1. TODAY’S TOPIC: Ethics – deconstructing consent and participation with “vulnerable” populations

2. “Knowingly or not, every researcher submitting a proposal to a research ethics committee does so in the shadow of the Willowbrook study.” Ianco, T. (2006). Ethical challenges and complexities of including people with intellectual disability as participants in research. Journal of Intellectual and Developmental Disability, 31(3), 173).

3. Designing a Research Project: 1.Contact your advisor well in advance of the anticipated start date of your project – your advisor is the PI. 2.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. 3.Read them thoroughly.

4. Designing a Project, cont.: 4.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.

5. Designing a Project, cont.: 5.Revise, resubmit, receive feedback. Repeat as needed. 6.When your advisor approves the study, then complete the remaining paperwork (see IRB checklist). 7.Obtain signatures from your advisor and Department Chair – make sure to give them plenty of time to carefully read your proposal.

6. Designing a Project, cont.: 8.Submit signed paperwork to UNM’s IRB and wait 6-8 weeks. 9.If the study will be conducted in local schools, you must then complete a similar process with that school district, after UNM IRB approval. 10.NO data may be collected and no participants be contacted or recruited until the study is approved.

7. Designing a Project, cont.: 11.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. 12.You are also responsible for reporting, in writing, any changes to the study methodology (such as changes to any instruments, or participant selection).

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

10. Criteria for IRB approval (§46.111): 1.Risks to participants are minimized. 2.Risk-benefit ratio is reasonable. 3.Equitable participant selection. 4.Informed consent is obtained. 5.Informed consent is documented. 6.Data collected is monitored to ensure safety of participants. 7.There are adequate provisions to protect participant privacy and data confidentiality.

11. 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?)

12. 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))

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

14. 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)

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

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

17. Assigned Reading Questions 1.What are the primary issues for including diverse individuals as research participants? 2.What are the ethical considerations for including diverse participants? 3.How does the discussion in Finlay and Lyon about acquiescence relate to issues of consent? 4.What are some potential difficulties that need to be consider when involving individuals with intellectual disabilities as research participants?

18. Break

19. Elements of consent: 1.Description of project (who, what, when, where, why, how). 2.Possible risks & benefits. 3.Alternative treatments, if used (i.e. experimental designs). 4.How will participants’ confidentiality and privacy be maintained? 5.How will potential injuries be addressed, if risk is involved?

20. Elements of consent, cont.: 6.Compensation? 7.Information on voluntary nature of participation and that consent can be withdrawn. 8.Information that participants are not giving up their rights. 9.Contact information. 10.Other information, as needed.

21. CONSENT VS. ASSENT WHY DOES CONSENT/ASSENT MATTER

22.  Look over the case studies with your assigned groups.  Come up with as many solutions as you can think of to provide these participants with information about this research.  Come up with as many solutions as you can think of to ensure that these participants are actually providing consent.  Share your best solution for providing information and gaining consent! Small Group Activity:

23. Has Consent Occurred? http://www.news.com.au/travel/travel-updates/jetstar-refuses-flight-to-disabled-woman-saying-she-couldnt-understand- instructions/story-e6frfq80-1226655448751

24. Has Consent Occurred? http://www.oregonlive.com/pacific-northwest news/index.ssf/2011/05/internal_investigation_will_look_at_why_disabled_man_had_to_crawl_out_of_jail_lobby_after_release.html

25. Has Consent Occurred? http://www.islingtontribune.com/sites/all/files/nj_islington/imagecache/main_img/images/news/jean.jpg

26. Has Assent Occurred? http://saintmaryshome.blogspot.com/

27. Quick questions, quandaries, concerns or comments?

28. THANK YOU!