Participant Communication with Investigators and the IRB as Part of Informed Consent Process- POL031   

 

 

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

 

Review/Revised Date: 2/16/2010

 

Category: Research

 

Policy Owner: Vice President for Research

Policy Contact:

 

   
 
 

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.