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Principal Investigator Responsibilities
General responsibilities of investigators
While the Common Rule does not enumerate specific investigator responsibilities, OHRP has provided a set of Frequently Asked Questions on that covers their interpretation of these responsibilities.
In contrast, the FDA regulations do include specific investigator responsibilities. These are listed in 21 CFR 312.60-69.pdf.
21 CFR 312.60 An investigator is responsible for ensuring that an investigation is conducted according to the signed investigator statement (the FDA's 1572 form), the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. An investigator shall, in accordance with the provisions of part 50 of this chapter, obtain the informed consent of each human subject to whom the drug is administered, except as provided in 50.23 or 50.24 of this chapter. Additional specific responsibilities of clinical investigators are set forth in this part and in parts 50 and 56 of this chapter.
Through the act of submitting a protocol to the IRB, and being named as the principal investigator (PI) of that study, the PI is agreeing to assume the overall responsibility for the study conduct. By doing so, they are agreeing to:
- personally conduct or supervise the research;
- ensure that each individual to whom a task is delegated, is qualified by virtue of education, training, and experience (e.g., hospital certification, human subjects research training, state license) to perform each of their delegated tasks;
- protect the rights, safety and welfare of the participants who will be under their care. To do this they are agreeing that the research:
- is conducted in accordance with all federal regulatory requirements, state law and CHOP policies (including IRB SOPs);
- is conducted in accordance with the IRB approved plan; and
- that they will ensure the accuracy, security and integrity of the research data and the subsequent analysis of that data.
There are numerous links to terms on this page which go to other webpages on the IRB's website with more details and more information. At present the most comprehensive discussion of the investigator's responsibilities is the FDA's Guidance document Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects.
The process starts with the decision to perform the study, the design of the study, the communications with the IRB, the oversight of the study execution, the analysis and reporting of data, and the storage of the study data after study completion.
Overview of Principal Investigator Responsibilities
The principal investigator is responsible for knowing the research regulations that apply to their study, additional requirements imposed by the funding agency, study sponsor and relevant regulatory authority (e.g. adverse event reporting, progress reports).
ICH Good Clinical Practice - Investigator Responsibilities
The International Conference on Harmonisation (ICH) documents, serve as guidance for the conduct of all FDA-regulated drug, biologic and device clinical trials. ICH E6 Guideline for Good Clinical Practice enumerates the specific responsibilities of the study investigator. While ICH E6 goes beyond what might be necessary for many minimal risk clinical research studies, it is still a useful reference for investigators. Section 4 in particular, outlines the investigator's responsibilities; these cover the following areas:
- qualifications of investigators;
- resources available for conducting the research (time, space, subject population, funding);
- medical care of trial subjects;
- communications with the IRB/IEC;
- compliance with the protocol;
- investigational product accountability, use and storage;
- randomization procedures;
- informed consent of subjects; and
- trial records and reports.
Responsibilities Related to the Conduct of Human Subjects Research
The principal investigator is responsible for ensuring that:
- The protocol is scientifically sound and of scientific and social value;
- There are adequate resources - time, funding, space, staff - to conduct the research;
- They will provide sufficient oversight over all study activities and tasks delegated to others to ensure that the research is conducted in compliance with all applicable Federal Regulations and CHOP Policies and Procedures;
- IRB approval will be obtained before starting the study (enrolling subjects);
- After the research is approved, all required reports including: continuing review progress reports, unanticipated problems, protocol deviations - will be submitted to the IRB, the study sponsor and the relevant funding agencies in accordance with the CHOP IRB Policies and Procedures and sponsor/funding agency requirements;
- No changes will be made to the research without first submitting a request to the IRB amend the study and receiving the IRB's approval. The only exception to this requirement to obtain prior approval is when it is necessary to eliminate an apparent immediate hazard to subjects 45 CFR 46.103(b)(4). If a change is needed to eliminate apparent immediate hazards to subjects without prior IRB approval, the PI must report those changes promptly to the IRB.
- Study procedures that are considered human subjects research activities, including obtaining informed consent, will only be carried out by members of the IRB-approved investigative team;
- Each subject's valid, voluntary informed consent will be obtained and documented using an IRB-approved consent document (as required by the IRB) before initiating any research interactions or interventions;
- Each child's assent will be obtained and documented (as required by the IRB) in a manner consistent with the approved protocol;
- Data and study records (including consent documents) will be stored, retained and protected in accordance with the approved protocol, HIPAA requirements, CHOP records policies and other applicable regulations (e.g. FDA);
- Analyses and study reports will adhere to the pre-planned protocol analysis plan and in accordance with accepted statistical principles (e.g. ICH E9 Statistical Principles for Clinical Trials) and guidelines for reporting clinical trials and observational and diagnostic studies (CONSORT Statement (Clinical Trials), STROBE Statement (Observational Studies), STARD Initiative (Diagnostic Studies)).
Responsibilities Related to the IRB
Those responsibilities that relate to the IRB are covered in IRB SOP 801: Investigator Responsibilities.
Resources to Assist with PI Responsibilities
Process to change the study PI at CHOP (PI assurance form).
Considerations for planning and agreeing to conduct human subjects research.
Information on PI oversight and supervision of those to whom tasks are delegated.
Ensuring the integrity of the study as it is executed at all sites.
PI responsibility to submit changes to the research, continuing reviews/progress updates, and ...
Guidance on the PI’s responsibility to report unanticipated problems and protocol deviations.
Guidance on the regulatory and institutional requirements for document retention.