“ Research with human subjects ” SUA IRB Committee OrientationIRB Committee
Post on 03-Jan-2016
Embed Size (px)
Research with human subjectsSUA 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 PsychologyAnna Varvak, Ph.D.Professor of MathematicsTed Lowe, Ph.D.Professor of AnthropologyTomomi Tagawa SUA Student MemberJack Walker, M.A.English Language Programs Director
We are your friends!
What do we do?Dont evaluate the scientific merits of the proposed researchYou 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 knowledgesystematic: use of theory and hypothesesdesigned with a goalgeneralizable knowledgeuncovering causes
Why does the IRB oversee research with human subjects?Medical experimentsNazi Germany during WW2Tuskegee syphilis project
Psychological experimentsMilgram Obedience studies
The Belmont ReportEthical 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 BeneficenceThe 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 confidentialityPotential benefits: educational benefits or acquisition of new skill, material benefits (raffle), satisfaction gained from participating in scientific research social benefits
Principle of AutonomyParticipants 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 participateSample on SUA websiteTranslation, if necessarySignature not always necessary, depends on level of review (later)
Autonomy issues:Are you forcing participants to participate?
Any procedure that limits an individuals 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 etcmust be rationalized
Equal chances for compensation should be considered or rationalized
Status of your research:ExemptNo risk of harmTypicallyanonymous questionnairesnaturalistic observations in public places with no threat to anonymityArchival research, publically available dataDo not need signed informed consent, but need study information before startNote:You cant decide on your own that your research is exempt Need to apply for this status.
ExpeditedMinimal risk of harm or stress, not greater than risk encountered in daily life or routine physical or psych tests
TypicallyIdentifying information collectedRecording physiological data (weighing, voice recorded interview)Use of moderate exerciseStudies of perception, game theory or test development without stress
Full review by committeeGreater than minimal risk, involves stress or deceptionNeed for informed consent, threats to autonomy by using vulnerable populationsminorshomelesspsychiatric patientsadults with cognitive impairments (nursing home)Preferred if your mentor has expertise and qualifications to study these populations
Be preparedApplication requiresDescription of risks and benefitsProcedures for minimizing riskswording of informed consent or study information (website sample)wording of recruitment script how and when debriefing will take place, if applicableProcedures 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 protectedDont drive around OC with surveys in your backseat that have names attachedIf stolen, call me at 480-4240 immediately
Give the IRB timeMy office is located in Ikeda 420
Procedures need detailHow and where will you collect data? ExactlyWill 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 detailsHow 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
***I fixed grammar, to make it match.******Slight change in wording.***Slight change in formatting.**Slight change in grammar.