Research Policies

Final version amended and approved by the BOD on April 10, 2013

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 subjects, and to protect the environment, in all research that involves the University. Its ultimate goal is to ensure that researchers adhere to the guidelines and principles which prevent unethical practices consistent with recognized standards in the 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.

Guiding Principles

Recalling on the:

• Ethical principles, as determined by the University’s mission and as prescribed by universal rules governing moral integrity, human rights, animal welfare, respect for the environment, which shall be observed at all times in any kind of research activity under the auspices of NDU;
• Belmont Report (Appendix 1) and Lebanese enforced law when applicable;
• Policy on Conflict of Interest in Research;

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 humans 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 (NDU-IRB) in order to ensure full transparency and accountability to the University and to the overall scientific community;

Affirming that:

• NDU research adheres to professional and moral processes;
• The rights and well-being of subjects (human or animal) are adequately protected;

An NDU-IRB will be formed to implement the present Policy on Ethics in Research.

Role and Responsibilities of the NDU-IRB

The NDU-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 NDU-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 NDU-IRB;
• Ensure that appropriate mechanisms exist in 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 to all research participants during the mandate of the research process, unless a priori disclosure guidelines are agreed upon by all individuals involved;

Should the NDU-IRB recommend suspension or termination of a research project, the IRB shall make disclosure to the leading researcher(s) and research participants as well as all concerned administrators including, but not limited to, the VPSRD, the concerned Dean and Department Chair. The NDU-IRB's report must include a complete statement providing evidence for disapproval with supporting evidence for the withdrawal of support.

Composition of the NDU-IRB

The President designates the Vice-President for Sponsored Research and Development (VPSRD) as having ultimate responsibility for the assurance and implementation of the fulfillment of all NDU-IRB roles and responsibilities and for the compliance with research guidelines and procedures.

In coordination with the Faculty Deans, the VPSRD invites faculty members to express their interest to serve on the NDU-IRB. The selected members’ names are forwarded to the President for final approval. Members are selected based on the need of their particular expertise. They must be characterized by maturity, research experience, and academic expertise to qualify for membership as well as 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.

Members of the NDU-IRB are appointed to a one-year term that is renewable.

The NDU-IRB may not at times have the necessary expertise to judge the soundness (scientific or non-scientific) of a research protocol and may possibly be unable to provide a fair and accurate risk assessment. For these protocols, the NDU-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 NDU-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.

Submissions and Review Procedures

Prior to the implementation of the research project, each researcher shall:

• First, consult with the NDU-IRB prior to submission of a research proposal to discuss any issues relating to human, animal, and environmental subjects and the possibility of ethical considerations for the successful carry-out of the project.
• Second, secure the approval of the concerned Department Chair and Dean. In some circumstances, however, the NDU-IRB will consider delegating (should the concerned Dean communicate to the NDU-IRB in writing) to an appropriate person in the Faculty as long as that person is experienced in the requirements for protecting research subjects and has the authority to sign for the Department Chair in this regard. The responsibility for local supervision of the project, however, remains with the Department Chair.
• Third, submit the application form (Appendix 2), IC form (Appendix 3), and other forms whenever applicable to the NDU-IRB. The NDU-IRB checks the application to ensure that all the necessary documents/materials have been submitted for NDU-IRB review.

It is worth noting that research projects are reviewed according to the research potential level of risks to research subjects/environment, and as determined by the NDU-IRB. The risks to which research subjects may be exposed are classified as physical, psychological, social, and/or economic.

The NDU-IRB holds all research proposals to the same standards.

Training

In order to comply with the policy, the NDU-IRB members and researchers from NDU who wish to conduct human and/or animal subject research at the University are required to complete the online training as outlined in the Collaborative Institutional Training Initiative (CITI).

Acronyms