Procedure for Ensuring Qualifications of Investigators - IRB PRO103

Abstract:
This procedure lists the responsibilities of investigators, OIRB and IRB for ensuring that all investigators are qualified to perform their role (s) in conducting research.
Effective Date:
9/9/2010
Responsible Party:
Contacts:
None Assigned
Administrative Category:
Applies To:
Faculty, Staff, Students
Material Original Source:
UAB Human Research Protection Program

HRPP Document:     PRO103
Effective Date:   3/30/07
Revision Date:  4/21/10, 9/9/10, 7/30/11
Subject:  Procedure for Ensuring Qualifications of Investigators

PROCEDURE

Investigator Responsibilities:

The Investigator:

  • Indicates in the FOR200 Human Subjects Protocol (HSP) that individuals on the research team are licensed and/or credentialed, as applicable;
  • Completes his(her) human subjects protection training and ensures all others involved in the research project complete their training requirements (see PRO100 Procedure for Evaluating and Training Individuals Involved in the Human Research Protection Program);
  • Assures that all personnel responsible for obtaining consent are knowledgeable about the research protocol and are skilled, licensed, and/or credentialed, as applicable, for their role in the research project;
  • Conducts research according to UAB policies and procedures, applicable federal, state and local regulations, and relevant professional standards and ICH-GCP guidelines (EG) (see GUI342), if applicable;
  • Completes the section in the HSP providing his/her qualifications (FOR200) and, as requested, credentials for conducting the research;
  • Submits the departmental protocol oversight review form (PORF; e.g., FOR205, FOR214).

The Student-Investigator, in addition to the above:

  • Obtains the signature of faculty advisor who will provide oversight for conduct of the research by the student.

OIRB Responsibilities

The Senior Staff:

  • Confirms the qualifications section of the HSP is complete for review by the IRB;
  • Confirms investigators, sub-investigators, research personnel, and those persons obtaining consent have completed initial and continuing human subjects education.
  • Obtains additional information regarding training or other documentation of qualifications or licensure of investigators, as requested by the IRB.

Administrative Staff:

  • Prepares training reports for protocols submitted for initial and continuing review.

IRB Responsibilities

The IRB:

  • Evaluates whether the research personnel are qualified to carry out the research;
  • When indicated, requests additional information, documentation of qualifications for proposed research.

Approved on July 30, 2011, by:

Ferdinand Urthaler, MD
IRB Chair

Denise Ball, CIP
OIRB Interim Director