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9 Ethical, Legal, and Regulatory Framework for Human Subjects Research
Pages 153-170

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From page 153...
... 3 The resulting Belmont Report, issued in 1978, drew a sharp distinction between research, defined as "an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge," and practice, or "interventions…designed solely to enhance the wellbeing of an individual patient or client." 4 In addition, and most important, the report articulated three basic principles that provide the ethical foundation for the conduct of research involving human subjects (see Box 9-1)
From page 154...
... BOX 9-1 Ethical Principles and Applications Outlined in the 1978 Belmont Report Ethical Principle Application in the Research Setting Respect for Persons Informed consent – information – comprehension – voluntariness Additional protections for persons with diminished auton omy Beneficence Maximizing benefits for research participants and society Minimizing harm to research participants Justice Ensuring fair distribution of the benefits and burdens of research 5 Ibid.
From page 155...
... 8 Furthermore, while the Belmont Report did not explicitly articulate an obligation to participate in research, some believe that as all are potential beneficiaries of biomedical and sociobehavioral research, all have a responsibility, when opportunities arise and risks are minimal, to participate in research, as broad participation contributes to a greater understanding of human health, disease, and the effectiveness of proposed therapies across a broader spectrum of society, thus providing benefits to the entire population. Thus, research involving human subjects poses profound and unanswered questions about our status as both potential participants in and beneficiaries of the knowledge gained from biomedical and behavioral studies and about our rights and responsibilities as individuals versus our obligations as members of society.
From page 156...
... Given these formidable questions about the application and scope of the Belmont principles, it is necessary to broadly reconsider the legal and regulatory frameworks governing human subjects research, including the optimal locus of regulatory authority within the executive branch. Should oversight reside within each executive branch agency that funds human research, as is currently the case, or within a single independent federal agency that oversees and regulates all federally funded human research?
From page 157...
... The rapidly changing circumstances surrounding research involving human subjects have led many to ask how the protections of human subjects articulated by the Belmont principles can best be maintained given new research capabilities, the accumulation and accessibility of large amounts of personal information, including health data, and the size and reach of the research enterprise. Addressing these challenges, which the framers of the Belmont Report and Common Rule could not have envisioned, will require judicious and creative thinking about how to balance our societal obligation to protect human subjects in research with the goal of maximizing the benefits to human well-being of society's investments in biomedical and sociobehavioral research.
From page 158...
... As will be demonstrated below, the current regulatory atmosphere indicates that our nation would benefit from a standing independent national advisory commission tasked with regularly examining and updating regulations governing all federally funded human subjects research and charged with addressing difficult and precedent-setting cases as well as matters of general policy. During a presentation at a recent meeting of the Secretary's Advisory Committee on Human Research Protections, 19 Lauren Hartsmith of the HHS Office of Human Research Protections (OHRP)
From page 159...
... Other laws or regulations that currently mandate the protection of human research participants would need to be examined as a part of the development of the envisioned safeguards. The omission of specifics on key tools and guidelines like the exemption determination tool, consent templates, and list of privacy safeguards is problematic; because the items are undefined at present, it is impossible to comment on their merit or utility prior to the issuance of the final rule.
From page 160...
... Examples of excluded research include: "collection and analysis of data, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes;" "quality assurance or improvement activities involving the implementation of an accepted practice to improve the delivery or quality of care or services;" and "public health surveillance activities, including the collection and testing of biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority and limited to those necessary to allow the public health authority to identify, monitor, assess, or investigate potential public health signals or the onset of a disease outbreak." 26 In assessing the proposed exclusions, one researcher observed that some exclusions "will likely be widely welcomed, such as…[an] explicit exclusion of journalism, oral history, biography, and historical scholarship activities." However, there is "worry that the exclusion of certain activities…could lead to a weakening of subject protections." "The proposed rule does not…offer insight into how determinations about whether the disclosure of information would reasonably place subjects at risk will be made." 27 Further, the NPRM does not sufficiently describe how the proposed exclusions will be implemented to ensure adequate protection of human research participants.
From page 161...
... 30 J Menikoff, HHS Office of Human Research Protections at May 18-19, 2016 SACHRP Meeting.
From page 162...
