Week 2 Activities
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School
McMaster University *
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Course
3D03
Subject
Medicine
Date
Jan 9, 2024
Type
Pages
7
Uploaded by esoo6
Activity #1: Havasupai Indian Tribe Case
Activity:Read the article below and answer the questions following the reference.
Mello, M.M., Wolfe, L.E. (2010) The
Havasupai Indian tribe
case
--
lessons for research involving stored
biologic samples. New England Journal of Medicine, Jul 15; 363(3):204 - 7. Epub 2010 Jun 9.
Summary
-
Arizona State University agreed to pay $700,000 to 41 members of the Havasupai Indian
tribe to settle legal claims that university researchers improperly used tribe members'
blood samples in genetic research.
-
1990s diabetes study, more than 200 blood samples were taken
-
Consent form described study as “the causes of behavioral/medical disorders”, but
samples were used for diabetes research and shared with other investigators
-
Tribe members particularly objected to three uses: a study evaluating the genetic basis
of schizophrenia, which could stigmatize the tribe; one examining inbreeding, which
raised stigmatization issues and concern related to a cultural belief that inbreeding
brings harm to one's family; and evolutionary-genetics studies suggesting that contrary
to the tribe's origin story, its ancestors migrated across the Bering Sea.
-
$500 million lawsuit filed in 2004 for fraud, breach of fiduciary duty, negligence, and
trespass
-
In addition to providing monetary compensation, ASU formally apologized and agreed to
work with the tribe on issues of health, education, and economic development +
returning samples
Issues
1.
Federal regulations require informed consent when identifiable biospecimens are
collected for research purposes, but provide little guidance on how to obtain informed
consent for future, unspecified uses.
2.
Whether removing donors' identifying information from samples (“anonymizing” them)
eliminates the ethical dilemma. No risk due to contributors, but dignity and autonomy
should be honored regardless?
In this scenario, anonymizing the samples would not have changed the oppositions held by the
participants
Conclusions
-
Researchers need to ensure that the study population's perspectives are understood
and considered.
-
Community consolidation should be used to identify perspectives and potential areas of
concern for future biospecimen use.
-
Moral significance of biospeciemen use, collective interests of the community relating to
research topics
Questions:
1. Is this a vulnerable population?
●
Yes
a. Did the tribe understand the consent form?
●
They consented to use of the samples for purposes other than what was
disclosed, this may be unrelated to participant understanding
b. Was their English adequate?
●
Not sure, but very unlikely
2. Use of research samples? Was this in accordance with TCPS2?
●
The three main principles are not in accordance with the TCPS2
●
Right to full disclosure - research was not in accordance to this principle
3. Is it possible to de-identify the samples collected when the entire population is
only 600?
●
Blood is one of the most specific identifiers of an individual. Depending on how
it’s done, it could be very “easy” to identify an individual strictly from their blood
sample
○
Take into consideration labels maybe? With names written on it etc etc
○
Unknown how many people the samples came from
4. Should we know more about their culture and beliefs before approaching them for
consent in a research study?
●
Yes, in order to respect the beliefs and cultural values these items should be
taken into consideration in order to create an ethical research study
●
Perspectives and potential areas of concern for future biospecimen use
should be identified with communities through group consolidating
●
For example
○
Within this study the tribe believed that their blood was being used for
research surrounding diabetes
○
Instead it was used for thing such as schizophrenia , inbreeding etc etc,
this created concern for the population that stigma may arise
corresponding the results
Activity 2 - Singleton Study
Questions
1. Were the study procedures reviewed by an IRB or other ethics review group?
Not clear bc report did not say
2. Are the study participants in this study “vulnerable subjects”?
●
Didn't really say , would relate to the autonomy of the person
●
Its complicated
3. Was coercion used in this study?
-
Signed a form agreeing that their participation is voluntary
-
Coercion was not present
-
Coercion includes a potential harm to the subject if not participating
4. Was informed consent obtained?
-
No, concealment was necessary to gather accurate data
-
Subjects were not aware of the nature of the patient scenario but they consented to
participate and gave implied consent by going into the scenario. Study was presented as
an assessment of their nursing skills.
5. Were participants deceived in any way?
-
Yes, nursing students were told they were just going to be taking vital signs, but were
then put in a situation of managing a patient who is experiencing an epileptic seizure
6. Were data collected covertly?
●
Covert is when research participants are deliberately misinformed about what the study
is about or they are unaware of their involvement in the study
●
No the participants did know they were being observed so it was not covertly
7. Did this study pose an ethical dilemma for the researcher?
-
Informed consent was not provided, responding to the scenario may have been outside
of the interests of the participants
8. Was anonymity assured?
-
Names were not recorded but demographic forms were filled out
-
Researcher was in the room so it is not anonymous, but confidentiality was followed
-
Anonymity can only happen if the researcher does not know the participants
9. Did the study participants themselves benefit from the study?
-
Not sure/wasn’t mentioned
-
Only benefit is they got 10$ out of it
10. Did participants ever learn about the purpose of the study?
-
They were debriefed after the study so yes
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Week 2: Small Group Activity #2
Activity # 1
Identify the study designs and consider key issues:
-
Ethics (eg, randomization of independent variable)
-
Design implications
-
Strengths and weaknesses of your design - is it the strongest you can use ethically?
