Transcript General

Protecting Research
Participants
University of North Carolina at Greensboro
What is Research?
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Research is an organized way to
gather information that is useful
for as many people as possible in
the future.
What is a Research Participant?
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Anybody we gather information about
The Belmont Report
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Respect
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Benefits Outweigh Harms
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voluntary consent
protect those who cannot make decisions
maximize benefits & minimize risk of harm
Justice
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the burdens and benefits of research
should be distributed fairly
The Belmont Report
“I don’t know what they used us for.”
Survivor of Tuskegee Syphilis Study, 1932-72
Applying Guidelines
Principle
Respect for
Persons
Benefits/Harms
Justice
Applications
•Informed
consent
•Privacy (Confidentiality and
Anonymity)
•Protecting participants from harm
•Assessment of risks and benefits
•Choosing
participants
Applying the Principles in Your
Role
Honesty
 Informed Consent
 Confidentiality
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Rights of the Research
Participants
Right to accurate and complete
information about the study
 Right to informed consent
 Right to refuse
 Right to privacy
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Elements of Informed Consent
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Your full name
Who is conducting the study
Purpose/content of the study
Approximate length of the study
Risks and benefits of participating (if any)
Participation is voluntary
Can stop participating at any time
Responses are confidential
INFORMED CONSENT
“GETTING PERMISSION FROM RESEARCH
PARTICIPANTS”
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Consent is a PROCESS...
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Researcher tells all important
information
Participant has chance to ask
questions
Researcher answers questions
Participant signs a consent form
agreeing to participate
UNDERSTANDING CONSENT
Clearly written
 Everyday words
 Plan for participants who cannot read
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Institutional Review Board
(IRB)
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An IRB is a committee that reviews
proposed research studies to ensure that
participants are protected from unfair
treatment and risks that could be caused
by the research
Every research project involving human
participants must gain the approval of at
least one IRB; sometimes more than one
Functions of the IRB
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Ensure that research participants are treated
ethically at all times (principles of the
Belmont report)
Ensure that researchers are adequately
gaining informed consent from every research
participant
Monitor projects to ensure adherence to
protocol
Provide a contact point for participants if they
are concerned about their rights
Handle reports of violations of participants’
rights or adverse outcomes of the research
Special Populations
Children and Minors
 Prisoners
 Pregnant women and fetuses
 Cognitively impaired persons
 Students/employees
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Confidentiality
We are dependent upon the goodwill of
the participants in order to carry out a
valid study
 This requires their trust
 Cornerstone of trust is knowing that we
will keep the information they provide
confidential
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Confidential vs. Anonymous
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Anonymous means the research
participant’s identity is not known, even to
the interviewer.
Confidential means we have identifying
information about the research participant
(in some cases, only a phone number
and/or first name) but we will not reveal
that information to anyone.
Confidential Means…
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Names will not be associated with
responses when results are reported
Information research participants give you
must not be shared with anyone else—not
even other interviewers
Do not tell research participants what other
participants have said, even if they ask you
what other people think
Information about a research participant
and/or his data can not be left in an
unsecured place.
Confidentiality is Serious
You must sign a Confidentiality
Statement before calling or speaking
with any research participants
 Violation of the terms of the Statement
is grounds for immediate dismissal.
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The Only Exceptions
If you have reason to believe a research
participant is in a situation so dangerous
that they are a threat to themselves or
others, alert your supervisor
immediately.
 Suspected child abuse must be reported
to the authorities per North Carolina law
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Privacy
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All personal information remains
confidential (private)
 Behaviors
 Lab tests
 Questionnaire results
 Age, phone numbers, etc
If Research Participants have
Questions…
For questions about the study, what the
data will be used for, etc.: principal
investigator or study staff
 For questions or concerns about rights
as a research participant: director of the
UNCG Office of Research Compliance
(Provided on Study Info Sheet)
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Summary
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Research involving people
 Helps make better programs or
treatments
 Only done with permission of
participants
 Rules to make it as safe as possible
 Must be approved by an IRB
Acknowledgements
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Slides adapted from work by
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Daniel K. Nelson
Director, Office of Human Research Ethics
Associate Professor of
Social Medicine and Pediatrics, UNC School of
Medicine
Teresa Edwards
Assistant Director for Survey Research and
Development
H W Odum Inst Research Social Sciences,
UNC