Human Subjects Protection

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Human Subjects Protection

• Presented by UW-Extension
• FLP and 4-H YD Human Subjects Research Protection
  Workgroup

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Members of the FLP 4-H YDHuman Subjects
Protection Workgroup

• Laurie Boyce, FLP
• Nancy Franz, 4-H YD
• Mary Huser, FLP (Chair)
• Larry Jones, FLP (currently with PDE)
• Ann Keim, FLP
• Donna Menart, 4-H YD
• Mike Perkl, Western District
• Sherry Tanumihardjo, FLP (UW-Madison)

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What is Human Subjects Protection about?
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What is Human Subjects Protection about?

• Protecting the rights and welfare of individuals
  involved in research by following
  well-established policies and procedures

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Principles of HSP

• Respect for Persons obtain informed consent
• Beneficence maximize benefits and minimize
  harms
• Justice equitable selection and recruitment
  fair treatment

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The Goal of Human Subjects Protection

• High quality research accompanied by high
  standards of research ethics.

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Why now?

• UW-Madison umbrella coverage prior to July 1,
  2000
• External factors made it not feasible for
  UW-Madison to extend coverage
• Result UW-Extension Institutional responsibility
  to enact HSP

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4-H YD and FLP Perspectives

• Ethical and moral obligations
• Best practice
• Protection of UW-Extension colleagues
• Reputation and credibility
• Public trust

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WNEP Perspective

• State-based staff ensure statewide WNEP program
  follows human subjects protection
• Coordinators ensure local WNEP program follows
  human subjects protection
• Coordinators help Educators understand and apply
  human subjects protection process

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Key Concept 1 of HSP

• 1. Persons/Volunteers Human Subjects
• ? The private information of program
  participants does not belong to us.
• ? Simple principle of honoring the educational
  relationship
• Ask before you take

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Definition of Human Subject

• A living individual about whom an investigator
  conducting research obtains
• data through intervention or interaction with the
  individual,
• or
• identifiable private information.

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Human Subjects Protection
Not just clinical trials or studies with children.
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Vulnerable Population

• A group of people who may be more susceptible to
  coercion or undue influence, such as
• youth under 18 years,
• pregnant women,
• prisoners, or
• persons with disabilities.

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Key Concept 2 of HSP

• 2. Permission Informed Consent
• ? Subjects are to be duly informed of
  potential risks and benefits
• ? Individuals (subjects) have the right to say
  no

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Key Concept 2 of HSP

• Informed Consent legally effective agreement
  given to the subject (or their representative)
• Assent childs affirmative agreement
• Permission agreement of parent(s) or guardians
  to the participation of child in research

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Key Concept 3 of HSP

• 3. Oversight
• Institutional Review Board (IRB)

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Role of UW-Extensions Institutional Review Board

• Evaluate research activity with the rights and
  welfare of subjects in mind.
• Weigh the potential risks with the benefits to
  the subjects and society.
• Determine the equity of subject selection.
• Review informed consent procedures.

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UW-Extension Institutional Review Board (IRB)
Members

• Vicki Washington, EEO/Chancellors Office (Chair)
• Laurie Boyce, FLP/Cooperative
• Mary Crave, Continuing
• Dan Hill, CRD/Cooperative
• Debra Ivey, 4-H YD/Cooperative
• Rev. Roger Nilles, Community Member
• Greg Wise, Chancellors Office

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Key Concept 4 of HSP

• 4. Documentation Assurance and Records
• Federal-wide Assurance of Protection for Human
  Subjects formal document between federal
  government and UW-Extension
• Comply with Federal minimum standards

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Documentation - Assurance

• All faculty, staff, students, and collaborating
  researchers who are involved in the use of human
  subjects in research are required to complete the
  HSP training and review process.

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Human Subjects Protection Online Training

• Found at www.uwex.edu/hsp
• Complete prior to submitting HSP request
• Affiliated with University of Miami

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Documentation - Records

• Human Subjects Protection Approval form
  (www.uwex.edu/hsp)
• Consent Documents
• Correspondence between IRB and Educator/Investigat
  or
• Other

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UW-Extension HSP Administrator

• Greg Wise
• greg.wise_at_uwex.edu
• 608.262.1470

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UW-Extension HSP Resources

• http//www1.uwex.edu/hsp/
• The following forms are available
• Decision Tree - Human Subjects Protection
  (handouts)
• Human Subjects Protection Approval (handout)
• Sample Consent Form for Evaluation Projects

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HSP Definitions Research

• The collection of information which is
• intended to prove or disprove a stated
  hypothesis,
• contributes to an established body of knowledge,
• intended to be replicated in other settings,
• generalized to a larger population,

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HSP Definitions Research

• The primary beneficiaries of the research are
  other researchers, scholars, and practitioners in
  the field of study.
• Publication of the results of the research is
  intended to inform the field of study.

