Policies and Guidelines

Federal Regulations and Guidance

Belmont Report

Federal Regulations (Code of) 45 CFR 46, Title 45, Part 46

OHRP Guidance on the Involvement of Prisoners in Research

Federalwide Assurance of Protections for Human Subjects with DHHS Office of Human Research Protections

Institutional Policies and Procedures

Policy For Student Projects

Students as Research Participants

Principal Investigator Eligibility Information

Confidentiality and Data Security

IT Security Standard

Cloud Storage Standard

Dropbox Guideline

 

SU Human Research Protection Program Standard Operating Procedures (SOPs)

SOP 001 – DEVELOPMENT, APPROVAL, AND MAINTENANCE OF HUMAN RESEARCH PROTECTION PROGRAM POLICIES AND PROCEDURES 

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 008 – IRB MEMBER TRAINING

SOP 009 – COMMUNITY OUTREACH

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 019 – ASSENT/DISSENT BY CHILDREN OR COGNITIVELY IMPAIRED ADULTS WHO LACK DECISION-MAKING CAPACITY

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 031 – IRB OFFICE RECORDS

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 039 – IRB OF RECORD

SOP 040 – COMMUNITY BASED PARTICIPATORY RESEARCH

GLOSSARY

 

Resources

IRB Discussion Forum

NIH Research on Human Specimens

DHHS Office for Human Research Protections (OHRP)

OHRP Human Subject Regulations Decision Charts

New Issue Online – The Researchers Toolbox