Trident University - Institutional Review Board
Institutional Review Board
Introduction
Trident University maintains a standing committee known as the Institutional Review Board (IRB). This committee exists for the protection of human subjects and requires students and faculty conducting research involving human subjects to submit their research proposals for review. Among others, the charge of the IRB is to ensure adherence to federal, state and local regulations as well as established ethical principles including respect for persons, beneficence and justice, as enunciated by the Belmont Report.
Respect for persons as an ethical principal includes an appreciation of persons as independent beings that are capable to voluntarily decide whether or not to choose to participate in research.
The IRB additionally addresses the issues of safeguarding individuals unable to make informed decisions, such as children or those not competent to understand the benefits or risks resulting from research. The IRB also considers procedures to ensure confidentiality of subjects. In research involving children federal guidelines mandate the use of parental consent forms and assent forms for the minor.
Beneficence regarding research is concerned with protecting subjects from harm and acting in the best interest of research subjects.
In order to prevent harm the IRB requires the researcher to carefully consider and analyze the risks and benefits of their study and then formally address them individually.The IRB Committee then has the responsibility to determine if these potential risks and benefits are clearly spelled out for both the Committee and potential subjects and whether the research can be approved based upon the listed risks/benefits analysis.
Justice as an ethical principle to be considered in human subject studies refers to the fact that subjects have the right to be aware of the potential risks of research when they are asked to participate. It also asks the researcher to consider who or which group will benefit from the proposed research. The researcher needs to ensure that potential risks are not being taken by only one segment of the population for the benefit of other larger groups of individuals.
Membership
The IRB membership shall include no less than five members appointed by the Vice President for Academic Affairs. Appointments are for two years. The membership shall include one faculty member from each of the colleges offering a Ph.D. program (recommended by the appropriate Dean and approved by the Vice President for Academic Affairs), one staff member (appointed by the Vice President for Academic Affairs), and one member, not otherwise associated with the university, representing the community. The Vice President for Academic Affairs shall appoint the Chair for the IRB.
The IRB shall propose guidelines and forms for exempt, expedited and regular/full reviews to be approved by the Vice President for Academic Affairs. The IRB shall also propose amendments to guidelines, procedures and processes consistent with federal regulations and university policy.
The Process
All research projects at TUI performed by any member of TUI community (Students, Faculty, Staff, and Administration Members) including the collection of data through intervention or direct interaction with identifiable individuals or the collection of identifiable private information will be referred for review by TUI Institutional Review Board (IRB). NO DATA MAY BE COLLECTED ABSENT IRB EXEMPTION OR APPROVAL.
Candidates/Applicants must complete the IRB Application and submit relevant supporting documents as outlined in the application. Such documents include but are not limited to prior/external IRB approvals, consent form, survey instrument and contact letters.
The timetable for review will vary depending on the nature of the study and issues of concern as well as the extent to which supporting documents have been provided.
In order to reduce delays, candidates/applicants are urged to ensure that the application form is fully completed and all relevant supporting documentation submitted.
Reviews
The decision whether or not a research project is exempt or subject to IRB review following the aforementioned criteria will be made by the Chair of the IRB. The Chair of the IRB will keep a file on all decisions for IRB referrals or exemptions.
Expedited reviews may be performed by the IRB Chair, the appropriate IRB member for his/her respective college, or by the Office of Vice President for Academic Affairs for research outside the Colleges. A written report will be submitted to the Chair of IRB for each expedited review followed by a formal recommendation of the IRB to the Office of Vice President for Academic Affairs.
All regular and/or full reviews require a quorum of 3 IRB members and will be completed within two weeks from the time that the referral was sent to IRB. For each review, the IRB can recommend approval, approval with amendments, request further information, or denial. All recommendations by IRB including minutes (where appropriate) from the meetings shall be forwarded to the Office of Vice President for Academic Affairs for confirmation.
In the event that approval is denied, and the applicant refuses to re-apply, the recommendation of the IRB may be appealed by formal petition to the Vice President for Academic Affairs. The Vice President for Academic Affairs shall render a decision within one week from the date of submission of the petition. The decision of the Vice President for Academic Affairs shall be final and binding.
Forms and Resources
Sample to Consent to Participate in Research
IRB Guidebook [Office for Human Research Protections (OHRP)]