Separation of Principal Investigators

 

Purpose

The purpose is to outline the policy and procedures for separation of faculty, staff or students who serve as the Principal Investigator (PI) on a research project involving human subjects.

Definitions

Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subject is defined as a living individual about whom an investigator (whether professional or student) conducting research obtains:

  1. data through intervention or interaction with the individual, or
  2. identifiable, private information.

 

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).

Principal Investigator (PI) is the lead researcher who retains primary responsibility for the design, execution, management, integrity and reporting requirements of a research project.

Institution is defined as any public or private entity or agency (including federal, state, and other agencies).

Employees or agents are individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. They may include staff, students, contractors, and volunteers.

An institution is considered engaged in research activities when its employees or agents for the purposes of the research project obtain: (1) data about the subjects of the research through intervention or interaction with them; (2) identifiable private information about the subjects of the research; or (3) the informed consent of human subjects for the research.

Policy

Research falls within the Institutional Review Board’s or Exempt Review Committee’s jurisdiction whenever it engages Marywood University in human research activities or takes place on its premises (physically or via subject recruitment).  Upon the decision of a Principal Investigator (PI) to separate from the institution, the PI must notify the Office of Research and Sponsored Programs so that a decision may be reached regarding the future management of the project. This decision may include:

  1. complete closure of the project;
  2. transfer of authority to another institution , where its IRB becomes the new IRB of record;
  3. identification of a new PI who is an employee or agent of Marywood University, where Marywood University retains status as the IRB of record;
  4. identification of a sponsor or new co-investigator who is an employee or agent of Marywood University, if one has not previously been attached to the project, where Marywood University retains status as the IRB of record.


Where complete closure is desired, all research activities must be terminated and no research activities may continue at another location.

Where transfer of authority to another institution is desired, the project file must still be closed with Marywood University’s IRB or ERC as of the date of the employee or agent’s separation. The PI must supply the IRB or ERC with the new institution’s Federalwide Assurance number at time of closure.

Where identification of a new PI who is an employee or agent of Marywood University is desired, the existing PI must submit a revision to the IRB or ERC and receive approval. The new PI must meet all training requirements.  

Where the original PI will continue in his/her role as lead researcher, but there is a need to retain Marywood University as the IRB of record, a new employee or agent of Marywood University must be named as sponsor or co-investigator if not already involved with the project. This individual must meet all training requirements. If there’s a new institution involved, the PI must review the institution’s policies to see if it requires the addition of Marywood University’s IRB to its Federalwide Assurance, and an authorization agreement between both institutions must be created.

Timing

The PI must notify staff of the Office of Research and Sponsored Programs within five business days of the decision to separate from Marywood University. The PI then has three business days to submit the appropriate documentation to the IRB or ERC.

Procedures

The PI consults with staff of the Office of Research and Sponsored Programs within the time frame noted above in order to decide the best method of action.

Complete Closure

  1. All research activities cease.
  2. The PI submits a final status/closure report form to the IRB or ERC via IRBNet.
  3. The appropriate office closes the file.


Transfer of Institutional Authority

  1. The PI submits a final status/closure report form to the IRB or ERC via IRBNet.
  2. The PI includes on the form the Federalwide Assurance (FWA) number of the new institution. FWA numbers may be found at the Office of Human Research Protections’ website at http://ohrp.cit.nih.gov/search/ by clicking on the FWA tab and entering the institution’s name.
  3. The appropriate office closes the file.
  4. The PI applies for review at the new institution.


Identification of a New PI (Employee or agent of Marywood University)

  1. The PI submits a revision application form to the IRB or ERC via IRBNet, requesting a change in PI.
  2. The new PI must be an employee or agent of Marywood University and meet all training requirements.


Retention of Institutional Authority Where PI Remains as Lead

  1. The PI submits a revision application form to the IRB or ERC via IRBNet, requesting the addition of the new team member (sponsor or co-investigator) who is an employee or agent of Marywood University.
  2. The new team member must meet all training requirements.
  3. If the PI is at another institution, he/she must review the new institution’s policies to see if it must add Marywood University’s IRB to its Federalwide Assurance, and an authorization agreement between both institutions needs to be created. This would retain Marywood University’s status as the IRB of record.


Related Policies

  • Approval of Research
  • Closure or Withdrawal of Research
  • Mandatory Training
  • Responsibilities of Investigators and Sponsors


History

5/19/2014 - Created