Activities Requiring IRB Review - Lakeland Community College - Institutional Review Board

Research Involving Human Subjects

Human Subject Regulations Decision Chart

Office of Human Research Protections, U.S. Department of Health and Human Services

Consult OHRP’s decision charts at: http://www.hhs.gov/ohrp/regulations-and-policy/decision-trees/index.html.

HUMAN SUBJECT REGULATIONS DECISION CHARTS: 2018 REQUIREMENTS
These charts are intended to aid those who need to decide if an activity is research involving human subjects that must be reviewed by an institutional review board (IRB) and whether informed consent or the documentation of informed consent can be waived under the 2018 Requirements found for the U.S. Department of Health and Human Services (HHS) at 45 CFR part 46, Subpart A.

Exempt Research

Exemptions (2018 Requirements)

"Unless otherwise required by law or by department or agency heads, research activities in which the only involvement of human subjects will be in one or more of the categories in paragraph (d) of this section are exempt from the requirements of this policy, except that such activities must comply with the requirements of this section and as specified in each category."

Code of Federal Regulations - Exempt Research

https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-A/part-46/subpart-A/section-46.104

Decision Tool

Am I Doing Human Subjects Research?

National Institutes of Health, U.S. Department of Health and Human Services

"The Office of Extramural Research (OER) has developed a quick decision tool that should assist you with determining if your research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research. This tool should not be used as the sole determination of exemption."

https://grants.nih.gov/policy/humansubjects/hs-decision.htm