NIH Human Subjects Policies and Guidance
- NIH Guide Notice 08/2/2012 - Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval (NOT-OD-12-129)
- NIH Guide Notice 08/02/2012 - Prior NIH Approval of Human Subjects Research in Active Awards Initially Submitted without Definitive Plans for Human Subjects Involvement (NOT-OD-12-130)
- 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
- 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
- Certificates of Confidentiality Kiosk
- Data and Safety Monitoring
- 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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