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The Collaborative Institutional Training Initiative
(CITI) online service offers
instruction for responsible conduct in research.

College-level review committees conduct expedited reviews of student research and course-related activities that are covered by the University Human Subjects Review Committee’s policies. While any application may be submitted to the UHSRC, student applications are normally submitted to the appropriate college committee, with the exception of dissertation research, which must be submitted to the UHSRC.


These guidelines are to be understood as complementing practices mandated by the professional ethics of a given discipline.

Allow a minimum of 2-3 weeks for approval depending on the completeness of the original application. All applications receive an expedited review unless they place their subjects in the "at risk" category of review. Please see Item 10 for additional review information.

1. Procedures and Forms. The policies and procedures of the UHSRC serve as the policies and procedures of all college committees reviewing student research. The forms used by student investigators to apply for approval, as well as the reviewers’ response forms, are the same as those used by the UHSRC. These forms can be downloaded from the top right section of this page.


2. College Committee Review. Research applications are reviewed independently by at least two members of the appropriate college 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.



3. Scope and Enforcement. The University HSRC policy document states that the UHSRC's review process applies to all research involving the use of human subjects, including:

a) Research that is funded or unfunded
b) Research that is pursued by any individual while in his/her role as a faculty member, staff, or student at EMU
c) Research that is done on the property of EMU, or using the facilities of EMU
d) Research that uses University personnel or students as subjects, except for data collection that will be used exclusively for administrative internal EMU use.


Student 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 UHSRC. College committees normally review student research. 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 procedures documents that are linked to these guidelines and available on this Web site.


4. 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 cases. 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, her greatest challenges in her job, and the effect of her 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.


5. 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 to (a) maintain confidentiality of the data, and (b) 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 (see Webpage on faculty and doctoral student research guidelines) 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 Eastern Michigan University policy document are in force. 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.

a) Whenever an application is reviewed, a written statement of approval or rejection is provided to the applicant. Students are provided with 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.

b) To develop an approved Consent Agreement please refer to the Developing a Consent Agreement
Webpage. This page will explain the reason for using a specific document to obtain consent and the appropriate structure and information needed for approval.

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. Faculty members supervising student research 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, student research projects that always require review when using human subjects include, :

a) Student independent studies that are formal research projects using human subjects
b) Undergraduate honors or master's thesis using human subjects

Note: Decisions about whether such individual projects are exempt from review 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 student 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 student project proposal.

8. Course-Related Activities Not Requiring Review.
All course-related student research activities may be reviewed; however, most such 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):

a) The results of the assignment are intended solely for use within the classroom setting
b) Appropriately licensed practitioners supervise a practicum experience in educational settings, including healthcare facilities

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 course-related activity involves more than minimal risk to participants, the University HSRC must review the activity. (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 does 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. Required Elements Checklist. The following sheets contain examples of the items that must be included in the Consent Agreement and that will be reviewed by the faculty conducting the expedited review of the protocol.


Please review this list to ensure that each item has been addressed in the Consent Agreement and the application for approval.


Checklist of Required Elements of Informed Consent

• A statement that the study involves research

• Purpose of the research

• Duration of subject’s participation

• Description of the procedures followed

• Means of public dissemination

• Description of foreseeable risks or discomforts to subject

• Description of benefits to subject or to others

• Disclosure of appropriate alternative procedures or courses of treatment

• Statement of extent to which confidentiality of records identifying subject is maintained

• Statement of how participant confidentiality is maintained in public dissemination

• For research of greater than minimal risk, information regarding medical treatments or counseling if personal injury or problems occur

• List of contacts who can answer questions about the research and subject’s rights and respond to research-related injury to subject. Contacts listed should include, at a minimum, the principal investigator (for questions about the research study) and the Chair of the HSRC that reviewed/approved the protocol.

• Statement that participation is voluntary

• Statement that refusal to participate will involve no penalty or loss of benefits

• Statement that the subject may discontinue participation at any time

• Statements of significant new findings developed during the research that may relate to the subject's willingness to continue participation

Conclusion

The intent of EMU’s 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.

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Content Posted 12/10/2012 | Design Posted 04/17/2012