Human Subjects Protections, Concepts, and
Procedures
Tom Lombardo, Ph.D.,
Director, Research Integrity & Compliance
&
Jennifer Caldwell, Ph.D.
Research Compliance Specialist
March 2013
100 Barr Hall, 662-915-7482
irb@olemiss.edu
Office of Research and Sponsored Programs
What is the IRB and why do I need to
know about it?
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IRB = Institutional Review Board
It is University policy AND State &
Federal law that “All human research…
must be reviewed and approved before
the research begins.”
Office of Research and Sponsored Programs
Why do we need regulations?
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Willowbrook (1950s)
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San Antonio Birth Control Study (1970)
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Tuskegee Syphilis Study (1932-1972)
“But this doesn’t apply to me: I’m just
doing a survey”
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University of VA – all human
subject research shut down –
because of a survey study.
 Parent
of research participant sued UVA over a survey
on medical problems of family members [violation of
his rights]
 $3M cost to fix everything
Office of Research and Sponsored Programs
What counts as “research?”
“A systematic investigation designed to develop or
contribute to generalizable knowledge.”
 Includes
pilot studies
 Excludes assessments of quality control and teaching,
DM polls, etc.
Office of Research and Sponsored Programs
Who is a “research subject?”
‘A living individual about whom an investigator
conducting research obtains data through
intervention or interaction with the individual
OR
identifiable, private information’
(human data or tissue)
Excludes de-identified secondary data sets
Office of Research and Sponsored Programs
Belmont Report-1976
3 Basic Ethical Principles
 Respect for Persons
 Tell
subjects who, what, why
 Get Consent – signed or implicit
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Beneficence
 Maximize
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benefits and minimize harms or risks
Justice
 “Spread”
the risks/benefits – justify excluding any group
(whites, females, etc.)
IRB: Gatekeeper of the Belmont Principles
“Investigators should not have sole responsibility for
determining whether research involving human
subjects fulfills ethical standards. Others who are
independent of the research must share this
responsibility”
National Commission on Institutional Review Boards, 1978
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Primary Goals of the IRB
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IRB is a resource to assist researchers’ compliance
with Federal Regulations.
(not a paperwork police force)
IRB’s success is measured by the degree to which
researchers’ habits are driven by ethical principles,
not by meeting regulations.
Office of Research and Sponsored Programs
INFORMED CONSENT

Decision-Making Competence
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Disclose information
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Consent / Assent
What would a reasonable person want to know before
agreeing to participate?
Comprehension: 6th grade reading level
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What are the Elements of Consent?
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This is a Research Study.
It’s Purpose is…
It will take you [30] minutes
In the study, you will…
Study Risks and benefits are…
Researcher and IRB Contact info
Your Participation is voluntary; you can quit any time
Could be signed consent, information sheet, oral
Office of Research and Sponsored Programs
Levels of IRB Review

Exempt (Administrative)
 Form:
Screening / Abbreviated Application
 Review: IRB Research Compliance Specialist
 Education: Brief UM Online reading/quiz

Expedited (Designated)
 Form:
Full Application
 Review: IRB Chair or Board Member(s)
 Education: Full CITI online courses

Full Board Review
 Convened
Meeting of Board
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Training
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Ensure that all personnel who will be involved in
your study have completed whatever training they
need! Information on training can be found on our
website at: research.olemiss.edu/irb/education
IRB will not even read your application until you
complete the required level of training for your
project!
Office of Research and Sponsored Programs
Exempt Research

Most survey research with adults
 Anonymous
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or innocuous
Research on educational practices – adults or
children
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Existing data or records that cannot be tied to Ss
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Does not require signed consent forms
Office of Research and Sponsored Programs
Expedited Research
Research activities that
1)
2)
Present no more than minimal risk to Ss
and
Involve only specific procedures listed in
the federal regulations
“A risk is minimal where the probability & magnitude of
harm or discomfort anticipated …. are not greater …. than
those ordinarily encountered in daily life or during the
performance of routine physical or psychological
examinations or tests”
Office of Research and Sponsored Programs
Full Board Review
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Examples:
 Child
studies with manipulations
 DXA
>
Moderate exercise
 Deception
 Treatment studies
 Some survey studies (e.g., bullying)
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Monthly meeting dates posted on website
Submissions must be received 2 weeks in advance
Office of Research and Sponsored Programs
SURVEYS
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Include all elements of consent
For online surveys: add a ‘Click here if you agree’
button
Must allow Ss to omit items
Cannot penalize for failure to complete
Qualtrics:

research.olemiss.edu/resources/surveys
Office of Research and Sponsored Programs
Tips to Save Time
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Most recent form:
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Get all forms directly from the website at
research.olemiss.edu/irb/protocol
Make sure to include ALL needed attachments
Appendices
 Survey or Interview Questions
 Permission letters from off-campus locations
 Information sheet or consent form
 Recruitment email, flyer, or script
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Double check that you have thoroughly answered each
question on the application!
Office of Research and Sponsored Programs