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 (PRO111) 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, Institutional Officials, and External Entities (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).