Institutional Review Board
Trident has a standing committee known as the Institutional Review Board (IRB). This board exists for the protection of human subjects and requires those students and faculty conducting research involving human subjects to submit their research proposals for review prior to data collection. 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 and recognized by the U. S. Department of Health Sciences.
Respect for Persons. The ethical principle of respect for persons includes the requirement to recognize persons as independent beings capable of voluntarily deciding whether or not to choose to participate in research. The IRB also 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. 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 researchers 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 IRB and potential subjects; and whether the research can be approved based upon the listed risks and benefits analysis.
Justice. The ethical principle of justice requires people be treated fairly. Subjects have the right to be aware of the potential risks of research when they are asked to participate. This principle also requires 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 another segment of the population.
IRB Membership
Federal regulations require that the membership include at least five members with diverse backgrounds (including one scientist member, one non-scientist member, and one member who is not affiliated with Trident). The IRB membership at Trident includes the following:
- Doctoral Coordinator IRB (Chair)
- At least four faculty members from colleges with doctoral degree programs (with at least one faculty member meeting the definition of a scientist member)
- At least one community member, not affiliated with Trident.
The IRB Committee nominates and recommends candidates for the community member position. The Dean of Research and Doctoral Studies and IRB Chair give final approval to all appointments of IRB members. The term for members shall be three years for faculty members (subject to faculty contract term), and one year for non-affiliated members. Memberships may be renewed for subsequent terms. IRB members are required to disclose any conflict of interest to the IRB Chair and respond to questions from the IRB as requested. A conflict of interest includes but is not limited to a protocol in which an IRB member participates as a researcher, supervises (e.g., dissertation chair, doctoral program chair), or has a financial interest. When a conflict of interest exists, the role of the IRB member shall be modified as follows: 1) Serve as a non-voting member for any IRB applications where there is a conflict, 2) Refrain from serving as an expedited reviewer for IRB applications where there is a conflict, 3) May assist in screening whether IRB applications are exempt from IRB review, provided they do not make the final determination that an IRB application is exempt.
What Requires IRB Review and Approval?
Any research involving human subjects must be approved by the Trident IRB prior to data collection. Research is defined as “a systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” (45 CFR 46. 102). This includes pilot studies and preliminary studies but does not include surveys that are designed to improve programs (rather than contribute to a body of knowledge). Human subjects are defined as a “living individual about whom an investigator conducting research obtains: 1) data through intervention or interaction with the individual, or 2) identifiable private information.”
No member of the Trident community (students, faculty, and staff) may access or collect research data on human subjects without Trident IRB approval.
Failure to submit an application to and receive approval of Trident IRD prior to commencement of data collection shall constitute a violation of university policy and subject the researcher (student, faculty, or staff) to sanctions ranging from suspension to termination from employment.
The Process
Complete information on the steps of the IRB Process, templates for the application form, informed consent and other documents, and specific information on the IRB process can be found on the IRB LibGuides page. Please review this information before you submit your IRB application and supporting documentation.
Reviews
When a new application is received by the IRB Committee, it is screened for:
- whether the principal researcher has IRB certification.
- whether the proposal/protocol was approved by the Doctoral Program Chair.
- the completeness of the application.
Any IRB application not meeting screening requirements will be returned to the applicant. The IRB Chair or designee will determine whether the research is exempt, expedited, or requires full committee review. The IRB Chair (or designee) will complete the exempt review. An expedited review will be performed by an IRB member and/or IRB Chair. If a full review is required, the IRB application will be reviewed at the next available regularly scheduled meeting of the IRB.
- To see if your research meets exempt requirements, review Exemptions.
- To see if your research meets expedited requirements review Expedited Review categories.
- If your research does not qualify under the exempt or expedited categories, a full review by the committee will be required. With very rare exceptions, almost all students qualify for either exempt or expedited review
The time period for IRB approval 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. Because IRB approval is dependent on the Principal Researcher addressing all issues found in the review, an estimate cannot be provided regarding the total time required for an IRB review. Please allow up to 5 to 7 business days to receive feedback on submitted IRB applications (less time for an exempt review and follow up reviews).