FDU Research Compliance: Policies and Procedures

Responsible Conduct in Research

Integrity Etc.Research ethics at Fairleigh Dickinson University are addressed through a series of unique polices and regulations on research compliance. Faculty and students must adhered to all research policy, practices, and procedures when applying for a government grant and/or conducting non-sponsored research at FDU.  For example, National Science Foundation (NSF) applicants are required to complete training in responsible conduct of research prior to the submission of an extramural proposal. Following is a brief summary of each and links to the specific policy, potential forms, and/or more comprehensive webpages.

Humane Care and Use of Non-Mammalian Vertebrates

This policy covers the use of non-mammalian vertebrates (i.e., fishes, amphibians, reptiles, and birds) for research and teaching at Fairleigh Dickinson University (FDU). It addresses animal welfare with respect to compliance with federal and state legislation, acquisition and maintenance, animal care and use, and implications for funding and publication in peer-reviewed journals.  Mammals (such as mice and rats) are specifically not covered in this policy, and are not currently being considered for use in research or teaching at FDU.

Policy on Animal Care and Use and Forms and Permit Applications


Conflict of Interest in Research

Conflict Management #2Fairleigh Dickinson University faculty and other research personnel, or “investigators” may have relationships with entities outside of the University that reasonably appear to be related to their institutional responsibilities.    In accordance with Public Health Service (PHS) Policy 42 CFR Part 50 Subpart F an investigator’s  Significant Financial Interests (SFI) must be disclosed to the University.  If the nature of the significant financial interest is such that it affects (or is perceived to affect) the design, reporting and conduct of PHS sponsored research, the University is required to identify, manage, reduce or eliminate the real or perceived financial conflict of interest in a timely manner.

Conflict of Interest in Research Policy and Conflict of Interest Disclosure Form


Policy on Research Misconduct

Research is among the most professionally regarded and highest forms of scholarship. Maintenance of high ethical standards of conduct in research activities is of vital concern to Fairleigh Dickinson University because research misconduct can inflict profound harm on the pursuit of knowledge. The purpose of this policy is to provide timely, fair, and effective procedures to address instances of research misconduct. A further purpose of this policy is ensure that research activities at Fairleigh Dickinson University are conducted in a manner that complies with University policy; applicable state and Federal laws; and the requirements of grant-makers and sponsors.

Policy on Research Misconduct


Research Mentorship at FDU

MentorshipThe IRB has determined that the role of Faculty Instructors/Mentors/Preceptors is critical to the success of our academic mission, that it is the responsibility of the University to adopt standards of excellence in research, and educate faculty and students on human subject protections, specifically when a research project is curriculum-required.

Purpose

The IRB resolves to comply with federal regulations, mitigate risk to the University, and promote best practices in research, education and training. First, the IRB seeks to strengthen the mentor/student relationship and revise the roles & responsibilities of faculty and students when proposing/conducting research. Second, when conducting research with undergraduate and graduate students, it is very important for faculty to consider and discuss sharing, dissemination or publication of research findings and authorship, particularly in the absence of university-wide guidelines for collaborative faculty-student publications. Third, with the administrative support of the Grants/Sponsored Projects (GSP) Office, specialized training will be provided at each campus to faculty and staff who serve as Faculty Instructors/Preceptors/Mentors to ensure they are well equipped to deliver course-related content on human subject protections, and to also extend support services to students of advanced standing.

The IRB is proposing mandatory completion of a comprehensive online human subject protections training course as prescribed by the IRB. Upon request, the IRB Human Research Compliance Manager will also schedule targeted training (e.g., honors and dissertation students).

Types of Collaborative Faculty-Student Human Subjects Research

The IRB outlined four major circumstances under which faculty Instructors/Mentors/Preceptors might assign/require a course-related research project. They are Course-Assigned, Instructor-Initiated, Student-Initiated, and Thesis-Driven Research.

1. A course-assigned project is for educational purposesonly and not customarily subject to IRB review and approval. The faculty instructor may require undergraduate students to participate in a course-onlyresearch exercise (i.e., intramural). This is a small-scale mock research investigation that is typically part of the curriculum with the research design developed by the faculty instructor, and all study participants drawn from within that specific classroom/course. The faculty instructor assumes responsibility to actively guide the student in the methods of their discipline. The faculty instructor is required to complete a comprehensive online human subject protections training course as prescribed by the IRB, and the instructor may request that their students also complete the same training course.

2. An instructor-initiated project is one where the students are asked to engage in a course-required extramural activity (i.e., required to enroll subjects other than their immediate classmates). Research projects that meet any of the above definitions will require IRB review and approval. Study findings may be shared, disseminated or published once IRB project approval is obtained. This research is designed by the instructor who serves as the principal investigator and assumes responsibility to actively guide the student in the methods of their discipline. In this instance, the students shall serve as co-investigators consistent with the classroom roster. The instructor must provide an attestation and make adequate provisions for monitoring the study conduct (e.g., participant enrollment) to safeguard subject participants. The faculty instructor and students are required to complete a comprehensive online human subject protections training course as prescribed by the IRB.

3. A student-initiated proposal is one best reserved for undergraduate Honors Students who are more capable of developing a research design as part of the honors thesis course requirement. When the research meets any of the above definitions, the student must submit an IRB application for review and approval. Study findings may be shared, disseminated or published once IRB approval is obtained. In these instances, honors student will serve as the principal investigator, and the instructor as faculty mentor. It is the responsibility of the faculty mentor to guide student scholars in the methods of
their discipline. The faculty mentor shall provide an attestation of commitment to sponsor the submission, evaluate the quality of the proposal and its research design, assist the student with IRB requirements, and make adequate provisions for monitoring the study conduct to safeguard subject participants. The faculty mentor and the honors student are required to complete a comprehensive online human subject protections training course as prescribed by the IRB.

4. Thesis-driven proposals are often pre-requisites for masters- and doctoral-level education eliciting greater independence yet supported by a preceptor and thesis committee. When the research meets any of the above definitions, the student must submit an IRB application for review and approval. Study findings may be shared, disseminated or published once IRB approval is obtained. As part of the IRB proposal, the faculty preceptor must also provide an attestation of commitment to sponsor the submission, ensure the integrity of the proposal and its research design, and make adequate provisions for monitoring the study conduct to safeguard subject participants. It is the responsibility of the faculty preceptor to guide student scholars in the methods of their discipline. The faculty preceptor and the thesis-level student are required to complete a comprehensive online human subject protections training course as prescribed by the IRB.