Principal Investigator (PI) Roles & Responsibilities

• Manage research staff, including post-doctoral fellows, students, technicians and lab managers
• Oversee the training and mentoring of post-doctoral trainees, fellows, and students
• Assure that all key research personnel have met training requirements
• Coordinate with school, department, and central administration to ensure that sponsored research activities are in accordance with all applicable regulations, policies, and procedures
• Ensure appropriate resources for research conduct
• Review, prepare, and submit results for publication and register publications, as required by sponsor

Proposal Submission

• Originate ideas for research and determine possible sources of funding
• Review funding opportunity announcements carefully and follow instructions for submission
• Prepare technical and/or scientific proposal
• Develop and coordinate budgets, administrative elements, and materials, including materials for subcontracts
• Ensure that sufficient staffing is requested to perform research detailed in proposal (especially processing reimbursements to visiting students for conferences/workshops, including gathering necessary materials for foreign students; this is not an allowable duty for GCMs). 
• Disclose and discuss with your department chair and dean when proposing cost share/ course buy-outs for proposal submission
• Secure cost share resources and letters of support well in advance of submission deadline
• Coordinate large proposals with ORSP
• Understand and comply with institutional limited submission process
• Complete proposal application and submissions by required deadlines
• Ensure the accuracy, content, and completeness of the Cayuse record and the final proposal package.
• Ensure all relevant campus offices have reviewed and approved the proposal prior to submission
• Ensure all related training and certification requirements are met.

Pre-Award Set-Up

• If needed, complete request for pre-spending from ORSP
• Complete “Just In Time” documentation requests from sponsor
• Modify project scope and coordinate all administrative items, including budget, if requested by sponsor

• Recognizes the University as the recipient of awards
• Review and confirm notice of award and award setup, including budget reconciliation
• The PI confirms they will not incur costs prior to the start date without specific agency approval (if required) and the PI will not conduct any research that has not yet had IRB or IACUC approval.
• Prepare any revisions to project scope, budget or changes in effort or other activities that may require prior approval from sponsor
• Monitor expenditures regularly to ensure that award expenditures are allowable and allocable per the award terms and conditions, and that they are expended to directly support and benefit the project
• Make purchases or designate lab staff to do so; this is not a GCM responsibility
• Ensure that reimbursements to visiting students for conferences/workshops are processed by the PI and/or staff paid by the grant (this is not a GCM responsibility)
• Monitor budget to ensure that grant funds are not over-expended. The PI will be responsible for any deficits and disallowances incurred against an award. In the instance that the PI does not have the funds available to cover the deficit, the PI’s Department will be responsible. 
• Reconcile P-card charges in a timely manner (this is not a GCM responsibility)
• Monitor subrecipient and consultant activity, including review and approval of invoices
• Notify GCM of upcoming staff terminations/separations.
• Comply with the terms and conditions of the award, and adhere to life of the award compliance responsibilities
• Ensure the accurate and timely submission of required technical/progress  reports throughout the life of the award
• Inform ORSP and Grants Accounting if contacted by the sponsor for an audit
• Confirm that all award records and data are maintained accurately and consistently over the award life cycle and through the sponsor and University’s records retention period (all data must be stored on a university-controlled system and access provided to IS)

Material Transfer Agreements (MTA)

• Consult ORSP prior to sending materials to collaborators to determine if an MTA is required. Coordinate requests for materials or with ORSP and submit any MTA received to them for review and approvals.

Closeout

• Review and approve all project expenses to ensure completion and compliance, including financial reports, final invoices, program income, and subrecipient performance
• Oversee completion of closeout documentation and ensure that all reporting requirements are met
• Work with ORSP to submit final technical and invention reports 
• Work with Grants Accounting and ORSP to resolve sponsored funds collection issues

Effort Reporting and COI/COC

• Complete salary planning and distribution
• Disclose existence of appointments at other institutions to departmental chair and to the university through the annual COI disclosure process
• Fulfill and manage effort commitments of project members: notify ORSP if effort for all Key Personnel is expected to decrease by more than 25% or if there will be disengagement of any Key Personnel. Changes must be submitted to ORSP for sponsor prior approval.
• Certify effort in Workday by the Fall, Spring, and Summer deadlines. These reports certify that the salaries charged to the sponsored project are a reasonable reflection of the work performed. Once the report is initiated, it must be fully certified within 45 days.
• Resolve effort discrepancies
• Federal regulations (specifically Uniform Guidance 2 CFR 200) require that effort reports be certified by an individual with first-hand knowledge of the work performed or a suitable means of verification that the work was done. Therefore, if a research staff member is unavailable to self-certify, the principal investigator will be required to certify on their behalf.

Human Research Participants

• Ensure the safety and protection of the rights and welfare of human research participants
• Oversee submission to, and approval by, the Institutional Review Board (IRB) and confirm protocol/grant congruency
• Ensure the IRB approves the protocol prior to initiating any research involving humans
• Conduct all human participant research according to the approved protocol, relevant regulations, laws, institutional and sponsor policies
• Obtain IRB approval prior to the initiation of amendments to a study, except for those changes that are implemented to eliminate immediate hazards to participants
• Respond to all compliance issues, including participating in post-approval monitoring
• Confirm and monitor that every relevant member of the research team is trained and in compliance with IRB policies and procedures, federal and state regulations, and other relevant University policies
• Promptly suspend or terminate research, as appropriate, and submit reports of these actions and other reportable events to the IRB

Clinical Trials

• Ensure clinical trials are conducted in accordance with Good Clinical Practice (GCP)
• Maintain current and accurate records in the Clinicaltrials.gov database

