IBC-POL-002 PI Eligibility

1.1 Purpose This policy establishes the eligibility requirements for Principal Investigators (PIs) submitting and maintaining Memoranda of Understanding and Agreement (MUA) with Cornell University's Institutional Biosafety Committee (IBC).

1.2 Scope This policy applies to all individuals seeking to serve as Principal Investigators on IBC protocols at Cornell University, including all associated facilities and programs under the purview of the Cornell IBC.

2.1 Principal Investigator (PI): The individual responsible for the conduct of research or teaching activities involving biological materials as described in an IBC-approved MUA.

2.2 Memorandum of Understanding and Agreement (MUA): The formal document submitted to and approved by the IBC describing the proposed use of biological materials.

2.3 Institutional Biosafety Committee (IBC): The committee responsible for reviewing and approving research involving biological materials at Cornell University.

2.4 USDA-ARS Employee: An individual employed by the United States Department of Agriculture – Agricultural Research Service (USDA-ARS). These employees may conduct federally funded agricultural research and may hold or be eligible for courtesy faculty appointments at Cornell University for collaborative research purposes.

2.5 USG Employee: An individual employed by the United States Government (USG) in any federal agency or department. For the purposes of this policy, USG employees who qualify for PI status must hold or are eligible for a courtesy faculty appointment at Cornell University.

3.1 Institutional Biosafety Committee

• Reviews and approves PI eligibility appeal requests
• Maintains and updates PI eligibility policy
• Ensures compliance with institutional and federal requirements

3.2 IBC Chair

• Reviews and approves PI status requests
• Makes final determinations on eligibility questions
• Addresses appeals and special circumstances

3.3 IBC Staff

• Processes PI eligibility requests
• Reviews documentation for completeness
• Provides recommendations to IBC Chair
• Maintains records of PI status approvals

3.4 Principal Investigators

• Maintain compliance with IBC policies and procedures
• Complete required training
• Submit accurate and complete documentation
• Supervise research personnel

4.1 AUTOMATICALLY ELIGIBLE PRINCIPAL INVESTIGATORS

Purpose: To define positions that inherently qualify for PI status based on their academic appointment and established research independence.

Eligible Positions: 

a) Academic Appointments

• Full Professors, including Research Professors
• Associate Professors, including Research Associate Professors
• Assistant Professors, including Research Assistant Professors
• Boyce Thompson Institute Faculty (please email cu_ibc@cornell.edu for system access)
• Emeritus Professors
• US Government Employees granted or eligible for courtesy faculty appointment
• Teaching-track faculty—including Teaching Professors, Lecturers, and Instructors at all levels—who lead laboratory-based instructional activities requiring IBC approval. Eligibility is limited to instructional use only (not independent research).

b) PIs, or Individuals with current PI status granted by:

• Office of Sponsored Projects
• Institutional Animal Care and Use Committee (IACUC)

Requirements:

• Must maintain active employment status with Cornell University
• Must comply with all IBC policies and procedures
• Must maintain current biosafety training requirements

4.2 ELIGIBLE WITH IBC APPROVAL

Purpose: To provide a pathway for qualified researchers who do not hold automatically eligible positions to serve as PIs on IBC protocols.

Eligible Positions:

• Research Scientists
• Staff Scientists
• Research Associates
• Post Doctoral Scholar, Fellow, Post Doctoral Associate
• Other Academic or Research Staff

Approval Process:

a) Initial Request:

• Candidate submits formal request to IBC office using IBC-Form-002
• All documentation must be submitted electronically to cu_ibc@cornell.edu 

b) Required Documentation:

• Description of relevant biosafety experience
• Current position and responsibilities
• Proposed research scope
• Justification for PI status need
• Funding information (if applicable)

c) Review Process:

• IBC staff reviews application for completeness, qualifications, and experience
• IBC Chair reviews application and approves decision

d) Conditions of Approval

• Initial approval valid unless position responsibilities change
• Approval may be revoked for non-compliance
• PI must notify IBC of any changes in position or responsibilities

4.3 NOT ELIGIBLE

Purpose: To clearly define positions that are not eligible for PI status due to institutional policies, regulatory requirements, or insufficient research independence.

