UAB Policy on Complaints and Inquiries for Research Participants, Investigators, Research Staff, and the Community - IRB POL011

UAB Policy on Complaints and Inquiries for Research Participants, Investigators, Research Staff, and the Community - IRB POL011

Abstract:
This procedure describes the responsibilities of the IRB and OIRB for facilitating communication regarding complaints and inquiries for research participants, investigators, research staff and the community.
Effective Date:
2/16/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     POL011
Effective Date:   3/30/07
Revision Date:  2/16/10
Subject:  UAB Policy on Complaints and Inquiries for Research Participants, Investigators, Research Staff, and the Community

POLICY STATEMENT

It is UAB policy that the UAB IRB and Office of the IRB maintain open communications with research participants, research investigators and staff, and members of the community as part of their mission to protect the rights, safety, and welfare of human research subjects. Communications include questions, complaints, inquiries for information, reports of concerns, or suggestions relating to specific research proposals or the Human Research Protection Program in general.

The Office of the IRB will develop procedures to implement this policy. These will include specific communication to investigators and research staff describing both the information in this policy and the ability to direct questions, concerns, and suggestions to the Institutional Official or Office of Research Compliance. Also, Investigators and research staff should be notified that UAB has a confidential “hotline” number to report issues or concerns in a confidential and anonymous manner and provide the “hotline” number. The Office of the IRB will maintain an electronic portal to receive and respond to communications from participants, the community, and investigators.

The Office of the IRB will catalogue the nature and dates of all received communications. Office of the IRB administrative staff will make a determination of whether a communication alleges unexpected risks or cannot be resolved through the research team, in which case the communication will be processed according to UAB Policy to Ensure Prompt Reporting of Unanticipated Problems Involving Risks to Subjects or Others to the IRB (see POL006). Also, OIRB administrative staff will make a determination whether a communication indicates potential noncompliance, in which case the communication will be processed according to UAB Policy on Compliance with Human Subjects Regulations or IRB Requirements or Determinations (see POL028).

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