Federal Regulations and Guidance
Federal Regulations (Code of) 45 CFR 46, Title 45, Part 46
General Data Protection Regulation (GDPR)
OHRP Guidance on the Involvement of Prisoners in Research
Institutional Policies and Procedures
Students as Research Participants
Principal Investigator Eligibility Information
Confidentiality and Data Security
SU Human Research Protection Program Standard Operating Procedures (SOPs)
SOP 002 – INSTITUTIONAL COMMITMENT TO HUMAN RESEARCH PROTECTIONS PROGRAM
SOP 003 – ROLES & RESPONSIBILITIES OF HUMAN RESEARCH PROTECTIONS PROGRAM STAFF
SOP 004 – ACTIVITIES SUBJECT TO IRB JURISDICTION
SOP 005 – KNOWLEDGE OF LOCAL RESEARCH CONTEXT
SOP 006 – COMPOSITION OF IRB COMMITTEE
SOP 007 – IRB MEMBER CONFLICT OF INTEREST
SOP 010 – IRB COMMITTEE DETERMINATIONS/MOTIONS
SOP 011 – IRB REVIEW OF HUMAN SUBJECTS RESEARCH EXEMPT FROM REVIEW
SOP 012 – EXPEDITED IRB REVIEW OF HUMAN SUBJECTS RESEARCH
SOP 013 – IRB FULL BOARD REVIEW OF HUMAN SUBJECTS RESEARCH
SOP 014 – AMENDMENTS TO PREVIOUSLY APPROVED APPLICATIONS
SOP 015 – IRB CONTINUING REVIEW
SOP 016 – LEGALLY EFFECTIVE AND PROSPECTIVELY OBTAINED INFORMED CONSENT
SOP 017 – DOCUMENTATION OF INFORMED CONSENT
SOP 018 – WAIVER OF INFORMED CONSENT
SOP 020 – APPROVAL AND EXPIRATION DATES ON INFORMED CONSENT DOCUMENTS
SOP 021 – SPECIAL CATEGORIES OF RESEARCH: CHILDREN
SOP 022 – SPECIAL CATEGORIES OF RESEARCH: PRISONERS
SOP 023 – SPECIAL CATEGORIES OF RESEARCH: COGNITIVELY IMPAIRED
SOP 024 – HUMAN RESEARCH PROTECTION PROGRAM QUALITY ASSESSMENT AND IMPROVEMENT
SOP 025 – COMPLAINTS REGARDING HUMAN SUBJECTS RESEARCH
SOP 026 – PROTOCOL DEVIATION/VIOLATION REPORTING
SOP 027 – REPORTING OF UNANTICIPATED PROBLEMS INVOLVING RISK TO PARTICIPANTS OR OTHERS
SOP 028 – INVESTIGATING AND MANAGING POTENTIAL ISSUES OF NON-COMPLIANCE
SOP 029 – SUSPENSION OR TERMINATION OF IRB APPROVAL
SOP 030 – REPORTING TO THE APPROPRIATE INSTITUTIONAL OFFICIALS, AND THE DEPARTMENT OR AGENCY HEAD(S)
SOP 032 – INSTITUTIONAL CONFLICT OF INTEREST
SOP 033 – OFFICE OF SPONSORED PROGRAMS/IRB/ORIP COORDINATION
SOP 034 – THE INSTITUTIONAL OFFICIAL’S AUTHORITY AND RESPONSIBILITIES
SOP 035 – REQUIREMENTS FOR IRB OFFICE STAFF EMPLOYMENT
SOP 036 – RECRUITMENT/ADVERTISING
SOP 037 – PAYMENT OF RESEARCH PARTICIPANTS
SOP 038 – INSTITUTIONAL FINANCIAL CONFLICT OF INTEREST
SOP 040 – COMMUNITY BASED PARTICIPATORY RESEARCH
Resources
NIH Research on Human Specimens
DHHS Office for Human Research Protections (OHRP)
OHRP Human Subject Regulations Decision Charts
New Issue Online – The Researchers Toolbox