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Application & Guidelines - Protection of Human Subjects
F.A.Q's
Q: How do I know if my study has to be reviewed by the Human Subjects Review Committee?
A: Most studies conducted by MSCD faculty or administrators will need to be reviewed by the committee if human subjects or participants are involved. This provides a protection for both the participants and for the researcher in case any problems arise. If you are not sure, contact the chair of the committee, Professor Jeff Forrest at 303-556-4380, forrestj@mscd.edu.
Q: What is an exempt study?
A: Exempt studies are those which the federal government permits to occur without institutional review. Studies are exempt when they involve (1) research in educational settings on standard teaching practices; (2) research involving educational tests, surveys, interviews, or observations, unless: (a) individual subjects can be identified, and (b) disclosure of responses could be damaging to subjects. Please contact the committee chair, Professor Jeff Forrest at 303-556-4380, forrestj@mscd.edu for clarification.
NOTE: Exempt protocols still require review, but that review is expedited.
Q: What materials do I need to submit to the committee?
A: The committee needs the original and eight copies of the MSCD Human Subjects Committee Review Form. Accompanying the form should be the answers to the ten questions; the research protocol; the informed consent form; any interview questions, questionnaires, or tests being used; and the debriefing form, if required. For exempt studies, the form only needs to be accompanied by a statement showing by which federal guideline the study is exempt and why, along with the research protocol and forms.
Q: Are there particular things the committee looks for?
A: The committee always looks for assurance that participants' privacy will be protected, that there will be no possible coercion of subjects, and that participants will be protected from any possible harm during the course of the study. It is particularly important to protect students who are research participants through classes they are taking, i.e. students who are under the control of their professors and may consequently feel threatened. Also, whenever MSCD students are participants, the committee always requires that the consent form include the name, address, and telephone number of the Human Subjects Committee chair in case the student has any questions, concerns, or complaints. For research involving minor age children, the committee is particularly concerned that both the child and parent/guardian are aware of and comfortable with the study; Special consent forms are necessary.
Q: Has the committee approved all studies submitted?
A: No. The committee has three options, all of which have been exercised. A study may be approved as submitted, it may be approved contingent upon certain changes, or it not be approved. The most common outcome is for the study to be approved contingent upon changes. The committee works with the researcher to expedite this process.
Q: How long does the approval process take?
A: Proposals that require full review (i.e., those that are not exempt) must be submitted to the committee at least one week prior to the monthly meeting. Currently, the committee meetings are scheduled for the first Friday of the month. The committee decision is transmitted to the researcher within a few days of the committee meeting. Often changes are referred to a subcommittee or the chair and can be approved within a week of the monthly meeting. Exempt protocols are reviewed as they are submitted and typically responded to within 10 working days of receipt.
Q: Have there ever been problems with student participants of approved studies?
A: Yes. Periodically students have raised concerns regarding their psychological wellbeing or health if they decided to participate in a study. There also once was a problem with students feeling they were being forced to participate in a study in class. The committee position is that students are never to be pressured to participate and should be reassured repeatedly that they may terminate study participation without penalty whenever they wish.
Q: When should I make reference to the availability of the MSCD Counseling Center to my subjects in the disclosure form?
A: You should include reference to and the availability of the MSCD Counseling Center whenever there is any chance of emotional stress by a subject resulting from any process related to your research protocol.
Q: Just what does the committee approval mean?
A: Committee approval means that the study has been reviewed and found to follow the MSCD Guidelines. Approval does not mean that the committee has passed judgment upon the research design except to determine that the design will not harm subjects or waste their time. Approval also does not mean that anyone in the MSCD community must participate in the study. For example, faculty members who are approached by researchers to allow data collection in class are under no obligation to agree and should not feel that committee approval requires or pressures them to participate.
Q: My questions have not been answered here. What should I do now?
A: Contact the committee chair, Professor Jeff Forrest at 303-556-4380, forrestj@mscd.edu or any other committee member. The committee wants to help you in your research plans.
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