Federal Regulations and Guidelines

For clinical research

Federal Websites

• National Institutes of Health (NIH)
• Clinical Research Guide for NHLBI Investigators: Preparing, submitting and managing a clinical research award can be challenging.  This site is designed to guide potential investigators in organizing a clinical research application and to provide information on conducting a study and maintaining an award. 
• Office of Science Policy, Office of Clinical Research and Bioethics Policy serves as the central locus for planning, developing, and coordinating NIH-wide policy activities for clinical and health care research, as well as promoting full integration of bioethical considerations as foundational to NIH-supported research. OCRPB’s three main areas of emphasis are policies related to clinical research and protections for human subjects,  genomics research, and the translation of research findings into health care.
• ClinicalTrials.gov
• Federal Drug Administration (FDA): Regulations impacting research with FDA regulated products (21CFR Parts 50 & 56, Part 54 (financial disclosure), Parts 312 & 314, Biomonitoring Inspection Program, Warning Letters, Debarment List, etc.)
• Office for Human Research Protection: Regulation, policies related to protection of human subjects. Federalwide Assurance & IRB processes and registration. Decision trees differentiating research from quality improvement/quality assurance.
• Office of Research Integrity (ORI): Information about policies, procedures and regulations related to the detection, investigation and prevention of research misconduct.

Federal Regulations

• 45 CFR 46: Protection of Human Subjects (NIH)
• 42 CFR Part 50, Subpart A: Scientific Misconduct Regulations
• 21 CFR 312: Investigational New Drug Application
• 21 CFR 314: FDA Approval to Market a New Drug
• 21 CFR 11: Electronic Records, Signatures
• 21 CFR 50: Protection of Human Subjects (FDA)
• 21 CFR 54: Financial Disclosure
• 21 CFR 56: Institutional Review Boards
• 21 CFR 812: Medical Devices

Federal Guidelines

• Information for Clinical Investigators (FDA)
• The Belmont Report: Ethical Principles & Guidelines for Protection of Human Subjects

For sponsored projects & grants

Federal Websites: General

• Code of Federal Domestic Assistance (CFDA) Numbers
• Code of Federal Regulations
• Federal Acquisition Regulations (FAR)
• Federal Demonstration Project (FDP)
• Federal Register

Federal Research Sponsors

• Department of Defense (DOD)
• Department of Health and Human Services Grant Policies & Regulations
• National Institutes of Health (NIH)
  • NIH Data Sharing Policy and Implementation Guidance 
  • NIH Grants Policy & Guidance
  • NIH Grants Compliance & Oversight
  • NIH Notices and Announcements
  • NIH Salary Cap
• National Science Foundation (NSF)
• NSF Policy Office
• Research.gov
• Office of Naval Research (ONR)

OMB Uniform Guidance