Principal Investigator Eligibility and Responsibilities

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Purpose
Policy
Eligibility
Responsibility
Planning and Development
Approvals

Study Execution
Study Closeout
Records Retention
Publication
Faculty Sponsor Requirement

1. Purpose

To outline the scope of the Principal Investigator (PI) responsibilities for research protocols conducted under the UT Southwestern Medical Center’s Institutional Review Board (IRB), and as part of UT Southwestern’s Human Research Protection Program (UT Southwestern HRPP).

UT Southwestern HRPP is a collaborative effort between affiliated entities: Children’s Medical Center (FWA#00005086) (CMC), Parkland Health & Hospital System (FWA#00001382), Texas Scottish Rite Hospital for Children (FWA#00001126), and UT Southwestern, which includes (FWA#00005087). This policy does not require any procedures in addition to those regulated by federal, state, and local regulations.

2. Policy

Principal Investigators are required to conduct studies that comply with applicable federal, state, and local regulations, including the U.S. Department of Health and Human Services (DHHS) regulations (45 CFR 46) and the U.S. Food and Drug Administration (FDA) regulations (21 CFR Parts 50 & 56). All PIs are required to complete training specified by the UT Southwestern IRB and outlined on the IRB website, and any additional training as required by the affiliated hospitals to secure site approval. All investigators must know and understand their ethical responsibilities in conducting human subject research outlined in the Belmont Report. The scope of the PI's obligations are outlined as follows:

1. The PI, regardless of title, is primarily responsible for all aspects of the study, including the protection of the rights, welfare, and safety of each human subject by adequate design and research conduct. The PI will adhere to the HRPP policies, inclusive of applicable policies from CMC, Parkland, TSRH, and/or UT Southwestern.
2. The PI is required to provide adequate oversight to the study ensuring supervision and training of staff, resource management, and appropriate medical care or appropriate referral for the human subjects and for possible research related injury resulting from study participation. Any responsibility delegated by the PI to member(s) of the Research Team (RT) continues to be performed under the PI's delegation and the PI retains final accountability.
3. The PI must ensure that the research is conducted according to the IRB approved research protocol and in a professional and ethical manner at all times.
4. The PI must ensure that any requirements of contracts, grants, or other legal agreements with a research sponsor and or funding source and/or affiliated site(s) are fulfilled.
5. PIs who fail to adhere to their responsibilities and obligations may have their privileges to conduct research suspended or terminated.

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3. PI Eligibility

The following policy defines who is eligible to serve as Principal Investigator (PI) on a UT Southwestern IRB protocol. The type of relationship an individual has with UT Southwestern determines whether they may serve independently as a PI on their own protocol or if a Faculty Sponsor is required.

UT Southwestern Faculty: Instructor, Assistant Professor, Associate Professor, or Professor may serve as PI on UT Southwestern IRB protocols without a Faculty Sponsor. The IRB is required to determine the qualifications of the PI. As appropriate to their role in research, investigators must be sufficiently qualified by education, training, and experience to assume responsibility for the proper conduct of the research.

  • Adjunct/Volunteer Faculty, Fellows, Residents, Staff (UTSW and Affiliated Hospitals) and Students require a Faculty Sponsor whose appointment meets the criteria in #1 above.
  • Faculty members from other UT campuses (e.g., UTA, UTD) may serve as PI on a UT Southwestern IRB protocol with a Faculty Sponsor whose appointment meets the criteria in #1 above. If the protocol involves a medical intervention, the Faculty Sponsor must be a physician.
  • If the PI is a UTD Faculty member conducting research at the Advanced Imaging Research Center (AIRC) a Faculty Sponsor is not required provided the PI obtains a letter of support and assurances from the appropriate Dean at UTD.

4. Responsibility

The responsibility to protect human subjects is shared by the sponsor, the collaborating institutions of the HRPP, and the IRB, with the ultimate responsibility for the conduct of the research held by the PI. The department chairperson affirms in the IRB application to the protocol's sound design, to the presence of sufficient resources to protect human subjects and to the competency of the investigator(s) to conduct the research project. The PI is responsible for all phases of the study including the following:

A. Planning and Development

i. Research Team Readiness

1.) Establish clear delegation of authority and provide adequate supervision in accordance with HRPP policy
2.) Certify that the RT is adequately qualified to conduct the study as specified
3.) Ensure the entire RT is trained on study procedures (both study specific and general operating procedures)

ii. Feasibility Assessment: Evaluate the feasibility of the protocol design for scientific, regulatory, and ethical aspects of the study as well as for resource requirements, e.g., staff availability, study documentation, sponsor relationship, study population, procedures and services, safety considerations, and space allocation

iii. Affiliate Planning

1.) Coordinate with any affiliate institutions to determine the extent of support necessary for the study as well as the ability to provide the resources in required timelines
2.) Comply with credentialing requirements
3.) Submit the required documentation for the affiliate's approval process
4.) Research-related activities will not be initiated at an affiliated site until after that site has issued an approval

iv. Financial Considerations

1.) Identify the type of funding for the study, e.g., industry or federal funds.
2.) Oversee budget development and billing aspects if any clinical services are provided.
3.) Oversee clinical research billing coverage analysis aspects if any clinical services are provided. Provide pertinent documents to affiliate sites to allow verification of the coverage analysis.
4.) Comply with financial disclosure and conflict of interest requirements for the RT, including updating existing disclosures and reporting any new disclosure to the COI Office and IRB within 30 days.

