Ethics, Populations, Data Safety and Integrity, and Finance Issues

Ethics

• Avoiding Conflicts of Interest in Multicenter Clinical Trials—Guidelines
• Human Embrionic Stem Cell Research
• Human Tissue Repositories—Guidelines
• Tissue Sharing in Informed Consent—Guidance

Populations/Research Subjects

• Certificates of Confidentiality
• Terms and Conditions for Accrual of Research Subjects
• Inclusion of Minorities and Women in Study Populations—Questions and Answers
• NIH Policy Documents:
  • Inclusion of Children as Participants in Research Involving Human Subjects—NIH Guidelines
  • Inclusion of Women, Minorities and Persons with Disabilities in NIH-Supported Extramural Scientific Meetings and Conferences
  • Inclusion Of Women and Minorities As Subjects In Clinical Research—NIH Guidelines

Data Safety and Integrity

• Data and Safety Monitoring Policy
• Data and Safety Monitoring Boards and Observational Study Monitoring Boards—Interim Policy
• Data Quality Assurance in Clinical Trials and Observational Studies—Guidelines

Adverse Events

• Adverse Events and Unanticipated Problems Reporting and Management—Interim Policy

Finance Issues

• Third Party Involvement in NHLBI-Supported Clinical Trials and Other Population-Based Studies

• NHLBI Funding Guidelines are also updated periodically in the Dear Colleague letters. These are found in the Communications from the Director category.
• Additional Extramural Policy Notices from the NIH Office of Extramural Research
• See also the Grants Policy and Guidance section of the NIH Home Page for additional information. This includes information on NHLBI and other NIH grants in the CRISP (Computer Retrieval of Information on Scientific Projects) and the NIH Guide to Grants and Contracts.