FAQs Institutional Issues
- 45 CFR 46 (the Human Research Regulations) FAQs (PDF - 38 KB)
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Assurance Process FAQs (PDF - 68 KB)
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Children: Research with Children FAQs (PDF - 69 KB)
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Exempt Research Determination FAQs (PDF - 26 KB)
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Informed Consent FAQs (PDF - 135 KB)
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Investigator Responsibilities FAQs (PDF - 44 KB)
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IRB Registration Process FAQs (PDF - 34 KB)
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Prisoner Research FAQs (PDF - 64 KB)
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Quality Improvement Activities FAQs (PDF - 37 KB)
IRB Review and Documentation
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Engagement of Institutions in Human Subjects Research: OHRP Guidance (2008) (PDF - 66 KB)
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Extension of an Institutional FWA via an Individual Investigator Agreement: OHRP Guidance (2005) (PDF - 43.9 KB)
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IRB Meetings Convened via Telephone Conference Call: OPRR Memorandum (2000) (PDF)
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IRB Registration Process FAQ (PDF - 34 KB)
Specialized Review Considerations
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Clinical Trial Websites: When is IRB Review Required and What Should IRBs Consider with Reviewing? (OHRP Guidance, 2005) (PDF - 33.5 KB)
Compliance Oversight
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Compliance Oversight Procedures Used by OHRP (2009) (PDF - 47 KB)
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Quality Improvement Activities FAQ (PDF - 37 KB)
OHRP Code of Federal Regulations
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Basic HHS Policy for Protection of Human Research Subjects |
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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. |
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Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research |
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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. |
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Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects |
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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. |
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Additional Protections for Children Involved as Subjects in Research |
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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. |
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Registration of Institutional Review Boards |
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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
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Informed Consent FAQ (PDF - 135 KB)
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Informed Consent, Legally Effective and Prospectively Obtained (OPRR Letter, 1993)
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Emergency Research Informed Consent Requirements (OPRR Letter, 1996)
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Investigator Responsibilities
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Financial Conflict of Interest: HHS Guidance (2004) (PDF - 85 KB)
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Investigator Responsibility FAQs (PDF - 44 KB)
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Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events: OHRP Guidance (2007) (PDF - 180 KB)
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Withdrawal of Subjects from Research: Data Retention and Other Related Issues: OHRP Guidance (2010) (PDF - 45 KB)
Vulnerable Populations
Children in Research
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Children Involved as Subjects in Research: Guidance on the HHS 45 CFR 46.407 ("407") Review Process (2005) (PDF - 113 KB)
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Children: Research with Children FAQ (PDF - 69 KB)
Prisoners in Research
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Prisoner Research: OHRP Guidance (2003) (PDF - 67 KB)
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Prisoner Research FAQ (PDF - 69 KB)
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Certificates of Confidentiality - Privacy Protection for Research Subjects: OHRP Guidance (2003) (PDF - 18.9 KB)
Protocol
Review
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Approval of Research with Conditions: OHRP Guidance (2010) (PDF - 63 KB)
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Continuing Review: OHRP Guidance (2010) (PDF - 52 KB)
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Exempt Research and Research That May Undergo Expedited Review
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Exempt Research Determination FAQ (PDF - 26 KB)
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Exempt Research: Exemptions for Public Benefit and Service Programs (OPRR Guidance)
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Expedited Review Procedures: OHRP Guidance (2003) (PDF - 207 KB)
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Quality Improvement Activities: OHRP Correspondence Regarding Indwelling Catheter Procedures (2008)
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Use of a Central Institutional Review Board (OHRP Letter, 2010)
Biological Materials &
Data
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Coded Private Information or Biological Specimens: OHRP Guidance on Research (2008) (PDF - 37.5 KB)
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Coded Private Information or Biological Specimens, Research Use (Video)
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Fetal Tissue Transplantation: OHRP Guidance (2003) (PDF - 14.7 KB)
