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ABOUT DSC IRB
A. What is an IRB and What does an IRB do?
IRB stands for Institutional Review Board. It is a committee established by an institution to review and to approve any resarch involving human subjects. The primary and ultimate goal of an IRB is to protect the rights and welfare of the human subjects in a research. That is why the fedearl government requires any research involving human subjects be reviewed and approved by the IRB.
It is DSC IRB's responsibility to ensure that all research follows requirements set forth by the insitution and the federal government to protect the human subjects. Please check out the Belmont Report, Part A, B, and C, for the ethical principals when conducting human subjects research.
B. Where is DSC IRB Office?
The Office of Institutional Research (IRO) oversees the IRB affairs. When you find IRO you find IRB. We have recently moved to a new location - Larkin Building South. The physical address is 20 North 600 East, St. George, UT 84770. We are right next to the DSC Health and Wellness Center (behind Taco Bell on St. George Blvd). In addition, we will soon change our name to Program Assessment and Institutional Research (PAIR).
IRB PROCEDURE AND TIME FRAME
A. Review Procedure
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Department level |
All research should be reviewed and approved by the department or the advisor. In order to document any review process between the student and the principal investigator (i.e., research advisor) a Clearinghouse Survey form is provided. Students should use this form at the very beginning once the research topic is decided. The advisor puts down any comments and suggestions about the research, sign and date it. Repeat the process until the research is finally approved. Prepare next level which is IRO review. |
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IRO level |
Send the complete package to the Institutional Research Office (IRO) for review. The package should include but not limited to the following:
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required forms
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Clearinghouse Survey with the advisor's comments and signautre
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approved research proposal (4~10 pages)
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approved survey questionnaire or interview questions if research is survey
Please see Forms and Other Requirements Part E for other possible supporting documents.
An IRO staff will check the completeness of the package, review the proposal and questionnaire, ask the researcher(s) to clarify questions, and decide whether or not the research can be exempt from IRB's review and approval.
Not all research needs to go through IRB. Many can be exempt. Check 45CFR46.101(b) for exemption categories 1.
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IRB level 2 |
Once the IRO request IRB's review and approval on a research, the researcher(s) and the principal investigator(s) (PI) will be notified by e-mail. Either the researcher(s) or the PIs will need to respond to any questions and/or suggestions made by the IRB committee. The committee will then determine wether to approve, conditionally approve, deny, or terminate the research. |
Notes:
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Though many studies are qualified for exemption, DSC IRB remains the right to sanction any research that may pose more than minimal risks to human subjects, deteriorate DSC's image or reputation, lack its merits, and involve sesitive topics and/or minors.
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Officials of the institution can apparove or disapprove a research which has already been approved by the IRB. However, those officials CANNOT approve a reseach which has not been approved by the IRB (see 45CFR46.112).
B. Review Time Frame
Normally, it takes up to four weeks (2 weeks for IRO review + 1 week for IRB review + 1 week for Q&A ) to go through IRO/IRB after submission. Applicants can expect one week less without going through IRB. All requests must be reviewed by IRO first.
Any of the following can seriously delay the reviewing process:
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a draft research proposal without proper editing (e.g., full of grammar errors, typos, incomplete sentences)
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submission without advisor's approval
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missing required forms and supporting documents
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unfinished forms
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slowness in responding to IRO's or IRB's questions
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bad hand writings
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last minute submission
Reseach applicants, especially student researchers, are fully responsible for their proof-read proposals to the IRB Committee.
Notes:
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All forms are in Word format. They can be downloaded and typed. If you must write, please print clearly and nicely so we can read.
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Please try not to submit your project at the very last minute at the end of term. Last minute submissions actually cause significant delay in review due to sudden workload increase at the IR office.
IRB COMMITTEE MEMBERS
A. Who is currently serving the committee and how to contact them?
SUBMISSION DEADLINE
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2011 ~ 2012 Deadline |
Date |
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Summer term |
06/13/2011 |
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Fall semester |
09/23/2011, 11/18/2011 |
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Spring semester |
02/17/2012, 04/13/2012 |
A. Can I still submit my research to the IRO if I miss those dates listed above?
Yes. The submission will be counted toward the next deadline.