-
Case 1A :
A nurse researcher found a relationship between teenagers’ level of knowledge about
birth control and their level of sexual activity: teenagers with higher levels of sexual activity knew
more about birth control than teenagers with less sexual activity. Identify study design to have
knowledge level as the independent variable
a.
case -control
Teens w/ sexual activity > knowledge about bc
Teens w/o sexual activity > knowledge about bc
Wat up
Activity #1
Case 1B:
A nurse researcher found a relationship between teenagers’ level of knowledge about
birth control and their level of sexual activity: teenagers with higher levels of sexual activity knew
more about birth control than teenagers with less sexual activity. Identify study design to have
sexual activity as the independent variable
●
Does the level of sexual activity influence teenagers' knowledge of birth control?
●
Would knowledge about birth control influence sexual activity of teens?
●
ID: Sexual activity
●
●
●
Activity # 1
Case 2A:
Suppose you wanted to study the coping strategies of AIDS patients at different points in
the progress of the disease. Design a cross - sectional study to research this question, describing
how subjects would be selected. Identify strengths and weaknesses of the design
Q: What is the level of coping stragegies of aids patients in 6 months and 12 months after
diagnosis?
Cross sectional study - weaknesses
●
Less persuasive than longitudinal designs
●
This design is economical but it imposes issues for knowing changes incurred
over time
●
Can’t ensure internal validity
●
Many factors that cannot be controlled or manipulated (eg, demographic data
such as patient’s sex and age that may influence coping)
Design
-
Two groups of patients with aids
-
One group 6 months after diagnosis
-
One group 12 months after diagnosis
-
Both groups studied at the same point in time
-
Data collected by self reporting? questionnaires
Activity # 1
Case 2B:
Suppose you wanted to study the coping strategies of AIDS patients at different points in
the progress of the disease. Design a longitudinal study to research the problem. Identify strengths
and weaknesses of the design
Key issues:
Ethics
-
If a beneficial coping strategy is identified, should this information be shared with
poorly-coping subjects to promote welfare?
Design implications
Longitudinal study looking at coping strategies throughout the lifespan
-
Self-reporting with questionnaires about coping strategies used by the individuals and
questions related to psychosocial stress, efficacy of coping, wellbeing, quality of life
-
Same questionnaire given throughout time, ex. Checking in with subjects after 1 month,
6 months, 12 months
Strengths and weaknesses
-
Strengths
-
Continuity can be better for internal validity, easier to follow individuals and
identify correlations between coping strategies and ability to cope
-
Weaknesses
-
Dropout & death
-
Wanting subjects to be at same point at diagnosis, may be difficult to recruit
Case 3:
Suppose that you were interested in testing the effect of a special high - fiber diet on cardiovascular
risk factors (e.g, cholesterol level) in adults with a family history of cardiovascular disease.
Recommend a research design for this problem, indicating what confounding variables you would
need to control and how you would control them. Identify the major threats to the internal validity
of the design.
Q:What are the effects of a high fiber diet for cardiovascular risk factors for adults with a family
history of cardiovascular disease?
Longitudinal,
RCT
, cohort
Quasi-experimental
- is looking at the effectiveness of a high-fiber diet on CV risk factors on
individuals that have a family history of CV disease. Those with a family history of CV disease serve
as the experimental group, so there is no random allocation of groups
Confounding variables
: many factors may contribute to CV risk, can’t ensure fiber in diet is the only
difference, must be able to ensure diet adherence. Can attempt to control or make note of activity
level, engagement in health relevant behaviors like smoking, degree of relative with heart disease.
Major threats to internal validity
:
Ethics (eg, randomization of independent variable)
-
Design implications
-
Longitudinal study, check in with subjects diet & CV health status throughout time
Case 4:
Below is a description of a fictitious study. Read the description and then answer the factual
questions that follow.
Brusser and Janosy wanted to test the effectiveness of a new relaxation/biofeedback intervention on
menopausal symptoms. They invited women who presented themselves in an outpatient clinic with
complaints of severe hot flashes to participate in the study of the experimental treatment. These 30
women were asked to record, every day for two weeks before their treatment, the frequency and
duration of their hot flashes. The intervention involved five 1 - hour sessions over a period of a week.
Then, for the two weeks after the treatment, the women were asked to record their hot flashes again
every day. At the end of the study, Brusser and Janosy found that, on average, both the frequency
and average duration of the hot flashes had been significantly reduced in their sample of 30 women.
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They concluded that their intervention was an effective alternative to estrogen replacement therapy
in treating menopausal hot flashes.
Short Answer Questions
a. What is the independent variable in this study?
-
relaxation/biofeedback intervention - this is the red herring lol??
-
Treatment for hot flashes
b. What is the dependent variable in this study?
-
Frequency of menopausal symptoms, duration of hot flashes
c. Was there a random assignment in this study?
-
No, women were recruited from the outpatient clinic already experiencing severe hot
flashes they sought out care for.
d. Is the design experimental, quasi-experimental, or non-experimental? (Quasi-experimental)
-
Quasi-experimental, there is no control group but there is an intervention tested on the
subjects, bc no randomization
e. Is the study design within-subjects or between-subjects?
-
Within subjects, everyone received the same treatment as there is no control group or
alternative treatment
f. Was there blinding or double blinding in this study?
-
No, they were participating in the intervention; either you knew you were receiving the
intervention or not
-
Patients know they are receiving the intervention
-
There is only one experimental group
g. Was history a possible threat to the internal validity of this study?
-
Bias by placebo effect; data obtained is subjective and relies on the patient's self reporting.
Patients are not blinded. All women received the intervention, a conclusion was made stating
biofeedback is more effective than estrogen replacement therapy but there was not a group
on HRT that was used for comparison.
-
The women are self-selected
-
History unknown - confounding variables; have these women received / are they receiving
hrt? Other treatment?