Clinical research is an increasingly complex enterprise, which requires knowledge and skills that are outside the traditional training of physicians and other healthcare professionals. The investigator must, for instance, understand what are the responsibilities of screening research participants, obtaining free and informed consent and supervising a trial. Although it is primarily the sponsor or CRO’s duty to select investigators with adequate training to successfully conduct a clinical trial, IRB/REBs also have a responsibility to assess investigator qualifications as part of their mandate to protect the rights and welfare of research participants.

It is a regulatory duty of IRB/REBs to request Investigator qualification information

The International Conference on Harmonization – Good Clinical Practice: Consolidated Guideline (ICH-GCP)- which has force of law in Canada – requires in Article 3.1.3 that: “The IRB/IEC should consider the qualifications of the investigator for the proposed trial, as documented by a current curriculum vitae and/or by any other relevant documentation”.
These requirements state that:
“In order to fulfill these responsibilities, the IRB needs information about the qualifications of the investigator(s) to conduct and supervise the proposed research… if the reviewing IRB has no knowledge of either the clinical investigator or the institution (e.g., the IRB is not affiliated with the institution where the research will be conducted; the IRB has no previous experience with the investigator), the IRB would likely need to take additional steps to evaluate the investigator’s qualifications. Such steps may include, as appropriate, reviewing the curriculum vitae of the investigator, subinvestigators, and other necessary study staff, verifying professional associations and medical licensure, or reviewing relevant publications and the investigator’s training in good clinical practice.”
Based on this FDA guidance document, independent or non-institutional IRBs/REBs are assumed to require more information than institutional IRBs/REBs regarding the Principal Investigator’s (PI’s) qualifications – including good clinical practice training – in order to determine whether they are qualified to conduct specific research studies.
Given that the primary role of IRBs/REBs is the protection of research participants’ rights and wellbeing, it is our view that Investigators’ proof of training in good clinical practice must also include awareness of human research participant protection issues. This view is also in line with the ICH-CGP, which holds that the IRB/REB should request “any other relevant documentation” in order to evaluate the Principal Investigator’s qualifications.

What information is required by the IRB/REB?

If you’ve ever completed Veritas IRB’s Principal Investigator and Site Submission Form, you’ll know that our fully independent IRB/REB requires that each PI (or QI for Qualified Investigator in Canada) provide the IRB with information regarding their specific qualifications in both research and the protection of human research participants (using a checklist):
  • Current medical, dental, or professional license
  • List of any board certifications
  • Number of years the PI has been conducting research studies, and number of years at the current research site

Any certifications/degrees in human research participant protection, such as:

    • APPI (CPI)
    • DIA (CCI)
    • SOCRA (CCRP)
    • Graduate/undergraduate researcher studies/degree
Any additional training completed, in the past 3 years, on human research participant protection, including:

    • CITI Program: Course in the Protection of Human Research Subjects
    • FDA Information Sheets, and the Belmont Report (US)
    • ICH-GCP guidelines
    • NIH Human Participant Protections Education
    • OHRP training modules
    • Tri-Council Policy Statement (TCPS2) (Canada)

This information set permits Veritas IRB to ensure that each approved PI/QI is fully qualified to conduct the specific research project, while respecting both good clinical practice and the protection of research participants’ rights and well-being.

This type of qualification evaluation can identify Investigator training gaps that could otherwise jeopardize the scientific integrity of the research data and the well-being of research participants.
The Veritas IRB Inc. Editorial Board

The Veritas IRB Editorial Board covers questions of research ethics, clinical trial conduct, and human research participant protection primarily for sponsors, CROs and investigators/researchers. // Le blogue de Veritas IRB aborde des questions de l'éthique de la recherche, de la bonne conduite des essais cliniques, et de la protection des participants à la recherche dans une perspective axée sur les promoteurs de la recherche, les organismes de recherche sous contrat (ORCs ou CROs), et les chercheurs.