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Human Subjects Q & A






The United States Department of Health and Human Services has issued regulations for protecting human subjects in research studies. To comply with these regulations, EMU’s Human Subjects Review Committee reviews all proposals for research that utilizes humans as subjects.

The intent of the EMU policy and related review procedures is to eliminate or minimize research-related risks to human beings and to provide for informed and voluntary participation by subjects, while complying, as an institution, with federal rules.

The EMU Human Subjects Review Committee's goal is to work with faculty to promote research that protects all participants, including the investigators. When faculty conduct research that has been approved by the UHSRC, their personal liability is limited in the same way that it is when they are teaching in the classroom or conducting other activities associated with the terms of their employment. UHSRC members are available to help faculty at any stage of their research development or review.

1. What is the function of the EMU Human Subjects Review Committee?
2. What types of research projects must faculty submit to the UHSRC review process?
3a. Are any classroom-related research projects included under these procedures?
3b. Is faculty assessment of classroom instruction exempt?
4. How does this review work?
5. What are the review criteria?
6. What does a faculty member need to do prior to conducting research?
7. What can a faculty member expect from the UHSRC once a proposal has been submitted for review?
8. Is any research exempt from this review process?
9. What if a faculty member has questions regarding any phase of the UHSRC process?


Q & A

1. What is the function of the EMU Human Subjects Review Committee?

The UHSRC is responsible for developing and utilizing policies and procedures that apply to research in which human beings may be at minimal or greater risk as a consequence of participating in an investigation or experimental procedure (See #5 for definition of minimal risk).

2. What types of research projects must faculty submit to the UHSRC review process?

While external funding agencies require a review by an institutional human subjects review committee prior to a funding decision, it is not only externally funded research that needs to be reviewed. Rather, the human subjects 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 faculty, staff, or students at EMU
    (c) Research done on the property of, or using the facilities of, EMU, or
    (d) Research using University personnel or students as subjects.

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3a. Are any classroom-related research projects included under these procedures?

Classroom activities that use human subjects are exempt from review as long as the purpose of the activity is purely pedagogical and the results are intended solely for use within the classroom setting.

EXAMPLE: Results Used in Classroom vs. Public Dissemination

If a management professor were to ask each student to interview his or her partner in class about sexual harassment at work, and the results were to be shared and discussed in class only, then the research would not fall under the UHSRC policy. If, however the faculty member, or students, intended to classify and analyze the interview results and disseminate them publicly, then the research project would have to be reviewed by the committee. In this case, or in the case of thesis research or independent study, the instructor of the course or faculty supervisor is responsible for having the research reviewed by a departmental, collegiate, or University-level HSRC.

EXAMPLE: Vulnerable vs. Nonvulnerable Groups

Course instructors must pay particular attention to assignments and projects that might result in the use of "vulnerable" categories of human subjects. For example, a student might be planning to study preschool-aged children's understanding of television commercials by interviewing children about a series of commercials that had been videotaped for this purpose. In addition to obtaining the informed consent of the children's preschool teacher and parents, the student (or faculty member supervising this research) need not seek approval from the UHSRC, but could submit this project either to an appropriate college- or department-level review committee for approval. If, however the student were planning to interview these same preschoolers about their parents' divorces, a study that could place the children at more than minimal risk emotionally, it would be necessary for the student researcher and his or her supervisor to submit the proposal to the UHSRC.

In general, then, if students are interviewing, surveying, or observing the behavior of students in class, professionals, or other nonvulnerable adults, and if the results will not be publicly disseminated only in the classroom, the class activity does not need to be submitted for review. If, however the students wish to use subjects from a vulnerable category, such as children, the research must be reviewed by the appropriate committee, even if the results are not used outside of the classroom.

Finally, students may not conduct unsupervised research in which there is greater than minimal risk to human subjects. Furthermore, all research involving more than minimal risk, whether it is student or faculty research, must be reviewed by the UHSRC. These same guidelines must be followed whether the research is being planned to fulfill a thesis requirement, to obtain credit for an independent research course, or to fulfill one of the requirements in a regularly scheduled course.

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3b. Is faculty assessment of classroom instruction exempt?

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 other course products (e.g., papers). These extensions 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 anonymous. Such anonymous data, collected for purposes of improving instruction, should not put students at more than minimal risk and thus does not require human subjects review. (Please note: If the results of the assessment research are to be disseminated publicly, then the project must be reviewed by the appropriate departmental, college, or University committee.)

4. How does this review work?

Once a "Request for Approval of Research Involving Human Subjects" has been submitted to the UHSRC, the chairperson of the Committee typically assigns the proposal to two members of the Committee for independent review. Each reviewer decides whether the project should be exempt from further review, approved, conditionally approved, or whether additional information must be obtained from the investigator in order to reach a decision. If both reviewers decide that the proposal should either be approved or exempt from further review, the researcher will be notified of this approval and may begin research. This expedited review procedure typically requires lower than two weeks from the time a request for approval is received.

Reviewers may also recommend conditional approval of a project. For instance, they may suggest that additional steps be taken to inform subjects fully of risks associated with their participation in the research, or they may recommend that procedures be modified to ensure that information obtained about individuals will remain confidential. If the investigator agrees to such provisions, the research may then begin without further review. If not, an appeal may be made to the full Committee. All proposals in which there might be more than minimal risk of harm to participating subjects are reviewed by the full Committee.

