For Expedited and Full Review Research
The United States Department of Health and Human Services regulations for the protection of human subjects at 45 CFR 46.109(e) require previously approved full and expedited human subjects research be re-approved at intervals appropriate to the degree of risk, but not less than once per year.
Note: Research that qualified for Exemption does not require continuing review.
Continuing review and re-approval of research must occur before the one (1) year anniversary date of the original approval or the research must stop (no new subjects enrolled and no research conducted with previously enrolled subjects). Also, re-approval cannot occur more than 30 days prior to the expiration date. The expiration date is the anniversary date. It is the investigator’s responsibility to apply for continuing review in a timely manner.
Federal regulations allow up to two (2) annual continuing reviews for a total project approval time of three years. If the research will continue beyond three years, a new application will need to be completed and submitted to the IRB for review before the expiration date.
Continuing review and re-approval will be conducted through the same review process as the original application: expedited review or full committee review at a convened meeting. An exception is made if full review research is in the “data analysis only stage; it may be reviewed through an expedited process.
Procedures for submitting a continuing review in IRBNet
1. Log into your original project in IRBNet and locate the HSU IRB Continuing Review Research Form” under “Forms and Templates” in the Left Hand Menu.
2. Complete the Continuing Review Form. Before you complete the next step, make sure you also have:
- A copy of the final approved version of the original application including any modifications previously approved by the IRB
- A copy of the current informed consent document and any newly proposed consent document
3. Return to your project in IRBNet and click “Create a New Package” from the Left Hand Menu.
- Attach your Continuing Research Form via the “Designer” tab on the Left Hand Menu.
- If there have been modifications to your Application Form, please attach the revised Application Form.
- If there have been changes to your Informed Consent, please attach.
4. Link NIH Training Certificate to the new package for PI and all Investigators.
5. Electronically “Sign” the package
- The PI and all Investigators (for group study) must “Sign.”
6. Click the “Submit this Package” from the Left Hand Menu.
- Select your Organization (Henderson State University)
- Click “Continue.”
7. Select the Submission type “Continuing Report” and add any additional comments before clicking “Submit.”
Allow at least two weeks for Expedited Review. Full Reviews may take longer as meetings are conducted at scheduled meeting times during the academic years. Check the HSU IRB website for the IRB meeting calendar or call the IRB Office/Graduate Assistant/IRB Chair to confirm the meeting date so the review can be completed before the expiration date.
Application
Note: If your research has been completed (including all data analysis) since the last review, complete the Final Report Form instead of applying for continuing review.
Updated 03/28/2017