Version 3- June 10 2014
USE OF EXCESS CLINICAL SAMPLES FOR RESEARCH
This form is intended to be used by the Principal Investigator and the custodian (usually the person
providing the specimen) to determine the human subject nature of the excess clinical specimens.
Step 1: Determination of Non-Human Subject Research
Are you doing research?
___ Yes ___ No
If yes
Is the subject alive?
___ Yes ___ No
If yes
Was the data/specimen collected solely for clinical purposes as
part of routine clinical care or management of the patient?
___ Yes ___ No
If yes
Will you be requesting excess tissue samples?
___ Yes ___ No
If yes
Then this is not the appropriate form to
use
If no
Were you as PI, Co-PI, or research staff involved through direct
interaction/ intervention in collecting data/specimen?
___ Yes ___ No
If no
Will you be collecting or requesting identifiable information
pertaining to the data/specimen collected?
___ Yes ___ No
If yes
Then this is Human Subject Research,
please submit to the IRB as
appropriate.
If no
Then the data/specimen you intend to collect is considered a NON-HUMAN SUBJECT RESEARCH and therefore no
submission to the IRB is required. However, it is recommended that the investigators document their determination by
placing a copy of this completed questionnaire in their files to address any future queries about the project.
Version June 16, 2014
Version 3- June 10 2014
STEP 2: Fill-in below form
A. Requester Information
Requesting Principal Investigator (Print):
Title Of study:
Department/ Division:
Telephone:
Office location:
Email Address:
Date of Request:
/
/
B. Number of Samples requested:
C. Sample Selection Criteria (clinical laboratory service):
Hematology
Serology
Other, please specify:
Chemistry
Parasitology
Identify the parameters/criteria for selecting samples or patients, please be specific/explicit (e.g. normal CBC, HBA1c
>8%, creatinine > 1.5, etc….):
Please note that the following information can be released with the samples: sample date, age, and
gender. The below listed identifiers cannot be released without IRB approval and must be deleted from
a dataset to be considered completely de-identified:
1. Names (individual, employer, relatives, etc.)
2. Address (street, city, county, precinct, postal code,
etc. – initial 3 digits if geographic unit contains less
than 20,000 people, or any other geographical codes)
3. Telephone numbers
4. Fax numbers
5. Any government issued identification numbers
6. Medical record numbers
7. Dates (except for years)
a. Birth date
b. Admission date
c. Discharge date
d. Date of death
e. Ages > 89 and all elements of dates indicative
of such age (except that such age and elements
may be aggregated into a category “Age >90”)
Version June 16, 2014
8. E-mail addresses
9. Insurance or Health Plan Beneficiary numbers
10. Any Account numbers
11. Certificates/license numbers
12. Vehicle Identifiers and Serial numbers (e.g., VINs,
License Plate numbers)
13. Device Identifiers and Serial Numbers
14. Web Universal Resource Locators (URLs)
15. Internet Protocol (IP) address numbers
16. Biometric Identifiers (e.g. finger or voice prints)
17. Full face photographic images) and any comparable
images
18. Any other unique identifying number, characteristic,
or code
Version 3- June 10 2014
STEP 3: Obtain approval/ authorization
Attestation
I am requesting only anonymous information (no unique patient or sample identifiers, no codes); I will make no
attempt to link samples to patient records, and hence no IRB approval is required.
Please return form to Custodian in Laboratory Medicine
To be completed by PI:
I accept full responsibility for the appropriate handling, storage, and disposal of the information provided to me as a
result of this data request.
Cost center to charge to:
________________________________ __________________________________________ ______/______/________
Signed (Investigator)
Print Name
Date
________________________________ _________________________________________ ______/______/________
Signed (Chairperson/ Dept head)
Print Name
Date
To be completed by Department of Laboratory Medicine:
Cost of services:
________________________________ __________________________________________ ______/______/________
Signed (Custodian)
Print Name
Date
________________________________ _________________________________________ ______/______/________
Signed (Pathology Chairperson)
Print Name
Date
*Applicable fees and charges will be determined by Laboratory Medicine.
Note: Documentation of IRB review may be required by some professional journals when submitting research findings.
The IRB will issue a letter attesting that this work is non-human subject research and did not need IRB approval on
condition that all outlines steps have been adhered to.
Version June 16, 2014