Self-Certification Form For Determining Whether A Proposed Activity Is Research Involving Human Subjects - Mississippi Department Of Health
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1
2Self-Certification Form for Determining Whether a Proposed
Activity is Research Involving Human Subjects
Use this form if you are unsure if your project is research and whether or not you need to submit
your project to the MSDH IRB.
This form is not an approval by the MSDH IRB of research as Exempt or any other level of
review. If your project meets the definition of human subjects research you must submit the
project to the MSDH IRB for review.
Name
Mailing Address
Email
Phone
Project Title
1) Is your project “research”?
“Research” is defined under 45 CRF 16.102(d) as a systematic investigation, including research development, testing
and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition
constitute research for purposes of this policy, whether or not they are conducted or supported under a program which
is considered research for other purposes.
□ No
Is your project a
□ Yes
“systematic
investigation”?
“Systematic investigation” is an activity that involves a prospective research plan that incorporates
data collection, either quantitative or qualitative, and data analysis to answer a research question.
Systematic investigation involves a predetermined method for studying a specific topic, answering
a specific question, testing a specific hypothesis, or developing theory.
Examples of systematic investigations include, but are not limited to, observational studies,
interview (including those that are open-ended) or survey studies, group comparison studies, test
development, and interventional research.
□ No
Is the primary
□ Yes
intent of the
project for the
Investigations designed to develop or contribute to generalizable knowledge are those designed to
purpose of
draw general conclusions (i.e., knowledge gained from a study which may be applied to
contributing to
populations outside of the specific study population).
generalizable
knowledge?
To develop or contribute to generalizable knowledge requires that the results (or conclusions) of
the activity are intended to be extended beyond a single individual or an internal program.
Intent to publish results/conclusions in a peer-reviewed journal or to present at a regional or
national meeting does not determine this response. Thesis or dissertation projects conducted to
meet the requirements of a graduate degree are usually considered generalizable.
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570 East Woodrow Wilson
Post Office Box 1700
Jackson, MS 39215-1700
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601-576-8090
1-866-HLTHY4U
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