... waiver of consent for secondary research use of biospecimens."c The associations also reviewed comments on "proposals to mandate use of a single IRB for multisite studies; extend the Common Rule to all clinical trials regardless of funding source at institutions that receive federal funding for human subjects research; proposed standard security safeguards; and the proposal to post clinical trial consent forms to a federal website."d In addition, "general assessments of the status of the NPRM were considered."e The review found "significant opposition to most major proposals" and a number of responses that "suggested that the NPRM is overly complex, poorly written, and not supported by data."f The associations note that, in its comment letter, the Presidential Commission for the Study of Bioethical Issues "suggested that the primary proposal to expand the definition of ‘human subject' to include all non-identified biospecimens is incon sistent with the ethical rationale described in the NPRM and will stall certain kinds of research using deidentified biospecimens that pose no risk to human subjects and are unlikely to impact participants' autonomy interests."f Further, the HHS Secretary's Advisory Committee for Human Research Protections (SACHRP) "concluded that, ‘To the extent that the NPRM's core proposal is meant to ensure that subjects provide meaningful consent to future research with biospecimens and to prevent biospecimen re-identification, the NPRM would do nothing of the sort.'"g A "majority of responses, approximately 1,520, addressed one or more of the pro posed changes…involving non-identified biospecimens.
From page 163...
... In this group, two institutions did not comment on single review boards and only one institution expressed partial support for two of the three provisions. 74% of the top 40 ranked research institutions responded and 96% opposed the biospecimens and broad consent provisions.j __________________________ a Council on Governmental Relations and Association of Public and Land-grant Uni versities.
From page 164...
... The inability to envision future opportunities for research that could advance knowledge raises questions about the meaning and ethical sufficiency of "broad consent." If, for example, waivers were unavailable for the clinical use of biospecimens for which no research use was intended at the time of excision or collection, critical post facto correlations, for example, between the Zika virus and microcephaly, may go unrecognized. Redefining research with de-identified biospecimens as human subjects research would impose significant burdens and limitations on research institutions and the ability of research institutions to obtain specimens from health institutions that do not have the infrastructure or resources to comply with the proposed revisions to the Common Rule.
From page 165...
... 33 That some find the implications of broad consent for future research troubling 34 is another compelling example of the need for thoughtful deliberation about how best to protect individual human research subjects while continuing to advance medical knowledge that will benefit many -- including, potentially, subjects themselves and their loved ones. Further, there is little evidence that individuals understand exactly what they are being asked to consent to.
From page 166...
... Further, the associated financial 37 and societal costs will be significant. Many clinical care facilities, such as those serving underserved or rural populations, for example, may not be able to bear these costs, thereby undermining the principles of justice and beneficence by skewing research toward studies and populations that can be accommodated only at large medical centers.
From page 167...
... In addition, the overarching legal and regulatory frameworks and institutional arrangements governing human research subjects require reconsideration and clarification. Addressing contemporary challenges associated with human subjects research, including new research capabilities and contexts; the profusion, sharing, and accessibility of personal data; and increasing privacy concerns, will require creative and forward-looking legal, regulatory, and institutional frameworks.
From page 168...
... Congress should charge the proposed commission with examining and updating as necessary the ethical, legal, and institutional frameworks governing human subjects research. The commission should make recommendations to the President, Congress, and relevant federal agencies regarding how the basic ethical principles governing human subjects research should be applied to unresolved human research questions and novel human research contexts, including but not limited to: Research involving anonymous and de-identified human biospecimens; Research involving large datasets, for example, research with human ge nomic, transcriptomic, proteomic, or metabolomic data or associated DNA, RNA, and protein analyses and relevant integrated approaches; Research in which the interests of discrete and insular communities are at stake; Clinical studies conducted in emergency settings; Research involving adults with diminished decision-making capacities; 40 The committee notes that the National Research Council report cited earlier recommended the formation of an independent committee or commission to address comparable issues.
From page 169...
... Recommend to the President and Congress ethically sound regula tory approaches for unresolved questions in human subjects re search, including: The scope of human research activities that should be covered by federal regulations for human subjects research (including the determination of the types of low-risk research activities, such as some types of sociobe havioral research, that should fall outside the scope of the regulations) ; How regulation should address the increasingly blurred boundaries be tween research and medical care and the means by which new regula tions should distinguish between the two; How to incorporate investigator responsibilities into human subjects re search regulations; and How to balance individual rights, such as the right to privacy, with col lective obligations to advance public health and well-being.
From page 170...
... The committee further recommends that the regulatory structure protecting human research subjects not be revised until the national commission has issued its report and the research community, patient groups, the public, and others have had an opportunity to consider and respond to the commission's recommendations.


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