I. Introduction and Purpose
Congruent with the mission of Notre Dame University-Louaize (NDU), which promotes "excellence in scholarship, lifelong learning, human dignity, and moral integrity," the Policy on Ethics in Research is set to protect the rights, dignity, welfare, and privacy of both human and non-human research subjects, as well as to protect the environment in all research involving the University. Its ultimate goal is to ensure that researchers adhere to guidelines and principles that prevent unethical practices, consistent with recognized standards in various academic disciplines.
Research projects usually involve complex social, legal, and ethical issues. The Policy and Procedures set forth in this document are applicable to all faculty, staff, and students at the University, as well as to external research and administrative partners whose research activities involve human subjects, animals, and/or the environment
II. Guiding Principles
Recalling the:
- Ethical principles determined by the University’s mission and prescribed by universal rules governing moral integrity, human rights, animal welfare, and respect for the environment, which shall always be observed in any kind of research activity under the auspices of NDU.
- Belmont Report (Appendix 1) and laws enforced in Lebanon, where applicable.
- University Research and Grants Policy.
Recognizing that:
- Academic researchers understand the importance of obtaining Informed Consent (IC) from the participants, and parent/guardian, if applicable.
- Any research project must consider the rights, safety, risk-to-benefit ratio, and protection not only of human beings, as specified in the Belmont Report, but also of animals and/or the components of the environment involved in the study.
- After considering property rights, any researcher shall be bound to fully disclose the methods and results related to his/her research when requested by the Institutional Review Board (IRB) of the University to ensure full transparency and accountability to the University and the overall scientific community.
Affirming that:
- NDU research adheres to professional and moral processes.
- The rights and well-being of research subjects (human beings, animals, and the environment) are adequately protected.
An IRB implements the present Policy on Ethics in Research.
III. Role and Responsibilities of the IRB
The IRB shall ensure that all individuals involved in research abide by the set policy and guiding principles. The following list is a summary of the most important responsibilities of the IRB:
- Offer advice, information, and guidance rather than act as a legislative or judicial body.
- Recommend modifications, if necessary, for proposals submitted by the University researchers, regardless of the location of research activities.
- Oversee and determine intervals of periodic review, where appropriate.
- Recommend suspension or termination of research not conducted in accordance with IRB requirements or complicit in the foreseen or unforeseen possible serious harm to research subjects.
- Prepare an annual report to the University Research Board on the operations of the IRB.
- Ensure that appropriate mechanisms exist within the University to resolve issues related to ethical procedures and ethical violations when conducting research.
- Ensure the provision of appropriate training for all University academic and non-academic staff to equip them with the knowledge and competencies required for the ethical treatment of research subjects.
- Ensure full confidentiality for all research participants during the mandate of the research process unless a priori disclosure guidelines are agreed upon by all individuals involved.
Should the IRB recommend suspension or termination of a research project, the IRB shall make disclosure to the principal and collaborating researchers as well as all administrators involved in the approval process. The IRB's report must include a complete statement providing evidence for disapproval with supporting evidence for the withdrawal of support.
IV. Composition of the IRB
The President designates the Assistant Vice President for Research and Graduate Studies (AVPRGS) as having ultimate responsibility for the assurance and implementation of the fulfillment of all IRB roles and responsibilities and for compliance with research guidelines and procedures.
In coordination with the Faculty Deans, the AVPRGS invites one full-time faculty member from each Faculty, selected from among those active in research with a strong record of research in their respective field of expertise. They must be characterized by maturity, research experience, and academic expertise to qualify for membership, as well as to be able to ascertain the acceptability of proposals in terms of risks and benefits, institutional commitments, regulations, applicable laws, and standards of professional conduct and practice. The names of the selected faculty members are forwarded to the President for final approval to serve as IRB members.
Members of the IRB are appointed to a two-year term that is renewable.
The IRB may not at times have the necessary expertise to judge the soundness (scientific or non-scientific) of a research protocol and may be unable to provide a fair and accurate risk assessment. For these protocols, the IRB chair may call upon an ad-hoc committee for assistance to review the scientific merit by performing an in-depth review of the study, or legal counsel to assist the IRB in conducting its duties. The ad-hoc consultants/legal counsels have no voting rights and must disclose whether they have any conflicts of interest with the protocol.
V. Submission Steps for IRB Review Procedure
Prior to the implementation of the proposed research, the primary researcher should (refer to
Appendix 3).
[Print out Appendix 3 and use it as a checklist to ensure the completion of the steps needed to complete the IRB Protocol Form and that the necessary supporting documents are uploaded/attached with the IRB Protocol Form (Appendix 2).]
The IRB Committee Chair will send the principal and collaborating researchers an official letter to indicate the status of the Research Proposal: accepted, rejected, or in need of review.
VI. Completion of Proposed Research
Upon completion of the proposed research, the principal researcher should inform the IRB of the status by submitting a copy of the research study to close the IRB file.
VII. Training
The IRB members and researchers from NDU who wish to conduct human, animal, and/or environmental research at the University are encouraged to complete the online training as outlined in the Collaborative Institutional Training Initiative (CITI).
Policy History and Review
Last Original Version:
- Approved by the University Council on March 18, 2016
- Approved by the Board of Trustees on May 9, 2016
Updated Version:
- Drafted by the Institutional Review Board, Fall 2023
- Approved by the University Council on November 9, 2023
- Approved by the Executive Committee of the Board of Trustees on November 29, 2023
1The CITI Program is a subscription service, providing Research Ethics Education to all members of the research community. Online training can be obtained at https://www.citiprogram.org/