Future Uses of the Department of Defense Joint Pathology Center Biorepository (2012) / Chapter Skim
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3 Ethical, Legal, and Regulatory Considerations
3 Ethical, Legal, and Regulatory Considerations
Pages 65-108
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From page 65... ...
The chapter finishes with an examination of the federal laws and regulations, DoD d irectives and instructions, and Armed Forces Institute of Pathology and Joint Pathology Center (JPC) regulations regarding research on bio specimens and their associated data.
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From page 66... ...
Public Health Service syphilis study at Tuskegee, the Jewish Chronic Disease Hospital case, the Willowbrook hepatitis study, and other such events in the United States from the 1930s to the 1970s transformed approaches to research involving human subjects (Katz, 1972) , recent attention to problematic uses of human biologic m aterials in research have altered the ethical, legal, and regulatory landscape of bio repositories.
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From page 67... ...
The term seems accurate enough in suggesting that the JPC is archiving material of potential value. But by placing emphasis on the biologic material, tissue repository fails to signal the presence of associated data in the JPC collections, such as medical records and pathology reports, or of the digital slide collection.
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From page 68... ...
In 1999, when the National Bioethics Advisory Commission issued a report with recommendations on the ethical use of stored human tissue, it was reflecting a new sensitivity to the ethical, legal, and regulatory issues raised by collecting, storing, and using those specimens and associated data. A substantial literature has since arisen analyzing the ethical and legal issues raised by such collections of human material (Eiseman et al., 2003; Weir and Olick, 2004)
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From page 69... ...
To address that question, the following section discusses the surrounding ethical and legal landscape and the current challenges posed as the standards evolve. Traditional Ethical Principles and the Need for a Contemporary Approach Three and a half decades have passed since the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued its landmark Belmont Report in response to its mandate from Congress "to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research" (National Research Act, PL 93-348; July 12, 1974)
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, which allows research without consent on de-identified samples that were not originally collected for research, continues this approach by determining that de-identified specimens are not considered "human subjects" at all (OHRP, 2008a)
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Although issues of that sort were not in the foreground when the Belmont principles were set forth, the desire not to foreclose all research for which obtaining individual informed consent would be difficult or impossible was certainly on the minds of the authors of the federal regulations on human-subjects research, now stated in the Common Rule. Influenced in particular by large-scale studies that involved data that were either publicly accessible or anonymous or that involved the use of dead bodies or material obtained from them (as was an accepted part of hospital a utopsies and m edical-school education)
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From page 72... ...
It is also important to recognize, where appropriate and possible, responsibility to the individual sources of biological specimens and data -- sometimes called participants -- even if the research does not qualify as research on human subjects under the Common Rule. Because of the historical nature of the JPC collection, it makes more sense to adopt a governance framework that captures the fiduciary obligations of the collection holders (such as stewardship over the specimens and data)
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From page 73... ...
. In the United States, in contrast, requirements for informed consent to research on biologic specimens have generally been closely connected with risks to privacy and confidentiality, considered the major risks posed by research uses of excised tissue and associated data (Elger and Caplan, 2006; Tutton, 2010)
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. Studies suggest that sources want more control, even though they do not necessarily insist on exercising specific informed consent to particular research protocols (Hoeyer, 2008; Wendler and Emanuel, 2002)
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The principle of beneficence has generally been specified through two complementary general rules: to do no harm and to maximize possible benefits and minimize possible harms (National Commission, 1978)
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Institutional Review Regulatory compliance Board Subject protections Access Request Assess security risk Establish terms of use Data & Material Access Negotiate IP as needed Committee Conduct audits Collect progress reports Provide input into policies Community Advisory Oversight for practices Board Consultation for difficult cases FIGURE 3-1 A biorepository governance mechanism that uses a scientific review committee, an institutional review board, a data and material access committee, and a community advisory board. NOTE: IP = intellectual property.
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From page 77... ...
One example-addressed later in the chapter -- is the tension between the Common Rule (as interpreted by OHRP) , which allows general consent for research uses of donated tissue, and HIPAA, which requires authorization by a patient for the use of his or her protected health information (PHI)
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From page 78... ...
