Which member of the research team has ultimate responsibility for the experiment?

Sen. Doc. No. 09-032

SPECIAL REPORT of the RESEARCH COUNCIL concerning

PRINCIPAL AND CO-PRINCIPAL INVESTIGATORS: ELIGIBILITY, ROLES, RIGHTS, RESPONSIBILITIES,  AND OBLIGATIONS

 Presented at the 683rd Regular Faculty Senate Meeting March 26, 2009

COUNCIL MEMBERSHIP:  Jenny Adams, Leslie Button, Lori Clarke, Paul Cormier, Kourosh Danai, David Evans - Chair, Andrea Foulkes , Cynthia Jacelon, Jane Kent-Braun, Paul Kostecki, Mason Lowance, Michael Malone, Michael Maroney,   Ernest May, Jane Miller, John Mullin, David Ostendorf, William Patterson, Stephen Rich, Jay Schafer, Linda Shea, Lynnette Leidy Seivert, Carol Sprague, Martha Taunton, Emily West, Hilary Woodcock

Principal and Co-Principal Investigators: 

Eligibility, Roles, Rights, Responsibilities, and Obligations

 Definition(s)

Principal Investigator (PI) – A Principal Investigator is the primary individual responsible for the preparation, conduct, and administration of a research grant, cooperative agreement, training or public service project, contract, or other sponsored project in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.

Co-Principal Investigator or Co-Investigator (Co-PI/Co-I) –Co-PIs/Co-Is are key personnel who have responsibilities similar to that of a PI on research projects.  While the PI has ultimate responsibility for the conduct of a research project, the Co-PI/Co-I is also obligated to ensure the project is conducted in compliance with applicable laws and regulations and institutional policy governing the conduct of sponsored research.

Faculty Participant – University of Massachusetts Amherst Faculty may be involved in projects key personnel without the same responsibilities of a PI or Co-PI/Co-I.  These faculty are not responsible for the conduct of the project, are not a signatory to an MOU, and normally do not share in the return of indirect cost, unless specified in the MOU.  Faculty participants may participate in the research, may collect salary, and may have a role in publications.  A Faculty Participant may also be referred to as a   Faculty Investigator or Senior Personnel.  The term “faculty Participant” is used below to refer to this category.

Eligibility

Being granted PI and Co-PI status is a privilege granted to eligible University personnel who meet the criteria identified below.  All persons granted PI and Co-PI authority must accept all of the responsibilities associated with the application for and administration of awarded sponsored projects.

Each PI and Co-PI certifies with every proposal submission that all information provided is true and complete and that the proposal conforms to the University policies and procedures applicable to sponsored activities.  In order to be certified as a PI or Co-PI, a researcher must confirm that he/she will comply with all regulatory compliance directives; that all information submitted within the proposal is true, complete, and accurate to the best of his/her knowledge; that any false, fictitious, or fraudulent statements or claims may subject the investigator(s) to criminal, civil, or administrative penalties; and that the investigators(s) agree to accept responsibility for the conduct of the project and to provide all required reports as applicable if a project is awarded as a result of the proposal.

Upon accepting the award, each PI , Co-PI and, if appropriate, each Faculty Participant must also confirm  that he/she will be responsible for project management of the award and agree to carry out the project with the highest professional standards and within the time period awarded.  The PI assumes responsibility to read, understand, and comply with all of the terms and conditions contained in the award.  Finally, the PI must confirm that he/she understands his/her responsibility to abide by University and sponsor policies, procedures and directives for the proper administration of sponsored projects.

Who can be a PI?

