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Human Subject Regulations


The following is based on a United States Department of Health & Human Services web page located here. The Office for Human Research Protections (OHRP) provides 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. The following program addresses 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.

CONSIDERATIONS

The following program is 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.

The following program is necessarily a generalization and may not be specific enough for particular situations. Other guidance documents are available related to specific topics, at OHRP Policy Guidance by Topic. OHRP invites inquiries for additional information.

The following program does not address requirements that may be imposed by other organizations, such as the Food and Drug Administration, National Institutes of Health, other sponsors, or state or local governments.

Click here to access the Human Subjects Regulations Review