GENESIS HEALTH SYSTEM INSTITUTIONAL REVIEW BOARD
DETERMINATION OF RESEARCH/NON-RESEARCH ACTIVITY
Federal regulations and Genesis Health System policies require IRB review of research involving human subjects.
Please complete and submit this form to the Institutional Review Board for a determination of whether the
proposed activities constitute Human Subjects Research.
1. Title of Project:
2. List all Individuals involved with the project (add additional lines, if needed).
Name
Telephone
Email
3. Brief Summary of Purpose and Rationale. Provide a brief non-technical description of the project, including
the purpose and activities to be conducted. Typical summaries are 50-100 words.
4. Please complete the following checklist.
*To ensure you answer the questions correctly, please click on the underlined words to see
definitions of key terms.
Yes
Is it Research?
(HHS 45 CFR 46)
Does it Involve
Human Subjects?
(HHS 45 CFR 46)
Is the activity a systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to generalizable
knowledge?
Is information being obtained about living individuals?
Is the information collected through intervention (i.e., physical
procedures or manipulation of the environment) with individuals?
Is the information collected through interactions (i.e., communication
between the investigator and participant – surveys, interviews, tests,
observations) with individuals?
Will you be accessing identifiable private information about the
participant? See definition of “identifiable private information” at the end
of the application for a list of 18 elements considered as identifiable
private information.
If this project uses existing data or specimens, answer the following:
Describe the source of the data or specimens (i.e., from whom/where):
Are the data or specimens publicly available?
Was the data or specimen originally collected for administrative
purposes, or as part of clinical care (e.g., medical record, clinical database)
or another research study?
If yes, which one:
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No
Not
Sure
Are the data coded?
Is it a Clinical
Investigation as
Defined by the
FDA?
(21 CFR 50 and
21 CFR 56)
Will any of the personnel involved in the project (this includes
individuals providing the data or specimens, individuals listed on grants,
co-authors and/or faculty advisors) have access to a key that deciphers
the code?
Does your project include a test article and one or more human subjects,
including analysis or comparison of outcome data about a drug or
device?
Will any data resulting from this project be submitted to the FDA?
Principal Investigator Assurance Statement
My electronic signature that will accompany the submission of this application and all supporting documents to the
Genesis Health System Institutional Review Board certifies that the research described in this application and all
supporting materials will be conducted in full compliance with the Genesis Health System Institutional Review
Board Guidelines and Federal regulations governing human subject research.
Furthermore, I will notify the IRB if the scope of the activity changes in such a way that the answers on this form
are no longer valid. I will ensure that all collaborators, students and employees assisting in this project are informed
about these obligations. All information given in this form is accurate and complete.
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DEFINITIONS
Systematic Investigation
A systematic investigation is one that attempts to answer a research question (i.e., hypothesis) using a step-by-step
method to collect data or information in an organized and consistent way. The data or information is analyzed either
quantitatively or qualitatively and conclusions are drawn from the results.
 Examples include, but are not limited to, observational studies, interview (including those that are
open-ended) or survey studies, group comparison studies, test development, program evaluation and
interventional research.
 Although, continuous quality improvement (CQI) and quality assurance (QA) activities often follow a
systematic method of gathering information the findings are generally utilized for internal program
improvements and do not meet the definition of “research.”
Generalizable knowledge
Studies designed to develop or contribute to generalizable knowledge are those designed to draw conclusions,
inform policy or generalize findings beyond a single individual or internal program. Examples of activities that
typically are not generalizable include:

biographies

oral histories that are designed solely to create a record of specific historical events

service or course evaluations, unless they can be generalized to other individuals

services, or concepts where it is not the intention to share the results beyond Genesis or any agency
supporting the research

classroom exercises solely to fulfill course requirements or to train students in the use of particular
methods or devices

quality assurance activities designed to continuously improve the quality or performance of a
department or program, where it is not the intention to share the results beyond Genesis
Identifiable Private Information
Private information includes information about behavior that occurs in a context that an individual can reasonably
expect will not be made public (e.g., a medical or school record). Private information must be individually
identifiable (i.e., the identify of the participant is or may be determined by the investigator or associated with the
information) in order for obtaining the information to constitute research involving human subjects. Examples of
studies using private information include: medical record reviews, lab studies on identifiable tissues and specimens,
private interviews or surveys of opinions or attitudes.
De-identified data means that the data does not include any of the 18 protected health information elements set for
in the Privacy Rule and listed below:
Names
Account numbers
Telephone numbers
Certificate/license numbers
Dates: Any elements of dates (other than
year) for dates directly related to an
individual, including birth date, admission
date, discharge date, date of death. For
ages over 89: all elements of dates
Vehicle identifiers and serial numbers (VIN),
including license plate numbers
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(including year) indicative of such age,
except that such ages and elements may be
aggregated into a single category of age 90
and older
Any geographic subdivisions smaller than a
State, including street address, city, county,
precinct, zip code and their equivalent
geocodes, except for the initial three digits
of a zip code
Device identifiers and serial numbers (e.g.,
implanted medical device)
Fax numbers
Web universal resource locators (URLs)
Electronic mail addresses
Internet protocol (IP) address numbers
Social security numbers
Biometric identifiers, including finger and
voice prints
Medical record numbers
Full face photographic images and any
comparable images
Health plan beneficiary numbers
Any other unique identifying number, code,
or characteristic, other than dummy
identifiers that are not derived from actual
identifiers, and for which the reidentification key is maintained by the health
care provider and not disclosed to the
researcher
Coded Data
Coded data are data where the identifying information (e.g., name or social security number) that would enable the
investigator to readily find out the identify of the individual to whom the private information or specimens pertain
has been replaced with a number, letter, symbol or combination thereof (i.e., code), and a key to decipher the code
exists, enabling linkage of the identifying information to the private information or specimens.
FDA Definition of Clinical Investigation
FDA defines clinical investigation as any experiment that involves a test article and one or more human subjects and
that is one of the following:
 subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or
520(g) of the act, or
 is not subject to requirements for prior submission to the Food and Drug Administration under these
sections of the act but the results of which are intended to be submitted later to, or held for inspection by,
the Food and Drug Administration as part of an application for a research or marketing permit.
 The term does not include experiments that are subject to the provision of 21CFR58, regarding non-clinical
laboratory studies. [From 21 CFR 50.3(c); 21 CFR 56.102(c)]
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