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Humans Subjects Protection - University of Wisconsin

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Human Subjects Protection
(HSP)
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
1
What is human subjects protection?
Human subjects protection involves
protecting the rights and welfare of
individuals who participate in our research
and non-research assessments.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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What are “research”
and “non-research assessments”?
“Research” is the collection of information/data which is
intended to prove or disprove a stated hypothesis and add to a
knowledge base. Results are expected to apply and be used
beyond the site of the data collection. The purpose of research
is to build knowledge and inform researchers, scholars, and
practitioners in the field of study
“Non-research assessments” are what we call �evaluations’.
They involve the collection of information/data which is
intended to improve the quality of a program, to assess the
value of programs or services received by the participants, or
to inform the design and development of an educational
program. The purpose is to inform decision making, increase
accountability, and improve program quality.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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What are “human subjects”?
Anyone – individuals, people - about whom or from
whom we collect information/data.
Such as:
– Program participants
– Volunteers
– Community members
Remember, information and data mean the same
thing. These words are used interchangeably.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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This is not just about clinical trials
or studies with children.
This is not just for someone else,
this is about YOUR work!
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Why is human subjects protection
important? Why should I care?
• Because we want to ensure that we are following
the highest ethical standards as we conduct our
work.
• Because we must follow federal policy guidelines.
Known as the Common Rule, the federal regulation provides three basic
protections for human subjects involved in research: review by an Institutional
Review Board (IRB); commitment to use informed consent; and institutional
assurances that the regulations will be applied to all research.
• And, because it is fundamental to good
scholarship and professional behavior.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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• The HSP guidelines apply to ALL UWExtension employees (payrolled persons)
involved in any research or non-research
assessments.
• It involves how we do our work – it is not an
add-on or afterthought.
• It solidifies our reputation and credibility.
• It maintains the public’s trust in us.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Three core principles underlie HSP,
known as the Belmont Principles
They include:
1. Respect: acknowledge the dignity and
freedom of every person
2. Beneficence: maximize the benefits and
minimize any harms associated with the
effort
3. Justice: ensure equitable
election/recruitment and fair treatment of
every person
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Oversight and management of HSP is with the Human
Subject Administrator in the Chancellor’s Office of UWExtension
http://www.uwex.edu/hsp
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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What do I need to do?
• Visit the HSP web site and become familiar with
the resources there
• Complete the HSP online training module
– Found at www.uwex.edu/hsp
– Complete prior to submitting your 1st HSP
request; otherwise your application will not be
considered
– Completion takes about 1-3 hours
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Follow the HSP Decision Tree
http://www.uwex.edu/hsp/documents/DecisionTree.pdf
• The Decision Tree is a
self-assessment that will help
you determine the best course
of action for your data
collection effort.
• It also provides documentation
of your actions.
• The Decision Tree involves 8 steps. You are
advised to complete the decision tree regardless of
type of project.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Decision Tree – Step #1
Will you be collecting information from or about
human beings?
(a) → No – no action required (STOP)
(b) → Yes – go to Step #2
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Decision Tree – Step #2
What is the purpose of the
information you will be collecting?
(a) → Research –
Continue through Step #7; submit “Request for
Approval” to HSP Administrator
(b) → Non-Research Assessment –
go to Step #3
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Decision Tree – Step #3
What is the intended use of the collected information/data?
(a) → To publish information – continue through Step #7;
contact HSP Administrator
– to publish/share/communicate beyond those
immediately involved in the program
(b) → To provide program accountability or improvement –
go to Step #4
– only sharing results with individuals or organizations
directly involved in the planning, management, and/or
implementation of the program
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Decision Tree – Step #4
From whom are you collecting information?
(a) → Vulnerable Populations – make any adjustments to
protocol; go to Step #5
Vulnerable = people who are more susceptible to coercion or
undue influence, e.g.
– Youth under 18 years of age
– Persons with disabilities
– Pregnant women
– Prisoners
– Others where participation may be considered involuntary
(b) → Non-Vulnerable Adults – go to Step #5
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Decision Tree – Step #5
Sample:
Is the privacy and confidentiality of participants
protected?
(a) → Participants can be identified – make any
adjustments to protocol; go to Step #6
(b) → Participants cannot be identified – go to
Step #6
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Decision Tree- Step #6
Could the nature of the information being collected
place participants at risk?
(a) → Could reasonably place at risk –
make necessary adjustments;
continue through Step #7
– risk = at risk of criminal or civil liability or be
damaging to the subject’s financial standing,
employability, reputation; sensitive personal or
private behavior-related information
(b) → Minimal risk – go to Step #7
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Decision Tree – Step #7
Consent
• Consent simply means seeking permission.
This is part of showing respect to people – what we do
in UW-Extension. People need to be “duly informed”.
• There are two types of consent:
– Active consent: individual agrees to participate;
provides a signature
– Passive or informed consent: individual is
informed – no signature is needed; participation
implies consent
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Whether active or passive, consent
language includes:
•
•
•
•
•
•
•
•
•
Title of the project/program (Required)
Names, titles, and affiliations of investigators (Required)
Purpose of the study (Required)
Confidentiality statement (Required)
Outline of Procedures (As appropriate)
Assertion of the voluntary nature of participation (As appropriate)
Information about who to contact (As appropriate)
Location where the HSP approval is on file (As appropriate)
Informed consent statement or signatures (As appropriate)
Best practice in UW-Extension is to include, at the minimum, simple
informed consent language with any data collection effort. Examples
are provided on this web site.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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What about consent for children under 18
yrs of age?
• Parents or legal guardians give permission for
children to be research subjects.
• Children between 11-17 also provide assent (they
sign too, but as a secondary feature to
parental/guardian approval).
• “Best practice” suggests that we would also do
this for non-research assessments involving
youth.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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Decision Tree – Step #8
Implementation. There are 3 possibilities:
1.
2.
3.
If you answered �research’ in Step 2, you need to complete and
submit the “Request for Approval” application to the HSP
Administrator.
If you answered �Yes’ to any of the (a) choices in Steps 3-6, you
probably do not need to submit for approval. If uncertain, consult
with the HSP Administrator.
If you answered �Yes’ to ALL the (b) choices in Steps 2-6, you do
not need to submit for approval. Sign and date the selfassessment and keep it on file.
Regardless of your action, include appropriate consent language in
your data collection effort.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
21
Key points to remember:
1. Human Subjects Protection is about �ethical’
practice – something we all want and need to
do.
2. Following the Human Subjects Protection
guidelines and applying “best practice” is our
responsibility – personal, professional and
organizational responsibility.
3. Information about HSP is available at
http://www.uwex.edu/hsp/
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
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• Complete the Decision Tree to determine the
best course of action for your research or nonresearch assessment (evaluation) project.
• �Consent’ simply means asking permission and
showing respect. Appropriate consent
language should be part of any data collection
effort.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
23
Getting Started
Consider working with a team on your first project
and learn together.
В© 2009 University of Wisconsin-Extension, Cooperative Extension, Program Development and Evaluation
24
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