Ineligible Positions:

• Graduate Students
• Undergraduate Students
• Temporary Employees
• Visiting Scholars (unless approved through exception process)
• Cornell Business Incubator Companies:
  • Center for Life Science Ventures
  • Praxis Center for Venture Development
  • Other affiliated incubator companies
• Cornell Cooperative Extension Employees

Rationale for Ineligibility:

1. Lack of Institutional Research Authority

• Certain positions, while having Cornell affiliation, are not authorized to conduct research on behalf of Cornell University
• Cornell Business Incubator scientists maintain Cornell affiliation but are employees of independent companies, not the University
• Courtesy appointments that do not conduct research on behalf of Cornell
• Positions without research components in their appointments (such as Lecturers “Of practice”) are not authorized to conduct independent research
• These positions do not have the institutional authority to represent Cornell as a Principal Investigator
• Research conducted by these individuals falls under the responsibility of their primary institution or company, not Cornell University

2. Training Status and Educational Roles

• Undergraduate, visiting, and graduate students are in training positions that require supervision of their research activities
• Student research must be conducted under the oversight of a PI-eligible sponsor
• Student work should be incorporated into their sponsor's MUA
• The sponsor assumes responsibility for the safety and compliance of student research activities
• The training nature of these positions requires direct oversight and mentorship in research conduct

3. External Organizations

• Cornell Cooperative Extension employees operate under a different administrative structure from Cornell's research enterprise
• Cornell Business Incubator companies, while affiliated with Cornell, are separate legal entities
• These organizations maintain their own organizational structure, policies, and procedures
• Research conducted by these organizations is to be managed through their respective institutional frameworks

While these organizations may collaborate with Cornell researchers, they cannot serve as independent PIs on Cornell IBC MUAs.

Additional Considerations:

• Ineligible individuals must work under the supervision of an approved PI
• The approved PI assumes all responsibility for compliance and safety
• Exceptions may be considered on a case-by-case basis through formal appeal to the IBC

5.1 Requesting PI Status

1. Application Submission
   • Complete IBC-FORM-002 electronically
   • Submit all materials to cu_ibc@cornell.edu 
2. Review Process
   • Initial Administrative Review
     • IBC staff reviews application package for completeness
     • Staff verify current biosafety experience
     • Staff confirms position eligibility per Section 4.2
   • Technical Review
     • IBC Chair reviews complete application
     • Evaluation of experience and qualifications, consults as appropriate
     • Assessment of research scope appropriateness
     • Approves or denies PI status  
   • Decision Communication
     • Written notification will be issued
     • If approved, PI may proceed with IBC MUA application
     • If denied, explanation provided with clear rationale and appeal options

5.2 Appeals Process

1. Submission Requirements
   • Submit written appeal within 30 days of denial
   • Include:
     • Original application materials
     • Additional supporting documentation
     • Specific point by point response to denial reasons
     • Any new relevant information
2. Appeal Review Process
   • Executive Committee Review
     • Independent review of complete package
       1. Consultation with University Counsel, ORIA leadership, and other relevant University officials, or subject matter experts as required. 
     • Possible request for in-person meeting
     • Consultation with department or College or Unit leadership if needed
     • Final review and approval or denial decided by the Institutional Biosafety Committee at a convened meeting
   • Final Decision
     • Written response will be issued from IBC staff
     • Decision of the IBC is final

5.3 Revocation of PI Status

1. Grounds for Revocation
   • Non-compliance with Federal, State, or Local Law or IBC policies or procedures
   • Change in position or responsibilities to ineligible status
   • Departure from institution
   • Extended absence without proper protocol coverage
   • Serious safety violations or incidents
2. Maintaining Active Status
   • Report position or responsibility changes
   • Maintain current biosafety training
   • Comply with Federal, State, and Local Law and all IBC policies
   • Submit MUA amendments as needed
   • Respond to IBC communications promptly
   • Submit annual review

Note that MUA suspension and revocation procedures are managed through the electronic application management system.

6.1 University policies

• OSP PI Eligibility Policy https://researchservices.cornell.edu/policies/pi-eligibility 
• IACUC Policy#340 PI Eligibility for Protocols   https://researchservices.cornell.edu/policies/iacuc-policy-340-principal-investigator-eligibility-protocols-involving-use-vertebrate 

6.2 Forms and Templates

• PI Status Request Form IBC-FORM-002
• Appeal Form IBC-FORM-003

Institutional Biosafety Committee Email: [cu_ibc@cornell.edu]