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Announcements, questions, or quandaries?
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Todays Topic

• Ethics - deconstructing consent and participation
  with "vulnerable" populations

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Small Group Activity

• Get into small groups. First, each, each person
  should share which terms they defined for the
  assignment due tonight. Pick several terms which
  at least one person defined in his/her paper.
  Discuss your understanding of these terms and
  develop a succinct and accurate definition of
  each one, including any information you learned
  from today's or yesterday's readings. Discuss how
  these concepts describe some of the key
  differences between "qualitative" (naturalistic
  or interpretivist) and "quantitative"
  (positivistic, objectivist) research.

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Designing a Research Project

• Contact your advisor well in advance of the
  anticipated start date of your project (i.e.
  several months in advance).
• Go to UNMs Research Compliance Services web site
  and download all of the forms that will be needed
  for your IRB.
• Read them thoroughly.

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IRB
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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, and
• all consent forms.

NOTE Expect that this will be the first of many
drafts.
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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), preferably as a pdf file (not typed).
• Provide the original and 1 copy for signatures to
  your advisor and Department Chair.

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Designing a Project, cont.

• Submit signed paperwork to UNMs IRB and wait 4-6
  weeks.
• If the study will be conducted in local schools,
  you must then complete a similar process with
  that school district.
• NO data may be collected and no participants be
  recruited until the study is approved.

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Designing a Project, cont.

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

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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?)

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Vulnerable Populations

• Children
• Students
• Pregnant women
• Prisoners
• Individuals with
• mental (intellectual) disabilities
• education disadvantages
• economic disadvantages

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Consent vs. Assent
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Elements of consent

• Description of project (who, what, when, where,
  why, how).
• Possible risks benefits. (discussion later)
• 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?

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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.

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Potential Benefits

• A benefit is a valued or desired outcome, an
  advantage. Benefits of research may accrue
  directly to the individual participating in the
  research, or benefit society as a whole, as is
  often the case in social, behavioral, or
  educational research.

UNMs IRB Policies Procedures Manual, 2006, p.
11
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Potential Risks

• Risk means the probability of harm, whether
  physical, psychological, social, legal or
  economic.

UNMs IRB Policies Procedures Manual, 2006, p.
11
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Types of IRB Reviews
what is the level of risk?

• Exempt
• Expedited
• Full

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EPEDITED Research

• Research that involves no more than minimal risk
  to participants.

Example Audiotaped teachers interviews on
beliefs about testing practices.
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Minimal Risk defined

• the probability and magnitude of harm or
  discomfort anticipated in the research are not
  greater in and of themselves than those
  ordinarily encountered in daily life or during
  the performance of routine physical or
  psychological examinations or tests.

UNM IRB Procedures Manual, 2006, p. 11
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Research undergoing FULL Review

• Research that does not qualify for exempted
  status or expedited review.

more than minimal risk
Example self-reporting of criminal behavior.
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Greater than minimal risk

• Gathering sensitive personal information,
• Deceptive research procedures,
• Covert observation in settings where individuals
  expect privacy,
• Data that could be embarrassing or harmful if
  revealed,
• Pain or physical discomfort,
• Medical records or protected health information,
  or
• Participants with disabilities.

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How does involvement of individuals with
disabilities impact the previous participant
selection issues?
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Looking ahead

• Research ethics continued

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Please take a minute for the minute paper.