Medical Records Review Forms
Forms: http://www.northwestern.edu/research/OPRS/irb/forms/medical records review.doc
This type of submission form is to be used only when medical records are used in a retrospective review
for a research study. This form simplifies the new project submission with a focus only on medical records
review. A medical records review submission assumes that all data for the study are already in the medical
record at the time of this IRB submission for the records in question. If prospective patient contact is
involved, please submit a new project submission form
A part of this form includes a request to waive consent if that is what the investigator wishes to do.
Investigators should read the documentation on waiver of consent before choosing this option.
Data collection forms are also to be included so the IRB can review that data gathered is in keeping with
the goals of the project as outlined in the protocol or research plan.
Appropriate HIPAA forms must also accompany this type of submission.
Research projects collecting Mental Health information
To NU Researchers:
Under the Illinois Mental Health and Developmental Disabilities Confidentiality Act
(“the Act”) (Link below), a person’s mental health information can only be used or
collected with the written consent of the person unless one of the Act’s exceptions (none
of which are applicable to research) applies.
There is no general exception for research. Nor does the Act include language allowing
for the disclosure of mental health information that has been stripped of key identifiers.
Consequently, until we receive clarifications from the Illinois Department of Public
Health, the IRB cannot approve research projects using or collecting mental health
information, for which a waiver of consent is requested.
If you have any questions regarding this matter, please contact Laurence Butaud-Rebbaa
at 312-503-3259 or e-mail email@example.com.
Medical Records Review: 09/01/2004