University of Minnesota
Institutional Review Board
http://www.research.umn.edu/irb
612-626-5654

Institutional Review Board home

Guidance & FAQs

Continuing Review

Why continuing review?

eResearch Central, http://eresearch.umn.edu/erc/ is a University Web initiative providing a central electronic location for University research forms, tools, and resources.

Researchers need to complete their IRB continuing reviews online, through eResearch Central.

Regulations state that the IRB must conduct Continuing Review of an approved study at intervals appropriate to the degree of risk, but not less than once per year.

The purpose of this process is to review an entire study and determine that the anticipated risks and benefits are reflected in the actual experience of subjects and that the safeguards in place at the time of original approval are, in fact, adequate to ensure the safety of subjects.

How the Process Works

  1. An email notice for "renewal" is sent to the principal investigator, co-investigators and coordinators prior to the annual review date.
  2. The notice contains a link to eResearch Central to access the online form.
  3. The continuing review form must be completed before the expiration date for processing and review.
  4. A copy of any consent and/or assents forms currently in use must be included with the continuing review form and can be uploaded electronically or sent via regular mail.

It is the principal investigator's responsibility to complete the continuing review form in a timely manner or the study may be inactivated.

Projects involving high risk may require more frequent review. The IRB may require frequent review or reports on a specific number of cases. The terms of the review and the written documentation required for that special review are delineated at the time the original approval is granted.

Continuing Review Form Help

TIP: Click the title to open/close the topic

Returning Forms Late

Forms not received at the IRB by the return date

A second notice will be sent via email as a reminder that the study is in jeapordy of expiring before it can be reviewed. It is important to return the form before this date so the IRB committee that originally reviewed the research study has an opportunity to review it during its monthly meeting.

Forms not received at the IRB by the study expiration date

The study will be inactivated and the appropriate federal regulatory agencies, funding agencies, and institutional officials will be notified. In some cases a new application will be required to reactivate the study if approval lapses.

Frequently Asked Questions (FAQ)

Enrollment numbers: Do I have to fill in the entire chart?

If the research study is funded by an NIH agency, all of the race and ethnicity numbers are required. These enrollment numbers are in line with NIH Policy on Reporting Race and Ethnicity Data.

If the research study is not funded by an NIH agency, only the "Totals" column is required. This column must be filled in completely for male, female, unknown, and total.

Unanticipated Problems: What are they?

An unexpected or unexplained event which might affect subject risk benefit analysis, confidentiality, or subjects’ willingness to continue in a project.

Translated short form: What is it?

A short form is a written document (in a language readable by the subject) stating that the elements of informed consent required by 45 CFR 46.116 have been presented to and understood by the subject or the subject's legally authorized representative. They are used in studies where the majority of subjects are english speakers, but a portion of the subject population will not be able to understand an english consent form. More about short forms

 

Don't see the question or answer you are looking for? Email us your question.

More Information

Affiliated Researchers

Researchers need to complete their IRB continuing reviews online, through eResearch Central. Access to eResearch Central requires that you have a valid x500 ID and that your HRPP records are associated with that x500 ID.

Instructions for Acquiring an ID

If you are not affiliated with the University of Minnesota, follow these steps to obtain guest access to a eReseach Central.

Click here to open/close the Instructions

Important: You must have a valid e-mail address and be prepared to enter your correct contact information for University of Minnesota administrative purposes. Your information will not be shared or made public.

  • Fill out the form with your correct and real information. You must use a valid e-mail address, or the guest account creation will fail within 24 hours.
  • You do not need to enter a sponsor or an entry code, as myU portal access is not needed for eResearch Central access.
  • If your account creation was successful, you should see the following message:

    Your guest account was successfully created.

    You will receive an e-mail confirming your Internet ID (your e-mail address) and your password.

  • You will then receive an e-mail from emadmin@umn.edu providing you with an 8 digit reference number (e.g. gf019999). You will then need to contact HRPP (irb@umn.edu or 612-626-5654) with that reference number so that your personnel file can be updated. Once your HRPP personnel file is updated, you will be able to access your protocols on http://eresearch.umn.edu/erc/

Please note that if your guest account was activated after your continuing review notice was sent, you will need to have your notice reset by help@eresearch.umn.edu if you wish to access that form online.

 

For more about Continuing Review, see chapter 6. Continuing Review in the Protecting Human Subjects Guide.