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Human Subjects Protection (HSP)

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  1. Human Subjects Protection (HSP)

  2. 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.

  3. 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.

  4. 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.

  5. This is not just about clinical trials or studies with children. This is not just for someone else, this is about YOUR work!

  6. 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.

  7. The HSP guidelines apply to ALL UW-Extension 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.

  8. Three core principles underlie HSP, known as the Belmont Principles They include: Respect: acknowledge the dignity and freedom of every person Beneficence: maximize the benefits and minimize any harms associated with the effort Justice: ensure equitable election/recruitment and fair treatment of every person

  9. Oversight and management of HSP is with the Human Subject Administrator in the Chancellor’s Office of UW-Extension http://www.uwex.edu/hsp

  10. 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

  11. 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.

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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.

  20. 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.

  21. Decision Tree – Step #8 Implementation. There are 3 possibilities: • 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 self-assessment and keep it on file. Regardless of your action, include appropriate consent language in your data collection effort.

  22. Key points to remember: • Human Subjects Protection is about ‘ethical’ practice – something we all want and need to do. • Following the Human Subjects Protection guidelines and applying “best practice” is our responsibility – personal, professional and organizational responsibility. • Information about HSP is available at http://www.uwex.edu/hsp/

  23. Complete the Decision Tree to determine the best course of action for your research or non-research assessment (evaluation) project. • ‘Consent’ simply means asking permission and showing respect. Appropriate consent language should be part of any data collection effort.

  24. Getting Started Consider working with a team on your first project and learn together.