“ 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 timeMy 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