NIH Policy Documents and Resources

These policies are described in the NIH Grants Policy Statement (rev. 12/2003) but are provided here for convenience.

• NIH Policy on Data Sharing
• NIH Policy for Data Safety and Monitoring in Clinical Trials
• Guidance on Reporting Adverse Events to Institutional Review Boards (IRBs) for NIH-Supported Multicenter Clinical Trials:
  All data-safety monitoring boards for multisite clinical trials must forward summary reports of adverse events to each IRB involved in the study..

Certificates of Confidentiality

Certificates of Confidentiality protect those with access to research records from disclosing identifying information in any civil, criminal, legislative, administrative, or other Federal, State, or local proceedings. Certificates are issued only when research information is sensitive and protection is necessary to achieve the research aims while protecting confidentiality and privacy.

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