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Protecting the rights and dignity of persons who serve as research participants, and promoting excellence in research
Research on human subjects
Decision charts—Is it research? Must it be reviewed? Is Informed consent needed?: The Office for Human Research Protections (OHRP) provides the following graphic aids as a guide for institutional review boards (IRBs), investigators, and others who decide if an activity is research involving human subjects that must be reviewed by an IRB under the requirements of the U.S. Department of Health and Human Services (HHS) regulations at 45 CFR part 46. OHRP welcomes comment on these decision charts. The charts address decisions on the following:
The charts are intended to assist IRBs, institutions, and investigators in their decision-making process and should not be used as substitutes for consulting the regulations. OHRP cautions that the full text of applicable regulatory provisions should be considered in making final decisions.
Institutional Review Boards
Research Involving Children
Federal regulations require special protections for children (45 CFR 46 Subpart D, Additional Protections for Children Involved as Subjects in Research.) The majority of studies involving children require full IRB review. If your research involves children, include in your Application a completed Research on Children (Persons under the age of 18) form.
Office for Human Research Protections (OHRP) Special Protections for Children as Research Subjects
General Regulatory Background:
HHS regulations at 45 CFR part 46 include subpart D, Additional Protections for Children Involved as Subjects in Research. All studies involving children, conducted or supported by HHS, which are not otherwise exempt, require IRB review in accordance with the provisions of subpart D. If an institution's IRB does not believe the proposed research meets the requirements of 45 CFR 46.404, 46.405, or 46.406 of subpart D (described below), but finds and documents that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children (in accordance with HHS regulations at 45 CFR 46.407(a)), the IRB or other appropriate institutional official may submit the protocol and supporting materials to OHRP for HHS consideration under the provisions of 45 CFR 46.407(b). Before submitting a protocol to OHRP, the IRB must determine that, in addition to meeting the requirements of 45 CFR 46.407(a) and other applicable sections of subpart D, the proposed research also meets all of the requirements of 45 CFR part 46, subpart A.
HHS will consult with a panel of experts under 46.407 only when the proposed research is conducted or supported by HHS. Note that if an institution has elected in its assurance to apply all of the subparts of 45 CFR part 46 to all of its human subjects research regardless of the source of support, and the IRB finds that the proposed research meets the conditions for review under 46.407, the IRB is not required to submit the protocol to OHRP for review if the research under consideration is not supported by HHS. In such cases, OHRP recommends that the institution consult with appropriate officials at the relevant federal agency or department supporting the research. When such research is supported by a non-federal sponsor, OHRP recommends that the institution consider convening an independent panel of experts in pertinent disciplines (e.g., science, medicine, education, ethics, law) and provide an opportunity for review and comment by the local community where the research is to be conducted before deciding whether to proceed with the research. Subpart D permits IRBs to approve three categories of research involving children as research subjects:
45 CFR 46.404 - Research not involving greater than minimal risk to the children. To approve this category of research, the IRB must make the following determinations:
45 CFR 46.405 - Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child subjects involved in the research. To approve research in this category, the IRB must make the following determinations:
45 CFR 46.406 - Research involving greater than minimal risk and no prospect of direct benefit to the individual child subjects involved in the research, but likely to yield generalizable knowledge about the subject's disorder or condition. In order to approve research in this category, the IRB must make the following determinations:
Patrice McClellan, Ed.D.
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