Library Document Details

Procedure for Maintenance of IRB Records - IRB PRO126

Abstract:
This procedure outlines the responsibilities of the OIRB regarding the maintenance of IRB records.
Effective Date:
11/2/2009
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO126
Effective Date:   3/30/07
Revision Date:  11/2/09
Subject:  Procedure for Maintenance of IRB Records

PROCEDURE

OIRB Responsibilities

The Administrative Staff:

  • Maintains a current listing of IRB membership and posts list on IRB web site (see PRO101 Procedure for IRB Member Roster and Quorum);
  • Maintains documents on IRB members qualifications and acknowledgements of confidentiality and conflicting interests by IRB members and consultants (see PRO104 Procedure for Qualifications and Composition of IRBs and OIRB Staff; POL009 policy and PRO109 procedure on IRB member and consultant conflicting interest);
  • Maintains protocol files (see PRO115 Procedure for Organization of Protocol Files);
  • Maintains files on Exemption Requests and Emergency Use Notifications;
  • Maintains minutes of convened IRB meetings, including agendas, information regarding member attendance, discussion held, determinations and actions, record of votes, and any additional or supplemental materials considered for the IRB’s review (see PRO146 Procedure for Documentation of Convened IRB Meetings);
  • Maintains files on Not Human Subjects Research designation applications.

The Senior Staff:

  • Arranges access to records for inspection and copying at reasonable times and in a reasonable manner in response to requests by authorized representatives of OHRP and the FDA as prescribed by federal regulations and in accordance with applicable UAB policy (e.g., SUP411 UAB INFORMATION DISCLOSURE AND CONFIDENTIALITY POLICY);
  • Grants access to IRB records by other individuals in accordance with UAB policy (see SUP411).

Approved on November 2, 2009, by:

Sheila Deters Moore, CIP
OIRB Director