Responsible Science Ensuring the Integrity of the Research Process: Volume II (1993) / Chapter Skim
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4 Reflections on the Current State of Data and Reagent Exchange Among ...
4 Reflections on the Current State of Data and Reagent Exchange Among ...
Pages 79-89
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From page 79... ...
Attention to these factors greatly enhanced acceptance of the regulations by the biomedical research community and increased public confidence in their reasonableness and effectiveness. By contrast, inadequate preparation and a lack of constituent participation resulted in initial resistance on the part of many social, education, and behavioral scientists to the extension of IRB requirements to activities not previously covered by such regulations.
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From page 80... ...
Scientists initially protested that nonsc~ent~sts on the review committees would unreasonably impede the conduct of research; however, the public pressures and scholarly recommendations were such that the new requirements withstood the negative pressure from academic administrators and clinical investigators.8 in sum, the [RB system was developed by the Public Health Service incrementally over a period of years and was supported by articles in respected scientific and medical journals, as well as by scholarly writings of experts in law and ethics. At the same time, public pressure for reform appeared in the lay press, and NTH administrators recognized both the need for change and the importance of an interdisciplinary approach to the development of new policies.
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From page 81... ...
. - 0 - -- I The National Commission set the standard of public accessibility, as required by its enabling legislation and the newly enacted "Government in the Sunshine" laws.9 When the commission held hearings, as it clid on each major topic of concern, everyone who requested an opportunity to be heard was permitted to testify.
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From page 82... ...
learned from the exchanges, and ultimately, a consensus emerged that satisfied the social and behavioral scientists without leaving the biomedical scientists and research administrators feeling that they had "sold out." A review of the witnesses who testified at the commission's IRB hearings demonstrates the breadth of concern among behavioral and social scientists. Among the 44 witnesses were 16 behavioral or social scientists, whose testimony focused largely on the difficulty of applying rules derived from a biomedical model to research involving participant observation, survey questionnaires, covert observation, and administration of standardized psychological or educational tests.
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From page 83... ...
Masses of data were collected on TRB membership, structure, and authority; voting and operating procedures; record keeping; administrative support; time spent on specific tasks; relation between the level of risk presented and the amount of time spent reviewing a protocol; number of times that protocols and consent forms were revised; and the reading level of approved consent forms. These data yielded useful (and sometimes surprising)
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From page 84... ...
The survey results were generally consistent with the testimony of witnesses at the hearings, in that behavioral scientists expressed frustration and disappointment about TRB members' lack of familiarity with the traditional methods of behavioral sciences, while the biomedical scientists complained about the disproportionate amount of time spent in preparing and reviewing protocols presenting no discernible risk to subjects (as in research involving by-products, such as body fluids and tissues, obtained from a diagnostic intervention. Interestingly, however, most researchers believed that the TRB system improved research more than it impeded it, and they were generally supportive of the TRB system overall.
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From page 85... ...
With one stroke, activities such as Head Start and medical assistance demonstration programs became "research with human subjects" for which TRB review and informed consent would be required. Efforts to incorporate the commission's recommendations into amendments to the TRB regulations became mired in an intramural conflict between officials at NIH (representing the Public Health Service's interests)
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From page 86... ...
Pursuant to the waiver provision, DHHS Secretary Richard Schweiker subsequently published a notice waiving TRB review and consent requirements for demonstration projects designed to test cost-sharing requirements in the Medicaid program.22 Shortly thereafter, the secretary published a proposal to exempt from IRB review "research and demonstration projects conducted under the Social Security Act and other Federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under Hose programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment."23 Although the President's Commission urged that the exemption be drawn more narrowly,24 the department rejected the commission's proposed modifications and exempted research and demonstration projects designed to evaluate programs under the Social Security Act and other public benefit or service programs, as originally proposed.25 In addition, the regulations were amended to permit IRBs to waive informed consent requirements for similar studies conducted under the auspices of state or local governments. Controversy over TRB review of public assistance demonstration projects continues, even today.
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From page 87... ...
Responses reflected outrage, a sense of betrayal, and frustration.30 A much fuller airing of the concerns of all interested parties, as well as a public deliberative process, would more likely produce a broadly accepted set of rules. Such an approach also would enhance public confidence in the process and substance of the rule making.
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From page 88... ...
10. See National Commission for the Protection of Human Subjects, 1978, "Institutional review boards: report and recommendations," Federal Register 43(November 30~:56174, 56184-85.
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From page 89... ...
, 1986, "Proposed model federal policy for protection of human subjects," Federal Register 51(June 3~:20204; Executive Office of the President (EOP) , Office of Science and Technology Policy (OSTP)
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