com s/geron 415x gerontechnology in smart home...
TRANSCRIPT
Com S/Geron 415X Gerontechnology in Smart Home
Environments
Institutional Review Board and Research Ethics
Dr. Hen-I Yang
Computer Science Department, ISU
April 21, 2011
Announcement
HW 5 due tonight
Final project submission on WebCT is now open
Final Deliverable for the whole group
A single page personal note regarding your contribution
Introduction
Many research will not be able to produce meaningful
results without involving human research participants
Prepare investigators involved in the design and/or
conduct of research involving human subjects to
understand
obligations to protect the rights and welfare of subjects in
research
It is not considered an ethical behavior to use individuals
solely as means to an end
Nazi Medical War Crimes (1939–1945)
injecting people with gasoline and live viruses, including
pregnant women
immersing people in ice water, and forcing people to
ingest poisons while remaining conscious
Many experimentations use twins
Many were gassed and dissected right after the
experimentations because they are unfit to work
December 1946, the War Crimes Tribunal at Nuremberg
indicted 20 physicians and 3 administrators for their
willing participation
The Nuremburg Code Voluntary consent of the human subject is absolutely essential
The experiment must yield generalizable knowledge that could not be obtained in any other way and is not random and unnecessary in nature
Animal experimentation should precede human experimentation
All unnecessary physical and mental suffering and injury should be avoided
No experiment should be conducted if there is reason to believe that death or disabling injury will occur
The degree of risk to subjects should never exceed the humanitarian importance of the problem
Risks to the subjects should be minimized through proper preparations
Experiments should only be conducted by scientifically qualified investigators
Subjects should always be at liberty to withdraw from experiments
Investigators must be ready to end the experiment at any stage if there is cause to believe that continuing the experiment is likely to result in injury, disability or death to the subject
Unit 731
Biological and chemical warfare R&D unit Conduct of
Imperial Japanese Army during WWII
Vivisection on prisoners without anesthesia
Weapon testing
Germ warfare
Deprivation of food and water
MacArthur secretly granted
immunity to the physicians of
Unit 731 in exchange for
providing America with their
research on biological warfare
The Syphilis Study at Tuskegee
The Syphilis Study at Tuskegee (US)
Happened in the1930‘s
Infected approximately 600 African-American men: about 400 with
syphilis (cases) and about 200 without syphilis (controls).
These men were recruited without informed consent and,
led to believe that some of the procedures done in the interest of
research (e.g., spinal taps) were actually ―special free treatment.‖
By 1936 it‘s obvious more man with syphilis developed complications
10 years later, death rate of man with syphilis is about twice as high
as control group
In1940s, penicillin was found to be effective in the treatment of
syphilis, but the participants were never told or administered the
antibiotics
Code and Regulations
Belmont Report – Three Basic Ethical Principles
Respect for Persons
Individual should be treated as autonomous agents
Persons with diminished autonomy are entitled to additional
protections
Beneficence
Do no harm
Maximize possible benefits and minimize possible harm
Justice
Requires that individuals and groups be treated fairly and equitably in
terms of bearing the burdens and receiving the benefits of research
Code and Regulations – Special Protections
45 CFR 46
Subpart B: additional protections for pregnant women, human
fetuses and neonates
Subpart C: additional protections for prisoners in biomedical
and behavioral research
Subpart D: additional protections for children
Case Study 1-1: Respect for Persons
Kevin, the division manager, announced in the monthly
meeting to all of his employees that a new blood work
for early detection of Alzheimer‗s is almost ready for
clinical trial.
Before that happens, he needs more data to ensure its
effectiveness, so he wants everyone in the meeting to take the
test
He goes on and explains how financially promising this new
tool is, and how a successful launch means to the year-end
bonus of everyone
He then mentions how important teamwork is and how lone
wolves have no place in the company
Case Study 1-2: Respect for Persons
Jane invited all the primary school kids in the library to try a new gadget that can help blind kids who cannot see to roam around.
She explained that the gadget beeps, make funny sounds and talks so users know if they will be running into obstacles.
She explained the gadget uses ultrasound, sound reflection and triangulation to determine users‘ location and possible obstacles.
