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Federal Register / Vol. 86, No. 8 / Wednesday, January 13, 2021 / Proposed Rules in addition to the issues that suggest a need for revision, is not without precedent. In its 2001 concluding report, the National Bioethics Advisory Commission NBAC made 30
recommendations that addressed areas including the scope and structure of the oversight system and the level of review applied to research; it emphasized the importance of the informed consent process, documentation and waiver of informed consent, protecting privacy and confidentiality, adverse event reporting, and review of cooperative or multi-site research studies.14
In January 2017, as part of an Executive Branch-wide update to the Common Rule, HHS promulgated revisions to Subpart A in order to modernize, strengthen, and make the Common Rule more effective. Among other things, the revisions established new requirements regarding the information that must be given as part of the informed consent process to prospective research subjects.15 The executive summary of the 2017 final rule noted that, to the extent appropriate, the intent is to eventually amend the other subparts of the HHS
human subjects protection regulations in 45 CFR part 46 subparts B, C, D, and E. 16
The notice of proposed rulemaking which led to the January 2017 revisions to the Common Rule proposed requiring consent for the use of de-identified biospecimens but not for the use of biospecimens from deceased individuals, which was outside the scope of the Common Rule. As a result of comments, the Common Rule agencies declined to finalized such requirements in the 2017 Common Rule.
See Federal Policy for the Protection of Human Subjects, 82 FR 7149, 7150, 7153 Jan. 17, 2017.17
However, federal and state courts have recognized the importance of obtaining informed consent prior to conducting medical procedures or research on human subjects, or before 14 National Bioethics Advisory Commission, Ethical and Policy Issues in Research Involving Human Participants. Bethesda, MD; 2001.
15 82 FR 7150. Examples of provisions of the Common Rule governing informed consent can currently be found at 75 CFR 46.116, 46.117, 46.204, and 46.205.
16 82 FR 7151.
17 For purposes of the 2017 Common Rule, a human subject includes a living person from whom a researcher obtains a biospecimen and, thus, requires informed consent with respect to the use of identifiable biospecimens in research. See, e.g., 45 CFR 46.101a, 46.102e definition of human subject, 46.104d7, d8. Similarly, under Subpart B, if information associated with fetal material is recorded for research purposes in a manner that living individuals can be identified, they are research subjects. 45 CFR 46.206b.

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tissue taken from an individual is used in research. In the seminal case of Canterbury v. Spence, the D.C. Circuit Court of Appeals observed that every human being of adult years and sound mind has a right to determine what shall be done with his own body. . . . True consent to what happens to ones self is the informed exercise of a choice, and that entails an opportunity to evaluate knowledgeably the options available and the risks attendant upon each. 18
Moreover, it is normally impossible to obtain a consent worthy of the name unless the physician first elucidates the options and the perils for the patients edification. Thus the physician has long borne a duty, on pain of liability for unauthorized treatment, to make adequate disclosure to the patient. 19
Subsequent courts have expounded that informed consent is necessary if a patients tissue is to be used in research, especially where the physician extracting the tissue or his or her institution has a research or commercial interest. For example, in Moore v.
Regents of University of California, the California Supreme Court held that, prior to providing medical treatment, a physician must obtain the patients informed consent, which requires disclosing all of the physicians research and economic interests.20 As Moore recognized, informed consent is particularly important where the physician extracts human cells for use in subsequent research, since a physician who treats a patient in whom he also has a research interest has potentially conflicting loyalties. This is because medical treatment decisions are made on the basis of proportionality weighing the benefits to the patient against the risks to the patient. . . . A
physician who adds his own research interests to this balance may be tempted to order a scientifically useful procedure or test that offers marginal, or no, benefits to the patient. 21 Courts in other states have since recognized that informed consent is required prior to conducting research or performing various medical procedures.22
Many states have banned or placed strict limits on using human fetal tissue 18 Canterbury v. Spence, 464 F.2d 772, 780 D.C.
Cir. 1972.
19 Id. at 783.
20 See Moore v. Regents of Univ. of Cal., 793 P.2d 479, 483 Cal. 1990.
21 Id. at 484 emphasis in original.
22 See, e.g., T.D. v. N.Y. State Office of Mental Health, 228 A.D.2d 95, 116 N.Y. App. Div. 1996
describing New York law regarding informed consent for being a human research subject;
DeGennaro v. Tandon, 873 A.2d 191, 189197
Conn. App. 2005 collecting cases requiring informed consent prior to undergoing medical procedures.

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in research.23 Those states that have not banned human fetal tissue research often require the consent of the pregnant woman for the fetal tissue donation.24
The research and medical communities have also recognized the importance of obtaining informed consent before engaging in human fetal tissue research. In June 2016, the American Medical Association AMA
issued a Code of Medical Ethics Opinion Code of Ethics Opinion that listed several steps that physicians involved in human fetal tissue research should take, including obtaining the informed consent of the pregnant woman.25 The AMA recognized that the use of fetal tissue for research purposes raises a number of ethical considerations, including the degree to which a womans decision to have an abortion might be influenced by the opportunity to donate fetal tissue. 26 It further recognized that concerns have also been raised about potential conflicts of interest when there is possible financial benefit to those who are involved in the retrieval, storage, testing, preparation, and delivery of fetal tissues. Consequently, to protect the interests of pregnant women as well as the integrity of science, the Code of Ethics Opinion stated that physicians who are involved in research that uses human fetal tissue should:
Not offer money in exchange for fetal tissue.
In all instances, obtain the womans voluntary, informed consent, including for fetal tissue from a miscarriage spontaneous abortion for research. Under the Code of Ethics Opinion, informed consent includes a disclosure of the nature of the research including the purpose of using fetal tissue, as well as informing the woman of a right to refuse to participate.
When fetal tissue from an induced abortion is used for research purposes, ensure that:
The womans decision to terminate the pregnancy is made prior to and independent of any discussion of 23 E.g., Ariz. Rev. Stat. Ann. 362302 2016;
Ark. Code Ann. 2017802 2019; Fla. Stat. Ann.
390.0111 2018; Ky. Rev. Stat. Ann. 436.026; La.
Rev. Stat. Ann. 40:1061.24 2015; Me. Rev. Stat.
Ann. tit. 22, 1593; Mass. Gen. Laws Ann. ch. 112, 12J 2008; Mich. Comp. Laws 333.2685; Minn.
Stat. Ann. 145.422; Mo. Ann. Stat. 188.036; N.D.
Cent. Code 1402.201; N.D. Cent. Code 14
02.202; N.M. Stat. Ann. 249A3; Ohio Rev.
Code Ann. 2919.14; Okla. Stat. Ann. tit. 63, 1
735; R.I. Gen. Laws 11541; S.D. Codified Laws 3423A17; Utah Code Ann. 767310; Wyo.
Stat. Ann. 356115 2017.
24 E.g., 17 CA ADC 100085 2019.
25 AMA Code of Medical Ethics Opinion 7.3.5, available at https www.ama-assn.org/deliveringcare/ethics/research-using-human-fetal-tissue.
26 Id.

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