Please check, just in case…

1. Please check, just in case…

2. Announcements: • No class next week. • Julia will not be checking email during Break – get your questions in ahead of time. • Your final paper is due at the start of class the following week. I will accept late papers only under documented, extraordinary circumstances that warrant an incomplete in the course (se UNM policy for incompletes).

3. Quick questions, quandaries, concerns or comments?

4. APA Tip of the Day: Attributing action – use of the editorial we “Inappropriately or illogically attributing action in an effort to be objective can be misleading. Examples of undesirable attribution include use of the third person, anthropomorphism, and use of the editorial we” [emphasis added] (APA, 2010, p. 69). • Note: This is sometimes referred to as use of the “royal we.”

5. Editorial we, cont. “For clarity, restrict your use of we to refer only to yourself and your co-authors (use I if you are the sole author of the paper). Broader uses of we may leave your readers wondering to whom you are referring; instead substitute an appropriate noun or clarify your usage” (APA, 2012, p. 69). “Some alternative to consider to we are people, humans, researchers, psychologists, nurses, and so on.” (APA, 2010, p. 70).

6. Caution! However, when referencing a group of people (e.g. “people, humans, researchers”) be very careful that you can support whatever statement you are making about that large group. Unless you have a citation to back up your statement, be careful about making blanket statements about groups, even if it sounds obvious. Example: Teachers care more about their students’ learning than earning a big paycheck.

7. Today’s Topic: Ethics – deconstructing consent and participation with “vulnerable” populations

8. Designing a Research Project: • Contact your advisor well in advance of the anticipated start date of your project – your advisor is the PI. • Go to UNM’s main campus Office of the Institutional Review Board (IRB) web site and download all of the forms that will be needed for your IRB. • Read them thoroughly.

9. Designing a Project, cont.: • With feedback from your advisor, develop a first draft of: • your research protocol, • any instruments (i.e. surveys, interview protocols, tests) you will using, • consent forms, • Recruitments materials. NOTE: Expect that this will be the first of many drafts.

10. Designing a Project, cont.: • Revise, resubmit, receive feedback. Repeat as needed. • When your advisor approves the study, then complete the remaining paperwork (see IRB checklist). • Obtain signatures from your advisor and Department Chair – make sure to give them plenty of time to carefully read your proposal.

11. Designing a Project, cont.: • Submit signed paperwork to UNM’s IRB and wait 6-8 weeks. • If the study will be conducted in local schools, you must then complete a similar process with that school district, after UNM IRB approval. • NO data may be collected and no participants be contacted or recruited until the study is approved.

12. Designing a Project, cont.: • If your study is approved, you are responsible for completing a yearly progress report for the IRB, even if you never end up conducting or completing the study, and for closing the study at the end. • You are also responsible for reporting, in writing, any changes to the study methodology (such as changes to any instruments, or participant selection).

13. IRB

14. IRB roles and responsibilities (§46.109) • To review, approve, require modifications, or disapprove research. • Require informed consent, in accordance with policy. • Require documentation of informed consent or waive documentation. • Notify instigators and the institution of their decisions. • Conduct continuing reviews, at least once per year.

15. Criteria for IRB approval (§46.111): • Risks to participants are minimized. • Risk-benefit ratio is reasonable. • Equitable participant selection. • Informed consent is obtained. • Informed consent is documented. • Data collected is monitored to ensure safety of participants. • There are adequate provisions to protect participant privacy and data confidentiality.

16. Safeguards in Participant Selection: • Vulnerable or special populations? • Coercion in recruitment of participants? • Rights and welfare of participants? • Informed consent (and assent)? • Explanation of risks and benefits? • Participant privacy and confidentiality? • Additional monitoring and safeguards. (Where will records be kept? Photos or other visual record? Internet security?)

17. Extra Participant Safeguards “When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.” (§46.111(b))

18. Vulnerable Populations • Children • Students • Pregnant women • Prisoners • Individuals with: • mental (intellectual) disabilities • education disadvantages • economic disadvantages

19. Equity in Participant Selection: “Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.” §46.111(a)(3)

20. Consent vs. Assent

21. Elements of consent: • Description of project (who, what, when, where, why, how). • Possible risks & benefits. • Alternative treatments, if used (i.e. experimental designs). • How will participants’ confidentiality and privacy be maintained? • How will potential injuries be addressed, if risk is involved?

22. Elements of consent, cont.: • Compensation? • Information on voluntary nature of participation and that consent can be withdrawn. • Information that participants are not giving up their rights. • Contact information. • Other information, as needed.

23. What might some issues in involving CLD individuals related to equitable participant selection and participant safeguards?

24. What might some issues in involving individuals with ID related to equitable participant selection and participant safeguards?

25. Break

26. Small Group Activity 1: “Jigsaw’ the assigned readings for tonight. Those people who read each article should take turns explaining and discussing the key points. Identify the primary issues for including diverse individuals as research participants illustrated in your article. Pay particular attention to issues related to research ethics.

27. Small Group Activity 2: • How did your small group discussion relate to issues of ethics in research and IRB requirements? • How does the discussion in Finlay and Lyon about acquiescence relate to issues of consent? • What are some potential difficulties that need to be consider when involving individuals with intellectual disabilities as research participants?

28. Looking ahead… Last class and Winter Break!

29. Please take a minute for the minute paper.