Responsible Research A Systems Approach to Protecting Research Participants (2003) / Chapter Skim
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7 Improving an Evolving National Human Research Participant Protection System
7 Improving an Evolving National Human Research Participant Protection System
Pages 197-216
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From page 197... ...
This chapter focuses on the relationship of individual Human Research Participant Protection Programs (HRPPPs) to a larger protection system one that includes sponsors, regulatory agencies, journal publishers, and policy makers.
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From page 198... ...
The committee applauds the emphasis of the Office for Human Research Protections (OHRP) on "protection without over-reaction" and the increased emphasis on providing education and engaging in discussion.
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From page 199... ...
Thus, DHHS created the National Human Research Protections Advisory Committee (NHRPAC) to provide expert advice and recommendations to the Secretary of DHHS, the Director of OHRP, and other departmental officials on a broad range of issues and topics pertaining to or associated with the protection of human research subjects.3 NHRPAC's charter reads in part as follows: The Committee will provide advice on the development and management of collaborations and communications between HHS and its operating and staff divisions and other pertinent elements of the federal government; the biomedical, academic, and research communities; non-governmental entities; and other organizations as necessary to further the interests of the human subjects protection enterprise.
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From page 200... ...
It also provides guidance on relevant accreditation standards.4 A similar independent body could be useful to the ongoing development of protections for research participants. The potential for conflicts in the current configuration of OHRP and NHRPAC justifies this proposal of an alternative model, which would provide ongoing advice and guidance on the scientific (clinical and social/ behavioral)
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From page 201... ...
It is difficult to justify denying the public knowledge about existing research, particularly if it is publicly funded. Even in the context of classified research sponsored or funded by the government, the protection of Research Ethics Review Boards (Research ERB)
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From page 202... ...
However, no truly centralized system exists for disseminating information about clinical trials of drugs or other interventions, making it difficult for consumers and health care providers to identify ongoing studies in which consumers could participate. In the absence of a centralized mechanism, hundreds of registries or accessible databases of ongoing studies have been created in the last several years, and their numbers are growing (Anderson et al., forthcoming)
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From page 203... ...
More recently, the Institute of Medicine (IOM) Committee on Medicare Payment for Participation in Clinical Trials has made the same recommendation (2000a)
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However, these sites sometimes provide inaccurate information about the clinical trial process, exclude key information in trial listings, and fail to disclose policies that address the use of personal information that is collected by the site. Based on these findings, the OIG recommended that FDA and OHRP jointly provide guidance to Research ERBs regarding their responsibility for reviewing Web sites, facilitate the adoption and use of voluntary standards for clinical trial Web sites, and encourage clinical trial Web sites to undergo periodic review by independent bodies.
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THE IMPACT OF THE HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT OF 1996 REQUIREMENTS AND PRIVACY ISSUES ON HRPPPS The regulatory landscape regarding patient privacy has continued to evolve in recent years. Clearly, among the most important issues that should be faced when conducting research involving human participants are protecting the privacy of information and assuring confidentiality.
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From page 207... ...
Although privacy and confidentiality issues are involved in all forms of research involving human participants, they are particularly important with respect to health services and social science research, because in these forms of research (as compared to clinical research) , privacy and confidentiality threats are often the primary risks to human participants.
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Researchers must also comply with state laws that are more stringent than the Privacy Rule; these state laws are specifically protected from preemption under the Rule.18 The Privacy Rule permits information to be used or disclosed for research only under the toIlow~ng conditions: First, ~t Information used in research is not individually identifiable, it is not protected health information and is not subject to the Rule.19 The revised Rule also provides for "Limited Data Sets," from which sixteen specific identifiers have been deleted, for research purposes if the covered entity obtains from the data user a data use agreement that limits use of the data and prevents further disclosure.20 Second, if use or disclosure of protected health information is authorized by the research participant, it may be used or disclosed to the extent of that authorization.21 Third, protected health information may be .
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From page 209... ...
, as permitted by the Rule.23 The HIPAA Privacy Rule imposes a new task on Research ERBsgranting waivers to permit the use and clisclosure of iclentifiable health care information without authorization by the research participants from whom the information was generated. The Rule also permits authorization waivers to be granted by new entities, called "privacy boarcis," which inclucle members of varying backgrounds who are competent to review privacy issues, have at least one nonaffiliateci member, and clo not allow members to review research with which they have conflicts of interest.24 It appears that privacy boards have been created to review research that is not subject to Research ERB approval, such as nonfeclerally funcleci research, and Research ERBs will normally review privacy issues for research otherwise .
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It is also important that other obligations under the Privacy Rule not be indiscriminately transferred to Research ERBs. Someone within a health care plan or a provider that conducts research involving de-identified data (or limited data sets)
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From page 211... ...
Recommendation 7.3: Groups addressing bioterrorism response mechanisms and research should pay special attention to the protection of research participants in their studies. Protection of human participants in research to counter bioterrorism presents special challenges that relate particularly to the understanding of a trial's risks and benefits as described during the informed consent process.
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From page 212... ...
If new prophylactic and therapeutic products are to be developed for use in the general population, additional research will be needed regarding the effects of these products in all populations. With the increased emphasis on bioterrorism research, all parties involved should understand that the basic ethical principles underlying the involvement of human participants apply, no matter how urgently needed the research may be.
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From page 213... ...
, formed by former President William Clinton to investigate past classified radiation experiments involving humans, has addressed the special concerns of classified research, and its efforts should serve as a guide to conducting ethical classified research (ACHRE, 1995~. In its expansive report, ACHRE made a number of recommendations regarding the ethical aspects of classified research.
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From page 214... ...
Although the changes have been accepted by 13 of the departments and agencies subject to the Common Rule, the Central Intelligence Agency and the Department of Defense are among those that have not signed off on the alterations (Spieler, 20021. The power to classify research has generally been reserved for security agencies, but in December 2001, President Bush extended the power to classify information as secret to the Secretary of DHHS (Mitchell, 20011.
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From page 215... ...
Emerging social issues will continue to influence the nature and direction of research involving humans. The potential for growth in research directed at countering terrorism or that is classified for national security requires extraordinary vigilance to ensure that public and social goals do not inappropriately and unfairly trample human rights and protections in research.
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From page 216... ...
216 RESPONSIBLE RESEARCH can society, especially in medicine and the health care system. Because protection programs are mandated to protect the rights and welfare of research participants, it is essential that they keep abreast of developments in the changing landscape of privacy regulations as they relate to health care and research.
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