TODAY’S TOPIC:
Ethics – deconstructing
consent and
participation with
“vulnerable” populations
“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).
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.
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.
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.
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.
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).
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.
Criteria for IRB approval (§46.111):
1.
2.
3.
4.
5.
6.
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.
7. There are adequate provisions to protect
participant privacy and data confidentiality.
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?)
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))
Vulnerable Populations





Children
Students
Pregnant women
Prisoners
Individuals with:
• mental (intellectual) disabilities
• education disadvantages
• economic disadvantages
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)
What might some
issues in involving CLD
individuals related to
equitable participant
selection and
participant safeguards?
What might some
issues in involving
individuals with ID
related to equitable
participant selection
and participant
safeguards?
Assigned Reading Questions
1.
2.
3.
4.
What are the primary issues for including
diverse individuals as research participants?
What are the ethical considerations for
including diverse participants?
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?
Break
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?
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.
CONSENT VS. ASSENT
WHY DOES
CONSENT/ASSENT
MATTER
Small Group Activity:
 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!
Has Consent Occurred?
http://www.news.com.au/travel/travel-updates/jetstar-refuses-flight-to-disabled-woman-saying-she-couldnt-understandinstructions/story-e6frfq80-1226655448751
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
Has Consent Occurred?
http://www.islingtontribune.com/sites/all/files/nj_islington/imagecache/main_img/images/news/jean.jpg
Has Assent Occurred?
http://saintmaryshome.blogspot.com/
Quick
questions,
quandaries,
concerns or
comments?
THANK YOU!