Library Document Details

Procedure for Observation of the Informed Consent Process in Ongoing Research - IRB PRO129

This procedure outlines responsibilities of the investigator, OIRB and IRB for observation of the informed consent process in ongoing research.
Effective Date:
Responsible Party:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:

HRPP Document:     PRO129
Effective Date:   3/30/07
Revision Date:  -
Subject:  Procedure for Observation of the Informed Consent Process in Ongoing Research


Investigator Responsibilities

The Investigator:

  • Assigns or appoints a disinterested, third party at his/her own discretion or in response to a request by the IRB, to monitor and/or oversee the research procedures including the informed consent process;
  • Assures the third party does not have a conflict of interest, is impartial to the research being conducted, and remains unbiased throughout the conduct of the study (see POL023 policy on, PRO123 procedure for managing investigator conflict of interest).

OIRB Responsibilities

The Senior Staff:

  • Reviews the HSP and informed consent documents for the use of vulnerable populations or the potential for vulnerability of the targeted population;
  • Requests additional information, as needed, regarding additional protections for inclusion of vulnerable populations, the informed consent process or documentation of consent;
  • Assures the informed consent document contains language appropriate for the use of a third-party advocate, if applicable;
  • Assists the investigator or IRB in the appointment of a third-party advocate, if deemed appropriate.

IRB Responsibilities

The Convened IRB, or Experienced Reviewer for the expedited review procedure:

  • Requires, at their discretion, third-party advocate in research involving a vulnerable population or where participants may become incapacitated and, therefore, vulnerable;
  • Requests the third-party advocate be involved in specific activities associated with the research (e.g., observation of the informed consent process).

Approved on March 23, 2007, by:

Ferdinand Urthaler, MD
IRB Chair

Sheila Deters Moore, CIP
OIRB Director