Approval of Human Approval of Human Subjects Research: Who Subjects Research: Who needs it needs it and why?and why?

Dr. Paula Garcia McAllister, IRB Dr. Paula Garcia McAllister, IRB DirectorDirectorNorthern Arizona UniversityNorthern Arizona UniversityPaula.Garcia@nau.eduPaula.Garcia@nau.edu928-523-4236928-523-4236Web: Web: research.nau.edu/compliance/irb research.nau.edu/compliance/irb

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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 Stanford Prison Experiment, 1971 ASU – Havasupai Tribe settlement

of $700,000 plus scholarships and facilities

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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

To accept the student’s online IRB application and respond to the conflict of interest question

To make sure students file continuations and amendments 7

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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8. Attachments8. AttachmentsInstruments: surveys, interview

questions, observation checklists, tests, etc.

Informed consent, parental consent, and child assent documents

Letters of support/permission to collect data

Recruitment flyers, emails, scripts

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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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Other Local IRBsOther Local IRBs Flagstaff Medical Center:

Cynthia.Beckett@nahealth.com, Director, Pediatrics/Perinatal Services & Evidence-Based Practice OR Gretchen.McMasters@nahealth.com Evidence-Based Practice Project Manager/Coordinator, 928-773-2346

Navajo Nation Human Research Review Board meets the 3rd Tuesday of each month at 9 AM in Window Rock, AZ, open to the public: http://www.nnhrrb.navajo.org/

Hopi Cultural Preservation Office: http://www.nau.edu/~hcpo-p/

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ResourcesResources Federal Government:

http://www.hhs.gov/ohrp/ IRB Profession: http://www.irbforum.org/,

http://www.primr.org/ 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

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