» PI Responsibilities

The following responsibilities are the sole responsibility of the Principal Investigator (PI) and may not be delegated.

• Obtaining IRB approval prior to initiating research involving human participants.
• Ensuring research personnel are qualified to perform delegated tasks and procedures, including but not limited to appropriate training, education, expertise, credentials, and privileges.
• Taking appropriate steps to ensure entities not under the control of the PI are qualified to perform any delegated task(s) (e.g., subcontractors, collaborating investigators, individuals at other research sites).
• Ensuring research is designed in a manner which:
  • Minimizes risks to participants: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.
  • Ensures risks to participants are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.
• Ensuring appropriate resources are available to conduct the research and protect participants, including adequate time to conduct and complete the research, an adequate number of qualified staff, adequate facilities, access to a population that will allow recruitment of the necessary number of participants, and availability of medical or psychosocial resources that participants may need as a consequence of the research.
• Reporting to the IRB any modifications, adverse or unanticipated problems, deviations, non-compliance, and research participant complaints that may arise during the conduct of the research study.
• Ensuring the confidentiality of research data, including signed consent documents, and all IRB approvals/correspondence
• Submitting continuing review at intervals determined by the IRB and a closure form at the completion of the research.
• Disclosing any personal, professional or financial conflicts of interests (COI) with the research.
• Ensuring the recruitment of research participants is performed in a fair and equitable manner where individuals are not discriminated against based on age, race, gender or ethnicity.
• Ensuring the informed consent process and method of documentation are appropriate for the type of research being conducted and study population; the informed consent of research participants is voluntary; and special protections are in place when consenting vulnerable populations.
• Notifying the IRB immediately of any audit or site visit by the Food and Drug Administration (FDA); any correspondence from or sent to the FDA; and any sanctions or actions taken against the Investigator, the Sponsor, or the research. (Note: for FDA regulated research only)
• Notifying the IRB immediately of any correspondence with regulatory authorities.
• Notifying the IRB of any decisions made to place administrative or other holds on the research by the study sponsor, a data and safety monitoring board/committee, a federal oversight agency, or another IRB.

External Collaborators for IRB studies

When Chapman researchers work with external collaborators on human subject research studies, the individuals are usually associated with a research organization with a human participant research program and have a registered Federalwide Assurance (FWA) on file with the Office of Human Research Protections.

• All training and other Chapman IRB policies apply to collaborators while appointed at Chapman and engaged in Chapman research.
• External collaborators may not be named as a PI, Co-PI, or Primary Contact for the study.
• PIs should not include external collaborators in their IRB submissions until after Chapman has approved their courtesy appointment. At that point, the collaborator should be named as Chapman personnel in Cayuse IRB’s Section 2a (not as external personnel). Collaborators may not engage in human participant research until the IRB approves their addition to the study team. 

Sponsor-investigator Responsibilities for CLINICAL TRIALS (for FDA regulated research only)

According to the Food & Drug Administration (FDA), a Sponsor is defined as a person who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator.

An Investigator means an individual who actually conducts a clinical investigation (i.e. under whose immediate direction the drug is administered or dispensed to a subject). In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. 

A Sponsor-Investigator is an individual who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. The term does not include any person other than an individual. The requirements applicable to a sponsor-investigator includes both those applicable to an Investigator and a Sponsor.

Sponsor-Investigators have the following responsibilities in addition to the ones outlined above:

• Selecting qualified investigators and monitors to ensure the protection of human participants.
• Providing information to study personnel to conduct the investigation properly.
• Ensuring appropriate documentation of protocol-specific training of all study personnel who have delegated responsibilities.
• Maintaining a delegation of authority (DOA) log that outlines the responsibilities of research personnel.
• Ensuring proper monitoring of research and participant data to include:
  • Appointment of study monitors who are qualified by training and experience, review the progress of the ongoing investigation and review and evaluate the safety and effectiveness of the data;
  • Investigators must outline their approach to monitor the research and participant data in their protocol and receive prospective IRB approval;
  • Ongoing monitoring of the clinical investigation must occur to ensure the rights, safety and welfare of research participants is protected; the reported clinical data are adequate and accurate; and the conduct of the trial is in compliance with the protocol and federal regulations;
  • Ensuring compliance of all participating investigator compliance; correct problems or terminate a site’s participation; and report terminations to the IRB and FDA.
• Ensuring that the investigation is conducted according to the investigational plan and protocol.
• Maintaining an effective/active Investigational New Drug (IND) or Investigational Device Exemption (IDE).
• Ensuring that the FDA and participating investigators are promptly informed of significant new information.
• Ensuring that the investigational product is shipped only to approved and qualified investigators.
• Completing and updating of Form FDA 1572 for all investigators and co-investigators, as appropriate.
• Completing a Certification of Financial Interests and Agreement of Clinical Investigators: Form FDA 3454 (https://www.fda.gov/media/70465/download)
• Providing information to conduct the investigation properly including:
  • Providing investigators with a copy of the investigational plan or protocol;
  • Ensuring investigators are informed of new observations;
  • If the research involves an IDE, sponsors must provide reports of prior investigations of the device.
• Ensuring the submission of safety reports to the IRB and FDA.
• Ensuring the submission of annual reports to the FDA for the IND or IDE.
• Ensure that the informed consent of research participants is obtained.
• Ensure that no screening procedures (e.g., washout period, fasting) is conducted prior to obtaining informed consent.
• Promptly investigate any safety reports that are received from investigators and provide follow up to the FDA.
• Ensuring the documentation and retention of the following:
  • All correspondence with investigator, monitors, IRBs and the FDA
  • Signed investigator agreements or statement (Form FDA 1572)
  • Financial disclosure forms
  • Records regarding anticipated or unanticipated adverse events or reactions
  • Labeling, shipment, control and disposition of the investigational product
  • Deviations from the protocol
  • Any other records pertaining to the conduct of the study

Resources

Investigators who are conducting FDA Regulated research should review the FDA Guidance: Investigator Responsibilities: Protecting the Rights, Safety, and Welfare of Study Subjects which can be found at https://www.fda.gov/media/77765/download.

To submit safety reports, investigators can complete a MedWatch Form/Form FDA 3500: https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting.

Sponsor-Investigators must also be aware of the FDA Regulations related to Good Clinical Practice (GCP) and clinical trials (https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/regulations-good-clinical-practice-and-clinical-trials).

For more information on whether or not a human research study can be conducted without an IND, see https://www.fda.gov/media/79386/download.

For more information about the IDE approval process, see https://www.fda.gov/medical-devices/investigational-device-exemption-ide/ide-approval-process.

For more information about monitoring clinical investigations, see https://www.fda.gov/media/116754/download.

For more information about financial disclosure requirements for clinical investigators, see https://www.fda.gov/media/85293/download.