Application For Exemption From Institutional Oversight Page 2

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Part 1: Determination of "Research" and Potential For Risk
- This section determines whether the project meets the Department of Health and Human Services (HSS) definition of research involving human subjects,
and if not, whether it nevertheless presents more than "minimal risk" to human subjects that makes IRB review prudent and necessary.
1. Is this project involving human subjects a systematic investigation, including research, development, testing, or evaluation, designed to
develop or contribute to generalizable knowledge?
(Note some instructional development and service programs will include a "research" component that may fall within HHS' definition of human subjects
research).
YES
NO
2. Does the project present physical, psychological, social or legal risks to the participants reasonably expected to exceed those risks normally
experienced in daily life or in routine diagnostic physical or psychological examination or testing? You must consider the consequences if
individual data inadvertently become public.
YES - Stop. This research cannot be exempted - submit regular application for IRB review.
NO-Continue to see if research can be exempted from IRB oversight
3. Are any of your participants incarcerated?
YES - Stop. This research cannot be exempted--submit regular application for IRB review.
NO-Continue to see if research can be exempted from IRB oversight.
from a health care provider
that contains any of the identifiers listed below?
4. Are you obtaining any health information
A. Names
B. Address: street address, city, county, precinct, ZIP code, and their equivalent geocodes. Exception for Zip codes: the initial three digits of
the ZIP Code may be used, if according to current publicly available data from the Bureau of the Census: (1) The geographic unit formed by
combining all ZIP codes with the same three initial digits contains more than 20,000 people; and (2) the initial three digits of a ZIP code for
all such geographic units containing 20,000 or fewer people is changed to '000'. (Note: The 17 currently restricted 3-digit ZIP codes to be
replaced with '000' include: 036, 059, 063, 102, 203, 556, 692, 790, 921, 830, 831, 878, 879, 884, 890, and 893.)
C. Dates related to individuals
i. Birth date
ii. Admission date
iii. Discharge date
iv. Date of death
v. And all ages over 89 and all elements of dates (including year) indicative of such ago. Such ages and elements may be
aggregated into a single category of age 90 or older.
D. Telephone numbers;
E. Fax numbers;
F. Electronic mail addresses;
G. Social security numbers;
H. Medical record numbers; (including prescription numbers and clinical trial numbers)
I. Health plan beneficiary numbers;
J. Account numbers;
K. Certificate/license numbers;
L. Vehicle identifiers and serial numbers including license plate numbers;
M. Device identifiers and serial numbers;
N. Web Universal Resource Locators (URLs);
O. Internet Protocol (IP) address numbers;
P. Biometric identifiers, including finger and voice prints;
Q. Full face photographic images and any comparable images; and
R. Any other unique identifying number, characteristic, or code; except a code used alone or in combination with other information to
identify an individual who is the subject of the information.
YES - Stop. This research cannot be exempted--submit regular application for IRB review.
NO- Continue to see if research can be exempted from IRB oversight.
Continue on the next page

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