Research Involving Human Participants

Research Involving Human Participants

The purpose of this policy is to assist investigators planning to conduct research involving human participants in designing their research and submitting it for approval. Proposals for participant research must be reviewed if it is conducted by any faculty, staff, student, or other individual functioning under the auspices of Excelsior.

In accordance with applicable regulations and professional standards of ethical conduct, it is the responsibility of Excelsior to reasonably ensure that, in research conducted under its auspices, the rights and welfare of human participants are adequately protected. The primary responsibility for protecting human participants, however, rests with each individual who initiates, directs, or engages in research. For Excelsior to fulfill its responsibility, it has established an Institutional Review Board (IRB). The IRB is authorized to review and approve all research proposals involving research participants conducted under the auspices of Excelsior, regardless of the source of funding, if any.

“Participants Research" is defined as a systematic investigation designed to develop or contribute to generalizable knowledge, which involves the collection of data from or about living human beings. It does not include research using published or publicly available documents or research on elected or appointed public officials or candidates for public office.

The members of the IRB are appointed to a three-year term by the provost and chief academic officer. In addition to other regulatory requirements, the membership of the IRB shall be composed of individuals of varying backgrounds who are qualified through experience, expertise, and the diversity of the members' racial and cultural backgrounds to assure complete and adequate review of activities commonly conducted under Excelsior's auspices, and to ensure respect for its advice and counsel for safeguarding the rights and welfare of human participants. The IRB shall possess the professional competence necessary to ascertain the acceptability of proposals in terms of institutional commitment and regulations, applicable law, standards of professional conduct and practice, and community attitudes.

The determination regarding whether a given activity should be considered human participants research will be made by the IRB or its designee. Certain categories of research involving little or no risk to participants do not need to be reviewed and approved by the full IRB and are eligible for less intensive review procedures. The IRB shall develop and promulgate appropriate categories of research and determine the review procedures for each category based on the federal “Common Rule.” The IRB shall apply additional criteria during the review of research involving Excelsior prospective and enrolled students, faculty, staff, or alumni.

Procedure

The primary purpose of Excelsior University’s Institutional Review Board (IRB) is to protect the rights and welfare of individuals (human subjects) who participate in research at Excelsior University. Excelsior University complies with the federally mandated process to review research proposals that involve human participants.

Procedures for submitting projects to the IRB can be found in the IRB Handbook: https://www.excelsior.edu/wp-content/uploads/2021/03/IRB-HANDBOOK.pdf.

The Excelsior IRB handbook is designed to provide information about the IRB process, including the factors that must be considered in conducting research with human participants, the types of projects that are subject to IRB review, the types of reviews conducted by the IRB, and the documentation required for each type of IRB review.