B. Why need dealines then?
Two purposes: time mangement and quality.research
A good time mangement will help IRB members and students distribute their workload evenly. In addition, students should prepare their projects as early as possible and work closely with their principal investigator(s). Our past experiece tells us that many poor quality student projects are the result of "last minute" submissions at the end of semester. These very late submissions actually cause delay because of sudden workload increase at the IR office.
FORMS AND OTHER REQUIREMENTS
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Form |
Purpose |
Download |
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Application Checklist |
a checklist for applicants to see if they include all required forms and supporting documents |
word
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Clearinghouse Survey |
Any project should be reviewed and approved by his/her advisor or department first with advisor's comments and signature. The approved project will then be reviewed by IRO and/or IRB. |
word
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Exemption Checklist |
a checklist to see if a project can be exempt from IRB's review under 45CFR46.101(b) |
word
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Human Subjects Request |
(1) for any research that exposes human subjects beyond minimal risks; (2) studies invloving clinical trials or experiments; (3) minors are the research subjects; (4) any research that is not exempt under 45CFR46.101(b), or sensitive topics that will have an impact on DSC or its students, faculty and staff |
word
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Informed Consent |
(1) for anonymous research; (2) names, ID numbers, and signatures are not required; (3) participants must be 18 or older; (4) returning of the survey/questionnaire implies that respondent's consent to participate |
word
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Participant Consent |
(1) for any research involving tracking research participants (examples are experiments and/or pre/post-test, survey, or interviews); (2) participants are minors (under age of 18); (3)names and/or ID numbers are required for tracking purpose; (4) parent or legal guardian has to be present and sign the form on behalf of minors; (4)signatures are required
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word
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Survey Request |
for any projects involving surveys, questionnaires, interviews, and observations |
word
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A. Which form should be used if my research is not about survey/interview/observation and/or trial/experiment?
Right now we do not have a form for that. We are currently builidng a form for a more general purpose that does not involve any survey, interview, observation, and/or clinical trial and experiment. It will be posted on the web page once it is finished.
B. Should I use Survey Request form or Human Subjects Request form?
Use Survey Request form if your research meets all of the following:
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survey/questionnaire/interview/observation type, and
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no name or ID is required, and
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no minors are involved
Otherwise, please use Human Subjects Request form.
C. Which consent form, Informed Consent or Participant Consent, should be used? Can I use both together?
The major difference between Informed Consent and Participant Consent is the signature. An Informed Consent DOES NOT require research subjects to sign in order to participate in the research.
However, Participant Consent requires research subjects to sign in order to participate. If your research involves clinical trials, experiments, and/or pre/post-tests, use Participant Consent form because this type of research usually need to track their subjects for research records/results. If there are minors involved in the research regardless its type, Participant Consent form is required for their parent(s) and/or legal guardian(s) to sign before children can do the research.
You may use both Informed Consent and Participant Consent forms; however, it is not necessary. We do not recommend it unless you have a very good reason. For the protection of human subjects, we try not to identify them with anything. In most cases, a simple Informed Consent will do.
D. Can I write my own consent form(s)? Do I still need to submit DSC IRB's Informed Consent form or Participant Consent form if I write my own?
You are welcome to construct your own consent form(s) to suite your own needs as long as you follow the general requirements set forth by the federal government. Please check with Code of Federal Regulations Title 45 Part 46 Section 116 (i.e., 45CFR46.116) for writing your own consent form/letter.
There is no need to submit DSC IRB's Informed Consent or Participant Consent form if you write your own consent form or letter.
E. What other supporting documents do I need to submit in addition to the required forms?
The following items are also required:
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finalized and approved (by the advisor or the department) research proposal (4 ~ 10 pages)
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finalized and approved (by the advisor or the department) questionnaire or interview questions if survey/interview is used
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any IRB submission or approval other than DSC IRB if available
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any proof of permission from the place where the research is conducted
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any posters, flyers, photos, ..., etc will be used for the research if available
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