Research Compliance SOPs

MERCER UNIVERSITY
IRB
STANDARD OPERATING PROCEDURES
TABLE OF CONTENTS

Administrative SOPs

SOP ADM 001.pdf     SOP Writing Procedure
SOP ADM 002.pdf     SOP Change Control for Revising or Updating SOPs
SOP ADM 003.pdf     Management of the IRB Staff
SOP ADM 004.pdf     Signatory Authority
SOP ADM 005.pdf     IRB Staff Training and Education
SOP ADM 006.pdf     Personnel Files
SOP ADM 007.pdf     Phone Message Policy
SOP ADM 008.pdf     Fee Schedule For IRB
SOP ADM 009.pdf     IRB Meetings
SOP ADM 010.pdf     Notification and Tracking of Continuing Review
SOP ADM 011.pdf     Record Keeping
SOP ADM 012.pdf     Facilitating Sponsor Audits
SOP ADM 013.pdf     IRB Minutes
SOP ADM 014.pdf     IRB Training Files
SOP ADM 015.pdf     Assurances

IRB SOPs

SOP IRB 001.pdf       IRB Authority, Membership and Permanent Positions
SOP IRB 002.pdf       IRB Member Education
SOP IRB 003.pdf       Review of Research
SOP IRB 004.pdf       Criteria for Approval
SOP IRB 005.pdf       Non Local Review
SOP IRB 006.pdf       Continuing Review
SOP IRB 007.pdf       SR – NSR Determinations
SOP IRB 008.pdf       Review of Protocols Involving Biologics
SOP IRB 009.pdf       Appeal of IRB Decisions
SOP IRB 010.pdf       Humanitarian Use Devices
SOP IRB 011.pdf       Expedited Reviews
SOP IRB 012.pdf       Exemption from IRB Review
SOP IRB 013.pdf       Conflict of Interest
SOP IRB 014.pdf       Confidentiality - Anonymity
SOP IRB 015.pdf       Serious Adverse Event Reporting
SOP IRB 016.pdf       Review of Safety Alerts
SOP IRB 017.pdf       Additional Protections – Pregnant Women, Fetuses,
                                 In Vitro Fertilization
SOP IRB 018.pdf       Additional Protections – Prisoners
SOP IRB 019.pdf       Additional Protections – Children and Minors
SOP IRB 020.pdf       Additional Protections – Cognitively Impaired
SOP IRB 021.pdf       Additional Protections– Traumatized and Comatose
SOP IRB 022.pdf       Additional Protections – Terminally Ill
SOP IRB 023.pdf       Additional Protections - Educationally or Economically Disadvantaged
SOP IRB 024.pdf       Additional Considerations – Inclusion of Women and Minorities
SOP IRB 025.pdf       Additional Protections – Students, Employees and Normal Volunteers
SOP IRB 026.pdf       Emergency Use
SOP IRB 027.pdf       Protocol Deviation Reporting
SOP IRB 028.pdf       Informed Consent
SOP IRB 029.pdf       Foreign Language Consents
SOP IRB 030.pdf       Emergency Exemption from Informed Consent
SOP IRB 031.pdf       HHS Inspections of the IRB
SOP IRB 032.pdf       Review of Advertisements
SOP IRB 033.pdf       Submission Requirements
SOP IRB 034.pdf       Voting Requirements
SOP IRB 035.pdf       Certificates of Confidentiality
SOP IRB 036.pdf       Compassionate Use
SOP IRB 037.pdf       Communication from the IRB
SOP IRB 038.pdf       Non-Compliance / Complaint Procedures
SOP IRB 039.pdf       Additional Safeguards
SOP IRB 040.pdf       Audits of Investigators / Sites

HIPAA IRB SOPs

SOP HIPAA 001.pdf   Guidance on HIPAA Compliance for Research (Involving the use of PHI)
SOP HIPAA 002 .pdf  Incorporating HIPAA Language in Informed Consents
SOP HIPAA 003.pdf   Handling HIPAA Complaints
SOP HIPAA 004.pdf   Procedure for Signing a HIPAA Authorization
SOP HIPAA 005.pdf   HIPAA Awareness Training and Education