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Funding
- Overview
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Clinical Research
Updated October 13, 2011
NIH and Federal Guidelines/Policies for Clinical Research
Table of Contents
NIH Human Subjects Guide for Grants and Contracts
Policies and Guidelines for Monitoring Clinical Research
Education and Training for Investigators Conducting Clinical Research
Protecting Confidentiality
Office for Human Research Protections and General Human Subjects Guidelines
U.S. Food and Drug Administration (FDA) Guidelines for Conduct of Clinical Trials
Gene Therapy, Stem Cells and Fetal Tissue
NIH Human Subjects Guide for Grants and Contracts
- NIH Forms & Applications
- Policy for IRB Review of Human Subjects Protocols in Grant Applications
- NIH-defined Phase III Clinical Trial Policy
- Requirements for NIH-defined Phase III Clinical Trials
- Inclusion of Women and Minorities as Subjects in Clinical Research
- Inclusion of Children Policy Implementation
- FAQ for Requirement for Education on the Protection of Human Subjects
- Research Involving Human Subjects (Office of Extramural Research Resources)
- Requirements for registering clinical trials into ClinicalTrials.gov
- NIH Public Access Policy
Policies and Guidelines for Monitoring Clinical Research
- NIH Policy Concerning Data and Safety Monitoring
- Further Guidance on Data and Safety Monitoring for Phase I and II Trials
- Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events
Education and Training for Investigators Conducting Clinical Research
- Training in the Responsible Conduct of Research
- FAQ for Requirement for Education on the Protection of Human Subjects
Protecting Confidentiality
- HIPAA Privacy Rule
- HIPAA Policy and Review
- NIH Announces Statement on Certificates of Confidentiality
Office for Human Research Protections and General Human Subjects Guidelines
- A comprehensive list of links for NIH information and guidance on human subject protection, informed consent, and Institutional Review Board (IRB) review can be found at http://www.hhs.gov/ohrp/
- Office for Human Research Protections (OHRP) Policy Guidance
- Title 45 Code of Federal Regulations Part 46 — Protection of Human Subjects
- The International Conference on Harmonisation (ICH): Regulatory Authority Guidance of Europe, Japan and the United States (http://www.ich.org/)
- NIH Bioethics Resources on the Web
- Belmont Report 1979 — Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- Conflicts of Interest — NIH Notices
U.S. Food and Drug Administration (FDA) Guidelines for Conduct of Clinical Trials
- Regarding Letters or Notices from the Food and Drug Administration (FDA)
- Guidance for Institutional Review Boards and Clinical Investigators
- FDA Information Sheet Guidances Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors
- Information for Clinical Investigators-Drugs (CDER)
- Information for Clinical Investigators-Devices (CDRH)
- Information for Clinical Investigators-Biologic (CBER)
