Self-Certification Form For Determining Whether A Proposed Activity Is Research Involving Human Subjects - Mississippi Department Of Health Page 2
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1
2If you answered No to both questions, you may stop here. You are not conducting research that needs to be
reviewed by the MSDH IRB. A copy of this completed form should be maintained in your project file. Do
not submit a copy of this form to the MSDH IRB.
2) Does your project involve “Human Subjects”?
Human Subject is defined under 45 CFR 46.102(f) as a living individual about whom an investigator conducting
research obtains:
1. Data through intervention or interaction with the individual, or
2. Identifiable private information.
□ No
Does the project
□ Yes
involve “intervention”
or interaction with a
“Intervention” includes both physical procedures by which data are gathered (for example,
human subject?
venipuncture) and manipulations of the subject or the subject’s environment that are
performed for research purposes. Interaction includes communication or interpersonal
contact between investigator and subject.
□ No
Does the project
□ Yes
involve collection or
access to identifiable
“Private information” includes information about behavior that occurs in a context in which
“private information”
an individual can reasonably expect that no observation or recording is taking place, and
by you or your staff?
information which has been provided for specific purposes by an individual and which the
individual can reasonably expect will not be made public (for example, medical record).
Private information must be individually identifiable (i.e., the identity of the subject is or may
be ascertained by the investigator or associated with the information) in order for obtaining
the information to constitute research involving human subjects.
□ No
Does the project
□ Yes
involve receipt of
(please answer the two below questions)
data/specimens that
were collected by
□ No
Are the data/specimens coded such that they could not be re-
another source with
□ Yes
identified without access to a link?
identifiable private
□ No
Is there a written agreement that prohibits you and your staff
information?
□ Yes
access to the link?
If you answered No to all 3 questions in section 2, or No to the first two questions and Yes to the third
questions and both sub-parts, you are not conducting research that needs to be reviewed by the MSDH
IRB. A copy of this completed form should be maintained in your project file. Do not submit a copy of this
form to the MSDH IRB.
Any other combination of answers means that the proposed activity may be research that involves human
subjects. You must submit an application to the MSDH IRB before starting your project. Visit the MSDH
website, , under the Institutional Review link for information and resources for submitting
your project to the MSDH IRB.
Your signature
Date
Print Name
Signature
I certify that the information above is true and accurate.
●
●
570 East Woodrow Wilson
Post Office Box 1700
Jackson, MS 39215-1700
●
●
601-576-8090
1-866-HLTHY4U
Equal Opportunity in Employment/Services
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