“ Research with human
subjects”
SUA IRB Committee Orientation
So you want to do research with
human subjects?
• Congratulations!
• Why do you need to
apply to the IRB?
• Who is the IRB?
• How do I apply?
Who is the IRB?
• Esther S. Chang, Ph.D. (Chair)
– Professor of Psychology
• Anna Varvak, Ph.D.
– Professor of Mathematics
• Ted Lowe, Ph.D.
– Professor of Anthropology
• Tomomi Tagawa
– SUA Student Member
• Jack Walker, M.A.
– English Language Programs Director
We are your friends!
What do we do?
• Don’t evaluate the scientific merits of the proposed
research
– You and your mentor are the experts
• We examine the proposed procedures, use of
psychological measurements, any informed consent
documents, and plans for debriefing, if applicable
• Do help to ensure that your research participants are
treated ethically according to established guidelines
Ultimately …
You are responsible and
accountable for the ethical
conduct of your research
What is Research?
 A systematic investigation designed
to develop or contribute to
generalizable knowledge
 systematic: use of theory and
hypotheses
 designed with a goal
 generalizable knowledge
 uncovering causes
Why does the IRB oversee
research with human subjects?
• Medical experiments
– Nazi Germany during WW2
– Tuskegee syphilis project
• Psychological experiments
– Milgram “Obedience” studies
The Belmont Report
• Ethical principles and guidelines for the
protection of human subjects of research issued
by US Dept of HHS (1979)
– Assessment of risks and benefits of your research
– Informed consent or study information for participants
– Details regarding the selection of subjects
Principle of Beneficence
• The need for research to maximize the
benefits and minimize any possible
harmful effects of participation
• Do your research procedures minimize
risk to participants?
– Potential harm: Psychological, physical harm,
loss of confidentiality
– Potential benefits: educational benefits or
acquisition of new skill, material benefits
(raffle), satisfaction gained from participating
in scientific research  social benefits
Principle of Autonomy
• Participants are treated with respect: as
autonomous individuals who are capable of
making decisions about their own participation
• Do you have a study information sheet or an
informed consent procedure?
– All info needed to make a decision whether to
participate
– Sample on SUA website
– Translation, if necessary
– Signature not always necessary, depends on level of
review (later)
Autonomy issues:
• Are you forcing participants to participate?
– Any procedure that limits an individual’s freedom
to consent is potentially coercive
– Deception must be justified (debriefing required)
– SUA students asking SUA students (how will you
minimize social pressure?)
• Explicitly state in application under your
procedures!
Principle of Justice
• EQUITY: Addressing the issue of fairness in
receiving the benefits of research and in
bearing any burdens
• Are your participants sharing in the benefits
and burdens equally?
– Selection of participants by age, gender,
ethnicity etc…must be rationalized
– Equal chances for compensation should be
considered or rationalized
The application
Status of your research:
• Exempt
– No risk of harm
– Typically
• anonymous questionnaires
• naturalistic observations in public places with no threat to
anonymity
• Archival research, publically available data
– Do not need signed informed consent, but need study
information before start
Note:
– You can’t decide on your own that your research is
exempt
– Need to apply for this status.
• Expedited
– Minimal risk of harm or stress, not greater
than risk encountered in daily life or routine
physical or psych tests
– Typically
• Identifying information collected
• Recording physiological data (weighing, voice
recorded interview)
• Use of moderate exercise
• Studies of perception, game theory or test
development without stress
• Full review by committee
– Greater than minimal risk, involves stress or
deception
– Need for informed consent,
– threats to autonomy by using vulnerable
populations
•
•
•
•
•
minors
homeless
psychiatric patients
adults with cognitive impairments (nursing home)
Preferred if your mentor has expertise and
qualifications to study these populations
Be prepared
• Application requires
– Description of risks and benefits
– Procedures for minimizing risks
• wording of informed consent or study information (website
sample)
• wording of recruitment script
– how and when debriefing will take place, if
applicable
– Procedures for maintaining confidentiality
• data will be downloaded with names for purposes of the raffle,
but immediately separated. I will save names in a different
file in a different folder from the data on my U drive account,
which is password protected
• Don’t drive around OC with surveys in your backseat
that have names attached
• If stolen, call me at 480-4240 immediately
Give the IRB time
My office is located in Ikeda 420
Procedures need detail
• How and where will you collect data?
Exactly…
– Will you walk around campus?
– Will you email the student body with a link to
your survey?
– Will you sit at a table at the Bistro?
– Will you go off campus?
• What will you say?
Important details
• How will you download data?
• How will you separate names with data during
data collection?
–
–
–
–
–
–
Walk around with a box?
Ask participants to mail it to you?
If names are attached, how will you separate them?
How will you store?
When and how will you throw your data away?
When will files with names be deleted? Where will they
be stored?
• Contact me if you lose data with names attached