Notification of a Review Preparatory to Research (RPR)

This form is used to notify the DUHS IRB of an investigator’s intent to review a potential subject’s protected health information (PHI) without subject authorization. Most commonly, this form is used if an investigator wishes to conduct a review preparatory to research, through the search of medical records, to find out if there are sufficient numbers of patients of particular interest at Duke.  Submission of the completed form will send an electronic notification to the DUHS IRB Office and to all e-mail addresses listed on the form.

Please note:

  1. This RPR form must only be used if PHI will be reviewed, but not recorded, prior to subject consent.  If PHI will be recorded prior to subject consent, whether or not the PHI will leave DUHS, you must request a Waiver or Alteration of Consent and HIPAA Authorization.  See the form “Waiver or Alteration of Consent and HIPAA Authorization" under Forms on the IRB website.  Do not use this RPR Notification form.

  2. In order to comply with the Privacy Rule (HIPAA), this RPR form must be used only if PHI will not leave DUHS.  If PHI will leave DUHS without subject authorization, you need to complete the form “Waiver or Alteration of Consent and HIPAA Authorization" found under Forms on the IRB website.

  3. If identifiable private information other than PHI will be recorded prior to subject consent, you must request a Waiver of Consent.  See the form “Waiver of Consent" under Forms on the IRB website.  Do not use this RPR Notification form.
Principal Investigator
   
Name:
Degree:
DUHS Faculty/Senior Staff?
Duke Unique ID #:
E-mail:
If within Duke, please provide Dept. / Div.:
If outside of Duke, please provide location:
   
Faculty Sponsor (if applicable)
   
Name:
E-mail:
   
Submitter (if not the principal investigator)
   
Name :
Duke Unique ID #:
E-mail
   
Protocol Information
   
1.
Does this refer to an existing IRB protocol?
If no, please proceed to question #3.
 
If yes, what is the IRB #?
2.
What is the Protocol Title?
3. Is the review of PHI for the purpose of developing a new research protocol?
 
If yes, please state the working title:
4. Is the review of PHI for the purpose of ascertaining or recruiting subjects for a study?
   
Protected Health Information (PHI) to be reviewed
 

Please describe the specific PHI that will be reviewed to prepare a research protocol and/or to ascertain and/or recruit subjects.

Principal Investigator's Affirmation:
The PHI is necessary for the purposes of this activity.
The PHI will be used solely for this activity.
The PHI will not leave DUHS.
The PHI will not be written down or recorded prior to the subject signing a research consent form.
I will not use the information accessed through this RPR procedure for any other purpose, including for presentation or publication.
   

Submit Form
After completing this form, click the SUBMIT button (only once) to deliver the notification to the IRB Office. Notification will be sent simultaneously to all e-mail addresses listed on this form. (Click the SUBMIT button only once; subsequent clicks will repeatedly submit the same form, assigning a new reference number (described below) with each submission.)

RPR Reference Number
Submission of the RPR form generates a reference number similar to the IRB number of an approved study. The RPR # should be used for all related correspondence with the IRB Office. Include a copy of the RPR form with all new-protocol and renewal submissions to the IRB.

Please address all concerns and questions to the board specialist assigned to assist your department.