United States Guidance
All Research
Department of Energy (DOE)
- DOE Human Subject Protection Program
- Office of Science – Grants and Contracts
- Grant Application Guide
- Human Subjects and Animal Welfare
National Science Foundation (NSF)
- Interpreting the Common Rule for the Protection of Human Subjects for Behavioral and Social Science Research
- Policy Office
- Proposal and Award Policies and Procedures Guide
- Responsible Conduct of Research (RCR)
- Ethics Core Digital Library
Office for Human Research Protections (OHRP)
Selected guidance documents are provided for convenience, however, one should review the entire Policy and Guidance Index above.
- Continuing Review – November 2010
- Engagement of Institutions in Research – October 2008
- Expedited Review Procedures – August 2003
- Genetic Information Nondiscriminatory Act: Implications for Investigators and IRBs
- Involvement of Prisoners in Research – May 2003
- IRB Approval of Research with Conditions – November 2010
- IRB Review of Clinical Trial Websites – September 2005
- IRB Review of Protocol and Informed Consent Changes in Cooperative Group Protocols (OHRP Memo to NCI, 2008
- IRB Written Procedures – Guidance for Institutions and IRBs – May 2018
- Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English – November 1995
- Quality Improvement Activities – FAQs – 2008
- Research Involving Coded Private Information or Biological Specimens – October 2008
- Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events – January 2007
- Withdrawal of Subjects: Data Retention and Related Issues – September 2010
- Written IRB Procedures – July 2011
Biomedical, Public Health, and/or Epidemiological Research
Conflicts of Interest
- AMA Financial Conflicts of Interest in Research Policy
- FDA Financial Disclosure by Clinical Investigators – February 2013
Centers for Disease Control
- Distinguishing Public Health Research and Public Health Non-Research – July 2010
- Inclusion of Women and Racial and Ethnic Minorities in Research – November 2010
Centers for Medicare and Medicaid Services (CMS)
- Instructions: Medicare Coverage Related to Investigational Device Exemption (IDE) Studies
- Medicare Coverage Investigational Device Exemption (IDE) Study Criteria Checklist and Study Criteria Crosswalk Table – October 2014
- Medicare Coverage Database
Food and Drug Administration
- ANDA Submissions – Prior Approval Supplements under GDUFA – October 2016
- Collection of Race and Ethnicity Data in Clinical Trials – October 26, 2016
- Considerations When Transferring Clinical Investigation Oversight to Another IRB – May 2014
- Charging for Investigational Drugs Under an IND – Questions and Answers – June 2016
- Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials – October 2008
- Electronic Source Data in Clinical Investigations – September 2013
- Establishment and Operation of Clinical Trial Data Monitoring Committees – March 2006
- Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers – June 2016
- (FDA) Information Sheets
- Financial Disclosure by Clinical Investigators – February 2013
- How to Comply with the Pediatric Research Equity Act – September 2005
- Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations – October 2018
- Individual Patient Expanded Access Applications – June 2016
- Informed Consent Elements 21 CFR 50.25(c) – Q&A (Small Entity Compliance Guidance) – February 2012
- Informed Consent Information Sheet – Draft Guidance – July 2014
- Investigator Responsibilities – Protecting the Rights, Safety, and Welfare of Study Subjects – October 2009
- IRB Continuing Review After Clinical Investigation Approval – February 2012
- IRB Responsibilities for Assessing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed – August 2013
- IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects – July 24, 2017
- IRB Written Procedures – Guidance for Institutions and IRBs – May 2018
- Minutes of Institutional Review Board (IRB) Meetings – September 2017
- Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring – August 2013
- Part 11, Electronic Records; Electronic Signatures – Scope and Application – August 2013
- Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Pediatric Study Plans – July 2013
- Use of Electronic Informed Consent – Questions and Answers – December 2016
- Use of Electronic Health Record Data for Clinical Investigations – July 2018
- Utilizing a Centralized IRB Review Process for Multicenter Clinical Trials – March 2006
Center for Drug Evaluation (CDER)
- Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA – December 2013
- Charging for Investigational Drugs Under an IND – Q&As (Draft Guidance) – May 2013
- Codevelopment of Two or More New Investigational Drugs for Use in Combination – June 2013
- Drug-Induced Liver Injury: Premarket Clinical Evaluation – July 2009
- Expanded Access to Investigational Drugs for Treatment Use – Q&As (Draft Guidance) – May 2013
- FAQs – Statement of Investigator (FDA Form 1572) – May 2010
- Gene Therapy Trials – Observing Subjects for Delayed Adverse Events – November 2006
- Hematologic Malignancy and Oncologic Disease: Considerations for the Use of Placebos and Blinding in Randomized Controlled Clinical Trials in Drug Product Development – August 2018
- Investigational New Drug Applications (IND) – Determining Whether Human Research Studies Can Be Conducted Without an IND – September 2013
- IND Exemptions for Studies of Lawfully Marketed Drug or Biologic Projects for the Treatment of Cancer – January 2004
Center for Device and Radiological Health (CDRH)
- The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] – July 28, 2014
- Adaptive Designs in Medical Device Clinical Studies – July 27, 2016
- Additive Manufacturing (3-D Printed Devices) – Technical Considerations for Additive Manufacturing (Draft Guidance) – May 10, 2016
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices – June 2013
- Criteria for Significant Risk Investigation of Magnetic Resonance Diagnostic Devices – June 20, 2014
- Custom Device Exemption – September 14, 2014
- Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software – January 14, 2005
- Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices – September 6, 2017
- Design Considerations for Pivotal Clinical Investigations for Medical Devices – November 2013
- Emergency Use Authorization (for Public Health Emergencies)
- Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Trials – September 12, 2017
- FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions – June 1, 2016
- FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations – June 2013
- Frequently Asked Questions About Devices – January 2006
- General Wellness: Policy for Low-Risk Devices – July 2016
- Global Unique Identification Database (GUDID;Draft Guidance)-September 2013
- Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials – February 5, 2010
- Humanitarian Use Device (HUD)
- Humanitarian Device Exemption (HDE): Questions and Answers (Draft Guidance) – March 18, 2014
- Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable – April 2006
- IT Improvements for IDE and EUA Submissions – August 2013
- (Guidance on) IDE Policies and Procedures – January 1998
- Laboratory Developed Tests (LDTs) – Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs) – October 3, 2014
- Mobile Medical Applications – September 2013
- Postmarket Management of Cybersecurity in Medical Devices – January 2017
- Pre-Market Approval (PMA) – General Information
- Pre-Market Notification (510k)
- Significant Risk and Nonsignificant Medical Device Studies – January 2016
- Software as a Medical Device (SaMD): Clinical Evaluation – (Software as a Medical Device Working Group; International Medical Device Regulators Forum) Draft FDA Guidance – August 2016