SOP #: I-B-6
SOP Area: Auditing the Informed Consent Process
University of Pittsburgh
Education and Compliance Office for Human Subject Research
______
Standard Operating Procedure
______Audit of Consent Form for 24-Hour Contact Information______
1.PURPOSE
a.To review consent forms for 24-hour contact information.
b.To verify the contact phone numbers provided in the consent form.
c.To evaluate the appropriateness of investigator response to contact number provided in the consent form document.
d.To review consent forms for inclusion of the correct phone numbers for the Human Subjects Protection Advocate.
2.SCOPE
This procedure applies to all audits of the contact information for all protocols submitted to the University of Pittsburgh Institutional Review Board.
3.RESPONSIBILITIES
The Education and Compliance Coordinators(ECO Coordinators) are responsible for selecting the protocols, making the phone calls during "off business hours" and reporting a summary of the findings to the Compliance Activity Review Subcommittee (CARS).
4.PROCEDURES
4.1The ECO Coordinator will randomly select protocols from the OSIRIS application for audit. The focus of selection will be on (but not limited to) protocols that have been determined to be greater than minimal risk.
4.2A copy of the consent form will be downloaded from the OSIRIS application and used to facilitate the audit.
4.3The consent form will be evaluated for appropriate language that provides instruction in case of an emergency, injury or adverse event. The numbers provided for the Human Subject Protection Advocate will be evaluated for correctness.
4.4After business hours on any given day or anytime during the weekend, the ECO Coordinator will follow the adverse event contact instructions provided in the consent form.
4.5Calls will be made and subsequent instructions followed (if applicable) until contact is made with a "real person" that could either respond to the call or who is in direct contact with a medical professional that can respond to an adverse event. The ECO Coordinator may choose to pursue calling until they personally speak with the medical professional.
4.6Upon reaching a "real person", full disclosure of the call as a quality assurance measure will be provided to that individual.
SOP #: I.B.6
SOP Area: Monitoring of the Informed Consent Process
University of Pittsburgh
Education and Compliance Program RCCO
4.7The ECO Coordinator will document the process and the success or failure to reach an individual who could take appropriate action. This information will be summarized in a report and submitted to the CARS which will review the report and determine the need for further action.
5.0REFERENCES/DOCUMENTATION
Attached 24-Hour Contact Number Tracking Form(attached)
Original: 8/1/01
Reviewed/Revised: 11/20/03
Reviewed: 9/3/04
Revised: 12/15/10
Reviewed/Revised 12/4/15
SOP #: I-B-6
SOP Area: Auditing the Informed Consent Process
University of Pittsburgh
Education and Compliance Office for Human Subject Research
UNIVERSITY OF PITTSBURGH
Education and Compliance Office
Audit of 24-Hour Contact Phone Number as Listed in the Consent Form Document
IRB #______Date______ECO Coordinator______
Principal Investigator______
Protocol Title______
______
Review of Informed Consent Document:
Statement of whom to call in case of injury?
Number listed for Human Subject Protection Advocate?
Record of Calls Placed:
Call #1:Time______To______Phone______
Results:
Call #2:Time______To______Phone______
Results:
Call #3:Time______To______Phone______
Results:
Call #4:Time______To______Phone______
Results:
1
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