Form B2
YALE-NEW HAVEN HOSPITAL CLINICAL LABORATORIES
USE OF EXCESS CLINICAL SAMPLES FOR RESEARCH (HIPAA TRACKING)
A. Requester Information
Requesting Investigator (Print): __________________________________ Date of Request: ______/______/_______
Department: _________________________________ Campus Address: ____________________________________
Telephone: __________________ Email Address: ___________________________HIC#______________________
B. Sample Selection Criteria
Identify the parameters/criteria for selecting samples or patients. ____________________________________________________
_________________________________________________________________________________________________________
C. Information Requested
List the data elements you are requesting for each case. (Example: Patient name, YNHH medical record number, birth date, sample
lab number, sample date, sample type, clinical findings)
_______________________________________________________________________________________________
D. Authorization/Attestation (select one)
Not for research, now or in the future
____ I certify that I am requesting this information strictly for treatment, payment, quality assurance, or other healthcare
operations within Yale University/Yale-New Haven Hospital. The results of this search will NOT be used for case finding
preparatory to research, or for actual research purposes. This information will not be released outside of this institution. a
Explain purpose (Use back of form if needed)_____________________________________________________________
_________________________________________________________________________________________________________
Research
____ I am requesting only anonymous information (no unique patient or sample identifiers, no codes) (HIC approval and
HIPAA tracking are not required)a,b
____ I am requesting the minimum amount of individual identifiers, or coded information, required for research purposes.
These patients have not signed informed consent for samples or information to be taken for research (HIPAA tracking required)c
____ Patients have signed informed consent to allow their samples to be used for research (HIPAA tracking not required)c
a, Return form to Laboratory Medicine Research Coordinator.
b. Note: Documentation of HIC review may be required by some professional journals when submitting research findings
c, Human Investigation Committee (HIC) approval/exemption required. (Complete and submit this form to the HIC in
conjunction with the research proposal. Copy of approved form must be provided to Laboratory Medicine at
june.stevens@ynhh.org).
I accept full responsibility for the appropriate handling, storage, and disposal of the information provided to me as a result of this
data request. I attest that I will only release this information to other investigators approved on this HIC protocol, will only use this
information for the scope of the approved protocol, and neither I nor any other investigator will use this information, alone or in
combination with other information, to attempt to obtain information not approved by the terms of the research protocol
_____________________________________ ___________________________________ ______/______/________
Signed (Investigator)
Print Name
Date
To be completed by the Human Investigation Committee (HIC) (required for any data requests for research purposes):
HIC #:___________________ Approval/Exemption Date: ______/______/______ Expiration Date: ______/______/______
I certify that the data requested on this form falls within the scope of the above referenced research project, that the requestor of
this information is an approved investigator on that protocol, and that the HIC approves release of this information to the
investigator by the YNHH Clinical Laboratories’ staff. HIPAA tracking required: YES
 NO
______________________________________ ______________________________________ ______/______/______
Signed (HIC Staff)
Version 12/27/13
Print Name
Date