” for certain incapacitated patients

See, e.g., Fla. Stat. Ann. § 393.13(4)(c)(6) (2007). However, these statutes would probably exclude studies that do not offer a prospect of direct medical benefit, as such studies could not plausibly be considered a form of treatment.

See Saks , supra note 20.