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