General Description
Policy Summary:
Trinity University's IRB Human Subjects Policy ensures the protection and ethical treatment of individuals participating in research. All research involving human subjects must be reviewed and approved by the Institutional Review Board (IRB) to comply with federal regulations, safeguard participants' rights and welfare, and maintain the integrity of the research process.
Purpose:
USE OF HUMAN SUBJECTS IN RESEARCH
When a research project involves human subjects and also involves the use of federal grant funds, it is subject to policies described primarily in the Code of Federal Regulations, 45 CFR 46, entitled “Protection of Human Subjects.” The policy of Trinity University is to comply with these regulations in all cases of research involving human subjects. These regulations provide for the creation of a human subjects review committee known as the Institutional Review Board (IRB).Considerations
Trinity University has established the IRB in order to review research protocols that involve human subjects and to approve, disapprove, or require modifications in such research. In its review, the IRB ensures that risks to subjects are minimized and that these risks are reasonable in relation to anticipated benefits. It also ensures that selection of subjects is equitable and not coercive and that informed consent will be sought and documented from each prospective subject. It also ensures that there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.
I. INSTITUTIONAL REVIEW BOARD PROCEDURES
Gathering information systematically for the sole purpose of informing or improving educational programs at Trinity or informing or improving Trinity's institutional effectiveness does not constitute the kind of "research" that the IRB must oversee, according to federal regulations. Therefore, these activities do not need to be reviewed, although the IRB is always available for consultation about them upon request.
B. Types of Research that Need IRB Approval
In general, any research conducted by faculty, staff, or students that involves living human beings is subject to IRB review. Research involving survey or interview procedures or involving observation of human behavior should be submitted for IRB review. Even though 45 CFR 46 exempts some research of this type, Trinity University policy requires its submission to the IRB
C. Information that Should Be Submitted to the IRB
An investigator should always feel free to make an informal inquiry to the chair of the IRB. Persons submitting research for review should supply information that will allow the IRB to weigh those considerations described above.
Proposals should be submitted to the Chair of the IRB through the IRB Canvas page. All proposals must be submitted with a title and a completion date.
When proposals are being submitted as part of an academic course, if multiple projects are proposed, it is preferred that proposals be submitted in batches to the Chair of the IRB, by the course instructor, and after his/her review of the proposals.
“Risk” should be interpreted in a broad sense to mean not just physical risk but also legal, psychological, social, and economic risk. Discomfort, pain, and embarrassment should be minimized and justifiable in terms of anticipated benefit(s). (“Minimal risk” is quite explicitly defined in 45 CFR46. Designating a project “minimal risk” does not diminish the responsibilities of either the IRB or the investigators, nor does it eliminate the requirement for obtaining informed consent.)
If a survey, interview, or test is involved, the investigator should include a copy of the exact form that will be used. A description of the informed consent process and a copy of the consent form(s) must be submitted. Items submitted to the IRB will, in general, be kept in IRB files and will not be returned.
D. The Review Process
Research involving minimal risk and that is not exempt from review may receive an “expedited review” by the IRB Chair or by some other IRB member designated by the chair. Most of the human subjects research at Trinity University either is exempt or can be expedited, and the expedited review process normally takes less than one week. Research involving more than minimal risk requires approval at a convened meeting of the IRB, and this process could involve a month or more.
Proposal authors should consider and plan for the IRB approval when scheduling the preparation of a proposal. If a meeting of the full board is needed, applicants are typically expected to attend that meeting.
It is expected that the applicant will simultaneously submit a copy of the request to the IRB and the chair or supervisor of the applicant’s department, or appropriate supervisor in the case of a request from an administrative office. The chair or supervisor will inform the IRB and the applicant of any concerns they have about the proposal.
E.Monitoring of Projects
All projects approved by the IRB must be monitored. When the project has been completed, or at the end of the period in which a project has been approved (typically 12 months), investigators must inform the IRB (1) whether the project is continuing or terminating, and (2) whether or not there were any adverse effects experienced by participants in the study. If continuing, the project proposal must be resubmitted to the Chair of the IRB for further consideration for the next year.
F. Informed Consent
The main purpose of the informed consent process is to ensure that prospective research subjects are presented, in understandable language, the information that might influence the decision of giving or withholding consent to participate in the research project. Another qualification of the consent process is that the subject exercise free choice and not be subject to coercion or excessive inducement. Articles 46.116 and 46.117 of 45 CFR 46 contain descriptions of informed consent and its documentation, including conditions under which the process may be waived. For much of the research conducted at Trinity University, an appropriate informed consent process (and consent form) would include:
- A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subjects’ participation, and a description of the procedures to be followed.
- A description of any reasonably foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others that may reasonably be expected from the research.
- A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
- An explanation of whom to contact for answers to pertinent questions about the research and about research subjects’ rights.
- A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
- A statement that participants must be 18 years of age or older to participate in the study.
A copy of the consent form should normally be given to the person signing the form.
G. IRB Membership: Duties of the Board and the Chair
The Trinity University Institutional Review Board consists of at least five faculty, a representative from the administration, an undergraduate student, and two persons from the community with no other affiliation with Trinity University. Members have varying backgrounds so that they can completely and adequately review the research activities that are commonly conducted at Trinity.
Members of the board are appointed by the Vice President for Academic Affairs and do not serve set terms. Once appointed, members remain on the board until removed by the Vice President.
The IRB elects one of its members to serve as Secretary to create minutes of IRB meetings.
At least once per semester, the Chair provides a written report to the IRB of his/her activities (exempted and expedited proposal decisions).
The Chair reviews all outcome reports submitted by investigators as part of the monitoring process, and brings any information about adverse outcomes back to the IRB as needed.
If the Chair is unavailable for more than two weeks, s/he may designate a member of the IRB to serve as Acting Chair for that period of time. Typically, the member serving as Acting Chair must have at least two years of experience on the IRB prior to this designation.
Archives of previous proposals and decisions will be maintained by the Office of Academic Affairs.
H. Human Subjects Ethics Training Requirements
All individuals engaged in research involving human subjects that is determined by the IRB to be more than minimal risk (that is, research reviewed at a convened IRB meeting) must complete ethics training prior to protocol approval.
It is also the responsibility of the principal investigator on such projects to ensure that all individuals who have a substantial role in conducting the research, such as co-principal investigators, students, research assistants, and technicians, receive ethics training prior to beginning work. A “substantial role” includes:
- Recruiting potential research participants,
- Obtaining informed consent from prospective research participants,
- Interacting or intervening with participants to collect research data, or
- Analyzing or drawing conclusions from identifiable research data.
For research within a course taught by a Trinity faculty member, it is the responsibility of the instructor to ensure that all students have the information they need to conduct the research in a way that meets adequate ethical standards. The instructor or PI should:
- provide appropriate training to students and other personnel, and/or
- direct students and other personnel to appropriate training in ethics standards and regulations concerning human subjects research.
Attachments
Attachments:
Revision Management
Revision History Log:
|
Revision #: |
Date: |
Recorded By: |
|---|---|---|
| v2.0 | 7/12/2024 2:44 PM | Pamela Mota |
| v1.0 | 8/5/2020 9:15 AM | Sarah Perales |
Vice President Approval:
|
Name: |
Title: |
|---|---|
| Megan Mustain | Vice President for Academic Affairs |