Working With Human Subjects

1. Working With Human Subjects

2. Workshop Objectives • Participants will be able to: • decide when an educational innovation requires IRB review • identify characteristics of educational research that are of concern to IRBs • decide when asking for “exemption” is a viable strategy • address informed consent requirements for educational research • negotiate the process for obtaining IRB approval of educational research

3. Why IRBs?

4. IRB Responsibilities • The main focus is the protection of human subjects • Ensures that benefits are reasonable in relationship to risks • Ensures that informed consent process is in place • Requires appropriate documentation of informed consent or (occasionally) waives documentation in accord with regulations • Notifies investigators of decisions in writing

5. Criteria for IRB Approval • Risks to subjects are minimized • Risks to subjects are reasonable in relationship to the anticipated benefits • Equitable selection of subjects is addressed • Measures are in place to ensure informed consent is obtained

6. Criteria for IRB Approval • Describe measures that informed consent will be documented according to all regulations and policies • Safety of subjects is ensured by the monitoring of collected data • Privacy of subjects and confidentiality of data is addressed • Vulnerable subjects are safeguarded from coercion or undue influence

7. Who is a Human Subject? • A human subject refers to a living individual about whom an investigator, conducting research obtains… • data through intervention or interaction with the individual or • identifiable private information

8. What is Private Information? • Private information occurs in a context in which an individual can reasonably expect the information will not be made public • Private information must be individually identifiable

9. Important Distinctions • Anonymous: the identity of the person has never been known • Anonymized: the person has a code number that is now permanently de-linked from the data

10. Will my study be considered research? • Research means a systematic investigation … to develop or contribute to generalizable knowledge • If you might publish the results, it’s research

11. What Concerns the IRB • Ratio of risk to the participants and benefits to stakeholders • Unfamiliar with risk assessment in education • Participant protection • Participant identity • Coercion • Documentation, documentation, documentation

12. Engineering Ed Research and IRB Exemption

13. Exempt Status • “Exemption” refers to the federal policy for Protection of Human Research Subjects • Six categories of research that qualify for exempt status • Three are relevant to educational research

14. Exemption Category 1 • Research involving normal educational practices, such as research on: • instructional strategies • instructional techniques • curricula • classroom management methods

15. Exemption Category 2 • Research involving the use of educational tests, surveys, interviews or observation of public behavior, unless:…

16. Exemption Category 2 …unless: human subjects can be identified; and any disclosure of the subjects' responses could place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation

17. Exemption Category 4 • Research involving existing data, documents, records, if these sources are publicly available or if the subjects cannot be identified.

18. Use of Deception • “Exempt” categories do not apply to research involving deception of subjects where the investigator does not disclose the true purpose of the research and/or the results of the subject’s participation in the study

19. Exemption Summary • Am I likely to be exempted? Probably yes • Do I need still need to apply for exemption?Definitely yes

20. Informed Consent

21. Different levels of consent • Full written consent • Implied consent • Waiver of informed consent

22. Important Distinction • Waiver of informed consent • Informed consent not needed • Waiver of documentation of informed consent • Informed consent is necessary but written and signed documentation from the participant is not

23. Waiver of Informed Consent • The research presents no more than minimal risk to subjects AND • The waiver will not adversely affect the rights and welfare of the subjects AND • The research could not practicably be carried out without the waiver AND • Where appropriate, the subjects will be provided with additional pertinent information after participation

24. Waiver of Documentation of Informed Consent • That the only record linking the subject and the research would be the consent document and the principle risk would be the potential harm resulting from a breach of confidentiality, or • That the research presents no more than minimal risk of harm and involves no procedures for which written consent is normally required outside the research context.

25. invitation to participate purpose, duration, procedures foreseeable risks/ benefits alternatives, if any confidentiality conditions compensation for injury contact persons for questions voluntary nature of participation provide copy Essential Elements for Consent Document

26. IRB Process

27. When do You Need IRB Review? • Simple answer: whenever you think you might publish (disseminate) the results • Types of IRB review • Exemption review • Expedited review • Full review

28. Expedited Review • Minimal risk research that fits one of nine specified categories may be reviewed by the IRB utilizing expedited procedures • Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes

29. Expedited Review • Collection of data from voice, video, digital, or image recordings made for research purposes • Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

30. Making the Application • Read the instructions (I know, its obvious) • Work with someone with IRB experience • Contact the IRB staff with questions • If you don’t hear anything after submission, investigate