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UCM Human Subjects - Institutional Review Board (IRB)
Human Subjects process at UCM:
1. Applications are submitted by the Principal Investigator to the IRB through the community group site on Blackboard. Go to the community tab using either the Organization Search or Organization Catalog modules. Once located, click the drop down next to the Human Subjects Committee and select Enroll.
Go to the application tab and find the application type you are submitting. Attach the application as well as materials including surveys, consent, letters of permission and recruitment wording. Student researchers are to email their advisor a copy of the application. You will see your submission posted in the gradebook. Reviewers' decisions generally take about two weeks.
2. CITI Responsible Conduct of Research (RCR) training certificate is required prior to approval. The new RCR basic course is the course required.
3. When you have completed the study or are renewing, complete this: Project Status Form. It documents the number of subjects and any adverse events the subjects experienced.
(If you are not currently enrolled in courses but are working on your thesis, please contact the Graduate School to enroll in GRAD 5001. This will give you Blackboard system access.)
Not Human Subjects Research Determination - This form determines whether or not an IRB review is required. A formal "not human subjects determination" letter will be sent if approved.
Exempt Application - Exempt research is where the subjects are usually anonymous, no intervention and minimal risk.
Expedited Review Application - These are typically for research which has identifiable information, an intervention and minimal risk. Click for categories of research that may have an expedited review.
Full Review Application - Full reviews address research that is associated with greater than minimal risks or includes protected populations including minors, pregnant women, fetuses or prisoners. The IRB offers assistance prior to this type of submission. This is due 5 days before the meeting dates listed below (see meeting schedule).
Renewals - If there are no changes, resubmission of old forms to Blackboard are needed in order to evaluate these against current regulations and policies. If amending and renewing, an amendment first and renewal second are suggested.
Upon approval of the application, the IRB staff will email you an official approval.
Informed Consent Templates
Consent This template meets federal requirements 45 CFR 46 Section 116.
Assent This form should be modified in language written to the age of the child. Considerations include determining child's age, maturity, or psychological state.
Ages 5-7: Verbal assent - script required
Ages 8-12: Age and language appropriate written assent form
Ages 13-18: May separately sign the same as the parental permission form
Waiver or Modification of Informed Consent - Federal regulations permit the researcher to waive or alter the consent document under specific criteria. The waiver or alteration must be accompanied by adequate justification for the request.
Frequently Asked Questions
Meeting Schedule, Membership and Operations
The Spring 2015 meeting schedule is 1/23, 2/6, 2/20 (DOC 107), 3/6 (DOC 107), (3/20 no meeting spring break), 4/3, 4/17 at 1 pm in ADM 315 unless otherwise noted. All applications and revisions must be completed by 5/1.
Reporting Concerns for Human Subjects Research
The UCM IRB recommends that concerns related to IRB first be discussed with one's supervisor, since many instances can be corrected within the research team. Alternatively, the IRB Compliance Officer may be contacted at firstname.lastname@example.org.