She explained if they want to participate, they will be blind folded and walked around the reading rooms wearing the gadget
She promised it will help blind kids and it will be a lot of fun, you know, ―just like piñata‖
Case Study 1-3: Respect for Persons
Michael creates a flyer to recruit participants for testing out the new EZ medication dispenser. The flyer says the study needs people 65 or older, and must take 3 or more kinds of pills on a daily bases.
When participants arrive, Michael tells them that EZ medication dispenser is not yet ready, but they are invited to participate in a talking medicine reminder assistant instead
Each participant is asked to fill out a questionnaire that details the kind of medications that the person is on, and the schedule and dosage for each medication
To ensure the observation is complete and reviewable, and that the participants‘ behaviors will not be altered in the lab, Michael installed a pinhole camera to observe and record how participants interact with the medicine reminder
Ethical Questions
In this study, is the researcher‘s behavior ethical?
If not, which part of the behavior is unethical or in the gray
area?
What would you change to make the study conforming
better to the commonly accepted values?
Respect for Persons
In practice, this principle is realized with the informed
consent process.
During this process, the participants must:
Give their consent freely and voluntarily
Have the decisional capacity to understand the information
presented to them
Be provided complete information about the study in order to
make an informed decision
Things to avoid
Coercion
Age and capacity inappropriate explanations
Bait and switch
Informed Consent The three fundamental aspects of informed consent are:
Voluntariness Individuals‘ decisions about participation in research should not be influenced by
anyone involved in conducting the research: ―...consent must be freely given or truly voluntary.
Comprehension Individuals must have the mental or decisional capacity to understand the
information presented to them in order to make an informed decision about participation in research.
Disclosure The purpose of the study
Any reasonably foreseeable risks to the individual
Potential benefits to the individual or others
Alternatives to the research protocol
The extent of confidentiality protections for the individual
Compensation in case of injury due to the protocol
Contact information for questions regarding the study, participants‘ rights, and in case of injury
The conditions of participation, including right to refuse or withdraw without penalty
Informed Consent Process
The types of situations where informed consent can be
waived
Appropriate involvement of legally authorized
representatives for consent
Obtaining consent from vulnerable populations, e.g.
pregnant women, prisoners and children
The need to undertake community consultation when the
individual‘s interests are intimately entwined with their
community‘s interests
Case Study 2-1: Beneficence
Mary designed a study about mobility issue in which she
recruits 60 participants who are 65 years or older and
require walkers or wheelchairs to move around
Participants in the experimental group stays in a house with no
ramp access for a whole week
Participants in the control group stays in a house with ramp
access for a whole week
A researcher is assigned to observe their moving patterns and
the number of times they fall when getting in and out of the
house
The researcher is told to strictly follow the ―non-interfering‖
protocol to ensure the integrity of the study
Case Study 2-2: Beneficence
Charlie is curious about whether one believes in extra-
terrestrial aliens has any effects on the longevity
Charlie randomly picks 1000 individuals from the phone book
He calls each of the selected individual and ask them if they
believe in extra-terrestrials
He then asks how old they are
Every year he calls back to the same initial group and see if
they are still alive and whether they have changed their belief
about aliens
He analyzes the data to reveal the effects of beliefs in extra-
terrestrial aliens versus the longevity
Case Study 2-3: Beneficence
Beth is conducting a study on older adults who are 90
years old or older.
She devises a detailed survey to collect data on their religious
beliefs, daily activities and chronic diseases.
She recruits oldest olds to partake the study
To demonstrate the geographical impacts on extreme longevity,
she breaks down the data based on the county first, and then
analyze if religious beliefs, activities and chronic conditions
combined with their geographical locations can be used as
effective indicators for extreme longevity
She publishes the results in gerontology journal to explain her
findings
Beneficence
Maximizing possible benefits and minimizing possible harms to research participants
Protections against risks
Definition of minimal risk
Methods of weighing risks against anticipated benefits
Potential benefits for the research participants
Te use of compensation for participation in research
Equipoise and need for there to be genuine uncertainty about whether one treatment is superior to another
Privacy and confidentiality of research participants and research data
Use of coded private information to protect confidentiality
Use of IRB to provide oversight
Situations that allow for an IRB expedite review procedure
Data and safety monitoring for clinical trials
Risk
Risk is the ―probability that a certain harm will occur.‖
Minimal Risk: ―that 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
Type of Risks and Protections
Physical
Psychological
Social
Legal
Economic
Undue Inducement
Is troublesome because:
offers that are too attractive may blind prospective subjects to
the risks or impair their ability to exercise proper judgment;
and
they may prompt subjects to lie or conceal information that, if
known, would disqualify them from enrolling — or continuing
— as participants in a research project.‖
Careful consideration of compensation is not only critical for
beneficence, but may be critical for sound research.
Considerations should include, but are not limited to, issues
like participants‘ medical, employment, and educational status,
and their financial, emotional, and community resources.
Case Study 3-1: Justice
Steve wants to conduct a study on the impacts of rigorous daily routines on longevity, but it is very difficult to ensure the participants will follow the daily routine to the letter in the general population
Steve figures that since prisoners are by default living in controlled environments, they are the perfect sampling population
With the help from the warden, Steve divides prisoners into two groups, one goes on about their lives regularly and the other group must follow the rigorous routine
If the results show positive impact on longevity, the daily routine can be expanded to general public to save people‘s lives
Case Study 3-2: Justice
Jennifer has came up with a device to map out the optimal path in the supermarket for grocery shopping, she believes this devices will allow older adults to live more independently for longer
She conducts a study to learn if the device indeed encourages people to shop for grocery more frequently and without assistance
When she was working on the project, she tweets about the device online all the time,
When the study is announced, all her friends and fans flooded her with requests to be in the experimental group
She feels excited and honored by the responses, and
involves all her friends in the experimental group and gives them the device to try out, while
most of the regularly recruited participants are assigned to the control group
Case Study 3-3: Justice
―Kidney diseases associated with hypertension occurs in
the African American population at a rate 13.1 times
greater than that of their white counterparts‖
US census data: African American accounts for 12.3% of
US population
Tom is devising a study on the effects of medicines for
hypertension on kidney diseases, and he plans to recruit
5% Caucasian and 95% African American as participants
The findings may shed new lights on whether controlling
hypertension using medications is an effective way to
reduce the possibility of kidney diseases for all population
Justice
Justice:
Fair procedures and outcomes in the selection of research
participants,
Distribution of benefits and burdens among the populations
participating in research
Individual justice:
Benefits of participation in research are offered to a diverse eligible
population
Risks of participation in research are shared by a diverse population
Social justice: (consideration to classes of subjects)
The ability of members of that class to bear burdens
The appropriateness of placing burdens on already burdened person
Justice
Inclusion of women, minorities and children
Use of placebos – is it ethical?
Incomplete disclosure and deception
Debriefing participants after the study
International research
Research in resource-poor countries
IRB @ ISU
The purpose of the ISU IRB is to ensure that the rights and safety of human participants in research are protected
IRB advises investigators in designing research projects that minimize potential harm to participants, reviews all planned research involving human participants prior to initiation of the research, approves research that meets established criteria for protection of human participants, and monitors approved research to ascertain that participants are being protected
It takes 4 – 6 weeks on average to get approval
Should be in the final report [Gerontologist]
IRB Application
Application Form can be found at
http://www.compliance.iastate.edu/irb/forms/docs/RIHAp
plication091310.docx
You are asked to provide
General information about the study (e.g. personnel, funding
and review information)
Study specifics (e.g. recruitment/selection, study protocol,
consent process, data analysis and others)
Environmental health and safety (more applicable to medical or
biomedical projects, usually not so much for CS or design
projects)
Sample Informed Consent Form
Video recording usually requires a separate consent
A template can found at
http://www.compliance.iastate.edu/irb/forms/docs/Inform
ed-Consent-Doc-Template.doc
Remember the three principles for consent form
Voluntariness
Comprehension
Disclosure
Conclusion
Belmont Report Research Ethics 3 Principles
Respect for Persons
Individual should be treated as autonomous agents
Persons with diminished autonomy are entitled to additional protections
Beneficence
Do no harm
Maximize possible benefits and minimize possible harm
Justice
Requires that individuals and groups be treated fairly and equitably in
terms of bearing the burdens and receiving the benefits of research
In practice, any study at ISU that involve human participants
need to submit study protocol to be reviewed by IRB, which
takes 4 – 6 weeks so preparation in advance is recommended