Persons holding the following positions may be designated as PIs in applications for externally sponsored funding:

1. All tenured and tenure-track Assistant, Associate, and Full Professors and Librarians.
2. All persons holding appointments as Research Assistant Professor, Research Associate Professor and Research Professor, Extension Specialists, and Clinical Professors.
3. All persons holding Adjunct, Visiting, Emeritus or other faculty positions at the University of Massachusetts, Amherst not included under 1 or 2, and who have the approval of the appropriate governance bodies of a Department and, also, the approval of the Dean of the relevant School or College.  Such approval is indicated by the signature of the named governance bodies on the Kuali Record.  PI’sin one of these categories should also include a Co-Principal Investigator from appointment types included in 1 and 2 above.  In the event a Co-Principal Investigator is not named, the appropriate governance bodies of the Department and, also, the Dean of the relevant School or College shall accept full fiscal and administrative liability and responsibility for the actions of the Principal Investigator included in this category.
4. All Post-Doctoral Fellows who have the approval of the appropriate governance bodies of a Department and, also, the approval of the Dean of the relevant School or College.  Such approval is indicated by the signature of named governance bodies on the Kuali Record. The Post-Doctoral Fellow’s mentor must be listed as a co-principal investigator.
5. All Professional Staff who are not also students, provided they have the approval of the appropriate governance bodies of a Department and the approval of the Dean of the relevant School or College or the Vice Chancellor, if an administrative unit.  Such approval is indicated by the signature of the named governance body or bodies on the Kuali Record.

Note:  Neither undergraduate nor graduate students may be designated as PIs.  When a Sponsor’s program guidelines require the student to be listed as PI on the Proposal application, the student’s mentor/advisor shall be the PI of record on Kuali Record and responsible for the conduct and oversight of the project.

Who can be a Co-PI?

Persons eligible for designation as PI are also eligible to be designated as Co-PIs.  No undergraduate or graduate students may be designated as Co-PIs.  Persons who are located at other universities and who do not hold appointments in eligible categories at the University of Massachusetts Amherst may not be designated as Co-PIs.  Relations with collaborators at other universities, research institutes or corporations should be handled through subcontracts to the institutions involved.

PI Responsibilities:

PROPOSAL PREPARATION AND SUBMISSION

General

The Principal Investigator confirms that the entire proposal meets requirements outlined in the Program Announcement, Request for Application (RFA), Request for Proposal (RFP), or other application instructions. Examples of such requirements include, but are not limited to, award minimums/maximums, page limitations, font/margins, electronic file type/size, deadlines, and mailing addresses. The Principal Investigator may delegate this responsibility to Departmental Administrative Staff. If the Principal Investigator’s unit lacks Departmental Administrative Staff for proposal preparation or other sponsored programs administration requirements, he/she assumes these responsibilities or seeks support from the respective Department/Unit Head or Dean.

Technical Proposal

The Principal Investigator:

• Prepares the technical proposal and may collaborate with others in its preparation.
• Identifies the need for subrecipient agreements.
• Determines whether on- or off-campus space in addition to that already assigned to the Principal Investigator is needed.  (The Principal Investigator identifies the need, and requests it from his/her supervisor, or other appropriate University manager.)
• Takes responsibility for keeping his/her CV or biosketch updated.
• Ensures that procedures used are consistent with sound research design and do not unnecessarily expose subjects to risk/harm.
• Assures that the design is appropriate to the proposed question.
• Determines that the project will contribute original scholarship.

Proposal Budget

The Principal Investigator:

• Prepares or directly supervises the preparation of the budget and its justification.
• Selects the appropriate facilities and administrative or indirect cost rate from the negotiated rates, under guidance from OGCA and/or the Dean’s Office.
• If appropriate, makes a Facilities & Administrative cost (i.e. Indirect Cost) waiver request to the Department Head and Dean and then forwards this request to the Vice Chancellor for Research and Engagement for final approval;
• Requests matching funds from University officials or identifies in-kind contributions from appropriate sources, when necessary.
• Proposes cost sharing through contributed effort or other approved mechanisms and seeks approval from appropriate University officials.
• Identifies all available financial resources in direct support of this or other research endeavors (other support) either at proposal submission or “Just In Time” in accordance with sponsor requirements.
• Identifies anticipated program income.

