Guidelines for College-Level Human Subjects Review Committees
College-level review committees are formed to conduct expedited reviews of student research and course-related activities that are covered by the University Human Subjects Review Committee’s policies. Although any application may be submitted to the UHSRC, student applications are typically submitted to the appropriate college-level committee.
In order to ensure that the University protects faculty liability, the University Human Subjects Review Committee (UHSRC) must explicitly sanction college committees. College committees report only to the UHSRC, not to each other. As part of the establishment of a sanctioned committee, guidelines are developed that outline a review process that parallels that of the UHSRC and follows the ethical guidelines stated in the UHSRC’s policy document.
1. Establishing an Approved Committee. To establish a sanctioned committee, a college must apply to the UHSRC for approval. The application must include a statement of need (including an estimate of the number of applications that would be reviewed by the committee each year) and the names(s) of potential committee members who have served on the UHSRC. Prior to approval, all members of a committee must participate in an orientation program conducted by the UHSRC.
2. Composition and Meetings. College committees have a minimum of five faculty members. One member of each committee must be a member of the UHSRC (or have previously served on the UHSRC). The chairperson of each committee is responsible for keeping records of proposals reviewed and serves as a liaison to the UHSRC. (See Section 11 regarding record keeping. ) Research applications are reviewed independently by at least two members of the appropriate committee in a manner parallel to the UHSRC’s expedited review process If, however, any member of the committee recommends disapproval or believes that the proposed research may put participants at more than minimal risk, the proposal must be forwarded to the UHSRC for review. To avoid confusion about student research being submitted to the UHSRC, the College committee should attach a memo to the application packet to the effect that the proposal was regarded to be beyond minimal risk and is therefore being forwarded to the UHSRC. (See Section 5 for a definition of "minimal risk. ")
3. Procedures and Forms. The policies and procedures of the UHSRC serve as the policies and procedures of all college review committees. The forms used by investigators to apply for approval, as well as the reviewers’ response forms, are the same as forms used by the UHSRC. For a committee to remain viable, applicants shall be notified within three weeks of the status of their request for approval.
4. Scope and Enforcement. The UHSRC Policy Document states that the UHSRC's review process applies to all research involving the use of human subjects, including:
• Research that is funded or unfunded
• Research that is pursued by any individual while in his/her role as a faculty member, staff, or student at EMU
• Research done on the property of EMU, or using the facilities of EMU
• Research using University personnel or students as subjects, except for data collection that will be used exclusively for administrative internal EMU use
Research that has not been approved by the UHSRC or one of its approved college committees may not be conducted at the University or under its auspices. All faculty and staff research, as well as dissertation research, must be reviewed by the University HSRC; the circumstances under which course-related activities and student research do, and do not, require Committee review are discussed in items 6, 7, and 8 below. For additional information concerning the research approval and oversight functions of the UHSRC, as well as information concerning the enforcement of HSRC policies and procedures, see the University policy and procedure documents that are appended to these guidelines and available on the Office of Research Development Web site.
5. Minimal Risk. A pivotal issue in the review process is whether or not the proposed research might place subjects at more than minimal risk. There is no simple, objective criterion that can be applied in all such judgments. The University's policy document on human subjects research states that "minimal risk means that the risks of harm anticipated by the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. " This definition acknowledges that most people's daily lives include challenges and stresses. In practice, the kinds of experiences that most people have on a typical day are considered minimal risk; exposing subjects to the kinds of physical or psychological stresses that make some days rather painful or disturbing are judged to involve more than minimal risk, even though such experiences may not always cause lasting harm. It is possible that research involving more than minimal risk may be approved; however, all research involving more than minimal risk to participants must be reviewed by the UHSRC. If there is uncertainty about whether the research involves more than minimal risk, an application for approval may either be sent directly to the UHSRC, or it may first be submitted to a college committee for a judgment regarding the level of risk involved.
Example from Business: Minimal Risk. An interview in which a student asks a manager to describe her job, the greatest challenges in her job, and the effect of long hours on her home life.
More than Minimal Risk.Students interview a manager about her feelings of competency on the job, her relationship with her boss, the likelihood that she will leave her job due to stress and dissatisfaction, the dynamics of her last performance appraisal, her appraisal of her boss’s competency, and the effects on her marriage of her work life.
Example from Health and Human Services: Minimal Risk. Graduate nursing students frequently survey practicing nurses about the activities they perform related to the identified taxonomy of nursing interventions.
More than Minimal Risk. The purpose of a graduate nursing study could be to study the effectiveness of various cardiac rehabilitation interventions in patients with heart disease (e. g., post-coronary artery bypass surgery or post-heart attack). This might involve a supervised exercise program. There is a possibility that subjects could demonstrate a cardiac dysrhythmia or have another heart attack.
6. Course-Related Student Research Requiring Review.When undergraduate or graduate students conduct research involving human subjects as part of a thesis project or analogous independent, formal research project, it is subject to the same ethical standards, review, and procedures as faculty research. Supervising faculty members are responsible for having this research reviewed by a college HSR committee, or by the UHSRC. Doctoral dissertation research involving human subjects must be reviewed as faculty research, that is, by the UHSRC. Specifically, those student research projects that always require review when using human subjects include student independent studies that are formal research projects using human subjects and undergraduate or master's thesis using human subjects.