At the end of the chapter, the committee offers some concluding reflections on consent and custodianship of biological materials and associated data. CONSIDERATIONS REGARDING THE SOURCE OF SPECIMENS The DoD, noting that the JPC repository contains consultation material from both military facilities and civilian providers, asked the committee to offer comments on whether materials from civilian providers could be used in the future in the same manner as those from military facilities.
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. Rules regarding personal representatives under the HIPAA Privacy Rule are explicated in 45 CFR 164.502(g)
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to researchers and research institutions; and second, access to particular specimens, and sometimes related data, for particular research projects. The two differ in that a presumption of relatively easy access to specimens seems to accompany the creation of a biobank, whereas a case-by-case decision process admits of the possibility, but not necessarily the probability, that researchers will be able to make use of material in the JPC collection for research purposes.
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CONSIDERATIONS REGARDING RESEARCH ON DIAGNOSTIC SPECIMENS AND ASSOCIATED DATA The committee was asked to offer advice on whether tissue collected for clinical use may be used for research, including cases in which the tissue came from patients who did not specifically consent to its use in research. As noted above, this is a complex question of law, ethics, and policy.
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That included the acceptability of research not only on tissue but on the associated material (such as X-ray images and computed tomography scans) and clinical data (such as patient information provided by the contributing physician up to and including patient medical records)
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The form states that "pathology consultation records contain individually identifiable health information." Although it notes that the contributor's providing patient information on the form is voluntary, it also says that "if the information is not furnished, a consultation may not be possible." Thus, research on specimens might include research on associated data. Furthermore, a portion of the repository's BRAC Collection consists of only records with no associated biospecimens.
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From page 84... ...
Further, when such use is permitted, the goal is to articulate the various considerations and conditions surrounding research use. Generally speaking, research on biospecimens and associated data in the United States is subject to two16 primary sets of federal rules related to the protection of study subjects and their health information: those promulgated under HIPAA and the implementing regulations at 45 CFR Part 164, and the so-called Common Rule, the regulations for protection of h uman subjects in research adopted by federal departments and agencies that conduct and sponsor such research (including the DoD and the Department of Veterans Affairs)
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that health care professionals and institutions are permitted to make. PHI is defined as "individually identifiable health information" that is held or transmitted by a "covered entity."18 Although the HIPAA Privacy Rule applies to information uses and transactions necessary for the provision of health care, it is also applicable to a great deal of information used in health research.
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In crafting the Privacy Rule, HHS acknowledged that it is not always possible to obtain authorization for using or disclosing PHI for research, particularly in circumstances in which thousands of records may be in TABLE 3-1 Individual Identifiers Under the Privacy Rule The following 18 identifiers of a person or of relatives, employers, or household members of a person must be removed, and the covered entity must not have actual knowledge that the information could be used alone or in combination with other information to identify the individual for the information to be considered deidentified and not protected health information. · Names · A ll geographic subdivisions smaller than a state, including county, city, street address, precinct, ZIP code (first 3 digits OK if geographic unit contains over 20,000 persons)
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Privacy and confidentiality protections are included as important protections against some kinds of risk in research. The framework for achieving the goal of protecting human subjects is based on two foundational requirements: the informed consent of the research participant and the review of proposed research by an IRB.
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Some research on human biospecimens and associated data does not constitute research on human subjects as defined by the Common Rule. OHRP has issued guidance on ethical approaches to such research on human materials (2008a,b)
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Use or disclosure involves no more than minimal risk to the privacy of individuals because of the presence of at least the following elements: (a) An adequate plan to protect health information identifiers from improper use or disclosure, (b)
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IRB or Required for projects involving Required for all projects involving privacy board requests to alter or waive the human subjects supported, conducted, requirement individuals' authorization for or regulated by a federal department the use or disclosure of their or agency. protected health information for research purposes.
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. cIn order to qualify as minimal risk there must be an adequate plan to protect health information identifiers from improper use or disclosure, an adequate plan to destroy identifiers at the earliest opportunity in the absence of a health or research justification or legal requirement to retain them, and adequate written assurances that personal-health information will not be used or disclosed to a third party except as required by law, for authorized oversight of the research study, or for other research uses and disclosures permitted by the Privacy Rule.