Regulatory Requirements

The Principal Investigator:

• Prepares the appropriate forms (either at proposal submission time or “Just In Time” in accordance with sponsor requirements) for the University Human Subjects IRB, or the Animal Care IACUC, the Radiation Safety Office and/or the Office of Environmental Health and Safety (EH&S), if the proposal involves:
  • human subjects;
  • live animals as subjects;
  • recombinant DNA, infectious agents, narcotics or biological toxins;
  • human blood or body fluids;
  • radioactive materials and/or ionizing or non-ionizing radiation-producing equipment;
  • hazardous materials; or
  • Protected Health Information (PHI).
• Completes a Participation Agreement (PAG) prior to conducting sponsored research.
• Discloses all potentially significant conflict of interest situations, and prepares a Conflict Disclosure Form and submits it to his/her supervisor, Department Head and Dean.
• Affirms that he/she is not excluded or debarred from receiving Federal funds, and is not delinquent in student loans.
• Ensures that other personnel involved in the project sign the University Kuali Record as required.

Kuali Record

The Principal Investigator:

• Prepares or directly supervises the preparation of the Kuali Record. (The Principal Investigator must be the person who checks the boxes on the in section V of the Kuali Record; this responsibility may not be delegated.)
• Discloses the involvement of other departments or schools/colleges and ensures the appropriate signatures are included in the Kuali Record approval.
• Signs the Kuali Record. This responsibility cannot be delegated and the signature certifies that each item on the form is filled-out completely and accurately.

PRE-AWARD REQUIREMENTS

Pre-Establishment/ Pre-Award of Expenditure Account

The Principal Investigator requests pre-established accounts, if necessary. The Department/Unit Head will authorize and approve the pre-established account. (Department Administrative Staff should be cognizant of the need for (and use of) pre-established accounts, which minimizes cost transfers and/or reallocations.)

Small Business Subcontracting Plan

When applicable and required by the Sponsor’s requirements, the PI works with the Procurement Office and Departmental Administrative Staff to develop a Small Business contracting plan.

Negotiations with Sponsor

Formal negotiations with the sponsor are conducted only by OGCA staff.  All submissions of revised budgets and revised work scopes, as well as other information requested by the sponsor, must be coordinated with and submitted by OGCA to the sponsor.

The Principal Investigator role in negotiations:

• Negotiates informally and forwards the approved revised project work scope to OGCA for submission to the sponsor.
• In collaboration with Department Administrative Staff and the Office of Grant & Contract Administration (OGCA), the Principal Investigator modifies the project budget in line with the sponsor’s instructions for modification. (Department Administrative Staff should be involved in any budget modification, as this can impact other budgeting and effort issues on other projects or departmental accounts.)
• The Principal Investigator communicates with the Co-PIs and other Faculty Participants concerning any changes in scope of work or budget that would substantially impact their participation in the project.  When Co-PIs or other Faculty Participants have their participation impacted substantially, the PI should provide to them verbatim copies of the relevant sections from peer reviews when those are available.
• Completes a revised Kuali Record and forwards the complete package through the signature process.
• Notifies the appropriate regulatory office if changes to project scope will affect approved protocols.
• Obtains approvals if cost sharing becomes necessary.

Acceptance of Award

When the Principal Investigator receives from OGCA the Principal Investigator Award Agreement (PIAA), he/she reviews the Notice of Award (NOA) that stipulates the approved budget and the terms and conditions of the award, and further delegates to Departmental Administrative Staff the review of the NOA for their part in helping the PI administer the project.  The PI then must sign and return the PIAA to OGCA indicating his/her acceptance of the terms and agreement to carry out the project in compliance with the terms in the NOA, University policy, and other applicable regulations and guidelines.  OGCA shall furnish a copy of the PIAA to the Co-PI’s and other Faculty Participants if they are named in the MOU.

