Guidance for Clinical Investigators, Sponsors, and IRBs – Adverse Event Reporting to IRBs —Improving Human Subject Protection – January 2009 Procedural(FDA)
Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events – Dated: January 15, 2007(OHRP)
OHRP: Reviewing and Reporting Unanticipated Problems and Adverse Events(OHRP Video)
Certificate of Confidentiality – Dated: February 25, 2003(OHRP)
Special Protections for Children as Research Subjects(OHRP)
Research with Children – Frequently Asked Questions(OHRP)
Guidance for Sponsors, Investigators, and Institutional Review Boards Questions and Answers on Informed Consent Elements, 21 CFR § 50.25(c) – February 2012(FDA)
Comparison of FDA and HHS Human Subject Protection Regulations(FDA and HHS)
Guidance for IRBs, Clinical Investigators, and Sponsors – IRB Continuing Review after Clinical Investigation Approval – February 2012(FDA)
Guidance on IRB Continuing Review of Research – Dated: November 10, 2010(OHRP)
Declaration of Helsinki(OHRP)
Belmont Report(OHRP)
Nuremberg Code(OHRP)
Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors(FDA)
Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection(OHRP)
Financial Disclosure by Clinical Investigators – 21 CFR Part 54(FDA)
Guidance for Industry – E6 Good Clinical Practice: Consolidated Guidance – April 1996(FDA/ICH)
Health Insurance Portability and Accountability Act of 1996(HHS)
Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule(HHS)
Human Subject Regulations Decision Charts(OHRP)
Protection of Human Subjects (Informed Consent) (21 CFR Part 50)(FDA)
Office of Human Research Protections – Informed Consent Checklist(OHRP)
Guidance for Institutional Review Boards (IRBs) – Frequently Asked Questions – IRB Registration – July 2009(FDA)
Office for Human Research Protections (OHRP) – IRB Guidebook(OHRP)
Guidance for Industry – Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects – Procedural October 2009(FDA)
Investigator Responsibilities – Frequently Asked Questions (FAQs)(OHRP)
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors – Frequently Asked Questions About Medical Devices – January 2006(FDA)
Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies – January 2006(FDA)
Frequently Asked Questions: Prisoner Research(OHRP)
OHRP Guidance on the Involvement of Prisoners in Research(OHRP)
Glossary of Clinical Trial Terms(NIH)
Protecting Human Research Participants Training – National Institutes of Health, Office of Extramural Research – Available in English and Spanish(NIH)
Collaborative Institutional Training Initiative (CITI)(CITI)
OHRP: Research Involving Vulnerable Populations(OHRP Video)
