Rutgers SHP - Policies

SCHOOL POLICY

Subject : RESEARCH Title : GRADUATE STUDENTS AS PRINCIPAL INVESTIGATORS Coding : 5.2
Category :
Responsible Executive : Associate Dean for Research Responsible Office : SHP Research
Adopted : 2/11/2013 Amended : Last Reviewed : 2/11/2013

I. Purpose
Consistent with its mission of promoting scholarship and the development of professional level research expertise, the School of Health Professions (SHP) permits its Masters and Doctoral level students to be the Principal Investigator (PI) of record on research protocols. Many Masters candidates must complete an evidence-based Capstone Project under the direction of a committee chaired by a SHP Faculty member as a requirement for graduation. The project is the culmination of knowledge gained in students' graduate coursework and provides an opportunity to demonstrate an analytical approach to the identification and resolution of real-world research problems. Completing an IRB Review process and responsibly conducting research are essential parts of the graduate students training in how to conduct ethical, scientifically valid work. This policy establishes procedures to insure that graduate students and their Committee Chairs adhere to University policies regarding research and IRB protocols
II. Accountability
  1. The Associate Dean for Research, the Assistant Dean for Student and Alumni Affairs, and the Department Chairs and Program Directors are responsible for the implementation of this policy.
  2. It is the responsibility of Masters and Doctoral candidates and their Committee Chairs/Faculty mentors to adhere to this policy. Training on the responsible conduct of research in health care settings is an important component of a well-trained Masters- or Doctoral-level students education and a component of appropriate supervision.
III. Applicability
This policy applies to all graduate students enrolled at SHP in Masters or PhD programs who are initiating a research project involving human subjects in partial fulfillment of their degree requirements as well as to their Committee, Faculty mentors, Program Directors and Department Chairs.
IV. Definition

IRB: Unless otherwise mandated, SHP students shall utilize the Institutional Review Board (IRB) for the Newark campus.

MS: Refers to Master of Science.

PhD: Refers to Doctor of Philosophy.

PI: Refers to Principal Investigator or the person accepting the leading scientific role and ethical responsibilities involved in conducting a research project.

Protocol: Refers to the document approved and on file with the IRB that describes the methods and procedures for protection of human subjects in the students graduate research.

V. Policy
No Masters or Doctoral student shall be cleared for graduation without submission of a request for closure of his/her research protocol and receipt of a formal acceptance of said closure from the IRB, or submission of a request for modification of approved research requesting a change in Principal Investigator.
VI. Procedures

A. TRAINING AND SUPERVISION REQUIREMENTS

  1. At the time graduate students prepare their proposal for internal review and approval by the Department Chair, the Committee Chair will review with students the University's Guidelines for Conduct of Research and Scholarly Activities.
  2. In addition, all students engaged as PI on a research protocol will complete IRB- provided mini-training on Responsibilities of a Principal Investigator for Human Subjects Research, available through the SHP Office of Research. Graduate students must complete this training before final approval of their research project.
  3. Masters and Doctoral students must also complete the mandatory IRB Human Subjects Training and Responsible Conduct of Research (RCR) training.  Students are required to adhere to the University policies related to HIPPA Policies as well as those listed below:

    Human Subjects Research: Protection of Human Subjects
    Human Subjects Research: Medical Care
    Research Misconduct
    Investigator Conflict of Interest

  4. Masters and Doctoral students shall submit their research projects to IRB for review to obtain approval of their research or to obtain an exemption. Committee Chairs are required to be listed as co-investigators and are expected to work with the student to prepare his/her application and respond appropriately and in a timely fashion to the IRB review.
B. DOCUMENTATION OF CLOSE-OUT PROCEDURES
  1. Doctoral- or Masters-candidate PIs must formally close their IRB protocols or transfer PI status in order to fulfill their degree program requirements. 
  2. Committee Chairs shall not approve the final thesis, dissertation or research project of any student without confirmation via eIRB that a closure or modification request has been submitted and approved by the IRB.
  3. Closure or modification of the IRB protocol will be documented on the graduation checklist provided by the SHP Office of Student and Alumni Affairs.
  4. There may be instances in which access to the use of third-party datasets do not permit graduate students to serve as PIs. In this case, the Committee Chair shall accept the PI role, however, confirmation that upon completion of the graduate research project that the student is not a PI on any study shall still be required for the students graduation.
C. NONCOMPLIANCE
  1. In the event that the student is dismissed, unwilling, or due to extenuating circumstances, unable to comply with the protocol closure policy, the Committee Chair who is named on the application has the responsibility of filing a final report/closure request with the IRB.
  2. In the event that a Committee Chair leaves the employment of the University or due to extenuating circumstances, is unable to complete the final report/closure request, the Program Director or Department Chair will assume this responsibility.

VII. POLICY DISSEMINATION TO GRADUATE FACULTY

  1. Copies of this policy and Responsibilities of a Principal Investigator for Human Subjects Research will be posted on the SHP Research webpage, and distributed to all SHP Graduate Faculty.  All SHP policies are also posted on its policy website.
  2. New members of the graduate Faculty will be provided with a copy of this policy as part of their orientation by the Associate Dean for Research.
GRADUATE STUDENTS AS PRINCIPAL INVESTIGATORS
     Amended: