UAB Policy on Inclusion of a Procedure for Participants to Communicate Questions and Concerns to Investigators and the IRB as Part of Informed Consent Process - IRB POL031

Abstract:
This policy describes the inclusion of a procedure for participants to voice questions and concerns to the Investigator or the IRB as part of the Informed Consent Process.
Effective Date:
2/16/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     POL031
Effective Date:   3/30/07
Revision Date:  2/16/10
Subject:  UAB Policy on Inclusion of a Procedure for Participants to Communicate Questions and Concerns to Investigators and the IRB as Part of Informed Consent Process

POLICY STATEMENT

It is UAB policy that human subjects receive the following information from investigators and the IRB as part of the informed consent process:

  • For research involving more than minimal risk, when medical treatments are available if injury occurs, where further information may be obtained, and whom to contact in the event of a research-related injury;
  • An explanation of whom to contact for answers and responses to pertinent questions, concerns, or complaints about the research and the research participant’s rights;
  • An explanation of whom to contact in the event the research staff cannot be reached or to discuss the research with someone other than the research staff.

See also: PRO131 Procedure for Participants to Communicate Questions and Concerns to Investigators and the IRB as Part of Informed Consent Process.


Approved on March 1, 2010, by:

Richard B. Marchase, PhD
Vice President for Research and Economic Development

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director