Policy:

• ClinicalTrials.gov and FDAAA - This Web site seeks to help NIH awardees understand their roles and responsibilities in relation to FDAAA, and how to certify compliance.
• Inclusion of Children Policy Implementation Page
• NIH Grants Policy Statement (12/03)
• Inclusion of Women and Minorities as Participants in Research Involving Human Subjects Policy Implementation Page
• NIH Policies and IC Guidance for Data and Safety Monitoring of Clinical Trials
• Required Education in the Protection of Human Research Participants Policy
• Frequently Asked Questions for the Requirement for Education on the Protection of Human Subjects
• Revised Policy For IRB Review of Human Subjects Protocols in Grant Applications

Guidance:

• Certificates of Confidentiality Kiosk
• National Advisory Council on Drug Abuse Guidelines for Administration of Drugs to Human Subjects
• National Advisory Council on Alcohol Abuse and Alcoholism - Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation - Revised May 2005
• NIH Guidance on Informed Consent for Gene Transfer Research
• NIH HIPAA Privacy Rule Information for Researchers
• NIMH Issues to Consider in Intervention Research with Persons at High Risk for Suicidality
• Research Involving Individuals with Questionable Capacity to Consent: Points to Consider
• Research Involving Private Information or Biological Specimens (PDF)

NIH Guide for Grants and Contracts:

• NIH Guide Home
• NIH Guide Notice 11/2/2004 - Revised PHS 398 (DHHS Public Health Service Grant Application) Now Available
• NIH Guide Notice 3/16/2005 - Updated Instructions to the PHS 398
• NIH Guide Notice 12/30/2004 - "NIH Implementation of Office for Human Research Protections (OHRP) Guidance on Research Involving Coded Private Information or Biological Specimens"
• NIH Guide Notice 9/17/2004 – " Notice on Implementation of Office for Human Research Protections (OHRP) Guidance on Research Involving Coded Private Information and Biological Specimens"

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