NEMOURS
POLICY AND PROCEDURE MANUAL
SUBJECT: Principal Investigator Eligibility
No. 5.9.3
EFFECTIVE DATE: September 6, 2006
SUPERSEDES: N/A
SECTION: Corporate Ethics &
Responsibility
DEPARTMENT: Research Integrity
NAME/TITLE: David J. Bailey, MD, MBA, President and Chief Executive Officer
SIGNATURE:
DATE APPROVED: September 6, 2006
1. PURPOSE:
To establish standards to determine an individual’s eligibility to be a Principal
Investigator (“PI”) for research studies conducted under the auspices of any Nemours
entity.
2. POLICY:
Research is an essential part of Nemours’ mission and serving in the role of a PI on
behalf of Nemours is a privilege, not a right. Nemours will carefully select those
individuals whom are qualified to serve in the role of PI for research studies conducted at
any Nemours entity, as set forth in this policy. Nemours will oversee and be accountable
for the actions of each PI on a research study conducted by Nemours, as required by
Nemours’ Federalwide Assurance (“FWA”). An individual must be an employee of
Nemours (and may not be a student, intern, resident, or fellow) to be named as PI of a
Nemours research study, unless an exception is granted to an external applicant by the
Nemours research oversight committees as outlined in this policy.
2.1 The Nemours Research Oversight Committees (IRB, CRRC, IBC, and IACUC) will
determine which individuals are qualified to be named a PI for a proposed research
study.
2.2 The research oversight committees may disapprove, table or suspend any
previously approved or continuing research in the event it determines the proposed
PI (or acting PI) is not qualified to assume (or continue to carry out) the obligations
and responsibilities of that role.
2.3 Individuals who are associated with, but not employed by Nemours (such as
community physicians or employees of affiliated institutions) may not ordinarily be
designated as a PI. Exceptions to this general rule may be granted by the research
oversight committees and the Director of the applicable research division in
accordance with the procedures listed in Section 4.2 below.
3. DEFINITIONS:
3.1
Federalwide Assurance: The formal agreement between Nemours and the federal
Office of Human Research Protection signed by the Institutional Official and under
which Nemours agrees to be accountable for the regulatory and ethical compliance
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POLICY AND PROCEDURE: Principal Investigator Eligibility
3.2
3.3
3.4
No. 5.9.3
of any individual conducting research under its auspices, regardless of the funding
source for the research.
Institutional Official (“IO”): The Director of Nemours Office of Human Subjects
Protection or other member of Nemours leadership who signs the Federalwide
Assurance on behalf of Nemours.
Principal Investigator (“PI”): The individual named on the research application form
and approved by the appropriate research oversight committee as the person
responsible for the administrative, financial, procedural and scientific aspects of a
research study or protocol. The PI is responsible and accountable for the proper
conduct of the proposed protocol, including all related activities undertaken and
performed by any member of the Research Team (“RT”); ensuring the RT has
fulfilled all training requirements for the protocol; obtaining all required IRB, CRRC,
IBC, or IACUC determinations and approvals; and complying with applicable
Nemours policies. In addition, the PI is responsible for oversight of and
compliance with all federal and state regulations that apply to the financial
management of the protocol; budget management; personnel management; effort
reporting and cost sharing.
Research Oversight Committee: A Nemours committee responsible for the review
and approval and continuing review of research studies, e.g., Clinical Research
Review Committee (scientific merit) (“CRRC”); Institutional Review Board
(protection of human subjects) (“IRB”); Institutional Animal Care and Use
Committee (animal research) (“IACUC”); and Institutional Biosafety Committee
(biological safety) (“IBC”)
4. PROCEDURES:
4.1
Nemours Associates seeking designation as a PI
4.1.1 Initial Application: A Nemours associate applying for designation as a PI on
behalf of Nemours for a proposed (or existing) research study will complete
the initial application process set forth by the specific research oversight
committee responsible for the area of the proposed research.
4.1.2 Review of Initial Application: The appropriate research oversight committee
will review the initial application documents and take appropriate steps to
confirm that the Nemours Associate seeking designation as a PI has the
required qualifications to fulfill all the responsibilities of a PI and to conduct
and administer the proposed research study, as more fully set forth below.
4.1.3 Qualifications: At a minimum, the Associate seeking designation as a PI
must possess (and provide evidence of, if requested) education, training,
and experience in the discipline encompassed by the proposed research
study. The Associate must agree in writing to conduct the study in
compliance with all applicable regulations and in accordance with
applicable policies and procedures of Nemours Office of Human Subject
Protection. The Associate must also meet all eligibility requirements of
external sponsors and/or government agencies or institutions, as required.
4.1.4 Approval or Disapproval of Application: Approval of the underlying
research study by the appropriate research oversight committee includes
approval of the initial application documents and designation of the applying
Associate as the PI for that research study. If the research oversight
committee determines that the applying Associate is not qualified to be
designated as the PI, the research oversight committee will document the
reasons for the disapproval and communicate that decision to the
appropriate research unit.
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POLICY AND PROCEDURE: Principal Investigator Eligibility
4.1.5
4.1.6
4.2
No. 5.9.3
Employment Status Change: A Nemours Associate applying for designation
as (or already designated as) a PI is obligated to immediately report any
change in his/her status as a Nemours Associate to the appropriate
oversight committee.
PI Status Change: The appropriate oversight committee must approve any
changes in PI status for a particular research study prior to the
implementation of such PI change on the research study.
Exceptions – External Applicants seeking designation as a PI
4.2.1 Initial Application: Individuals who are not employed by Nemours and who
seek designation as a PI on behalf of Nemours for a proposed (or existing)
research study must follow the initial application process set forth by the
specific research oversight committee responsible for the area of the
proposed research, must meet the qualifications set forth in Section 4.1.3
above, and follow the following additional procedures:
4.2.2 Additional Information: External applicants must submit a summary of the
proposed research study together with an explanation of the need for an
exception to Section 2.3 to the appropriate research oversight committee,
and a determination will be made jointly as to whether additional
information is needed regarding the external applicant prior to the final
decision on the applicant’s qualifications.
4.2.3 Individual Investigator Agreement: External applicants applying for
designation as a PI on behalf of Nemours must also sign a Nemours
Individual Investigator Agreement prior to final designation as a PI by the
research oversight committee, and prior to initiating any actions or research
regarding the approved research study.
4.2.4 Review of External Applicant’s Initial Application: After receipt of the Initial
Application, Additional Information, and the Individual Investigator
Agreement signed by the applicant, the appropriate research oversight
committee will then determine whether the external applicant meets the
qualifications set forth in Section 4.1.3 and is otherwise an appropriate
individual to receive designation as a PI on behalf of Nemours.
4.2.5 Final Determination and Communication: Approval of the underlying
research study by the appropriate research oversight committee includes
approval of the initial application documents and designation of the external
applicant as the PI for that research study.
4.2.5.1 Approved applications for external applicants will be forwarded to
the IO and will include a copy of the Nemours Individual
Investigator Agreement. The IO will sign the Individual Investigator
Agreement and return the executed agreement to the Director of
the research unit where the research study will take place, who
will forward a copy of the executed Individual Investigator
Agreement to approved external applicants.
4.2.5.2 If the research oversight committee determines that the external
applicant is not qualified to be designated as the PI, the research
oversight committee will document the reasons for the disapproval
and communicate that decision to the appropriate research unit.
Review/Revision Dates:
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