Protection of Human Subjects

To what does this policy apply?

Defines the scope and applicability of the Federal Policy for the Protection of Human Subjects (Common Rule) to research involving human subjects.

Definitions for purposes of this policy.

This provision defines key terms used in the Common Rule for the protection of human subjects in research, including definitions for research, human subjects, and institutional review boards.

Assuring compliance with this policy—research conducted or supported by any Federal department or agency.

This provision mandates that institutions conducting federally supported research provide written assurance of compliance and certify that research has been reviewed and approved by an IRB.

Exempt research.

This provision defines the specific categories of human subjects research that are exempt from the requirements of the Common Rule, including conditions for educational, behavioral, and secondary research.

[Reserved]

This provision is a reserved section of the federal regulations regarding the protection of human subjects.

IRB membership.

This provision establishes the requirements for IRB composition, including member expertise, diversity, and conflict of interest policies.

IRB functions and operations.

This provision outlines the operational requirements for IRBs, including meeting procedures, recordkeeping, and reporting of unanticipated problems.

IRB review of research.

This provision defines the IRB's authority and procedures for reviewing, approving, and conducting continuing reviews of research activities.

Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research.

This provision specifies the criteria and procedures for using expedited review for research involving minimal risk.

Criteria for IRB approval of research.

This provision outlines the specific criteria an IRB must use to evaluate and approve research involving human subjects.

Review by institution.

This provision clarifies that institutional officials may conduct additional review of research approved by an IRB but cannot approve research that the IRB has disapproved.

Suspension or termination of IRB approval of research.

This provision grants the IRB authority to suspend or terminate research approval for noncompliance or unexpected harm to subjects.

Cooperative research.

This provision mandates the use of a single IRB for cooperative research projects conducted in the United States, with specific exceptions.

IRB records.

This provision mandates the preparation and maintenance of adequate documentation for IRB activities and specifies record retention periods.

General requirements for informed consent.

This provision establishes the mandatory elements, processes, and exceptions for obtaining legally effective informed consent from human subjects participating in research.

Documentation of informed consent.

This provision outlines the requirements for documenting informed consent in research, including the use of written forms, short forms, and circumstances under which documentation may be waived by an IRB.

Applications and proposals lacking definite plans for involvement of human subjects.

This provision mandates that research projects involving human subjects must be reviewed and approved by an IRB before any human subjects are involved, even if specific plans were not initially defined in the grant application.

Research undertaken without the intention of involving human subjects.

This provision requires that if research initially planned without human subjects is later modified to involve them, it must undergo IRB review and approval before proceeding.

Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal department or agency.

This provision describes the process by which federal agencies evaluate research applications involving human subjects, considering risks, protections, and potential benefits.

[Reserved]

This provision is reserved.

Use of Federal funds.

This provision prohibits the expenditure of federal funds for research involving human subjects unless all requirements of the human subjects protection policy have been satisfied.

Early termination of research support: Evaluation of applications and proposals.

This provision allows federal agencies to terminate or suspend research support if an institution fails to comply with human subjects protection policies.

Conditions.

This provision authorizes federal agencies to impose additional conditions on research projects when necessary for the protection of human subjects.

To what do these regulations apply?

This provision specifies the applicability of research regulations concerning pregnant women, human fetuses, and neonates conducted or supported by DHHS.

Definitions.

This provision provides definitions for terms such as fetus, neonate, and pregnancy as they apply to research regulations involving vulnerable populations.

Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates.

Institutional Review Boards must review and approve research involving pregnant women, fetuses, and neonates only when it satisfies all applicable subpart requirements.

Research involving pregnant women or fetuses.

Research involving pregnant women or fetuses is permitted only when specific conditions regarding risk, benefit, consent, and investigator conduct are met.

Research involving neonates.

Research involving neonates of uncertain viability, nonviable neonates, and viable neonates is permitted only under strict conditions regarding risk, benefit, and parental consent.

Research involving, after delivery, the placenta, the dead fetus or fetal material.

Research involving the placenta, dead fetus, or fetal material must comply with all applicable federal, state, and local laws, and may trigger human subject protections if identifiers are recorded.

Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of pregnant women, fetuses...

Research that does not meet standard approval criteria may be funded by the Secretary only if it addresses serious health problems and meets specific ethical and public review standards.

Applicability.

These regulations apply to all HHS-supported biomedical and behavioral research involving prisoners as subjects, in addition to other applicable human subject protection requirements.

Purpose.

The purpose of these regulations is to provide additional safeguards for prisoners involved in research due to the potential for coercion in an incarcerated environment.

Definitions.

Defines key terms for prisoner research, including prisoner, minimal risk, and DHHS, to ensure consistent application of research protections.

Composition of Institutional Review Boards where prisoners are involved.

IRBs reviewing prisoner research must include a prisoner or prisoner representative and ensure a majority of members have no association with the prison.

Additional duties of the Institutional Review Boards where prisoners are involved.

IRBs must ensure prisoner research meets specific criteria regarding risk, subject selection, and informed consent, and institutions must certify compliance to the Secretary.

Permitted research involving prisoners.

This provision outlines the specific conditions and regulatory requirements under which DHHS-supported biomedical or behavioral research may involve prisoners as subjects.

To what does this subpart apply?

This provision defines the scope and applicability of subpart D requirements to all DHHS-conducted or supported research involving children as subjects.

Definitions.

This provision provides key definitions for terms such as children, assent, permission, parent, and guardian as they apply to research involving children.

IRB duties.

This provision mandates that IRBs review and approve research involving children only when it satisfies the specific conditions of the subpart.

Research not involving greater than minimal risk.

This provision sets the requirements for IRB approval of research involving children that presents no greater than minimal risk.

Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects.

This provision outlines the criteria for IRB approval of research involving children that presents more than minimal risk but offers the prospect of direct benefit.

Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder o...

This provision outlines the criteria for IRB approval of research involving children that presents more than minimal risk but no prospect of direct benefit.

Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children.

This provision outlines the process for approving research involving children that does not meet standard criteria but addresses serious health or welfare problems.

Requirements for permission by parents or guardians and for assent by children.

This provision details the requirements for soliciting and documenting parental permission and child assent in research protocols.

Wards.

This provision sets specific requirements for including children who are wards of the state or other agencies in research, including the appointment of an advocate.

What IRBs must be registered?

Institutional Review Boards (IRBs) designated under an approved federalwide assurance that review HHS-supported human subjects research must register with HHS.

What information must be provided when registering an IRB?

This section specifies the contact, administrative, and protocol-related information required for the registration of an Institutional Review Board.

When must an IRB be registered?

An IRB must be registered and accepted by OHRP before it can be designated under a federalwide assurance, with registrations effective for three years.

How must an IRB be registered?

IRBs must be registered electronically through the designated OHRP portal, with a written submission process available for institutions lacking electronic capabilities.

When must IRB registration information be renewed or updated?

IRBs must renew registration every three years, update contact information within 90 days of changes, and report the disbanding of an IRB within 30 days.