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HSP Definitions Evaluation

• The collection of information which is
• intended to inform participants,
• improve the program quality,
• assess the value of programs or services received
  by the participants.

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HSP Definitions Evaluation

• Evaluation studies are not
• intended to be replicated in other settings, or
• expected to be generalized to a population beyond
  the site of the data collection.
• The primary beneficiaries are the program
  participants.

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Evaluation Example

• Adult Leader Training end of session feedback
  form asking participants about
• ? quality of training,
• ? beneficial aspects of training,
• ? recommendations for future trainings,
• ? additional information or resources of
  interest.

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Evaluation Example

• Adult Leader Training
• Intent is to use information collected to improve
  training and information will be used only by
  UW-Extension educator with internal audiences
• ? Not required to submit for HSP Approval

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Evaluation

• Evaluation ?
• Internal Use ONLY ?
• No Requirement to follow HSP procedures
• Best Practice Incorporate consent language on
  feedback form

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Sample Consent Form Language Evaluation Project

• Please complete the following (title of the
  project) evaluation. The results of the
  evaluation will be used (purpose of the project).
  Your participation in this evaluation is
  voluntary and confidential. If you have any
  questions, please contact (your name, title,
  affiliation, and phone number). Completion of
  this evaluation implies your consent to
  participate. Thank You.

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Evaluation Example

• What if evaluation information is to be shared
  with external audiences?
• Newspaper article
• Public presentations
• Research paper

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Evaluation Example

• Evaluation ?
• External Use ?
• Strongly Encouraged to follow HSP procedures
• Complete Decision Tree sign, date and file
• Incorporate consent form language in feedback
  forms (see www.uwex.edu/hsp)

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Sample Consent Form Language Evaluation Project

• Please complete the following (title of the
  project) evaluation. The results of the
  evaluation will be used (purpose of the project).
  Your participation in this evaluation is
  voluntary and confidential. If you have any
  questions, please contact (your name, title,
  affiliation, and phone number). A copy of the
  Human Subjects Protection Decision Tree is on
  file in the (name) County UW-Extension Office.
  Completion of this evaluation implies your
  consent to participate. Thank You.

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Program Example

• Parenting Class for Teen Mothers

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Decision Tree Step 1

• Will you be collecting information from or about
  human beings?
• ? No -- you are exempt
• ? Yes -- go to Step 2

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Decision Tree Step 2

• What is the purpose of the information you will
  be collecting?
• ? Research submit request (Step 9)
• ? Evaluation
• ___ Internal Use not required to submit
• ___ External Use go to
• Step 3

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Decision Tree Step 3

• What is the source of funding that underwrites
  the collection of information?
• ? Grant, gift, contract, collaborative submit
  request (Step 9)
• ? UW-Extension go to Step 4

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Decision Tree Step 4

• From whom are you collecting information?
• ? Vulnerable Populations submit request (Step
  9)
• ? Non-Vulnerable Adults go to Step 5

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Decision Tree Step 5

• Is confidentiality of participants protected by
  the method of data collection?
• ? Participants can be identified submit
  request (Step 9)
• ? Participants cannot be identified go to Step
  6

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Decision Tree- Step 6

• Could the information being collected place
  participants at risk?
• ? Could reasonably place at risk submit
  request (Step 9)
• ? Would not place at risk
• go to Step 7

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Decision Tree Step 7

• How do you intend to use the information
  collected?
• ? Publicly submit request (Step 9)
• ? Internal only for program improvement go to
  Step 8

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Decision Tree Step 8

• ? Follow best practices and include consent form
  language or a consent form.
• ? Sign, date and file decision tree form,
  evaluation questions and consent form.

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Decision Tree Step 9

• Implementation
• Follow process to submit your request to
  UW-Extensions Human Subjects Protection
  Administrator