Policies & Guidelines

NINDS and NIH policies, regulations, and guidelines are influenced by many Government organizations including HIPAA, OHRP AND FDA. The following are government organizations:

• NINDS/NIH Policies for Monitoring Clinical Research
• Office for Human Research Protections and General Federal Guidelines
• U.S. Food and Drug Administration (FDA) Guidelines for Conduct of Clinical Trials
• Office of the Inspector General (OIG)
• Office for Civil Rights - HIPAA Privacy Rule : Information for Researchers
• Promoting Objectivity: Avoiding Financial Conflict of Interest
• Other Important NINDS/NIH Policy, Regulatory and Guideline Web Resources
  • Information Required in NIH Grant Applications
  • Human Genetics Repository
  • Gene Therapy, Stem Cells and Fetal Tissue
  • NIH Data Sharing Policy
  • Privacy Protection for Research Subjects: Certificate of Confidentiality
  • Terms of Award

 

-----------------------------------------

Monitoring Policies

• Guidelines for Budgeting for Data and Safety Monitoring Activities
• NINDS Guidelines for Data and Safety Monitoring in Clinical Trials
• Guidelines and Policies for Monitoring Clinical Research
• Outline of DSMB Report
• NINDS Policy on Monitoring NINDS-Supported Clinical Research
• NINDS/NIH Policies for Monitoring Clinical Research
• Study Initiation Flow Chart [PPT] [PDF]
• NINDS Data and Safety Monitoring Board Conflict of Interest and Confidentiality Statement

-------------------------------------------

Miscellaneous

1. Ancillary Studies of NINDS-supported Clinical Trials and Epidemiological Studies
2. Conversion of Grant to Cooperative Agreement
3. Requiremenet for No-cost Extension Progress Reports
4. Incremental Funding of Large Multicenter Studies
5. Clinical Research Application Process for Large/Expensive Clinical Research Projects
6. Manual of Procedures (MOP)
7. MOP Template [MS Word] [PDF]
8. Guidelines and Policies for Clinical and Data Center Operations
9. Pilot Studies for Clinical Trials in Neurological Disorders
10. Progress Assessment Checklist for NINDS Clinical Studies
11. NINDS Quality Assurance Guidelines
12. Reporting of Accural and Demographics
13. Enrollment of Subjects into Clinical Trials - Information Requested on Participant Availability at Clinical Sites [MS Word] [PDF]
14. Applicant Interview or "Reverse-site Visit"
15. Multicenter/Phase III Clinical Trial Cooperative Agreement
16. Supplemental Infomation [MS Word] [PDF]
17. NINDS Terms of Award for Clinical Research