Protecting Data Privacy in Health Services Research (2000) / Chapter Skim
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2 Human Subjects Protection and Health Services Research in Federal Regulations
2 Human Subjects Protection and Health Services Research in Federal Regulations
Pages 40-50
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From page 40... ...
regulations on the protection of human subjects are review by institutional review boards and informed consent from participants in research. Background of Federal Regulations The Belmont Report (Belmont, 1979)
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From page 41... ...
These difficulties stem, in large part, from the history of the documents articulating human subjects protection and the nature and methodology of HSR federal regulations assume that clinical research is the paradigmatic use of human subjects and therefore are directed primarily toward avoiding physical harm to the individual subject. HSR studies, however, are generally more removed from the human subjects, because they employ methodologies for sorting, linking, and otherwise manipulating previously collected data.
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From page 42... ...
through the Office of Human Research Protections (OHRP, formerly Office for Protection from Research Risks or OPRR) in which they have agreed to comply with federal regulations for any human subjects research, even those projects that are funded by some non-federal source and would not otherwise to covered by the regulations.
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From page 43... ...
The regulations define a human subject as "a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information (45 CFR 46.1 02(f)
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From page 44... ...
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From page 45... ...
In particular, the regulations might mislead investigators to exempt their own research, when in fact the protocol may not meet regulatory criteria for exemption. In addition, some committee members remarked that the regulatory term expedited may be unfortunate, since surely both investigators and IRB members would wish all IRB reviews to be completed promptly.
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From page 46... ...
For a project that is research involving human subjects and is not exempt, the IRB must ensure that the subjects have given free and informed consent to participate unless the informed consent requirement may be waived. In general, the IRB must ensure that the subjects receive adequate information about the research protocol, and its possible benefits and risks, in a form that is understandable to them, and that their consent was not coerced (45 CFR 46116(a)
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From page 47... ...
If the research is to be conducted at another institution, the IRB may rely on the confidentiality policies and procedures in place at that institution rather than carrying out its own assessment of the confidentiality of the data. Furthermore, the IRB may never even consider the issue of confidentiality if the study itself is eligible for exemption or expedited review according to the provisions of the federal regulations.
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From page 48... ...
to hold institutions accountable for the resource commitments they made in their assurances. Update: OPRR's enforcement efforts have brought attention to IRB resource shortages at individual institutions and have led to additional support for IRB function at a number of those institutions and quite likely at others that have taken note of the OPRR efforts.
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From page 49... ...
HSR investigators and their IRBs have concluded that individual informed consent, especially on a study-by-study basis, is one of the aspects of the clinical research model that is impossible to apply in research conducted by analyzing previously collected data. At the same time, the law presumably passed because a sizable number of citizens were concerned, which would be consistent with the results of a 1993 Harris Health Information Privacy Survey showing that 64 percent of respondents said their permission should be required before their records could be used in medical research, even if no personally identified information about them were published.
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From page 50... ...
The committee hopes that the practices highlighted in the following chapters will facilitate HSR with appropriate and feasible mechanisms for the protection of human subjects, and will stimulate the development and dissemination of more advanced practices in the future. The scope of this study, highlighting the empirical collection of practices, recognized that good normative principles are already codified in the federal regulations, but that no amount of codification can provide adequate direction for the day-by-day, study-by-study, work of an IRB.
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