Because Ethics and Compliance Matter
Institutional Review Board (IRB)
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.
The IRB membership shall include no fewer than five members with varying backgrounds appointed by the Provost. Appointments are for two years. The membership shall include four faculty members representing at least two colleges offering a Ph.D. program (approved by the Dean of the College, Faculty Council on Committees [FCC], and the Provost), at least one non-scientist member (appointed by the Provost), and one member, not otherwise associated with the University, representing the community (nominated by the IRB Committee and approved by the FCC and Provost). The Provost shall appoint the Chair of the IRB. Any IRB member must disclose a conflict of interest to the IRB Chair, and recuse him/herself from voting, review, and discussion of that protocol, except for addressing questions from the IRB as requested. A conflict of interest of an IRB member includes but is not limited to a protocol in which an IRB member participates as a researcher, supervises (e.g. dissertation chair), or has a financial interest. The IRB shall propose and establish guidelines and forms for exempt, expedited, regular and full reviews. The IRB shall also propose and establish amendments to guidelines, procedures and processes consistent with federal regulations and university policy.
All research projects at TUI performed by any member of TUI community (students, faculty, staff, or administrators) that includes 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 member of the TUI community may collect research data on human subjects without prior Trident IRB approval.
Candidates must complete the entire IRB application and submit relevant supporting documents as outlined in the application. Supporting documents include but are not limited to prior or external IRB approvals, written permission from appropriate administrators at the study site on their department’s letterhead, participant consent form(s), research protocol, data collection instrument(s), documents used to recruit participants (e.g. contact letters, flyers, advertisements), statement concerning financial interests of the researcher, and written proof of consent or compliance with requirements of foreign jurisdictions. The informed consent should include the title of the study, name and credentials (e.g. doctoral candidate) of the principal researcher, description of the study (including risks and benefits to subjects), description of financial benefit to subjects or the student, description of the voluntary nature of the study and the participant’s right to withdraw, contact information for Principal researcher, Committee Chair, and IRB Chair, and spaces for signature of the research participant and/or legal representative (if applicable).
Items Required for IRB Review
It is the responsibility of each candidate to ensure proper completion of their application and inclusion of the following items:
[ ] Certificate of completion of online training on “Protecting Human Research Participants.”
[ ] Completed IRB application
[ ] Approved research protocol/methodology
[ ] All data instruments (e.g. surveys, questionnaires, data fields accessed from existing sources)
[ ] Permission to administer study and/or access data (e.g. written permission from appropriate administrators at study site, copy of service agreement, and/or supporting documentation that data is public use)
Required for Studies Involving Data Collection
[ ] Informed Consent Form. See example
This form should include:
[ ] Title of study
[ ] Name and credentials of Principal Researcher (e.g. doctoral candidate)
[ ] Why the participant was selected for the study (i.e. selection/eligibility criteria)
[ ] Purpose of the study
[ ] Procedures involved for participants
[ ] Potential risks and discomforts (such as inadvertent release of sensitive information)
[ ] Potential benefits to subjects and/or society
[ ] Whether participant will receive payment for participation
[ ] Statement regarding confidentiality
[ ] Description of voluntary nature of the study and the right to withdraw
[ ] Contact information for Principal Researcher, Dissertation Mentor, and IRB
[ ] Signature (or e-signature) block for indicating consent of research participant and legal representative (if applicable)
[ ] Participant assent form (if applicable for children under 18)
[ ] All documents used to recruit participants (e.g. contact letters, flyers, advertisements)
Other Requirements (if applicable)
[ ] HIPAA waiver (for studies involving protected health information)
[ ] Other IRB approvals of the proposed study(including supporting documents)
The decision, whether or not a research project is exempt or subject to IRB review (i.e. full or expedited) following the aforementioned criteria, shall be made by the IRB Chair or IRB Chair designee. The Chair of the IRB will keep a file on all decisions for IRB referrals or exemptions.
The IRB Chair or IRB Chair designee may perform expedited reviews. When the IRB Chair determines that a full review is required, the IRB will conduct such a review at its next available regularly scheduled meeting. An IRB quorum (three members) is required to convene an IRB meeting. Based on majority vote, the IRB may recommend approval, approval with amendments, request further information, or denial. All recommendations by the IRB including minutes (where appropriate) from the meetings shall be communicated to the applicant and retained by the IRB Chair.