Study Responsibility & IRB Paperwork
The Principal Investigator (PI) is the fully responsible for the conduct of all aspects of his/her IRB approved protocol. Due to the significance of this responsibility, IRB-01 will only accept protocol paperwork that has been signed by the PI. This assures us that the PI is aware of the conduct of his/her protocol. Paperwork signed by a Co-Principal Investigator (Co-PI) or sub-Investigator (sub-I) will not be accepted, processed, or reviewed and will be returned to the sender/PI.
Obviously PIs can sometimes be unavailable for a significant length of time (e.g. travel, medical reasons, etc.) and might not be available to oversee their protocol and/or sign protocol related paperwork. In these events, the PI must obtain a “temporary PI” to oversee the conduct of the protocol in the PI’s absence and to sign any protocol related paperwork. This temporary transfer must be written, protocol specific, for specific and limited time frame, and signed by both the PI and the temporary PI. The temporary PI must already be listed as a co- or sub- investigator on the protocol (otherwise a protocol revision will be necessary). The transfer should be obtained prior to the PI’s absence, and should be submitted to the IRB (1) when first obtained and (2) with any subsequent submissions that the temporary PI signs. You should use our Temporary Transfer of Study Responsibility Form (for paper submissions) or designate a PI Proxy (within myIRB).
Researchers must comply with all UF policies and procedures as well as all applicable federal, state, and local laws regarding the protection of human subjects in research, including, but not limited to the following:
- Obtaining IRB approval prior to involving any human subjects (including their data or tissue) in research studies.
- Only the IRB may determine if research is exempt from Federal regulations (investigators may not make the final determination of exemption).
- If the project involves VA patients, facilities, staff, or resources, you must obtain approval from the VA Research & Development (R&D) Committee before initiating the research at the VA.
- Other committees: you are responsible for obtaining approval from all appropriate offices related to the conduct of your research project (e.g. billing compliance, radiation review, biosafety review, etc).
- Continuing Review: apply for renewal of your IRB approved projects prior to the expiration date. If your project expires, you may not do any of the following: (1) enroll or screen any new subjects, (2) perform any study interventions, unless the IRB finds that it is in the best interest of individual subjects to continue participating in research interventions or interactions, (3) collect, use, or report any data, and/or (4) receive any study funding.
- Insuring that only qualified personnel conduct the study according to the approved Protocol, and in compliance with each individual’s scope of practice.
- Insuring the rights and welfare of each research subject, and that the subject’s rights and welfare must take precedence over the goals and requirements of the research.
- Implementing no changes in the approved Protocol, Informed Consent Form or other IRB approved study related documents without prior Institutional Review Board (IRB) approval, except in an emergency when it is necessary to safeguard the well-being of human subjects.
- If applicable, only a qualified clinician may be responsible for study-related healthcare decisions.
- Ensuring that anyone obtaining informed consent has read the protocol and has sufficient knowledge of all information provided in the informed consent document.
- Obtaining legally effective informed consent from human subjects or their legally responsible representative before any research-related screening or intervention commences and using only the currently approved, stamped Informed Consent Form, when applicable.
- Providing each subject enrolled in the study a copy of the IRB-approved informed consent document at the time of the consent, unless the IRB has specifically waived this requirement.
- Unless specified otherwise, all signed informed consents and other research related documents (including but not limited to paperwork submitted to and approved by the IRB) should be retained throughout the study and for a minimum of three additional years after the study is completed/closed with the IRB (check with the IRB and/or your sponsor regarding how long your records need to be retained).
- Promptly reporting any serious & unexpected adverse events, unanticipated problems involving risks to subjects and/or others, or any changes made to eliminate apparent immediate hazards to subjects to the IRB in writing within 5 working days of occurrence or discovery of occurrence.
- Promptly reporting any interim reports (for example, Data Safety and Monitoring Board reports) or other events that require IRB monitoring.
- Reporting progress of approved research to the appropriate IRB, as often as and in the manner prescribed by the IRB on the basis of risks to subjects, but not less than once per year. This includes submitting a closure report to the IRB once the research is completed or terminated.
- Completing investigator training as required by the Institutional Review Board.
- RESEARCH RECORDS must be retained after completion of the research. Researchers must comply with the longest
- Applicable standard according to current institutional policies. UF & Shands researchers must retain research records for a minimum of three years or longer depending if any of the following are involved: HIPAA, medical treatment, patents, or
- Contractual language with a sponsor. For research involving the VA records must be retained indefinitely until VA
- Regulations establish a shorter retention period. Lastly, research data is the property of the institution and you must comply with all institutional requirements before destroying, copying, or transferring any research data. Additional information is available HERE
- You are responsible for notifying all parties about the approval of your research projects, including your co-Investigators and supervisor.
- Research investigators will advise the IRB and the appropriate officials of this Institution and other institutions of the intent to admit human subjects who are involved in research protocols. When such admission is planned or a frequent occurrence, those institutions must possess an applicable OHRP-approved Assurance prior to involvement of such persons as human subjects in those research protocols.
- If conducting research involving products regulated by the Food and Drug Administration (FDA), the investigator will comply with all applicable FDA regulations and fulfill all investigator responsibilities (or investigator-sponsor responsibilities, where appropriate), including those described at:
- Reporting the emergency use of an approved test article to the IRB within 5 working days.
- Submitting paperwork in accordance with IRB Submission Acceptability Standards.
- If unavailable to conduct or direct this research personally, as when on sabbatical, leave, or vacation, to: (1) arrange for a co-investigator to assume research related responsibilities in the researcher’s absence, and (2) to notify the IRB in writing of this change prior to the absence.
- In the event that employment with the university is discontinued, to do one of the following with each approved/active study prior to leaving the university: (1) transfer the study to a new principal investigator or (2) close the project. These changes must be sent in writing to the IRB by submitting either a formal revision or a Continuing Review/Study closure report. This notification must be submitted in advance (prior to the termination of employment).
- No research investigator will seek to obtain research credit for, or use data from, patient interventions that constitute the provision of emergency medical care without prior IRB approval. A physician may provide emergency medical care to a patient without prior IRB review and approval, to the extent permitted by law (see Section 116[f]). However, such activities will not be counted as research nor the data used in support of research.
All investigators should review and be familiar with:
- The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research
- The U.S. Department of Health and Human Services (DHHS) Regulations for the Protection of Human Subjects at 45 CFR 46
- IRB-01 Policy & Procedures
- For research that involves the Creation, Collection, Use, Or Disclosure of Protected Health Information as Covered by HIPAA
- For research that involves the North Florida/South Georgia Veterans Health System
- For research that involves FDA regulated agents, drugs, or devices: (http://www.fda.gov/)
PI’s affiliation with UF, Shands, or NF/SG VAMC ends
Prior to leaving UF/Shands/VA, the PI must either (1) revise their protocol to name a new PI or (2) close their study by submitting a Study Closure Report.
In the event the PI fails to do either, responsibility for the study defaults to the PI’s supervisor (department chair, dean, etc.). The supervisor is responsible for the conduct of the study and must either name a new PI and renew or close the study once approval expires.