Ethical Conduct of Clinical Research Involving Children (2004) / Chapter Skim
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3 Regulatory Framework for Protecting Child Participants in Research
3 Regulatory Framework for Protecting Child Participants in Research
Pages 93-112
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From page 93... ...
The Belmont Report, issued by the Commission in 1978, served as the basis for the core regulations applicable to all federally supported, conducted, or regulated research involving humans (National Commission, 1978a)
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From page 94... ...
A number of commissions and committees have recommended that federal policymakers formally extend regulatory protections for human participants in research to all research, regardless of the source of funding or the regulatory status (see, e.g., NBAC, 2001b and IOM, 2003a)
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From page 95... ...
The Common Rule or Subpart A: Basic Regulations As discussed earlier, in 1991 the federal government slightly revised and extended to 17 other federal agencies the regulations that formed Subpart A of the human research protection regulations that had been adopted in 1981 by DHHS. (The regulations that established this Common Rule also provided that each agency could adopt procedural modifications appropriate to its functions and responsibilities.)
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From page 96... ...
As part of ensuring their compliance with the applicable regulations, institutions are held to a number of requirements, including: · the development of an acceptable statement of ethical principles for the protection of human participants in research, whether or not the research is covered by federal regulations; · the designation of one or more IRBs and the provision of resources to those IRBs sufficient to meet their responsibilities; · the provision and updating of a list of IRB members that includes information sufficient to indicate their expected contributions to the IRB and their relationship (if any) to the institution; · the development of written procedures that IRBs should follow in conducting their reviews and fulfilling their other responsibilities; and 1The FDA regulations are found in two parts of the Code of Federal Regulations, 21 CFR Parts 50 (Protection of Human Subjects)
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From page 97... ...
Institutional Review Boards (IRB) Beyond the general institutional responsibilities of IRBs described above, the federal regulations specify additional requirements for IRBs.
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From page 98... ...
. special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educa tionally disadvantaged persons.
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From page 99... ...
(See discussion below of additional requirements for adverse event reports and data and safety monitoring bodies.) Exempt Research and Expedited Review Certain categories of research may be exempt from review under the provisions of Subpart A, although research institutions may independently require that research in these categories be reviewed.
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From page 100... ...
Chapter 4 discusses the concepts and interpretation of minimal risk and related terms. Subpart D: Special Protections for Children In 1983, DHHS adopted special protections for child participants in research, generally referred to as Subpart D because of their location in Subpart D of 45 CFR 46.
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From page 101... ...
The general boundaries of research involving children that DHHS can conduct or support are laid out in four sections of Subpart D that largely correspond to the recommendations of the 1977 report on children by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission, 1977)
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From page 102... ...
§46.406 Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition DHHS will conduct or fund research in which the IRB finds that more than minimal risk to children is presented by an intervention or procedure that does not hold out the prospect of direct benefit for the individual subject, or by a monitoring proce dure which is not likely to contribute to the well-being of the subject, only if the IRB finds that: (a) the risk represents a minor increase over minimal risk; (b)
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From page 103... ...
involve subjective or ambiguous concepts that have caused and that continue to cause considerable uncertainty, confusion, and disagreement among IRB members, investigators, and others who encounter them. Agreement to Participate in Research Parental Permission Because children are not legally able to provide consent in their own right, the federal regulations generally require that parents or guardians provide permission before children can be enrolled in research.
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From page 104... ...
As noted previously in Box 3.2, federal regulations on human research protections define children in terms of state laws defining the legal age at which an individual can consent to the treatments or procedures involved in the research. The legal age of majority is now 18 in all states except Mississippi (age 21)
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From page 105... ...
. The report also recommended that NIH provide additional guidance about the elements that should be included in data and safety monitoring plans for clinical trials and that NIH-funded clinical trials be monitored "with the same rigor and scrutiny as trials carried out" for products subject to FDA approval (IOM, 2003a, p.
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From page 106... ...
. Without mentioning adverse events as such, both DHHS and FDA regulations require that IRBs have written procedures for the prompt reporting to the IRB, appropriate institutional officials, and the relevant Department or Agency head of "any unanticipated problems involving risks" to human research participants or others (e.g., investigators)
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From page 107... ...
. Data and Safety Monitoring Boards and Data Monitoring Committees The discussion below focuses primarily on federal policies for data and safety monitoring during clinical trials designed to test the safety and efficacy of drugs and other products.
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From page 108... ...
As noted above, NIH requires that summary reports of adverse events be provided to relevant IRBs for multisite trials. Commercially sponsored research regulated by FDA is covered by draft guidance on the establishment and operation of what the agency calls data monitoring committees (FDA, 2001c)
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From page 109... ...
For long-term genetic studies involving children or family members, monitoring boards may include individuals familiar with the short- and long-term impact of genetic information on the psychological status of children. In general, even if it is not required by sponsors, IRBs should require that some form of data and safety monitoring be incorporated into pediatric research protocols that involve more than minimal risk and that this
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From page 110... ...
Both DHHS and FDA rules include provisions on foreign research. The DHHS rules note that procedures for protecting human research participants may differ in other countries and that these procedures may be substituted if the department or agency head determines that the procedures provide protections equivalent to those provided for under DHHS rules (45 CFR 46.101(h)
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From page 111... ...
. The 1996 ICH guideline, which was also published as guidance by the FDA, does not provide explicit special protections for children (except as part of provisions related to informed consent)
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From page 112... ...
These issues include the uncertainty and confusion over the interpretation of key concepts in the regulations; the adequacy of pediatric expertise in IRB review of research involving children; and the lack of regulatory protections for adults and children participating in research that is not federally conducted, funded, or regulated. The following chapters highlight a number of additional concerns, including the lack of data on the performance of the system of research protections for children.
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