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Fetal Tissue Transplantation Research, Public Law 103-43, Section 498A (1993)
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Genetic Information Nondiscrimination Act (GINA): OHRP Guidance (2009) (PDF - 38 KB)
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Human Embryonic Stem Cells, Germ Cells, and Cell-Derived Test Articles: OHRP Guidance (2002) (PDF)
Checklists & Decision
Trees
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Informed Consent Checklist (1998) (also listed under Informed Consent)
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
- Electronic Records; Electronic Signatures (21 CFR Part 11)2
- Protection of Human Subjects (Informed Consent) (21 CFR Part 50)3
- Additional Safeguards for Children in Clinical Investigations of Food and Drug Administration-Regulated Products (21 CFR Parts 50 and 56)4
- Informed Consent Elements (21 CFR 50.25(c))5
- Exception From General Requirements for Informed Consent (21 CFR 50.23(e))6
- Financial Disclosure by Clinical Investigators (21 CFR Part 54)7
- Institutional Review Boards (21 CFR Part 56)8
- FDA IRB Registration Rule (21 CFR 56.106)9
- FDA IRB Registration Rule (21 CFR 56.106) (printable PDF version)10
- Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58)11
- Investigational New Drug Application (21 CFR Part 312)12
- Foreign Clinical Trials not conducted under an IND (21 CFR 312.120)13
- Expanded Access to Investigational Drugs for Treatment Use (PDF - 216KB)14
- Charging for Investigational Drugs (PDF - 204KB)15
- Form 1571 (Investigational New Drug Application)16
- Form 1572 (Statement of Investigator)17
- Applications for FDA Approval to Market a New Drug (21 CFR Part 314)18
- Bioavailability and Bioequivalence Requirements (21 CFR Part 320)19
- New Animal Drugs for Investigational Use (21 CFR Part 511)20
- New Animal Drug Applications (21 CFR Part 514)21
- Applications for FDA Approval of a Biologic License (21 CFR Part 601)22
- Investigational Device Exemptions (21 CFR Part 812)23
- Premarket Approval of Medical Devices (21 CFR Part 81424)
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
- Protection of Human Subjects; Informed Consent26 (January 27, 1981)
- Protection of Human Research Subjects; Standards for Institutional Review Boards for Clinical Investigations27 (January 27, 1981)
- Protection of Human Research Subjects; Clinical Investigations Which May Be Reviewed Through Expedited Review Procedure Set Forth in FDA Regulations28 (January 27, 1981)
- Protection of Human Subjects; Informed Consent; Standards for Institutional Review Boards for Clinical Investigations29 (November 1988)
- Federal Policy for the Protection of Human Subjects30 (June 18, 1991)
- FDA Policy for the Protection of Human Subjects31 (June 18, 1991)
- Protection of Human Subjects; Informed Consent; Proposed Rule32 (September 21, 1995)
- Protection of Human Subjects; Informed Consent, Part II33 (October 2, 1996) [html]
- Protection of Human Subjects; Informed Consent and Waiver of Informed Consent Requirements in Certain Emergency Research; Final Rules34 (October 2, 1996) [text]
- Protection of Human Subjects; Informed Consent35 (December 22, 1995)
- Protection of Human Subjects; Informed Consent Verification; Final Rule36 (November 5, 1996)
- Categories of Research That May Be Reviewed by the Institutional Review Board (IRB) Through an Expedited Review Procedure37 (November 9, 1998)
- Protection of Human Subjects; Informed Consent, Exception from general requirements38 (October 5, 1999)
- Additional protections for children39 (66 FR 20589-600, April 24, 2001)
- Exception from General Requirements for Informed Consent40 (71 FR 32827, June 7, 2006) [PDF41]
Part 54
- Financial Disclosures by Clinical Investigators42 (63 FR 5233, February 2, 1998)
- Financial Disclosures by a Clinical Investigator43(63 FR 72171-81, December 31, 1998)
- Current Good Manufacturing Practice Regulations and Investigational New Drugs45 (January 17, 2006)
Parts 312 and 314
- Proposed New Drug, Antibiotic, and Biologic Drug Product Regulations46 (June 9, 1983)
- New Drug and Antibiotic Regulations47 (February 22, 1985) 48
- New Drug, Antibiotic, and Biologic Drug Product Regulations49 (March 19, 1987)
- Investigational New Drug Applications and New Drug Applications50 (September 8, 1995)
- Investigational New Drug Applications and New Drug Applications51 (February 11, 1998)
- Disqualification of a Clinical Investigator52 (February 16, 1996)
- Disqualification of a Clinical Investigator53 (September 5, 1997)
- Expedited Safety Reporting Requirements for Human Drug and Biological Products54 (October 7, 1997)
- Clinical Hold for products intended for life threatening conditions55 (65 FR 34963-71, June 1, 2000)
- Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans56 (September 29, 2010)
- Disqualification of a Clinical Investigator57 (April 30, 2012)
Part 320
- Retention of BE and BA testing samples58 (April 28, 1993)
- Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans59 (September 29, 2010)
Part 812
- Quality System Regulations60 (October 7, 1996)
- Treatment Use of Investigational Devices61 (September 18, 1997)
- Withdrawal of Intraocular Lenses Regulation (Part 813)62 (January 29, 1997)
- Disqualification of Clinical Investigators63 (March 14, 1997)
- Modifications to the List of Recognized Standards64 (July 12, 1999)
- Modifications to the Medical Device and/or Study Protocol65 (November 23, 1998)
- Disqualification of a Clinical Investigator66(April 30, 2012)
Part 814
- Medical Devices; Humanitarian Use Devices Part V67 (June 26, 1996)
- 30-Day Notices and 135-Day PMA Supplement Review68 (October 8, 1998)
- Humanitarian Use of Devices69 (November 3, 1998)
Miscellaneous
- Part 11 Electronic Records; Electronic Signatures70 (March 20, 1997)
- Use of Bioresearch Monitoring Information System (BMIS)71 (63 FR 55873-6, October 19, 1998)
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Presiding officer72 (66 FR 45317-8, August 28, 2001