From the Faculty and Contract Staff Handbook……..

(5C) 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. Copies of 45 CFR 46 are available from the Office of Academic Affairs. 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 consider 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

A. 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.

Notable exceptions are:

1.   Research conducted in educational settings involving normal educational practices such as research on regular and special educational strategies or research on the effectiveness of or the comparisons among instructional techniques, curricula, or classroom management methods.

2.   Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.

3.   Research involving existing data or records or human artifacts if they are publicly available or are used in such a manner that subjects cannot be identified.

B. Information that Should Be Submitted to the IRB

An investigator should always feel free to make an informal inquiry to the chair or the secretary of the IRB. Persons submitting research for review should supply information that will allow the IRB to weigh those considerations described above. If a research proposal is involved, that proposal will often contain all or most of the information required by the IRB. “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 CFR 46. 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.

C. The Review Process

Research involving minimal risk 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 is in this category, and the review process normally takes less than one week. Research involving significant 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.

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.

D. 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:

1.   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.

2.   A description of any reasonably foreseeable risks or discomforts to the subject.

3.   A description of any benefits to the subject or to others that may reasonably be expected from the research.

4.   A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.

5.   An explanation of whom to contact for answers to pertinent questions about the research and about research subjects’ rights.

6.   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.

Other considerations in obtaining informed consent may be appropriate in certain cases; for example, when an experimental treatment is involved, when the true purpose of the research cannot be divulged to the participants, or when the research involves children or prisoners. The consent form may not include any language that releases, or appears to release, the investigator or his/her institution from liability, or that waives, or appears to waive, any of the subjects’ legal rights.

A copy of the consent form shall be given to the person signing the form.

E. IRB Membership

The Trinity University Institutional Review Board consists of nine persons: five faculty, a representative from the administration, an undergraduate student, and two persons from the community with no other affiliation with Trinity University.