Research Regulatory Affairs

Rutgers University

• HSPP Standard Operating Procedures (SOPs) Feb 2014 (PDF)
• 90.2.11 Policy for Human Subjects Protection and the Institutional Review Board (PDF) (From the Rutgers Policy Library)
• Clinical Trials Registration and Results Reporting Policy (PDF)
• Standards for Privacy of Individually Identifiable Health Information (PDF)
• Definition of "Directory Information" For Rutgers (Related to FERPA)
• Rutgers Federalwide Assurance (FWA)
• RBHS Policy Library: Vice President for Research Policies

New Jersey State Statutes

• Access to Medical Research Act (PDF)
• Age of Majority 9:17B-3 (PDF)
• Genetic Privacy Act (PDF)
• Limitation of Guardian Power for Eligible Elderly Persons (njlaw.rutgers.edu)
• 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)
• 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

• International Compilation of Human Research Standards [2018 Edition]

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)