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Although the Common Rule restricts its definition of "human subjects" to living individuals, HIPAA applies to both the living and the deceased. HIPAA requires assurance from researchers who seek to use or disclose PHI from deceased persons that With and colleagues (2011)
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Consent is currently required unless research falls under the deidentification exceptions, including waivers, contained in the Common Rule and the HIPAA Privacy Rule. Much of the justification for not requiring consent rests on the idea that as long as participants remain unidentifiable, potential harm is so limited that it makes consent unnecessary.
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In addition to applying the Common Rule, Directive 3216.02 requires the appointment of an independent medical monitor for research involving more than minimal risk to participants, requires auditing for research misconduct, requires training in research ethics for personnel involved in research with human participants, and includes a variety of other substantive and procedural requirements beyond those in the Common Rule. In November 2011, the DoD issued Instruction (DoDI)
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Armed Forces Institute of Pathology and Joint Pathology Center Rules Addressing Human-Subjects Research and Privacy A number of AFIP22 and JPC regulations articulate their compliance with civilian and military human-subjects research and privacy rules. The 22JPC, which became fully operational in September 2011, is still in the process of establishing its own regulations and policies.
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· designating appropriate representatives to carry out privacy func tions in accordance with applicable federal and state laws and regulations. · incorporating parameters to monitor and improve compliance with health information privacy standards in the design of the organiza tional compliance program.
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that we may disclose your protected health information to researchers when authorized by law, for example, if their research has been approved by an institutional review board that has reviewed the research proposal and established protocols to ensure the privacy of your protected health information. And, as noted in Chapter 1, the JPC Contributor's Consultation Request Form (2011a)
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Investigators and others who collected and stored human biological mate rials now have the opportunity to correct past inadequacies by obtaining more specific and clearly understood informed consent. It also specifically addressed research use of pre-existing samples -- those obtained before the implementation of its recommendations -- urging (p.
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From page 99... ...
Several well-recognized challenges regarding informed consent to research involve archival biospecimens. Even when recontact and consent or reconsent are possible because the individual sources are still alive, requesting consent for already archived materials can be prohibitively expensive; further, the act of contacting a source for consent can itself be regarded as an invasion of the privacy or, at the least an unwelcome intrusion, especially for persons who were unaware that their or their family's tissue was used for research (Bathe and McGuire, 2009)
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No Yes Conduct Research; No Need to Is the proposed research minimal risk (data Re-Consent shared in restricted database, ethical review, con dentiality, research not potentially stigmatizing or sensitive)
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. If the JPC continues to collect biospecimens and associated data, it will need to determine what kind of consent is appropriate for the research use of the newly acquired materials and the extent (if any)
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risk vs. benefits sample use riskbenefit tradeoff which permits diverse gained · Meaningful choice · Issues at stake for participant preferences and · Respects negative right is possible without individuals other than facilitates recontact of privacy through overburdening source or risk of reidentification · HIPAA requires purpose requiring minimal risk of institution with consent (anonymization is not the specific information for reidentification processes only concern)
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not meet autonomy nonresponders · Misses an important · Can be difficult to obligations while creating · Can be difficult to ensure public education identify all data and undue burdens) that notification has been opportunity specimens for removal · Can be difficult to ensure read and understood correctly consent has been read or, · Can be difficult to ensure given the broad nature of that notification has been consent, understood read and understood · Can be disruptive to the research collection Special · Current standard of · Preventive approach to · Historically traumatized · As technology improves our considerations practice in most settings liability risk populations may need ability to manage individual · Useful for routine · Public websites and additional choice options preferences, these dynamic projects and minimal risk materials can serve to build trust consent options should or high-public-benefit multiple purposes (such · Proposed changes to the become more useful projects (such as public- as marketing, outreach)
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2006. Belmont revisited: Ethical principles for research with human subjects.
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2003b. Protection of personal health information in research: Understanding the HIPAA privacy rule.
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1978. Belmont report: ethical principles and guide lines for the protection of human subjects of research, report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
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2008. The importance and value of protecting the privacy of health information: Roles of HIPAA Privacy Rule and the Common Rule in health research.
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PowerPoint presentation before the Committee on Review of the Appropriate Use of AFIP's Tissue Repository Following Its Transfer to the Joint Pathology Center.
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