IRB Review Process

IRB Review Process

The IRB application process starts with your submission of the application form, consent forms and other required materials. The DSU IRO staff pre-reviews your application to make sure all of the necessary materials are present for IRB review.

Four Steps to Determine if Your Activity is Exempt from Full IRB Review

Step 1 Determine if your activity is Research

If your activity is not research it does not fall under the purview of the IRB. You DO NOT need to submit an application. If you have questions about this please contact the IRB office: 435-652-7595.

Step 2 Determine if your activity involves Human Subjects

If your activity is research but does not involve human subjects as defined by the regulations your activity is not subject to the purview of the IRB. You DO NOT need to submit an application. If you have questions about this please contact the IRB office: 435-652-7595.

Step 3 Is your human subjects research Exempt from full IRB review?

If your human subject research does not meet the precise requirements for one or more of the exempt categories (check with Exemption Checklist) you do not qualify for exempt from full IRB review and must submit a full review IRB application. You may request expedited review if appropriate. Do not submit an exempt application form. If you research meets one or more exempt categories, go to Step 4.

Step 4 Complete the following forms and submit them with your proposal to the DSU IRB office.

  • Research Proposal Evaluation List signed by principal investigator (for students only)
  • Clearinghouse Survey Form
  • Exemption Checklist Form
  • Informed Consent Form
  • Survey/Interview/Observation Request Form
  • Survey or interview questions

Full IRB Review Procedure and Time Frame

If your project needs a full IRB review, submit the following forms with your proposal to the DSU IRB office

  • Research Proposal Evaluation List signed by principal investigator (for students only)
  • Clearinghouse Survey Form
  • Human Request Subject Form
  • Participant Consent Form
  • Survey/Interview/Observation Request Form
  • Survey or interview questions

Review Procedure

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.
IRO Level: Send the complete package to the Institutional Research Office (IRO) for review. The package should include but not limited to the following:

  • required forms
  • Clearinghouse Survey with the advisor’s comments and signautre
  • approved research proposal (4~10 pages)
  • approved survey questionnaire or interview questions if research is survey (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).

IRB Level: 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:

  1. Though many studies are qualified for exemption, DSU IRB remains the right to sanction any research that may pose more than minimal risks to human subjects, deteriorate DSU’s image or reputation, lack its merits, and involve sensitive topics and/or minors.
  2. 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).

Review Time Frame

Submit your IRB forms at any time. Please allow 1-2 weeks for an IRO review. If the research is exempt, expect 2-3 weeks (including the initial 1-2 weeks for the IRO review). If the research is non-exempt, it takes up to 4 weeks or more for a full IRB review (2 weeks for IRO review + 1 week for Q & A and then an IRB committee review).

EXEMPT RESEARCH SUBMISSION/RESPONSE SCHEDULE

Summer 2015 Submission Date Will Receive Response  by     
06/05/2015 06/19/2015
06/19/2015 07/03/2015
07/03/2015 07/17/2015

NON-EXEMPT RESEARCH SUBMISSION DEADLINE

 Summer 2015 Deadline IRB Meeting Schedule
06/12/2015 07/03/2015
Fall 2015 Deadline to be announced

Any of the following can seriously delay the reviewing process:

  • a draft research proposal without proper editing (e.g., full of grammar errors, typos, incomplete sentences)
  • submission without advisor’s approval
  • missing required forms and supporting documents
  • unfinished forms
  • slowness in responding to IRO’s or IRB’s questions
  • bad hand writings
  • last minute submission
  • Reseach applicants, especially student researchers, are fully responsible for their proof-read proposals to the IRB Committee.

Notes:

  • 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.
  • 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 Process Video