approval of human subjects research: who needs it and why?
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Approval of Human Subjects Research: Who needs it and why?. Dr. Paula Garcia McAllister, IRB Director Northern Arizona University [email protected] 928-523-4236 research.nau.edu/compliance/ irb. What is the IRB?. - PowerPoint PPT PresentationTRANSCRIPT
Approval of Human Approval of Human Subjects Research: Subjects Research: Who needs it and why?Who needs it and why?
Dr. Paula Garcia McAllister, IRB Dr. Paula Garcia McAllister, IRB DirectorDirectorNorthern Arizona UniversityNorthern Arizona UniversityPaula.Garcia@nau.edu928-523-4236928-523-4236research.nau.edu/compliance/irb research.nau.edu/compliance/irb 1
What is the IRB?What is the IRB?The Institutional Review Board is a
panel of researchers, non-researchers, and community members concerned with protecting the rights of individuals participating in research in terms of:
Risk of physical, mental, emotional or financial harm
Full disclosure of research procedures and outcomes
Confidentiality of personal information, views and opinions
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Does my project need to be Does my project need to be reviewed by the IRB?reviewed by the IRB?Does it involve human subjects?Will you be obtaining personal
identifiable information? Does it involve a systematic
investigation in which you interact with people?
Will it be published, presented, or disseminated beyond the classroom environment?
Is it a thesis or dissertation? 3
What is human subjects What is human subjects research?research?
Research is “a systematic investigation that is designed to develop or contribute to generalizable knowledge.”
Human subject means “a living individual about whom an investigator conducting research obtains: data through intervention or interaction with
the individual, or identifiable private information.”
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm
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Past events shaped today’s Past events shaped today’s regulations:regulations: Nazi Human Experimentation,
search Steven Spielberg Video Archive of Nuremberg Trials
Monster Study, 1939, settled in 2007
Tuskegee Syphilis Study, 1932-1972 Guatemalan STD Study, 1946-1948 ASU – Havasupai Tribe settlement
of $700,000 plus scholarships and facilities
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Cases from PsychologyCases from Psychology Robbers Cave Experiments – 1954 Harvard Psilocybin Experiments –
research on psychedelic drugs – 1960-1962
Milgrim Experiments – 1961-1963 Stanford Prison Experiment, 1971 APA Position Against Torture and Other
Cruel, Inhuman, or Degrading Treatment or Punishment and Its Application to Individuals Defined in the United States Code as “Enemy Combatants” – 2008
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What do I need to do as a What do I need to do as a researcher?researcher?Have a research plan that warrants
the use of human participantsBe knowledgeable about the
federal guidelines for human subjects research (CITI tutorial)
Provide the IRB with a fully-detailed plan for complying with the guidelines
Carry out your plan in good faith
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What are the responsibilities What are the responsibilities of the faculty sponsor?of the faculty sponsor?To guide the student researcher
through the research design process
To take the CITI tutorialTo review the student
researcher’s IRB application and provide feedback
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What will the IRB ask for?What will the IRB ask for?1. Participants1. ParticipantsHow many?Different groups Age rangeSocial or occupational situationsSpecial categories:
◦ children, pregnant women and their fetuses, and prisoners are considered vulnerable,
◦ economically or educationally disadvantaged persons, and cognitively impaired persons may also require additional safeguards
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2. Recruitment2. RecruitmentWhat is your plan for recruiting
participants?Include all flyers, email
messages, memos, etc. that will be used
Should include topic, what is expected from participants, time/place, benefits and risks, compensation, contact info
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3. Informed Consent3. Informed Consent
PLAN for disseminating informed consent info to participants
How will it be delivered? (in person, email, telephone)
Must include specific elementsTemplates available on websiteSignature can be waived in rare
circumstances
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4. Methodology and Data 4. Methodology and Data CollectionCollectionWhat instruments will be used:
surveys, focus groups, observations, etc.
Special requirements for photographs, audio and video recordings
Off-campus sites, collaborators, partners, etc.
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5. Confidentiality5. ConfidentialityWill identifiers be revealed?How will confidentiality be
maintained?Data must be kept secure for 3
years after completion of studyPhotos and audio/video
recordings require a disposition plan and checkbox on informed consent form
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6. Benefits6. BenefitsWhat are the potential benefits to
the participants?What are the benefits to society or
the field?There may not be any direct
benefits to individualsCompensation is described
separately and should not be coercive, should be a small token of thanks that is culturally appropriate
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7. Risks7. RisksWhat are all the possible risks
participants may face, including psychological, social, or physical
If minimal, say ‘no more than the risk encountered in everyday life’
What will you do to minimize risks? (e.g., provide contact information for counseling service)
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What else will the IRB ask What else will the IRB ask for?for?Descriptions of the research free of
jargon, acronyms, and overly technical language
Support documents from collaborating partners, target agencies, or off-campus locales
Designation of other researchers involved
All instruments (surveys, questionnaires, checklists, assessments, etc) even if in draft form
Informed consent documents 16
Types of ReviewTypes of ReviewFull Board: greater than minimal
risk, vulnerable populationsExpedited: low risk, recordings,
focus groups, non-invasive procedures
Exempt: minimal risk, surveys, records review, de-identified data
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Other FunctionsOther FunctionsContinuing review: extend IRB approval
beyond the usual 12 month periodAmendments: report changes in
instruments, participants, sample, additional partners, sites, or researchers
Adverse events: unforeseen complications, problems, or other research-related negative consequences should be reported to the IRB as soon as possible
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Consequences of Non-Consequences of Non-ComplianceCompliance
All researchers are required to follow the guidelines in 45 CFR 46
Anybody can report non-compliance Disciplinary actions can include
suspension or termination of research, seizure of all data, prevention of publication or presentation, written reprimand, and sanction from conducting future research
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ResourcesResources Federal Government:
http://www.hhs.gov/ohrp/ Tribal IRBs: Contact IRB office for
information Educational Research Ethics (AERA):
http://www.aera.net/AboutAERA/Default.aspx?menu_id=90&id=717
Psychological Research Ethics (APA): http://www.apa.org/ethics/
Political Science Research Ethics (APSA): http://www.apsanet.org/content_9350.cfm?navID=12 20