Memorandum of Understanding (MOU):

A Memorandum of Understanding (MOU) is required for every funded grant or contract proposal that includes one or more Co-PIs.  The MOU must be signed by each PI and Co-PI, as well as their associated department head and dean thereby signifying each individual’s agreement to the responsibilities and terms as stated in the MOU.  The MOU may accompany the Kuali Record.  However OGCA will not authorize the establishment of any accounts for a funded grant or contract until the MOU has been filed. OGCA will provide a standard MOU for PI’s and Co-PIs.  If the PI and Co-PIs want to file their own MOU, these MOUs must make clear the mutual understandings among the signatories concerning the following issues:

1. Who may authorize expenditures from grant or contract funds.

2. Responsibilities for carrying out major tasks specified in the proposal and granting instruments, including the preparation of reports required by grants or contracts (with the exception of invoices and financial reports to be prepared by Accounting).

3.  Percent of Credit to be attributed to each PI, as reflected by a pro-rated share of the awarded dollars in annual sponsored activity and expenditure reports. (This should not be confused with the percentage of effort committed to the project by the investigators.)

4. Division of RTF returned to investigators, department heads and deans.

5. Rules of succession in the event of the resignation or incapacity of a signatory.

6. Authorship and IP rights. These rights should be consistent with existing policies and procedures.

7.  The Dept ID numbers for all investigators, their department heads and deans.

The terms of any MOU cannot contravene or replace existing statutory or University regulations.

POST-AWARD CONDUCT AND MANAGEMENT OF THE PROJECT

General

Principal Investigators should reference the Office of Research web site: (http://www.umass.edu/research) or contact appropriate university offices to obtain information about rules and requirements governing sponsored funding. Principal Investigators are responsible for knowing what actions require sponsor approval and for obtaining that approval with involvement/assistance from OGCA.

Individual faculty - as principal investigators, research directors, and mentors - encourage their students and other research personnel to participate in educational programs on the responsible conduct of research or research ethics.

Conduct of the Research

The Principal Investigator:

• Is responsible for all actions required to manage and complete the scientific and programmatic aspects of the sponsored project.
• Initiates programmatic changes to the project and seeks approval from the sponsor via request to OGCA when required.
• Initiates the hiring or assignment process and approves the selection or appointment of individuals to the project, and is responsible for communicating staff changes to Departmental Administrative Staff.
• Ensures the integrity and safeguarding of notebooks and scientific data.
• Ensures the completion, accuracy and timeliness of programmatic (technical) reports.
• Initiates requests for and monitors subrecipient agreements prepared by OGCA.
• Ensures the quality, timeliness, and programmatic (technical) performance of subrecipients.
• Initiates a materials transfer agreement with the office of Commercial Ventures and Intellectual Property (CVIP) when using or providing materials to or from another source.

Budget Management

While the Principal Investigator retains primary responsibility for financial accountability, the Principal Investigator or the Department/Unit Head can delegate an authorized representative to act on his or her behalf for departmental account/project management.  Accounts should be managed by persons trained in these responsibilities. The University Controllers Office is responsible for account management at the University level and responsible for all payments, invoices, financial reporting, etc. to the sponsoring agency.

The Principal Investigator:

• Initiates purchases.
• At the time expenditures are initiated, determines that expenditures are allowable, allocable, and reasonable; approves them; and provides scientific justification for the transaction, if necessary. In both budgeting and charging of expenses, the Principal Investigator adheres to Cost Accounting Standards, such as consistency in allocating costs.
• Initiates the process of documenting cost sharing and/or matching and for ensuring that cost sharing obligations are met from allowable and verifiable sources, including those by third party collaborators, if included in approved budget.
• Initiates requests for rebudgeting as the sponsor requires.
• Initiates cost transfer requests. When salary transfer requests are made, ensures these are based on actual effort expended and not merely as budgeted (per OMB Circular A-21).
• Identifies and proposes a resolution of any account deficit.
• Reviews subrecipient invoices for appropriateness and, to monitor progress of the work, approves payment of subrecipient invoices.
• Uses PeopleSoft for financial monitoring, identifies and resolves errors in the account in a timely manner; certifies or documents a monthly review of ledgers. If appropriate and required at budget period end, the Principal Investigator requests that remaining balances are carried forward.

