Assurance Process FAQs (PDF - 68 KB)
Children: Research with Children FAQs (PDF - 69 KB)
Exempt Research Determination FAQs (PDF - 26 KB)
Informed Consent FAQs (PDF - 135 KB)
Investigator Responsibilities FAQs (PDF - 44 KB)
IRB Registration Process FAQs (PDF - 34 KB)
Prisoner Research FAQs (PDF - 64 KB)
Quality Improvement Activities FAQs (PDF - 37 KB)
IRB Review and Documentation
Engagement of Institutions in Human Subjects Research: OHRP Guidance (2008) (PDF - 66 KB)
Extension of an Institutional FWA via an Individual Investigator Agreement: OHRP Guidance (2005) (PDF - 43.9 KB)
IRB Meetings Convened via Telephone Conference Call: OPRR Memorandum (2000) (PDF)
Specialized Review Considerations
Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005) (PDF - 33.5 KB)
Compliance Oversight
Compliance Oversight Procedures Used by OHRP (2009) (PDF - 47 KB)
OHRP Code of Federal Regulations
Basic HHS Policy for Protection of Human Research Subjects |
Sec. |
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To what does this policy apply? |
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Definitions. |
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Assuring compliance with this policy--research conducted or supported by any Federal Department or Agency. |
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[Reserved] |
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IRB membership. |
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IRB functions and operations. |
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IRB review of research. |
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Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. |
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Criteria for IRB approval of research. |
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Review by institution. |
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Suspension or termination of IRB approval of research. |
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Cooperative research. |
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IRB records. |
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General requirements for informed consent. |
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Documentation of informed consent. |
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Applications and proposals lacking definite plans for involvement of human subjects. |
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Research undertaken without the intention of involving human subjects. |
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Evaluation and disposition of applications and proposals for research to be conducted or supported by a Federal Department or Agency. |
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[Reserved] |
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Use of Federal funds. |
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Early termination of research support: Evaluation of applications and proposals. |
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Conditions. |
Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research |
Sec. |
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To what do these regulations apply? |
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Definitions. |
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Duties of IRBs in connection with research involving pregnant women, fetuses, and neonates. |
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Research involving pregnant women or fetuses. |
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Research involving neonates. |
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Research involving, after delivery, the placenta, the dead fetus or fetal material. |
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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. |
Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects |
Sec. |
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Applicability. |
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Purpose. |
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Definitions. |
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Composition of Institutional Review Boards where prisoners are involved. |
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Additional duties of the Institutional Review Boards where prisoners are involved. |
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Permitted research involving prisoners. |
Additional Protections for Children Involved as Subjects in Research |
Sec. |
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To what do these regulations apply? |
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Definitions. |
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IRB duties. |
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Research not involving greater than minimal risk. |
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Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. |
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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. |
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Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. |
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Requirements for permission by parents or guardians and for assent by children. |
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Wards. |
Registration of Institutional Review Boards |
Sec. |
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What IRBs must be registered? |
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What information must be provided when registering an IRB? |
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When must an IRB be registered? |
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How must an IRB be registered? |
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When must IRB registration information be renewed or updated? |
Informed Consent
Informed Consent FAQ (PDF - 135 KB)
Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)
Emergency Research Informed Consent Requirements (OPRR Letter, 1996)
Investigator Responsibilities
Financial Conflict of Interest: HHS Guidance (2004) (PDF - 85 KB)
Investigator Responsibility FAQs (PDF - 44 KB)
Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007) (PDF - 180 KB)
Withdrawal of Subjects from Research: Data Retention and Other Related Issues: OHRP Guidance (2010) (PDF - 45 KB)
Vulnerable Populations
Children in Research
Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") Review Process (2005) (PDF - 113 KB)
Prisoners in Research
Prisoner Research: OHRP Guidance (2003) (PDF - 67 KB)
Certificates of Confidentiality - Privacy Protection for Research Subjects: OHRP Guidance (2003) (PDF - 18.9 KB)
Protocol
Review
Approval of Research with Conditions: OHRP Guidance (2010) (PDF - 63 KB)
Continuing Review: OHRP Guidance (2010) (PDF - 52 KB)
Exempt Research and Research That May Undergo Expedited Review
Exempt Research Determination FAQ (PDF - 26 KB)
Exempt Research: Exemptions for Public Benefit and Service Programs (OPRR Guidance)
Expedited Review Procedures: OHRP Guidance (2003) (PDF - 207 KB)
Quality Improvement Activities: OHRP Correspondence Regarding Indwelling Catheter Procedures (2008)
Use of a Central Institutional Review Board (OHRP Letter, 2010)
Biological Materials &
Data
Coded Private Information or Biological Specimens: OHRP Guidance on Research (2008) (PDF - 37.5 KB)
Coded Private Information or Biological Specimens, Research Use (Video)
Fetal Tissue Transplantation: OHRP Guidance (2003) (PDF - 14.7 KB)
Fetal Tissue Transplantation Research, Public Law 103-43, Section 498A (1993)
Genetic Information Nondiscrimination Act (GINA): OHRP Guidance (2009) (PDF - 38 KB)
Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles: OHRP Guidance (2002) (PDF)
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 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
Parts 312 and 314
Part 320
Part 812
Part 814
Miscellaneous