Qualifications, Training, & Oversight Questions/Answers
Investigators and research staff are qualified by training and experience for their research roles, including knowledge of applicable federal, state, and local regulations; relevant professional standards; and the Organization's policies and procedures.
Investigators appropriately delegate tasks that are commensurate with staff qualifications and provide oversight throughout the study.
Answers
What Responsibilities and Qualifications are required for research investigators?
The Principal Investigator’s Guide to Responsibilities, Qualifications, Records and Documentation of Human Research list responsibilities and basic qualifications for conducting human subject research.
It is a succinct guide to enable compliance and includes an investigator’s local UK responsibilities when research reviewed by an external, Non-UK IRB.
What are the IRB's expectations regarding oversight and delegation for medical intervention studies and clinical trials?
Unless a study submitted to the Medical IRB is non-interventional, (e.g., survey, record review, or purely outcomes research), some form of medical oversight may be necessary. However, the degree and level of expertise needed can vary depending on risk level, condition, study population, applicable regulations, and external oversight (e.g., sponsor monitor; mentor). The Investigator Qualifications and Provision of Medical Oversight guide provides regulatory guidance on oversight, supervision, and delegation.
Inappropriate delegation is frequently cited in FDA warning letters. The FDA Guidance, Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects clarifies FDA’s expectations on delegation and oversight.
- The Investigator Qualifications and Provision of Medical Oversight guide [PDF] provides regulatory guidance on oversight, supervision, and delegation.
What is your process for task delegation?
Prior to describing delegation, the Principal Investigator should indicate his/her direct involvement in the conduct of the study including recruitment, obtaining consent, assessing eligibility criteria, events, and protocol procedures.
An investigator may delegate many tasks to study staff, if the tasks is within their scope of practice. Anyone delegated a task, must be qualified by education, training, and experience (and state licensure where relevant). In addition, the investigator would need to ensure that the delegation is consistent with any specifications in the research protocol or stipulations by the IRB. Medical procedures and assessments (including adverse event causality, un-blinding, treatment decisions) should not be inappropriately delegated to unqualified staff. Using task delegation logs is a best practice for clinical research, to define roles and indicate who serves in the PI’s absence.
Investigators designate which study personnel should be authorized to obtain informed consent on the IRB application for review by the IRB. The investigator must assure that the study personnel are informed regarding their obligations and commitments.
