Continuing

Continuing Review

Preparing Review Submission
1. Decide if subjects will be run on this IRB in the next year. This will make the IRB either "open to enrollment" or "closed to enrollment".

2. Go to this website to download the appropriate continuing review form. http://www.researchadmin.iu.edu/HumanSubjects/IUB/hs_continuing_rev.html

3. Fill out the form with all the standard information.

4. The form also requires some numbers pertaining to subjects, namely, the number of subjects run in the past year, and the number of subjects run since the beginning of the study.

To get the number of subjects run since the beginning of the study, go into the IRB folder on the ABC-server and find the previous year's Continuing Review form. Note both the number on the form, and also the date that it was submitted.
- Now you must determine the number of subjects run from the date of submission of the last continuing review to today.
  - Go into the big locked cabinet in room 330 and find the folders for every study run under this IRB from the date of submission of the last Continuing Review to today.
  - Look in the "Subject Sheets" manila folder to see how many subjects were run.
  - In addition, look at the subject sheets for this IRB on the clipboards in room 330 and note the number of subjects on these.
- These numbers together make up the total number of subjects run in the last year of the IRB.
On the form, put the number of subjects that have been run in the past year, and add this number to the total number of subjects run since the beginning of the experiment (the one given on the last Continuing Review form) to get the total number of subjects that have been run since the beginning of the study.
The form also asks for the number of subjects that have withdrawn and the number of subjects that failed screening.
- Generally speaking, for our studies, we usually put 0 for both of these. The only exception to this is if someone withdrew from the study for some really important and ethically serious reason (because they felt their privacy was being violated, an RA hit them etc.)

5. Create a new folder in the IRB folder on the server for the particular study. Name it with the past year and CR

for example: "2000-2001 CR"

Save the new Continuing Review form in this folder.

6. When you submit the Continuing Review, be sure to attach the word document versions of the ICS, SSS, screening survey (if there is one) and recruitment text from the experimental website.

VERY IMPORTANT NOTE:Be sure to submit the Continuing Review AT LEAST 2 weeks before it expires, because running subjects on expired consent forms is MAKING A PACT WITH SATAN

Upon Approval

1. Digital Form Storage

Go to the Z-drive on the desktop and open the IRB folder, then the existing IRB folder, then the folder for the particular experiment and, finally, the Continuing Review folder.
Open up the zip file that was attached to the IRB approval e-mail you received, and put everything into the CR (continuing review) folder.
There will also be a folder titled "Current Versions". Copy into this folder, the ICS, SSS and recruitment forms. Replace the forms that are in there, so that there is only one currently activate and approved version of each form.

2. Paper Form Storage

Print every attachment to the approval e-mail
Go to the IRB drawer in the file cabinet in room 330
Find the folder that matches the IRB
- make a new manila folder labeled with "Continuing Review" and the year of the IRB (e.g. 2010-2011)
In the new manila folder, put:
- protocol renewal
- continuing review application
- other forms: consent, SSS, recruitment script, screening questionnaire, etc.
Replace last year's forms in the IRB forms folder (or the current consent form folder for some IRB's)
- note: Old forms that have no replacement are KEPT

3. Replacing Consent Forms

All existing blank consent forms for this project are to be recycled and replaced with new signed forms.
Digital flash experiments need consent forms and expiration dates updated.

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