POLICY AND PROCEDURE: Principal Investigator Eligibility/ No. 5.9.3
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
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.
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.
2.1The 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.
2.2The 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.
2.3Individuals 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.
3.1Federalwide 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 of any individual conducting research under its auspices, regardless of the funding source for the research.
3.2Institutional 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.
3.3Principal 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.
3.4Research 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”)
4.1 Nemours Associates seeking designation as a PI
4.1.1Initial 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.
4.1.2Review 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.
4.1.3Qualifications: 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.
4.1.4Approval 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.
4.1.5Employment 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.
4.1.6PI 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.
4.2Exceptions – External Applicants seeking designation as a PI
4.2.1Initial 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:
4.2.2Additional 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.
4.2.3Individual 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.
4.2.4Review 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.
4.2.5Final 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.
220.127.116.11Approved 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.
18.104.22.168If 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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