Summary of Part 46—Protection of human subjects

IRB: Institutional Review Board

Subpart A—Basic HHS Policy for Protection of Human Research Subjects Title
§46.101 To what does this policy apply? This policy applies to research with human subjects done under a US federal government body (unless exempt).
§46.102 Definitions for purposes of this policy. List of definitions of terms.
§46.103 Assuring compliance with this policy—research conducted or supported by any Federal department or agency. Each institution must give an assurance that it complies with this policy.
§46.104 Exempt research. Some kinds of research are exempt from this policy:
(d)(1) low-risk educational settings
(d)(2) educational tests, surveys, interviews, observation of public behavior (if conditions are met)
(d)(3) benign behavioral interventions
(d)(4) Secondary research i.e. research on pre-existing data or biospecimens (if conditions are met)
(d)(5) Projects approved by a federal agency
(d)(6) Taste and food quality evaluation
(d)(7) Storage or maintenance of data or biospecimens for secondary research (if conditions are met)
(d)(8) Secondary research (if conditions are met)
§46.105-46.106 [Reserved]N/a.
§46.107 IRB membership. An IRB must have five qualified persons of diverse backgrounds, one of whom must be external to the institution.
§46.108 IRB functions and operations. The basic tasks of the IRB are:
(b) Keep a current list of the IRB members
(c) Have written procedures
(d) Have written procedures for prompt reporting to the IRB, and if mandatory, to a Federal department
(e) Review proposed research at meetings
§46.109 IRB review of research. The IRB review approves, require modifications, or disapproves all research activities.
It ensures documented informed consent.
It keeps research under review.
§46.110 Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. Rules to speed up an IRB review
§46.111 Criteria for IRB approval of research. A list of general criteria for research approval
§46.112 Review by institution. The institution may review and cancel research, but may not give IRB approvals.
§46.113 Suspension or termination of IRB approval of research. An IRB can suspend or terminate approval of research.
§46.114 Cooperative research. Rules for research done by multiple institutions.
§46.115 IRB records. IRB must keep certain records.
§46.116 General requirements for informed consent. A complicated set of requirements for informed consent:
(a) General
(b) Basic elements
(c) Additional elements
(d) Consent for the storing private information for secondary research
(e) Waiver or alteration of consents
(f) General waiver or alteration of consent
(g) Screening, recruiting, or determining eligibility
(h) Consent form
(i) Preemption
(j) Emergency medical care
§46.117 Documentation of informed consent. Informed consent must be on a signed, written form approved by the IRB.
§46.118 Applications and proposals lacking definite plans for involvement of human subjects. If the research uses human subjects but it was not in the original plan, it still has to go to the IRB (unless it is exempt).
§46.119 Research undertaken without the intention of involving human subjects. If the research starts but then the plan changes to uses human subjects, it still has to go to the IRB (unless it is exempt).
§46.120 Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency. The federal department or agency will evaluate the research proposal if it conducts or supports research with human subjects.
§46.121 [Reserved]N/a
§46.122 Use of federal funds. Federal government departments and agencies may not fund research that does not meet these standards.
§46.123 Early termination of research support: Evaluation of applications and proposals. The head of a federal department or agency may end or suspend support for research projects that do not meet these standards.
§46.124 Conditions. The head of a federal department or agency may impose extra conditions on the research if he/she thinks that they are necessary to protect human subjects.
Subpart B—Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research List of extra protections for pregnant women, human fetuses and neonates involved in research.
Subpart C—Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects List of extra protections for research using prisoners as subjects
Subpart D—Additional Protections for Children Involved as Subjects in Research List of extra protections for children
Subpart E—Registration of Institutional Review Boards Procedure for registering with the Office for Human Research Protections (OHRP)