Intentional Human Dosing Studies for EPA Regulatory Purposes Scientific and Ethical Issues (2004) / Chapter Skim
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2 The Regulatory Framework for Protecting Humans in Research
2 The Regulatory Framework for Protecting Humans in Research
Pages 46-65
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From page 46... ...
Many institutions hold assurances of compliance to the Common Rule, which are negotiated with the federal government. Such assurances cover all of the institution's research involving humans that is conducted or supported by one of the federal departments or agencies that have adopted the Federal Policy.
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From page 47... ...
According to the code, investigators alone are responsible for obtaining informed consent and deciding whether their research is in accord with the ethical principles. Following the issuance of the Nuremberg Code, several federal agencies began establishing policies for human research.
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From page 48... ...
. The amendments also required the informed consent of participants in the testing of investigational drugs, although permissible exemptions applied, and they emphasized the need for investigators to control the drug supply.
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The panel recommended that "Congress should establish a permanent body with the authority to regulate at least all Federally-supported research involving human subjects" (Tuskegee Syphilis Study Ad Hoc Advisory Panel, 1973)
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From page 50... ...
. The revised regulations placed primary emphasis on obtaining and documenting voluntary informed consent, but provided little guidance on assessment of risk and potential benefit or the selection of research participants.
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THE COMMON RULE The Common Rule applies to all research involving humans "conducted, supported or otherwise subject to regulation by any federal de
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FDA also has its own regulatory authority over research involving food and color additives, investigational drugs for human use, medical devices for human use, biological products for human use being developed for marketing, and electronic products that emit radiation. FDA also regulates research intended to support a change in the labeling of marketed products.
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From page 53... ...
. Research involving more than minimal risk requires full IRB review.
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whenever appropriate, by using pro cedures already being performed on the subjects for diagnostic or treat ment purposes. 4See also the discussion in Clarifying Specific Portion of 45 CFR 46 Subpart D That Governs Children's Research, Report from the National Human Research Protections Advisory Committee.
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From page 55... ...
In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cog nizant of the special problems of research involving vulnerable popula tions, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
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From page 56... ...
In addition to the periodic reevaluation of risks and potential benefits as part of continuing review, IRBs conduct as-needed reviews when investigators request an amendment to approved protocols or in the event of unanticipated problems with a research study. Current regulations require institutions to create written procedures for "ensuring prompt reporting to the IRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subject" (40 CFR 26.103(b)
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From page 57... ...
. These boards review data primarily from Phase 2 and 3 clinical trials from all participating sites and have access to unblinded data.5 Reporting Adverse Events As mentioned previously, one of the requirements for approval of research is that IRBs must ensure that as ".
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From page 58... ...
Two primary federal agencies take the lead in monitoring human studies subject to the Common Rule: OHRP and FDA, both housed within DHHS. Office for Human Research Protections OHRP is charged with protecting research participants in biomedical and behavioral research conducted or sponsored by DHHS and other federal agencies that follow the Common Rule.
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From page 59... ...
. Federal regulations require that protocols submitted under an Investigational New Drug Application include detailed descriptions of the "clinical procedures, laboratory tests, or other measures to be taken to monitor the effects of the drug in human subjects and to minimize risk" (21 CFR 312.23)
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From page 60... ...
NONGOVERNMENTAL ACCREDITATION PROGRAMS In recent years, there has been growing interest in nongovernmental performance-based accreditation systems to facilitate an emphasis on outcome measures in institutional research participants' protection programs and to meet evolving program needs. Participation in accreditation programs is a form of quality assurance, as efforts to prepare to meet accreditation standards should ordinarily have beneficial effects, and at a minimum, can help ensure that research programs conduct self-assessments, presumably noting and addressing deficient areas (IOM, 2001)
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From page 61... ...
FDA also can issue warning letters and restrict or disqualify investigators, IRBs, or institutions from conducting or reviewing research with investigational products. RECENT CONCERNS ABOUT HUMAN RESEARCH PARTICIPANTS Recent debate and analysis concerning the protection of research participants has focused on the federal and local institutions and agencies charged with this task, including federal regulatory agencies, academic and industrial laboratories, IRBs, and funding organizations.
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issued a report, Responsible Research: A Systems Approach to Protecting Research Participants, which provided an ethical and regulatory framework for institutions to create a system of protections involving investigators, research sponsors, research institutions, health care providers, federal agencies, and patient and consumer groups. The IOM report was in part written in response to systemwide concerns expressed by investigators, research institutions, IRBs, and others.
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From page 63... ...
The regulations rest on two principal objectives in the oversight of human research: the conduct of independent review of research protocols by IRBs and the provision of voluntary informed consent to participate in research. The regulations are enforced by 16 agencies that conduct or sponsor human research.
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From page 64... ...
2001. Preserving Public Trust: Accreditation and Human Research Participation Protection Programs.
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From page 65... ...
2002. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects (adopted 18th WMA General Assembly.
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