v. Document Development

1.) IRB application – using IRB checklists and online forms, to include a definitive plan for safety monitoring either by the PI or by a third party for studies of greater than minimal risk
2.) Study Documents – protocol, and as applicable, informed consent form, HIPAA Authorization, investigational brochure, recruitment materials, manual of operation, and/or standard operating procedures

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B. Approvals

Research-related activities, including recruitment, will not be initiated until all required approvals are obtained or after the expiration date of an approval, including, but not limited to:

i. Department
ii. Safety committees, as applicable
iii. Conflict of Interest Committee, as applicable
iv. IRB
v. Office of Clinical Research Facilitation
vi. Sponsored Programs Administration
vii. UTSW performance sites, including but not limited to: University Hospitals and Clinics, UTSW Ambulatory Services, Clinical Translational Research Center, and the Advanced Imaging Research Center
viii. Affiliate organizations or affiliated billing entities

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C. Study Execution

i. Provide referral for appropriate medical care for human subjects by ensuring the following:

1.) Outreach – equitable recruitment
2.) Inclusion/exclusion – confirm each subject's eligibility
3.) Informed consent – obtain and continue during study according to current regulations
4.) Medical attention – assess and provide for subjects' medical needs as related to the clinical trial via UT Southwestern or affiliate medical staff or referral as appropriate
5.) Protected Health Information (PHI) – assure compliance with regulations to access, obtain, use, and disclose PHI

ii. Ensure that the protocol is strictly followed, that the safety of all human subjects is monitored via a safety monitoring plan, and that all regulatory requirements are met, including obligations to FDA as outlined on the 1572 form if applicable or the 1571 form if an investigator/sponsor.
iii. Ensure accurate administration and management of investigational product, if applicable, according to HRPP policy and hospital/clinic requirements.
iv. Assess all reports, including reportable events, monitoring/audit reports and provide those that are required to be reported to the IRB/sponsor in a timely manner (see Adverse Events).
v. If RT is notified that a study will be reviewed or audited by FDA, OHRP or other external regulatory oversight agency, the PI is responsible for notifying the IRB office impending audit or review. Routine monitoring visits conducted by study sponsors do not require notification to the IRB; however, the PI must notify the IRB office should the Sponsor, or any internal monitoring or compliance group, have findings resulting in a protocol modification or other corrective action(s) to protect subjects, indicate serious or continuing non-compliance, or involve other regulatory actions.
vi. Maintain adequate and accurate study records that are readily available for inspection by internal and external monitors and by regulatory agencies.
vii. Manage each research study through active involvement in all aspects of the planning and conduct of the study, which may include the following:

1.) Routine meetings to monitor progress, to discuss concerns, and to update staff
2.) Internal assessment to verify that process and protocol requirements are followed
3.) Processes for corrective action to identify the root cause(s) of issues and prevent future occurrence(s)

viii. Routine resource review to evaluate budget (planned versus actual), staffing for study requirements, and time required to complete activities with given resources.
ix. Ensure that finder’s fees or enrollment incentives are not paid to RT for referring or recruiting prospective subjects. Such finder’s fees include any payment or gift to an individual who identifies a prospective subject.
x. Submit the continuing review report in a timely fashion to ensure a lapse in IRB approval date does not occur.
xi. Submit amendments/changes of any aspect of the research, including research design, intervention or procedures, number of subjects, subject population, informed consent documents, instruments, surveys or recruitment materials, and changes to the RT to the IRB for review. Ensure amendments/changes are not initiated until the IRB has approved.
Note: The only exception is when it is necessary to eliminate apparent immediate hazards to subjects and the IRB should be immediately informed of this necessity.
xii. Report unanticipated problems/adverse event or instances of serious or continuing non-compliance to the IRB within the timeframe outlined in the HRPP policy.
xiii. Request a change in PI to the IRB if you are not able to continue as PI on the study.
xiv. If the study involves research activities at an affiliated site, ensure that the study team complies with the policies and procedures of that site.

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D. Study Closeout

i. Ensure that all applicable guidelines are followed regarding protocol-specific end of study closeout procedures according to sponsor and institutional requirements.
ii. Ensure that all financial obligations, encumbrances, and reports are closed.

E. Records Retention

i. Ensure that all applicable guidelines are followed regarding protocol-specific end of study records retention procedures according to sponsor and institutional requirements.
ii. Follow the UTSW Records Management and Retention policy (FSS-201) for research related records.

F. Publication

Adhere to contract and grant requirements for publication. Ensure appropriate attribution of affiliated sites as specified by the policies and procedures of those sites

5. Faculty Sponsor Requirement

UT Southwestern-affiliated researchers who do not meet the above described criteria for eligibility to serve as PI must have a Faculty Sponsor.

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