Procedure for Participants to Communicate Questions and Concerns to Investigators and the IRB as Part of Informed Consent Process - IRB PRO131

Abstract:
This procedure outlines the responsibilities of the investigator, ORIB, and IRB to facilitate questions and concerns as part of the Informed Consent process.
Effective Date:
3/30/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO131
Effective Date:   3/30/07
Revision Date:  -
Subject:  Procedure for Participants to Communicate Questions and Concerns to Investigators and the IRB as Part of Informed Consent Process

PROCEDURE

Investigator Responsibilities

The Investigator:

  • Includes information in informed consent documents on whom to contact in the event of a research-related injury to the participant;
  • Includes in informed consent documents for research involving greater than minimal risk an explanation of any or no compensation, whether any treatments are available in the event of injury and what they consist of, or where further information may be obtained;
  • Includes a clear and concise statement in informed consent documents and recruitment materials on how to make contact with investigators, research staff, Human Subjects Protection Administrator and/or patient advocate for answers to questions regarding the research, treatment for injuries, and participants research rights;
  • Is available or makes research staff available to respond to participants;
  • Responds in a timely manner to participants.

OIRB Responsibilities

The Senior Staff:

  • Verifies informed consent documents plainly identify contact information for participants who have questions about the research or research subjects’ rights and whom to contact about a research-related injury;
  • Verifies informed consent documents provide instructions for contact through UAB IRB toll-free 800 phone number;
  • Verifies informed consent documents include information on whom to contact in the event of a research-related injury to the participant;
  • Verifies informed consent documents for research involving greater than minimal risk include an explanation of any or no compensation whether any treatments are available in the event of injury and what they consist of, or where further information may be obtained;
  • Verifies recruitment materials include contact information.

IRB Responsibilities

For Convened Review:

  • The IRB approves research only after confirming:
    • Informed consent documents plainly identify contact information for participants who have questions about the research or research subjects’ rights and whom to contact about a research-related injury;
    • Informed consent documents provide instructions for contact through UAB IRB 800 phone number;
    • Informed consent documents for research involving greater than minimal risk include an explanation of any compensation, whether any treatments are available in the event of injury and if so what they consist of, or where further information may be obtained;
    • Recruitment materials include contact information;
  • Identifies protocols that need 24-hour access to investigator and/or health care personnel.

For Expedited Review Procedure:

  • An experienced IRB member approves research only after confirming:
    • Informed consent documents plainly identify contact information for participants who have questions about the research or research subjects’ rights and whom to contact about a research-related injury;
    • Informed consent documents provide instructions for contact through UAB IRB 800 phone number;
    • Recruitment materials include contact information.

Approved on March 23, 2007, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director