POLICY
The investigator is responsible for the proper conduct of research. It is the investigator’s responsibility to comply with IRB policies and applicable regulatory requirements. This policy applies to all human subjects research conducted, while some sections may use terminology specific to clinical trials, the underlying principles apply broadly to all research interventions, data collection, and oversight.
Key Terms:
Investigator: The individual responsible for conduct of research. If the research is conducted by a team of individuals, the leader of the team is called Principal Investigator.
Qualifications and Agreement: All study team members including investigators and research staff must be qualified by education, training and experience to assume responsibility for the proper conduct of a research study. Investigators should be thoroughly familiar with the study protocol. When conducting clinical trials, investigators should be thoroughly familiar with the investigational product as described in the Investigator’s Brochure, in the product information and other sources.
Delegation of Authority: While the principal investigator may delegate specific research-related activities to qualified persons, they retain ultimate responsibility for the proper conduct of the research. The principal investigator must ensure that all delegated individuals are appropriately qualified and adequately informed about the protocol and their assigned duties. Documentation of these delegated responsibilities, including the individuals involved and the specific tasks, must be maintained in an up-to-date delegation of responsibility log, with the extent of documentation and oversight being proportionate to the nature and significance of the activities and the risks to participants and data reliability.
Adequate Resources: Investigators should have sufficient time and adequate qualified staff to properly conduct and complete the research. The Principal Investigator is responsible for ensuring that all persons assisting with the research are adequately informed about the protocol, investigational product(s) and their research related duties.
Care of Subjects: A qualified physician or, when appropriate, a qualified dentist (or other qualified healthcare professionals in accordance with local regulatory requirements)should have the overall responsibility for the research related medical care given to and medical decisions made on behalf of participants; however, the practical interactions and the delivery of medical care and decisions can be carried out by appropriately qualified healthcare professionals in accordance with applicable regulatory requirements.
Conduct of Research: Investigators are responsible for ensuring that all research is designed with scientific rigor, adhering to the highest standards of the relevant discipline. The design should proactively aim to minimize potential harm to participants while maximizing the anticipated benefits. A core principle is to embed quality into both the scientific and operational aspects of all research from its inception. To achieve this, investigators should prospectively identify and define the factors critical to quality, which are fundamental to safeguarding participant protection and ensuring the reliability and interpretability of the research results.
For research studies involving greater than minimal risk to participants, the investigator must develop and submit a data safety monitoring plan for review and approval by the IRB, and subsequently ensure adherence to this approved plan. This data safety monitoring plan should clearly outline a systematic process for identifying, evaluating, controlling, communicating, reviewing, and reporting risks. The measures within this plan must be proportionate to the risks to participants and the criticality of the data being collected.
Investigators should recruit participants in a fair and equitable manner, weighing potential benefits of the research to the participants against their vulnerability and risks to them.
Investigators are responsible for ensuring that informed consent is obtained from all participants prior to their enrollment in research, unless an IRB waiver is granted. This process must utilize the informed consent materials and procedures that have received prior approval from the IRB. Investigators must diligently maintain all essential research records, understanding that these records are subject to direct access and inspection by the IRB and applicable regulatory authorities. Furthermore, investigators must ensure the accuracy, completeness, legibility, and timeliness of all data recorded in data acquisition tools and other research reports.
Additional Investigator Responsibilities Under IND/IDE: An investigator administering an investigational test article (drug, device, or biologic) is responsible for the research to be conducted in accordance with the plan of investigation as described in the FDA-approved IND/IDE, the signed investigator statement, and the IRB-approved investigational plan.
The investigator may not dispense an investigational drug to any person not authorized under the protocol to receive it. The drug, device, or biologic may only be used in subjects under the investigator’s personal supervision or under the supervision of physicians who are directly responsible to the investigator. Additionally, the investigator is required to maintain adequate records of the disposition of the test article, including dates, quantity, and use by subjects.
If the investigational drug is subject to the Controlled Substances Act, the investigator must take adequate precautions, including storage of the investigational drug in a securely locked, substantially constructed cabinet, or other securely locked enclosure, access to which is limited, to prevent theft or diversion of the substance into illegal channels of distribution.
Communication with IRB: Investigator must obtain IRB approval before initiating a research project involving human subjects when the research is conducted by or under the direction of any employee of UTHealth Houston or the research is conducted using the facilities of any UTHealth Houston institution.
Problem Reporting - The Investigator must report all significant changes or increased risks occur during the conduct of a research project to the IRB in accordance with the timelines set by IRB as described in the policy on Problem Reporting.
Compliance with Protocol - The Investigator must not implement any deviation from or changes of the protocol without agreement by the sponsor and prior review and documented approval from the IRB of an amendment, except where necessary to eliminate an immediate hazard (s) to subjects.
Continuing Review Reports - The Investigator should submit written summaries of the research status to the IRB in the timeframe required by the IRB.
Data Governance: The investigator is responsible for establishing and maintaining robust data governance processes throughout the entire research lifecycle to ensure the integrity, traceability, and security of all research data. This includes ensuring that all data, regardless of its format or source, adheres to principles of being attributable, legible, contemporaneous, original, accurate, complete, secure, and reliable.
Investigators must implement documented procedures for the full data life cycle, from capture and management to review, correction, transfer, and retention. This also involves the diligent use of relevant metadata and audit trails to track all data entries, changes, and workflow actions.
For any computerized systems utilized in research, the investigator must ensure they are fit for purpose, appropriately validated, and protected by adequate security controls, user management, and backup procedures. All data handling practices should be proportionate to the risks to participants and the reliability of research results, safeguarding confidentiality and aligning with ethical principles and applicable regulatory requirements.
Transparency Considerations: To uphold the ethical principle of transparency in research, investigators are responsible for ensuring that all applicable clinical trials are registered in publicly accessible and recognized databases, such as ClinicalTrials.gov, in a timely manner. This commitment extends to the public posting of research results, where appropriate and in accordance with institutional policies and ethical guidelines. Furthermore, investigators should consider the objective and non-promotional communication of trial results to participants, respecting their preference to be informed once the information becomes available.
Responsibility for Maintaining Records - The investigator is responsible for maintaining essential research records including regulatory binder documents, case report forms, source documents and signed consent documents.
For research under FDA oversight, records should be retained for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated. If no application is to be filed or the application is not approved for such indication, records are kept until 2 years after the investigation is discontinued and FDA is notified. The sponsor may have record retention requirements specified in the clinical trial agreement that must be followed instead of the 2 year minimum.
For all other research studies, records should be retained for at least 6 years after end of study and publication of the results (whichever is later).
Change of Principal Investigator: If the Principal Investigator is retiring or resigning from UTHealth Houston or is going away for an extended duration of time, the research project should be formally transferred to another investigator or closed. This investigator then assumes all the responsibilities as the Principal Investigator for the conduct of the research project until the original Principal Investigator returns. This change must be reviewed and approved by the IRB. (Principal Investigator Separation Checklist)
REFERENCES
- 21 CRF 312 Investigational New Drugs
- 21 CFR 812 Investigational Device Exemption
- Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects
- IRB Policy and Procedure – Problem Reporting
- Principal Investigator Separation Checklist
If you find errors in this document, contact [email protected]
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Document Number: |
101-G01 |
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Document Name: |
Investigator Responsibilities |
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Reviewed by: |
Associate Vice President, Research Compliance |
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Effective: |
1 Aug 2008 |
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Revision History: |
1 Aug 2011, I Jun 2016, 21 Jan 2019, 31 May 2021, 1 Jun 2026 |
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