FAQs Institutional Issues


 OHRP Code of Federal Regulations

Subpart A--

Basic HHS Policy for Protection of Human Research Subjects  

 

Sec.

 

46.101

To what does this policy apply?

46.102

Definitions.

46.103

Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency.

46.104-
46.106

[Reserved]

46.107

IRB membership.

46.108

IRB functions and operations.

46.109

IRB review of research.

46.110

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

46.111

Criteria for IRB approval of research.

46.112

Review by institution.

46.113

Suspension or termination of IRB approval of research.

46.114

Cooperative research.

46.115

IRB records.

46.116

General requirements for informed consent.

46.117

Documentation of informed consent.

46.118

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

46.119

Research undertaken without the intention of involving human subjects.

46.120

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

46.121

[Reserved]

46.122

Use of Federal funds.

46.123

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

46.124

Conditions.

 

Subpart B--

Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research 

 

Sec.

 

46.201

To what do these regulations apply?

46.202

Definitions.

46.203

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

46.204

Research involving pregnant women or fetuses.

46.205

Research involving neonates.

46.206

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

46.207

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, or neonates.

 

Subpart C--

Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

 

Sec.

 

46.301

Applicability.

46.302

Purpose.

46.303

Definitions.

46.304

Composition of Institutional Review Boards where prisoners are involved.

46.305

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

46.306

Permitted research involving prisoners.

 

Subpart D--

Additional Protections for Children Involved as Subjects in Research

 

Sec.

 

46.401

To what do these regulations apply?

46.402

Definitions.

46.403

IRB duties.

46.404

Research not involving greater than minimal risk.

46.405

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

46.406

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 or condition.

46.407

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

46.408

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

46.409

Wards.

 

Subpart E--

Registration of Institutional Review Boards

 

Sec.

 

46.501

What IRBs must be registered?

46.502

What information must be provided when registering an IRB?

46.503

When must an IRB be registered?

46.504

How must an IRB be registered?

46.505

When must IRB registration information be renewed or updated?

  

Informed Consent

Investigator Responsibilities

 

Vulnerable Populations

Children in Research

 

Prisoners in Research

 

 

Protocol Review

Biological Materials & Data

Checklists & Decision Trees

 

The charts do 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.

 

Chart 1: Is an Activity Research Involving Human Subjects?

Chart 2: Is the Human Subjects Research Eligible for Exemption?

Chart 3: Does Exemption 45 CFR 46.101(b)(1) (for Educational Settings) Apply?

Chart 4: Does exemption 45 CFR 46.101(b)(2) or (b)(3) (for Tests, Surveys, Interviews, Public Behavior Observation) Apply?

Chart 5: Does Exemption 45 CFR 46.101(b)(4) (for Existing Data, Documents, Records and Specimens) Apply?

Chart 6: Does Exemption 45 CFR 46.101(b)(5) (for Public Benefit or Service Programs) Apply?

Chart 7: Does Exemption 45 CFR 46.101(b)(6) (for Food Taste and Acceptance Studies) Apply?

Chart 8: May the IRB Review Be Done by Expedited Procedures?

Chart 9: May the IRB Continuing Review Be Done by Expedited Procedures?

Chart 10: May Informed Consent Be Waived or Consent Elements Be Altered under 45 CFR 46.116(d)?

Chart 11: May Documentation of Informed Consent Be Waived Under 45 CFR 46.117(c)?

 

FDA Regulations

FDA Regulations Relating to Good Clinical Practice and Clinical Trials

The documents posted below include publications that contributed to the development of final rules related to FDA's regulations on good clinical practice and clinical trials.25

Parts 50 and 56

Part 54

Part 210 44

Parts 312 and 314

Part 320

Part 812

Part 814

Miscellaneous