Research Involving Human Participants
The purpose of this Policy and Procedure is to assist investigators planning to conduct research involving human participants in designing their research and submitting it for approval.
Participant research must be reviewed if conducted by any faculty, staff, students, or any other person under the auspices of the College.
Institutional Review Board (IRB) practice during the COVID-19 Pandemic
Federal Regulation stipulates that a primary function of the Excelsior College Institutional Review Board is to protect the safety, welfare, rights, and privacy of all participants in human subject research. This includes research conducted by faculty, staff, or students at Excelsior College or in collaboration with other institutions.
To uphold this responsibility during the COVID-19 pandemic the IRB will pause the review of research proposals that involve face-to-face interactions with participants or direct sharing of materials with participants. The pause will continue until such time that restrictions on social contact are lifted. Research proposals that involve remote recruitment, data collection, and storage (e.g., telephone, teleconferencing, Qualtrics surveys, etc.) will continue to be reviewed by the IRB committee.
In regard to research currently being conducted under the approval of the IRB committee, none of these studies involve face-to-face interactions with research participants and will therefore continue without need for amendment. All current principal investigators (PI) have been notified of this finding. If a PI finds it necessary to modify active protocols due to COVID-19 restrictions they are directed to submit a request for protocol modification to the IRB committee and these will be prioritized for review by the committee. Any questions or concerns can be directed to IRB@excelsior.edu for an immediate response.
Statement of Policy
I. In accordance with state and federal regulations and professional standards of ethical conduct, it is the responsibility of the College 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.
II. In order for the College to fulfill its responsibility, it has established an Institutional Review Board (IRB). The IRB is authorized to review and approve all research involving research participants conducted under the auspices of the College, regardless of the source of funding.
A. ” 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.
B. The members of the IRB are appointed to a three-year term by the provost and chief academic officer. In addition to other requirements of state and federal regulations, the membership of the IRB shall be composed of individuals of varying backgrounds who are qualified through maturity, experience, expertise and the diversity of the members’ racial and cultural backgrounds to assure complete and adequate review of activities commonly conducted under the College’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.
C. The determination regarding whether a given activity should be considered human participants research will be made by the IRB or its designee.
D. 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.
E. The IRB shall develop and promulgate appropriate categories of research and determine the review procedures for each category.
The IRB shall apply additional criteria during the review of research involving Excelsior College prospective and enrolled students, faculty, staff or alumni.
Resources and Forms
- The IRB Handbook provides further information about the study application and review process.
- Application for Review
- Sample Volunteer Agreement Form
- Participant Research Policy Statement
When an investigator wished to collaborate with other institutions in addition to Excelsior, they must receive IRB approval from that institution as well. They should submit a copy of the approval letter with the project proposal.
All student investigators must have a faculty supervisor who is responsible for insuring that all procedures of the approval are complied with by the investigator. The faculty supervisor must sign the proposal certifying that the project is under her/his supervision.
All student investigators from institutions other than Excelsior, must have their research proposal approved by the Review Board at their respective college and provide proof of that approval. They must submit the name and contact information for their faculty member who is overseeing this project.
Contact the co-chairs of the IRB Committee, Lisa Rapple, PhD, and Karen Halaco, JD, at IRB@excelsior.edu. These messages will be answered in a timely manner.