Boston University
Charles River Campus IRB
Policies and Procedures
Title: Institutional Review Board (IRB) Policies and Procedures
Date: December 2, 2015

Purpose

The purpose of this policy is to outline the policies and procedures for drafting, reviewing, distributing, and revising IRB policies and procedures.

Procedures

Policy and Procedure Development

The IRB Director or designee is responsible for drafting new policies and procedures. The IRB Director will ensure that policies and procedures are in compliance with applicable regulations, laws, and institutional policies.

If the draft policy involves coordination with other University offices, the IRB Director will submit the draft policy to the representative of the other office for review to ensure consistency. The IRB Director will work with the representative of the other office to resolve any discrepancies.

Each policy will include the following information:

  • Title
  • Effective Date
  • Last Review/Update date
  • Revision number
  • Author
  • Approved name

Policy and Procedure Approval

Policies and procedures are presented at IRB meetings for review and approval. The IRB Director is responsible for making any changes required by the Board members in order to approve. After the policy and/or procedure is approved by the Board, the IRB Director sends it to the Institutional Official for final review and approval. Once it is approved by the Institutional Official, it will be placed on the IRB website.

Internal workflow policies and procedures: Policies and procedures for internal workflow are not reviewed at the IRB meeting or by the Institutional Official. These policies and procedures are drafted by the IRB Director or designee and then reviewed with the IRB staff. The IRB Director gives the final approval for these policies and procedures.

Policy and Procedure Distribution

With the exception of internal workflow policies and procedures, all new and revised policies are posted on the IRB website. These documents are also saved on the IRB shared drive which is accessible by the IRB Director and IRB staff.

If the IRB determines that the new or revised policy represents a major change, the IRB may send out a mass e-mail with the new and /or revised policy to users that are included in an IRB listserv.

Policy and Procedure Revision

Revisions to policies and procedures may be necessary in order to increase efficiency, decrease deviations, and/or to comply with new regulations, laws, or institutional policies. The IRB Director is responsible for revising policies and procedures.

Revised policies and procedures will be approved and distributed in the same manner as new policies and procedures. Minor and/or administrative revisions can be approved by the IRB Director and do not need to follow the process for approving new policies.

Once a policy has been revised, the former version of the policy will be archived and saved on the IRB shared drive.

Policy and Procedure Review

The IRB Director is responsible for reviewing IRB policies and procedures on an annual basis to ensure that they are still in compliance with applicable regulations, laws, and institutional policies. Revisions will be made as necessary. Revised policies and procedures will be approved and distributed in the same manner as new policies and procedures.

Title: Institutional Review Board (IRB) Policies and Procedures

Author: Cynthia Monahan

Effective Date: July 2, 2014

Last Review/Update Date: December 2, 2015

Revision #: 2

Approved Cynthia Monahan, IRB Director
Kathryn Mellouk, Associate Vice President-Research Compliance

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