Observation of the Informed Consent Process in Ongoing Research- PRO129   

Procedure
 

Investigator Responsibilities

• 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 and PRO123 procedure for managing investigator conflict of interest).

OIRB Responsibilities

Reviewing Staff:

• Reviews the application (FOR200) and informed consent documents for the use with populations protected under Subparts B, C, or D, 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:

• Requires, at their discretion, third-party advocate in research involving a populations protected under Subparts B, C, and D, 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).