Resources

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

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