Animal Subjects

• Oversee animal study protocol submission to, and approval by, the Institutional Animal Care and Use Committee (IACUC) and provide a full copy of grant for protocol/grant congruency
• Ensure that the animal study protocol is IACUC approved prior to implementing animal work and that all aspects of animal care and use are conducted according to the approved protocol
• Review/confirm animal charges 
• Confirm and monitor that every relevant member of the research team is trained and qualified for the procedures they will perform, including compliance with all Occupational Health and Safety enrollment requirements
• Comply with all federal, state and local regulatory and institutional inspections and compliance investigations
• Notify the IACUC Office of external collaborations involving animal work
• Notify the IACUC Office of animal work supported by funds from another institution

Responsible and Ethical Conduct of Research/ Research Integrity

• Conduct research in an ethical and compliant manner and promote and maintain an environment that encourages intellectual honesty and integrity
• Ensure integrity of all research activities and data
• Uphold secure and ethical data use, data confidentiality, and compliant data management, sharing, ownership, and retention practices
• Supervise and ensure the integrity of the research of all trainees and research staff
• Ensure Responsible and Ethical Conduct of Research (RCR) training for NSF supported undergraduate students, graduate students, and post-doctoral fellows as well as all trainees, participants, and scholars supported through applicable NIH, USDA and other federal agency awards
• Implement and follow responsible authorship practices, including adherence to discipline-specific guidelines

Research Security, Export Controls & International Compliance

• Understand and adhere to the WFU Research Security policy
• Complete required training modules prior to conducting research 
• Adhere to WFU’s Export Control Compliance Policy and federal policies for information, software, and materials used in research projects
• Review and follow improper foreign interference guidelines and adhere to federal regulations related to malign foreign talent programs
• Report potential research security issues to the WFU Research Security Officer
• Ensure compliance with requirements for international travel during research projects
• Accurately disclose and update all foreign collaborations
• Understand and adhere to all university and sponsor policies related to research misconduct

Conflict of Interest (COI)

• Understand and adhere to COI policies and processes and to all federal, state, and local regulations and sponsoring agency policies and procedures
• Meet initial and ongoing Conflict of Interest (COI) training and disclosure requirements
• Identify which individuals on the study team meet the definition of “investigator” and are subject to the COI requirements. Individuals are project investigators if, at any point during the life of a project, they directly or materially influence the research, or are responsible for the design, conduct, or reporting of records. Project investigators are required to disclose their significant financial interests, and each disclosure must be reviewed before funds may be spent.
• Adhere to the requirements of COI management plans that result from positive disclosures, if applicable
• Disclose all co-authors on publications since they are considered to be collaborators by some federal agencies.

Patents and Inventions

• Understand the terms of the WFU Patent Policy as well as the WFU Patent Acknowledgment.
• Ensure that the PI and all individuals they supervise disclose all inventions, whether they believe them to be invented at WFU or not, to Wake Forest Innovations. 
• Understand the intellectual property terms of their sponsored awards.
• Ensure that all inventions conceived or reduced to practice in their lab with support from sponsored awards are promptly disclosed to ORSP, the Vice Provost for Research, and  Wake Forest Innovations, including accurate reporting of the funding source.

Principal Investigators (PIs) play a fundamental role in ensuring a safe and compliant research laboratory environment. Their responsibilities cover a wide range of proactive, supervisory, and regulatory activities:

1. Leadership and Safety Culture

• Lead by example to promote a positive safety culture in the laboratory.
• Cultivate an environment where staff and students feel empowered to raise safety concerns without fear of retaliation.
• Instill ownership of safety among research personnel by empowering and holding them accountable for safe practices.

2. Hazard Identification, Assessment and Control

• Evaluate lab hazards, communicate associated risks, and train personnel on proper procedures and controls.
• Conduct and document Personal Protective Equipment (PPE) hazard assessments for all personnel and update them when introducing new hazards.
• Develop written protocols and Standard Operating Procedures (SOPs) for hazardous materials, procedures, and equipment and maintain them in the Google Drive Lab Safety Folder.
• Ensure all laboratory hazards are identified and controlled, and perform regular self-inspections.

3. Training and Communication

• Ensure lab members complete all required safety training, including general and lab-specific modules.
• Training for new individuals should be requested using the Training Request Form located in the Google Drive Lab Safety Folder.
• Provide clear instructions on safety concerns and mitigation strategies for all experiments and operations involving hazards.
• Communicate new safety issues and updates promptly to all lab personnel.

4. Supervision and Compliance

• Supervise and approve all work involving hazardous materials.
• Ensure compliance with University, local, state, and federal safety regulations and policies (e.g., OSHA, NIH, EPA).
• Respond to internal and external safety inspections, taking prompt corrective action as needed.

5. Incident and Exposure Management

• Investigate all laboratory injuries, exposures, and incidents, and report them using the Injury/Incident Form located in the Google Drive Lab Safety Folder.
• Notify employees, students, and visitors of hazard monitoring results and potential exposures, and ensure those with symptoms have access to medical evaluation.

6. Laboratory Operations

• Enforce the use of engineering controls (e.g., fume hoods), safe work practices, and the required PPE at all times.
• Ensure laboratory safety equipment is available, maintained, and functional.
• Test eyewash and safety showers at least weekly.
• Maintain and update emergency response and evacuation procedures, and ensure lab members are familiar with these protocols.

7. Documentation and Recordkeeping

• Maintain complete, current records of lab roster, training, hazard assessments, medical monitoring, safety incidents, and SOPs within the Google Drive Lab Safety Folder.
• Review and update lab safety plans and protocols (such as the Laboratory Research Safety Plan) at least annually.