UCM Human Subjects - Institutional Review Board (IRB)
1. Applications are submitted by the Principal Investigator to the IRB through the community group site on Blackboard. If you are not currently enrolled in courses but are working on your thesis, please contact the Graduate School to enroll in GRAD 5001 tol give you Blackboard access.
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. If you are not currently enrolled in courses but are working on your thesis, please contact the Graduate School to enroll in GRAD 5001 tol give you Blackboard access.
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..
3. When you have completed the study (or are renewing), complete the final (or renewal survey) in Blackboard. It is required documentation of the number of subjects in your study and any adverse events the subjects experienced.
Upon completion of the review, the IRB will email you an official letter.
Not Human Subjects Research Determination determines whether or not an IRB review is required.
Exempt Application is where the subjects are usually anonymous, no intervention and minimal risk.
Expedited Review Application is typically for research which has identifiable information, an intervention and minimal risk. Categories of research that may have an expedited review.
Full Review Application address research that is associated with greater than minimal risks or includes protected populations including minors, pregnant women, fetuses or prisoners. The IRB recommends getting our assistance prior to submission. This is due 5 days before the meeting dates listed below.
Amendments and Renewals - Minor amendments are typically handled through a written request posted on Blackboard. For major changes, please contact the IRB. If there are no changes for a renewal, 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.
Informed Consent Templates
Consent This template meets federal requirements 45 CFR 46 Section 116.
Consent for Internet-based surveys This template may be helpful for research involving online surveys.
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.
Meeting Schedule, Membership and Operations
The Human Subjects Review Committee will meet during the Spring 2016 semester in Ward Edwards 1550 at 1:00 p.m., Fridays: 1/22, 1/29, 2/5, 2/19, 3/4, 4/1, 4/15, 4/29 (meeting dates approved by Human Subjects Review Committee 1/29/16).
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.