Please note: Decisions about whether such individual projects are exempt from review or involve less than minimal risk are to be made by the appropriate review committee, not by the supervising faculty member.
7. Course-Related Activities That Must Be Reviewed. Course assignments that result in a collection (one or more) of independent formal research projects that will be, or are intended to be, disseminated to a community broader than those enrolled in the course must be reviewed by the appropriate committee. In certain instances, a course research assignment that is structured and mandates the use of appropriate professional and ethical practices in dealing with human subjects may be reviewed and approved as a template, eliminating the need for the review of each individual project proposal.
8. Course-Related Activities Not Requiring Review. All course-related student activities may be reviewed; however, most course-related student activities do not require review. Course assignments involving human participants other than members of the class do not require review if these assignments meet either of the following criteria (and are not included as student research as described in section 6 above):
• The results of the assignment are intended solely for use within the classroom setting OR
• A practicum experience in educational settings, including health care facilities, is supervised by appropriately licensed practitioners
Course assignments that meet either of the above-stated criteria are exempt from review; however, like all human subjects research, faculty should be sure that these projects and other assignments involving human participants, meet University and professional guidelines involving voluntary participation, informed consent, and confidentiality. When an instructor believes that course-related activities involving human participants might fail to meet criteria for exemption, it is the faculty member's responsibility to have that activity reviewed by the appropriate review committee. If the activity involves more than minimal risk to participants, the activity must be reviewed by the UHSRC. (Please note: If subsequently either student or faculty member wishes to analyze further the course assignment data and prepare it for dissemination, the research must be reviewed by the appropriate committee. )
9. Faculty Assessment of Classroom Instruction. Classroom assessment techniques (CATs) are procedures for obtaining information from students for the purpose of improving classroom instruction. CATs are designed to extend information typically obtained from examinations and/or course products (e. g., papers). These extensions of instruction include assessing academic skills and intellectual development, students' self-awareness as learners and their learning skills, and students' reactions to teachers and teaching methods, course materials, activities and assignments. Because the purpose is instructional improvement rather than individual student evaluation, data collection is typically anonymous. Such anonymous data, collected for purposes of improving instruction, should not put students at more than minimal risk and thus do not typically require human subjects review. (Please note: If a faculty member or other individual intends to disseminate the results of his/her assessment research, then as with all faculty research the project must be reviewed by the UHSRC. )
10. Confidentiality and Informed Consent. Two concerns central to the evaluation of virtually all student and faculty research proposals are confidentiality and informed consent. To be approved, an application for review must provide a thorough description of the steps that will be taken (a) to maintain confidentiality of the data, and (b) to obtain the legally effective informed consent of all participants or their legally authorized representatives, with special attention given to the protection of children and other vulnerable groups. All of the University's human subjects review committees follow the guidelines stated in the University's policy and procedures in assessing the adequacy of measures proposed to achieve confidentiality and informed consent. The guidelines pertaining to confidentiality and informed consent include numerous provisions that are not likely to be familiar to students. Therefore, these guidelines and the statement of ethical standards from the University's policy document are appended to this statement of college guidelines. Because supervising faculty are responsible for having student research reviewed, these faculty are urged to ensure that student researchers become familiar with this document and its appendices.
11. Record Keeping and Liability. The chairperson of each review committee is responsible for maintaining records of all reviewed research and serving as a liaison to the UHSRC. Once a college committee approves or disapproves a proposal, copies of the reviewer forms and the committee letter to the investigator notifying him/her of the status of the proposal must be forwarded to the Associate Dean of the College. One or more UHSRC members, whose findings will be reported back to the UHSRC, will review these files each year. At the end of each academic year, the chairperson of a college committee must submit to the UHSRC a report of committee activities. This report includes a list of applications evaluated by the committee, with the names of the principal investigators, faculty supervisors, project titles, and an indication of the decision made about each application. The annual report also includes the names of individuals who served on the committee for the prior year, as well as the names of those who will serve the following year. Complete records of the review process for each application are kept by the college for at least three years and are available for review by the UHSRC upon request.
Whenever an application is reviewed, a written statement of approval, conditional approval, or rejection is provided to the applicant. Students are provided with this written feedback when the application involves a thesis or other independent research project. In situations where a faculty member submits a single application for a course assignment that is the same (or very similar) for several students, the written feedback is given to the faculty member, who is encouraged to share it with participating students.
Conclusion. The intent of EMU policy and related review procedures is to ensure the elimination or minimization of research-related risks to human beings and to provide for informed and voluntary participation by subjects, while complying, as an institution, with federal regulations. The goal of the review process is to work with faculty and students to promote research that protects all participants, including the investigators. When investigators conduct or supervise research that has been approved by the UHSRC or one of its sanctioned review committees, their personal liability is limited in the same way that it is when one is teaching in the classroom or conducting other activities associated with the terms and conditions of his or her employment.