IRB Use of Consultants- PRO114   

 

 

Abstract: 
This procedure lists responsibilities for IRB members, the IRB Chair, OIRB and consultants for the IRB use of consultants.

Effective Date: 3/10/2010

 

Review/Revised Date: 6/26/2019

 

Category: Research

 

Policy Owner: Vice President for Research

Policy Contact:

 
   
 
 

 

procedure
 

IRB Responsibilities


IRB Members:

  • Request the Chair appoint a consultant whenever the member determines the assigned protocol requires expertise in a special area in which (s)he is unable to review a protocol adequately; or
  • Recommend a person whom (s)he contacted for information related to the research to serve as a consultant.

 

IRB:

  • May decide during review if a consultant is needed to assist in the review of the protocol.
  • Suggest or request the Chair or designee appoint a consultant.

 

Chair (or designee):

  • Examines the agenda for each meeting to determine if a consultant is needed for:
    • Scientific expertise.
    • Representation of vulnerable populations.
      • Research funded by Department of Education (National Institute on Disability and Rehabilitation Research) which purposefully includes children with disabilities or individuals with mental disabilities as research participants, will undergo review by at least one person primarily concerned with the welfare of these participants.
    • Understanding of local context.
    • Other issues.
  • Appoints consultants as necessary for research protocols to receive adequate review.

 

Consultant Responsibilities

 

Consultant:

  • Receives POL009 on IRB member and consultant conflicting interest.
  • Certifies in writing that (s)he has no conflicting interest.
  • Receives all documents submitted to the IRB for review.
  • Presents opinions on the protocol either by oral presentation at the time of convened IRB review or by written summary.
  • If present at the meeting, departs convened meeting before the final IRB deliberation and vote on the research protocol on which (s)he gave consultative input.

 

OIRB Responsibilities


Management staff:

  • Assists the Chair in identifying and contacting potential consultants, if needed.
  • Communicates with consultants on matters pertaining to IRB review and scheduling of assigned protocol review.
  • Ensures proper destruction of the materials provided to the consultant following the review.

 

Reviewing staff:

  • Alerts management staff or IRB members to potential need for a consultant.

 

Administrative staff:

  • Ensures consultant form and confidentiality form are signed prior to distribution of any materials.
  • Distributes protocol materials to consultants
  • Schedules consultant attendance at the IRB meeting, if needed.
  • Distributes written summary of consultant review, if provided, to IRB members with convened review materials
  • Documents in the IRB minutes key information provided by consultant during oral presentation.
  • Describes and attaches any written summary or presentation from the consultant in the minutes and the protocol record.