Ethics

1
Ethics IRB

• Doing right by your participants

2
Evaluation means people

• Recall
• Users and their tasks are identified
• Needs and requirements are specified
• Interface is designed, prototype built
• But is it any good? Does the system support the
  users in their tasks? Is it better than what was
  there before (if anything)?
• Evaluating your design requires human
  participants
• Issues of rights, respect, ethics

3
IRB, participants ethics

• Institutional Review Board (IRB)
• http//www.osp.gatech.edu/complaince.htm
• Reviews all research protocols involving human
  (or animal) participants
• Safeguarding the participants, and thereby the
  researcher and university
• Not a science review (i.e., not to assess your
  research ideas) only safety ethics

4
Ethics

• Testing can be arduous privacy is important
• Each participant should consent to be in
  experiment (informal or formal)
• Know what experiment involves, what to expect,
  what the potential risks are
• Must be able to stop without danger or penalty
• All participants to be treated with respect

5
Ethics certification

• Ethics is not just common sense
• Training being standardized to ensure even and
  equal understanding of issues
• Online CITI Training
• Required online training
• http//www.osp.gatech.edu/compliance/humans/Human_
  Training.doc
• http//www.citiprograms.org/

6
Why is this important?

• Some more history lessons
• Medical behavioral research roots

7
Some history

• Research prior to the 1900s
• WWII research ? Nuremberg Code, which includes
  the following guidance for researchers
• Informed consent is essential
• Research should be based on prior animal work
• The risks should be justified by the anticipated
  benefits
• Only qualified scientists must conduct research
• Physical and mental suffering must be avoided
• Research in which death or disabling injury is
  expect should not be conducted

8
Impact of Nuremberg Code

• Strength of law was missing
• Implicit in most research work (?)
• World Medical Association developed Declaration
  of Helsinki (1964)
• Code of research ethics that was a
  reinterpretation of Nuremberg Code
• Journal editors required research performed in
  accordance with the Declaration

9
Beecher article (1966)

• Dr. Henry K. Beecher, anesthesiologist,
  heightened the awareness of researchers, the
  public, and the press to the problem of unethical
  human subjects research
• Described 22 examples of research studies with
  controversial ethics

10
Ethical problems

• Lack of informed consent
• Coercion of undue pressure on volunteers (or on a
  parent to volunteer their child)
• Use of a vulnerable population
• Exploitation of a vulnerable population
• Withholding information
• Withholding available treatment
• Withholding information about risks
• Putting subjects at risk
• Risks to subjects outweigh benefits
• Deception
• Violation of rights

11
PHS syphilis study (1932-1971)

• Public Health Service study of natural history of
  syphilis in African American men
• 28 deaths
• 100 cases of disability
• 19 cases of congenital syphilis
• Ad hoc Panel formed by Congress determined study
  should be stopped (after the press blew the
  whistle) recommended federal regulations
  protecting human research subjects

12
The Belmont Report (1979)

• Principle of respect for persons
• Informed consent (throughout the study)
• Allows subject to withdraw from study maintains
  subjects welfare
• Principle of beneficence
• Social scientific value of research
• Validity of research
• Favorable risk-benefit ration
• Principle of justice
• Fair subject selection (inclusion exclusion)
• Methods of recruitment

13
Back to IRB
14
Protocol approval

• Obtain IRBWise username password
• Submit protocol, including description of
  experiment, participants, consent form, etc.
• Modify as necessary to ensure compliance
• Obtain approval
• Including approved consent form
• Conduct study appropriately

15
Recruiting participants

• Various subject pools
• Volunteers
• Paid participants
• Students (e.g., psychology students) for course
  credit
• Friends, acquaintances, family, lab members
• Public space participants e.g., observing
  people walking through a museum
• Must fit user population (validity)
• Motivation is a big factor not only but also
  explaining the importance of the research
• Note Ethics, IRB, consent apply to all
  participants, including friends pilot subjects

16
Consent

• Why important?
• People can be sensitive about this process and
  issues
• Errors will likely be made, participant may feel
  inadequate
• May be mentally or physically strenuous
• What are the potential risks (there are always
  risks)?
• Examples?
• Vulnerable populations need special care
  consideration ( IRB review)
• Children disabled pregnant students (why?)

17
Before study

• Be well prepared so participants time is not
  abused
• Make sure they know you are testing software, not
  them
• (Usability testing, not user testing)
• Maintain privacy
• Explain procedures without compromising results
• Can quit anytime
• Administer signed consent form

18
During study

• Make sure participant is comfortable
• Session should not be too long
• Maintain relaxed atmosphere
• Never indicate displeasure or anger (and over
  excitement)

19
After study

• State how session will help you improve system
  (debriefing)
• Show participants how to perform failed tasks
• Dont compromise privacy (never identify people,
  only show videos with explicit permission)
• Data to be stored anonymously, securely, and/or
  destroyed

20
Example material

• Consent form
• Study plan
• Demographic questionnaire
• Introduction script
• Interview

21
IRB contact information

• Georgia Tech IRB contact
• Melanie Clark(Melanie.Clark_at_osp.gatech.edu)
• http//www.osp.gatech.edu/complaince/humans/humans
  .htm
• More details on the Project web page