Library Document Details

Procedure for Complaints and Inquiries for Research Participants, Investigators, Research Staff, and the Community - IRB PRO111

Abstract:
This procedure lists the responsibilities of the OIRB and IRB for handling complaints or inquiries regarding research.
Effective Date:
3/30/2007
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:
UAB Human Research Protection Program

HRPP Document:     PRO111
Effective Date:   3/30/07
Revision Date:  -
Subject:  Procedure for Complaints and Inquiries for Research Participants, Investigators, Research Staff, and the Community

PROCEDURE

OIRB Responsibilities

The Clerical Staff:

  • Screens all inquiries by phone and directs call to the appropriate OIRB personnel available to assist the caller;
  • Treats all reports (e.g., mail, e-mail, fax or phone call) confidentially.

The Administrative Staff:

  • Maintains OIRB web site with current information on contacting staff members via telephone, including a toll-free 800 number, or via e-mail (see GUI323 OIRB Staff) or UAB anonymous and confidential telephone hotline;
  • Monitors and directs UAB IRB e-mail account for communications daily;
  • Screens all inquiries by phone and directs call to the appropriate available OIRB senior staff;
  • Treats all reports (e.g., mail, e-mail, fax or phone call) confidentially.

The Senior Staff:

  • Receives participant phone calls and written communication. Maintains record of all calls (requests for anonymity are honored) except those that do not require contact with the investigator or other simple requests (e.g., directions to UAB, simple call transfer from the toll-free line) in the Call Log (see SUP417 Call Log for Complaints & Inquiries for Research Participants or Community);
  • Documents question, concern, or complaint; takes appropriate action or refers to OIRB Director for resolution;
  • Treats all reports received (e.g., mail, e-mail, fax or phone call) confidentially;

The OIRB Director:

  • Reviews the Participant Phone Log regularly;
  • Takes appropriate action or refers to Chair for resolution;
  • Sends notice of the policy on communication for complaints and inquiries to investigators and research staff.

IRB Responsibilities

The Chair:

  • Reviews reports referred;
  • Discusses with OIRB Director those that may be administratively resolved;
  • Refers to the Compliance Subcommittee for fact finding and recommendations, as necessary
  • Refers to the convened IRB complaints that cannot be administratively resolved for appropriate determination and referral, as necessary.


Approved on March 23, 2007, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director