Oversight of Study Staff
The Principal Investigator is responsible for ensuring that all study staff are qualified, trained, and appropriately supervised to protect the rights, welfare, and safety of research participants and to maintain the integrity of the research.
While study tasks may be delegated, ultimate responsibility for study conduct remains with the PI.
Delegation of Study Responsibilities
The PI must ensure that study tasks and duties are delegated appropriately and documented. The HRPP has a delegation log template available as a resource.
Researchers are responsible for maintaining current study records clearly documenting:
- Study staff names, contact information, and roles
- Tasks assigned
- Dates of delegation
- Updating the log when staff or responsibilities change
- Ensuring staff only perform tasks for which they are trained and qualified
Delegation of tasks does not transfer responsibility away from the PI.
Training and Qualifications
Before engaging in research activities, study staff must complete all required training and maintain training currency throughout the study.
Required training may include:
- Mandatory Human Subjects Research (HSR) training (e.g., CITI)
- Protocol orientation and task-specific training
- Good Clinical Practice (GCP) training, when applicable
- HIPAA Privacy and Security training, when accessing protected health information
- Sponsor-required training, as applicable
Researchers are responsible for verifying training completion and maintaining appropriate documentation in the study staff records. These records must be made available upon request to the HRPP or IRB during protocol review, compliance review, regulatory inspection, or accreditation visit.
Supervision and Ongoing Oversight
Researchers must provide ongoing supervision appropriate to the complexity and risk of the study, including:
- Ensuring compliance with the IRB-approved protocol and consent process
- Monitoring study conduct and data integrity for compliance and safety
- Addressing errors, deviations, or performance issues promptly
Conflict of Interest (COI) Disclosures and Management
Researchers must ensure that all study staff comply with institutional COI disclosure requirements.
Responsibilities include:
- Obtaining required COI disclosures from each study staff member
- Reporting Significant Financial Conflicts of Interest (SFCOI) or other conflicts that could compromise participant protections or study integrity
- Complying with any required COI management plans and IRB disclosure requirements
The Potential COI Formis to be completed by each study staff member and provided to the PI to be placed in the study record. This form should be updated by each study staff member within 30 days of any relevant change and annually for as long as the study is ongoing. The PI and study staff members may complete the CITI Conflict of Interest training course if unsure about what needs to be reported. These forms must be made available to the HRPP upon request.
Reporting and Compliance
Researchers must ensure that study staff understand and follow reporting requirements, including prompt reporting of:
- Unanticipated problems involving risks to participants or others
- Protocol deviations or noncompliance
- Participant complaints or concerns
- Other issues requiring IRB notification
It is the PI’s responsibility to provide sufficient training, oversight, and monitoring of the conduct of the study to identify potential issues and address them appropriately. Reportable new information must be promptly reported using the appropriate forms.
Additional Information
Researchers are expected to follow all applicable University policies and HRPP Standard Operating Procedures (SOPs) during the conduct of research on behalf of ETSU.
The most relevant ETSU policies are available below: