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Funding
- Overview
- Funding Opportunities
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- Funded Research
- Clinical Research
- Policies & Guidelines
Clinical Research
Updated September 10, 2007
Clinical Research Links (NIH and Federal Policies)
NIH Policies for Monitoring Clinical Research:
- HIPAA Privacy Rule
- HIPAA Policy and Review
- Certificates of Confidentiality Kiosk
- Responsible Conduct of Research
- NIH Policy Concerning Data and Safety Monitoring
- Further Guidance on Data and Safety Monitoring for Phase I and II Trials
- Guidance on Reporting Adverse Events to IRBs for NIH-supported Multicenter Clinical Trials
- Regarding Letters or Notices from the Food and Drug Administration (FDA)
- NIH Policy on Reporting Race and Ethnicity Data: Subjects in Clinical Research
- NIH Announces Statement on Certificates of Confidentiality
Information Required in NIH Grant Applications:
- Policy for IRB Review of Human Subjects Protocols in Grant Applications
- 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
- NIH Forms & Applications (PHS 398, PHS 2590 forms and more)
Office for Human Research Protections and General Federal 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: New Policy and Procedures
- Title 45 Code of Federal Regulations Part 46 - Protection of Human Subjects
- The International Conference on Harmonization (ICH) Guidelines to Good Clinical Practice (GCP)
(http://www.ich.org/cache/compo/276-254-1.html)
- NIH Bioethics Resources on the Web
- Belmont Report 1979 - Ethical Principals 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
- Guidance for Institutional Review Boards and Clinical Investigators
- FDA Information for Health Professionals: Clinical Trials and Human Subject Protection
- FDA Information Sheets Guidance for Institutional Review Boards (IRB) and Clinical Investigators
- Information for Clinical Investigators-Drugs (CDER)
- Information for Clinical Investigators-Devices (CDRH)
- Information for Clinical Investigators-Biologic (CBER)
Gene Therapy, Stem Cells and Fetal Tissue
- Recombinant DNA and Gene Transfer
- NIH Guidance on Informed Consent for Gene Transfer Research
- Office of Biotechnology Activities
- Recombinant DNA Advisory Committee (RAC)
- Recombinant DNA and Gene Transfer Guidelines
- New Initiatives to Protect Participants in Gene Therapy Trials
- Approval Process for the Use of Human Pluripotent Stem Cells in NIH-Supported Research
- Use of Human Fetal Tissue
