GENESIS HEALTH SYSTEM MEDICAL CENTER
PREPARATORY TO RESEARCH REQUEST FORM
Instructions: Submit the original copy of this form to: ______________________. Please
retain a copy of this form for your records because it may be required before database or
other record custodians grant you permission to access PHI.
Principal Investigator:
Genesis Health System Employee?:  Yes
________________________________
 No
Principal Investigator’s Work Address:
Genesis Health System Department:
________________________________
________________________________
________________________________
________________________________
Work Phone Number:
Work E-mail Address:
________________________________
________________________________
I, _________________, am requesting permission, pursuant to the preparatory to
research exception, to use and/or disclosure PHI currently housed at Genesis Health
System Covered Entities (as defined below) for the following types activities (check all
that apply):

The development of a research question or idea for further study

The assessment of meeting study recruitment goals for Protocol Number/Study
Name ________________ by reviewing the number of potentially eligible beneficiaries
who could participate as subjects

The development of eligibility (inclusion and exclusion) criteria for Protocol
Number/Study Name ________________

The identification of specific individuals who may be eligible to participate in
Protocol Number/Study Name ________________

Other – please describe _______________________
Accordingly, I hereby acknowledge and certify that:
1.
I am permitted to use PHI only for the purposes of those preparatory to research
activities I have checked above. Initial here ________
Please describe in detail the use of the PHI: ____________________________________
_______________________________________________________________________
_______________________________________________________________________
2.
I will use only the PHI that is necessary for those preparatory to research
activities that I have checked above. Initial here ________
Please describe how the access to the PHI is necessary for research purposes: _______
_______________________________________________________________________
_______________________________________________________________________
3.
I will not physically remove any PHI, obtained in the course of my review of PHI,
from Genesis Health System Covered Entities. Genesis Health System Covered
Entities includes: [Insert Genesis Health System locations]. Furthermore, I
will not disclose the PHI obtained during preparatory to research activities under
any circumstances to anyone outside of Genesis Health System Covered
Entities. I understand that this means, for example, that I may not: (a) prepare a
list or other document that contains PHI obtained during preparatory to research
activities and take that list or document to my home, office or other off-site
location; (b) send an email or other electronic transmission that contains PHI
obtained during preparatory to research activities to anyone not physically
located on Genesis Health System Covered Entities’ premises; (c) save a
document to a CD or diskette or otherwise digitally save a document that
contains PHI obtained during preparatory to research and transmit, back-up or
otherwise transport that electronic file from the physical premises of Genesis
Health System Covered Entities; (d) share PHI obtained during preparatory to
research activities by telephone, fax, scan or other means with anyone not
physically located on Genesis Health System Covered Entities’ premises; or (e)
provide PHI obtained during preparatory to research activities to a third-party
funder or sponsor of a research study. Initial here ________
4.
I will not seek PHI that includes psychotherapy notes, information related to the
HIV status, mental health status, genetic testing results, drug or alcohol abuse
history of potential subjects, or any other information classified as sensitive under
Illinois or Iowa state law. Initial here ________. If, however, I determine that I
need access to sensitive health information, I will contact the IRB/Privacy Board
for further direction. Initial here ________
5.
Responsible Party
a. I will personally conduct all preparatory to research activities; or
b. I will conduct preparatory to research activities and will be assisted by
___________________________, and I will cause the listed individual to
comply with the requirement of this Request. Initial here ________
6.
I understand that I may not, under any circumstances, contact individuals I
identify during preparatory to research activities to request their permission to
participate in a research study without first obtaining the IRB/Privacy Board’s
permission to do so under a separate written request. I understand that
contacting potential subjects is not a preparatory to research activity covered
under this request. Initial here ________
Investigator’s Signature
Date
IRB/Privacy Board use only:
Date Request Submitted to IRB/Privacy Board: //
Date Request Reviewed by IRB/Privacy Board: //
Preparatory to Research Request is:  Approved  Denied  Conditionally Approved if
____________
___________________________________________________________________________________
IRB/Privacy Board Chairperson Signature: ________________________ (Date //)