Program Income

The Principal Investigator:

• When applicable, is required to understand the definition of program income.
• Identifies all program income and notifies the Controller’s Office when program is anticipated/received.
• Initiates the processes and proposes the allocation of program income.
• Monitors receipt of program income.
• Reviews program income reported to the sponsor by the University Controller’s Office.

Effort Reporting

To ensure compliance with the effort reporting (Plan Confirmation) policy, Principal Investigators sign and certify effort for themselves and employees on the grants in accordance with the University’s Time and Effort Reporting Guidelines, designed in compliance with OMB Circular A-21.

Project Transfer

All awards are made to the University and not to the individual investigator.  In the event a PI leaves the University, he/she must notify Co-PIs, Faculty Participants, the department head and dean of such departure in advance and seek appropriate next step instructions from the department head, dean, and OGCA.

Should the PI wish to take the grant/contract with him/her to the new institution, the PI must request and document written approval from his/her department head and dean to have the project officially relinquished.  Should the department head and dean approve of the transfer, the PI must provide OGCA with a memo confirming agreement to the transfer and other materials necessary to obtain appropriate sponsor permission.

Should the PI choose to leave the award with the University, the PI must notify OGCA of their departure as soon as possible and assist with the proper sponsor notification.  Such notification will either be a replacement investigator, or termination of the award.

Inventions and Intellectual Property

The Principal Investigator:

• Adheres to the principles and policies outlined in the University’s Intellectual Property Policy and the Conflict of Interest Policy.
• Ensures that all employees working on the project also comply with the policy.
• Initiates the disclosure process and completes the Invention Disclosure Form in order to notify the Office of CVIP.
• Assists in preparing patent applications.
• Assists in the processing of copyright registration or other intellectual property protection.

Implementing a Small Business Plan (if required)

The Principal Investigator:

• Directs purchases that are consistent with the project budget and the approved Small Business Plan (if required).
• The PI or his/her delegate interacts with Procurement staff regarding progress toward achievement of Small Business Plan goals and reviews periodic reports about goals.
• Provides an explanation when Small Business Plan goals are not achieved.

Project Closure

The Principal Investigator:

• Prepares the final programmatic (technical) narrative report, which may include contributions by subrecipients or collaborators.
• Submits any close out documentation needed in order for the Controller’s Office to submit financial status reports on a timely basis.
• Provides information on other close out reports, such as for patents (to OGCA) and on equipment (to Property and Inventory Control).
• Retains the scientific data in accordance with the University’s Policy on Access and Retention of Data.

Regulatory Compliance

The Principal Investigator:

• Prepares a Conflict Disclosure Form in order to notify her or his Department Head and Dean if a potential conflict of interest exists and makes additional disclosures in a timely manner if a conflict of interest arises.
• Is responsible for adhering to all educational and training requirements as the University requires.
• Adheres to protocols and policies for research subjects, and notifies the IRB or IACUC if changes are made to protocols.
• Meets continuing IRB/IACUC protocol review requirements and assists with inspections.
• Adheres to chemical, biological, physical and radiation safety requirements, and notifies the appropriate office if accidents occur.
• Adheres to the policies and procedures for using investigational new drugs and/or devices for clinical research.
• Participates in the annual cost sharing certification (if applicable), as well as the periodic space and equipment survey.
• Takes responsibility for adherence to record retention policy for all financial and scientific documentation.
• Takes responsibility for cooperating in the audit process, whether internal or external audit staff is involved.
• Takes responsibility for accounting of PHI disclosures, as required by HIPAA.
• Takes responsibility for understanding and compliance with all institutional and sponsor policies, practices, and procedures.

MOVED:        That the Faculty Senate approved the Principal and Co-Principal Investigators:

33-09               Eligibility, Roles, Rights, Responsibilities, and Obligations, as presented in Sen. Doc. No. 09-032.

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