Federal Regulations, Guidelines & Definitions

Research on human subjects

• United States Department of Health and Human Services Code of Federal Regulations Title 45 Part 46: Protection of Human Subjects  45 CFR §46.101- §46.504 

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:

• whether an activity is research that must be reviewed by an IRB
• whether the review may be performed by expedited procedures, and
• whether informed consent or its documentation may be waived.

Important Considerations

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.

• Decision Charts

Institutional Review Boards

• U. S. Food and Drug Association (FDA) Title 21 Part 56: 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:

• the research presents no greater than minimal risk to the children; and
• adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.

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:

• the risk is justified by the anticipated benefits to the subjects;
• the relation of the anticipated benefit to the risk presented by the study is at least as favorable to the subjects as that provided by available alternative approaches; and
• adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.

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:

• the risk of the research represents a minor increase over minimal risk;
• the intervention or procedure presents experiences to the child subjects that are reasonably commensurate with those inherent in their actual, or expected medical, dental, psychological, social, or educational situations;
• the intervention or procedure is likely to yield generalizable knowledge about the subject's disorder or condition which is of vital importance for the understanding or amelioration of the disorder or condition; and
• adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in HHS regulations at 45 CFR 46.408.

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