Policies and Regulations
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Rutgers University
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Clinical Trials Registration and Results Reporting Policy [Rutgers University] (PDF)
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Definition of "Directory Information" For Rutgers (Related to FERPA)
New Jersey
- Access to Medical Research Act (PDF)
- Age of Majority 9:17B-3 (PDF)
- Genetic Privacy Act (PDF)
- Human Stem Cell Research NJSA C.26:2Z-1 (PDF)
- Limitation of Guardian Power for Eligible Elderly Persons (njlaw.rutgers.edu)
- Minors in Adult Circumstances (NJ Dept of Children & Families Policy Manual) (nj.gov)
- Patient Rights 30:4-24.2 (PDF)
- Research in Schools (PDF)
- Research in the Office Setting (PDF)
- Research Involving Death Records / Certificates N.J.A.C. 8:2A-2.2 (2016) (PDF)
- Research Involving Emergency Medical Services N.J.A.C. 8:41-5.1 (2013) (PDF)
- Research with Prisoners [NJAC Title 10A; Chapters 1-10 NJ Dept of Corrections: Research]
- School Surveys and Parental Consent (2002) (njleg.state.nj.us)
- Title 9 - CHILDREN--JUVENILE AND DOMESTIC RELATIONS COURTS Section 9:6-8.10 - Report of Abuse
Federal Regulations
- APA Ethical Principles of Psychologists and Code of Conduct
- Additional Safeguards for Children in Clinical Investigations [FDA Subpart D] (FDA.gov)
- Code of Federal Regulations - Title 45 CFR Part 46
- Code of Federal Regulations - Title 21 CFR Part 50
- Code of Federal Regulations - Title 21 CFR Part 56
- Code of Federal Regulations - Title 21 CFR Part 312
- Code of Federal Regulations - Title 21 CFR Part 600
- Code of Federal Regulations - Title 21 CFR Part 812
- Clinregs (Online Database Of Country-Specific Clinical Research Regulatory Information) (NIH.gov)
- "Common Rule" 45 CFR 46 (hhs.gov)
- Declaration of Helsinki
- Device Advice: Comprehensive Regulatory Assistance (FDA.gov)
- Family Educational Rights and Privacy Act (FERPA) (Privacy of Student Education Records)
- FDA Guidance for IRBs and Clinical Investigators
- Genetic Information Nondiscrimination Act (GINA) (Genetic Research) (PDF File)
- Index, Information for FDA-Regulated Industry (FDA.gov)
- Information for Health Professionals (FDA.gov)
- International Compilation of Human Research Standards (hhs.gov)
- NIH - Certificates of Confidentiality Kiosk
- NIH FAQs Regarding Human Participant Research
- NIH Further Guidance on a Data and Safety Monitoring for Phase I and Phase II Trials
- NIH Policy - Required Education in the Protection of Human Research Participants
- NIH Policy for Data and Safety Monitoring
- Office for Human Research Protections (OHRP) - Policy Guidance
- OHRP International Compilation of Human Research Standards
- OHRP IRB Guidebook
- Protection of Pupil Rights Amendment (PPRA) (fpc.gov)
- Regulations for Drugs (FDA.gov)
- Regulations for Medical Devices (FDA.gov)
- Regulations for Vaccines, Blood & Biologics (FDA.gov)
- Regulations: FDA CFR Title 21 - Food and Drugs: All Parts 1 to 1499 Search (FDA.gov)
- Significant Differences Between HHS and FDA Regulation (FDA.gov)
- The Belmont Report
- The Nuremberg Code
International Laws/Regulations/Guidelines
Related Government Agency Links
- ClinicalTrials.gov
- Food and Drug Administration (FDA)
- National Cancer Institute (NCI)
- National Institutes of Health (NIH)
- National Science Foundation (NSF)
- United States Department of Defense
- U.S. Department of Health and Human Services (HHS)