Preparatory to Research Form
The Preparatory to Research Form serves as the request to access Protected Health Information (PHI) required for the preparation of a human subjects’ research protocol. This form should be presented to the WVU IRB when requesting access to PHI as part of a preparatory to research review process. In general, the entity providing you access to their PHI will need to keep track of all records you access as part of their requirement to account for disclosures of PHI under HIPAA.
Investigator Information
Investigator NameDepartment
PhoneEmail
Potential Title of Research Project (if applicable)
Request Rationale
1)Describe the Protected Health Information (PHI) you need to access to conduct this review preparatory to research:
2)Describe why access to the PHI requested is necessary to the preparation of or reporting on potential research?
3)List the locations where PHI will be reviewed (i.e. WVU Cancer Institute, Ruby Memorial Hospital, etc.):
4)List any members of the potential review team who will be assisting you in this review process who may also request access to PHI as part of this review.
Statement of the Investigator
I affirm that this request for access to Protected Health Information is:
sought solely to review protected health information as necessary to prepare a research protocol, report on potential research, or for similar purposes preparatory to research;
that no protected health information will be removed from the site that houses it in the course of the review;
the requested information constitutes the minimum necessary data to accomplish the preparation to the research;
I will not use the information accessed through this preparatory to research procedure for any other purpose, including for presentation or publication.
Signature of the InvestigatorDate
Data and/or Records Needed for Research Project
1)Selection Criteria (e.g.; asthmatics seen is Asthma Clinic)
2)Dates of required records: from ___/___/___ through ___/___/___
3)Please select the applicable variables to be viewed or recorded (list fields required from an electronic database, or list to be recorded from the paper record by the researcher):
Name FaxNumber
Phone Number Email Address
Geographic information smaller than state (i.e. zip code) Social Security Number (SSN)
Health plan beneficiary numbers Medical Record Number (MRN)
Certificate/license numbers Vehicle Identifiers and Serial Numbers
Device Identifiers Web Universal Resource Locators (URLs)
Internet Protocol (IP) address numbers Biometric identifiers, including finger and voice prints
Account Number Full Face photographic images and any comparable
Other identifying number, characteristic, or code Other (Please Describe):
Elements of dates (except year) directly related to an
individual, including birth date, admission date,
dischargedate, date of death; and all ages over 89
and all elements of dates (including year) indicative
of such age, except that such ages and elements may
be aggregated into a single category of age 90 or older
Note: A unique identifying number, characteristic, or code does not mean the unique code assigned by the investigator to code the data).
4)Anticipated sources of information (select all that apply)
Electronic files
Other ______
Acknowledgement of Preparatory to Research Request
The application has been reviewed and acknowledged as acceptable for the above-referenced Preparatory to Research request by the Office of Research Integrity and Compliance. The investigator is required to submit a protocol for review to the IRB before beginning human subjects’research.
ORIC/HRPP Director or Designee SignatureDate Acknowledged
Last Updated: 05/22/18