| I. Purpose |
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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
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| II. Accountability |
- 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.
- 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.
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| III. Applicability |
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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.
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| IV. Definition |
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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.
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| V. Policy |
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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.
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| VI. Procedures |
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A. TRAINING AND SUPERVISION REQUIREMENTS
- 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.
- 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.
- 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
- 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
- Doctoral- or Masters-candidate PIs must formally close their IRB protocols or transfer
PI
status in order to fulfill their degree program requirements.
- 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.
- Closure or modification of the IRB protocol will be documented on the graduation
checklist
provided by the SHP Office of Student and Alumni Affairs.
- 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
- 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.
- 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
- 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.
- 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.
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GRADUATE STUDENTS AS PRINCIPAL INVESTIGATORS
Amended:
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