Evaluating an Investigator’s Qualifications

Research related to COVID-19 has increased awareness in the community about the role of the institutional review board (IRBs) to protect the rights and welfare of research participants.  The regulations and guidelines in place to ensure the safety of research participants cover a wide range of areas that need attention.  In addition to evaluating a protocol, IRBs have additional responsibilities to ensure the safety of research subjects. One of the areas for consideration is the background of the principal investigator, as well as the qualifications and training for some research staff.

The FDA says that IRBs must consider the qualifications of the investigators in reviewing a protocol. While the guidance clearly puts the responsibility of identifying appropriately qualified investigators and study sites on the shoulders of study sponsors, IRBs have a responsibility to evaluate an investigator’s qualifications in the interest of protecting study subjects.

This evaluation may be relatively simple and straightforward, or it may entail a more involved assessment depending on a variety of factors, such as familiarity with the investigator.

In many cases, the IRB may have previous experience with an investigator or institution that would allow the IRB to readily determine that the clinical investigator is appropriately qualified to conduct and supervise the proposed research. Familiarity may be a double-edged sword, however. The IRB should have an objective assessment procedure rather than relying on familiarity with the investigator. An assessment process may include some or all the following documentation:

  • an updated curriculum vitae of the investigator and, if required, sub-investigators, and other necessary study staff that includes education, training, and experience
  • verified professional associations
  • verified medical licensure and/or certifications
  • relevant publications authored or co-authored by the investigator
  • investigator’s training in good clinical practice, HIPAA, Conflict of Interest, informed consent process, proper recruitment methods, and research ethics

Some research protocols may involve higher risks, vulnerable subjects, or novel technologies. In these cases, the IRB may also assess:

  • the investigator’s experience in conducting similar studies, demonstrated by recent presentations or publications, and
  • prior clinical experience with study intervention or study-related procedures

As part of the investigator screening process, IRBs may routinely check the FDA’s Web site for information related to clinical investigator inspections, Warning Letters, disqualification proceedings, and debarments. This information is publicly available.

To ensure that investigator qualifications are consistently assessed, even when the IRB is familiar with the investigator, IRBs will often have a procedure or checklist in place for evaluating and documenting investigator qualifications. This would apply to the principal investigator as well as the entire research team.