Resources for Researchers

Clinical Trials

• International Committee of Medical Journal Editors ICMJE | Recommendations | Clinical Trials
• NIH Policy on the Dissemination of NIH-Funded Clinical Trial Information | grants.nih.gov
• Regulations: Good Clinical Practice and Clinical Trials | FDA
• FDAAA 801 and the Final Rule – ClinicalTrials.gov
• eCFR : 42 CFR Part 11 — Clinical Trials Registration and Results Information Submission

Conflict of Interest

• eCFR : 21 CFR Part 54 — Financial Disclosure by Clinical Investigators
• 42 USC 1320a-7b: Criminal penalties for acts involving Federal health care programs (house.gov)
• Anti-Kickback Law 42 USC 1320a-7b: Criminal penalties for acts involving Federal health care programs (house.gov)
• Stark Law Physician Self Referral | CMS

Grants

• eCFR : 2 CFR Part 200 — Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards
• eCFR : Appendix IX to Part 75, Title 45 — Principles for Determining Costs Applicable to Research and Development Under Grants and Contracts with Hospitals
• NIH Grants Policy Statement | grants.nih.gov
• US NSF – About
• eRA Commons for NIH grants (Electronic Research Administration) Commonsplus (nih.gov)

Investigator Responsibilities

• eCFR : 21 CFR Part 312 Subpart B — Investigational New Drug Application (IND)
• eCFR : 21 CFR Part 812 — Investigational Device Exemptions
• Good Clinical Practice ICH GCP – Clarification of certain investigator responsibilities – ICH GCP
• eCFR : 42 CFR Part 50 Subpart F — Promoting Objectivity in Research
• eCFR : 45 CFR Part 94 — Responsible Prospective Contractors
• eCFR : 42 CFR Part 93 — Public Health Service Policies on Research Misconduct