To avoid undue delay in the processing of the research protocols, applicants are asked to make sure all of the following components are completed:
- All responsible individuals involved with the research that are directly involved with human subject participants and/or human subject’s identifiable data must successfully complete the Social/Behavioral Course, Basic Course IRB training.
- Choose ONLY the Social/Behavioral Course, Basic Course
- Submit a signed hard copy of the protocol to the Office of Research Integrity, MSC 5738 or stop by Blue Ridge Hall, Third Floor (Room # 342).
- It must contain signatures of all responsible researchers and the research advisor (if applicable)
- Submit an electronic copy of the form emailed as an attachment to email@example.com
- Protocols must be submitted electronically in MS Word (.doc) format
Reviewers are given five business days to evaluate each completed protocol.
|Review Application Form
|Review Application Form
||Human Research Review Request (Updated 08/29/2014)
- For more information on the difference between Full Board, Expedited, and Exempt review, please see FAQ's.
- To place an "X" in a check box, double-click the check box. The "Check Box Form Field Options" window will display. Under "Default value," select "Checked" and then click on "OK."
Alternative Certification Signature Page
- Recommended for use when needing to obtain signatures for additional PI's.
|Informed Consent Forms
||Sample Consent Form
- Used when:
- Subject is being interviewed
- Subject is being recorded (audio/video)
- Face-to-face interaction between researcher and subject
- Identifying information is being collected from subject (name, social security number, etc.)
- There are many circumstances where a researcher may choose to protect a subject's identity by not referring to them by name in their research (i.e., use a pseudonym). This serves to make their responses confidential, but is not the same as conducting an anonymous study. There should be a signature block for the researcher(s) and the participant.
|| Sample Cover Letter
- Used when:
- Subject's identity to remain "anonymous" ("Anonymous meaning that the researcher can in NO WAY identify the subjects)
- No identifying information is being requested
- A survey/questionnaire is being administered and the researcher will not be present while the surveys/questionnaires are being completed or that the participants will place their completed surveys/questionnaire in an envelope/box to ensure anonymity (Must be stated in the protocol and in the cover letter.)
- There should be a signature block ONLY for the researcher-- the participant should not sign anything in an anonymous study.
Sample "Web"/"Email" Consent Form
- Recommended for use with email and Qualtrics for Confidential Research
Sample "Web"/"Email" Cover Letter
- Recommended for use when using Qualtrics for anonymous surveys
|Verbal/Oral Informed Consent
Sample "Telephone" Survey Consent
- Telephone interviews require the researcher to obtain verbal consent. The investigator should convey essentially the same information on the phone as on a consent form.
|Parental Consent for Participants Ages 17 & Under
||Parental Consent Form (Updated 08/29/2014)
|Assent for Participants Ages 13-17
||Youth Assent Form
|Assent for Participants Ages 7-12
||Child Assent Form
|Additional Research Forms
||Site Letter of Permission
||Adverse Event Form
|End of Research
- This form is used for research that is now complete OR if research was not conducted.
Extension Request Form
- This form is used to request a continuation of a study beyond the original project end date.
Addendum Request Form
- This form is used to request a change to a previously approved protocol.
||IRB Reviewer Protocol Evaluation Form