It should be emphasized that the review process is not adversarial. When questions over necessary procedures arise, these are typically resolved through a simple exchange of additional information. Furthermore, because there is no limit to the number of projects that can be approved by the UHSRC, this review process is not evaluative in the sense that a sabbatical leave committee's review or fund-granting agency's review would be.

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5. What are the review criteria?

The review process focuses on the following questions:

    (a) What potential risks are there for subjects participating in the proposed research? Are the procedures adequate to minimize any risks?
    (b) If there are potential risks, should the knowledge from the research be pursued? Do the benefits outweigh the risks?
    (c) Are the procedures proposed by the researcher sufficient to ensure that there is informed consent on the part of the subjects and that their participation is voluntary?
    (d) Are the procedures sufficient to allow for confidentiality of information about individual subjects, both in gathering and disseminating information?
    (e) Are vulnerable populations involved? If so, have particular and appropriate steps been taken to ensure voluntary participation, legal consent, etc.? Is there equitable selection of subjects?

A pivotal issue in the review process is deciding whether or not the proposed research might place subjects at more than minimal risk. If it seems that the research would place subjects at more than minimal risk, then a review by the full University Committee is required. That is true of both faculty research and research conducted by students. 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 in the proposed research are not greater, considering possibility and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological tests or examinations." 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 stressors that make some days rather painful or disturbing would be judged to involve more than minimal risk, despite the fact that such experiences may not always cause lasting harm.

Two other issues central to the evaluation of virtually all proposals are the issues of confidentiality and informed consent. An application must provide a thorough description of the steps that will be taken to maintain the confidentiality of data. For instance, if the participants will be completing written questionnaires, will they be asked to include or omit their names from these forms? Even when names are omitted, individuals can sometimes be identified from demographic or other background information that they provide. When identifying information is needed, what other steps will be taken to ensure that the data will remain confidential? What steps will be taken to ensure the confidentiality of photographs and video or audio recordings?

Researchers must obtain the legally effective informed consent of participants or of their legally authorized representatives. This will mean obtaining a signed consent in essentially all cases. Researchers must seek such consent or assent (e.g., from a minor) under circumstances that provide the prospective subject with sufficient opportunity to consider whether or not to participate. These circumstances must also minimize the possibility of coercion or undue influence. Subjects must be informed of any foreseeable risks or discomforts. They must also be given an explicit statement explaining that their participation is voluntary, that refusal to participate will involve no penalty, and that they may discontinue participation at any time without penalty. Because great care must be taken in obtaining adequate informed consent, especially from children and various "captive" groups (including college students), the researcher is encouraged to examine relevant references listed in the resource section of this document for additional information on this issue (e.g., "University Procedures for Use of Human Subjects in Research" or "Code of Federal Regulations: Protection of Human Subjects").

6. What does a faculty member need to do prior to conducting research?

(a) First, obtain a copy of the form "EMU Request for Human Subjects Approval" form from the Graduate School, or download it from this Web site. In addition to answering the questions on this form, the researcher is asked to attach a copy of the full research proposal and copies of all instruments or tests to be used. If a full proposal has not been prepared for some other purpose, such as applying for a grant, one need not be prepared for the UHSRC process. Simply submit a statement that summarizes your research project. This summary must include a thorough description of the methods used, including tests, questionnaires, or other instruments.

(b) The material should next be submitted to one of two committees: the university HSRC or the college-level review committee. All faculty research involving the use of human subjects must be submitted to the UHSRC. If the project in question is student research, such as thesis research or a less formal research project being supervised, it may be submitted to a college-level review committee (unless it may put subjects at more than minimal risk, in which case it should go to the UHSRC). If it is not clear about where to submit a particular proposal, the Graduate School should be contacted. (The Graduate School is also the office to which requests for UHSRC review should be submitted.)

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7. What can a faculty member expect from the HSRC once a proposal has been submitted for review?

The researcher will receive an email indicating that the request has either been approved, disapproved, or approved with specific conditions. If the researcher concurs with recommendations and submits modification, a letter of approval will be issued and data collection may begin.

If the research proposed does not involve more than minimal risk, the proposal will receive an expedited review. If it is approved, you will typically received written notice of the committee's action within two to four weeks. If expedited reviewers recommend disapproval, your proposal will be reviewed by the full committee. A proposal may not be disapproved solely through the expedited review process.

8. Is any research exempt from this review process?

The University's review policy applies to all research involving human subjects; however, some types of research are exempt from continuing review by the UHSRC. The determination of which specific projects will be exempt is made through an expedited review process conducted by a department, college, or university-level review committee (not by the Investigator(s) proposing the research). The types of research activities that may be exempt are described in the document "EMU Policy on the Use of Humans as Subjects in Research and Instructional Investigations." As noted above, classroom activities require no committee review as long as the sole purpose of the activity is purely pedagogical and the results are used solely within the classroom setting.

9. What if a faculty member has questions regarding any phase of the UHSRC process?

At any time, the researcher may call the Dean of the Graduate School for information, and/or the researcher may wish to call a member of the HSRC for more detailed/ technical questions.

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Content Posted 03/07/2012 | Design Posted 04/17/2012