NIH Resources
NIH
- NIH Grants Page - Home page for the NIH Office of Extramural Research. Use this to access PHS 398 application and instructions, NIH Guide to Grants and Contracts, Grants Policy and Guidance, NIH policies and guidances, and any information relevant to applying for and managing NIH grants.
- NIH Guide - Funding opportunities and notices (NIH)
- OHRP Web site - Home Page
- OHRP - 45 CFR 46
- OHRP - Tips on Informed Consent
- OHRP - Guidance on Continuing Review
- OHRP - Issues to Consider in the Research Use of Stored Data or Tissues
- OHRP - Memo on Engagement of Institutions in Research
- OHRP - Assurance FAQs
- OHRP - IRB Registration FAQs
- OHRP - IRB general information
NIAID
- NIAID Human Subject Policies - NIAID Council News published this well-organized discussion of all NIH and NIAID policies pertaining to the conduct of research in human subjects.
- How To Write a Human Subjects Award Application
- NIAID Clinical Grants Checklists - These documents take you through the steps applicants and grantees follow to meet human subjects requirements, without linking to detailed information.
- NIAID Clinical Terms of Award - NIAID policy for the monitoring of grants that include research on human subjects. Incorporated in all applicable grants at initial award or annual renewal.
- Pharmacy Guidelines and Instructions for DMID Clinical Trials - This document describes appropriate storage, handling, and accountability of study products for DMID-sponsored clinical trials.
- NIAID Research Funding - NIAID grants and contracts
- Guidance for NIAID Clinical Terms of Award
- DMID/NIAID Source Documentation Guidelines
- DMID Clinical Research Page
- Good Clinical Practice Handbook (DMID)
- Regulatory File Document Guidelines (DMID)
- Human Subjects Regulations Decision Charts
- Decision Tree - Inclusion of Children
- Decision Tree - Data Safety Monitoring Plan
- Decision Tree - Inclusion of Minorities
- Decision Tree - Inclusion of Women
- Decision Tree - Research involving Private Information or Biological Specimens
- Decision Tree - Protection of Human Subjects from Research Risk