Human Subject Research by Students at William Paterson University

Human Subject ResearchatWilliam Paterson University

September 2015www.wpunj.edu/osp/irb 9/15/20151The WP IRB is concerned with Social-Behavioral and Biomedical research that is:

A systematic investigationDesigned to develop or contribute to generalizable knowledgeInvolves living human subjects about whom an investigator obtains either personally identifying data through intervention or interaction OR identifiable personal informationRegardless of location, reason or factors motivating the researchBelmont ReportThe Common Rule (45 CFR 46)29/15/20152Human Experimentation: The Good, The Bad, & The Ugly. SciShow Sept 18, 2013 (12.26 min.)http://www.youtube.com/watch?v=hRwWxELXakA

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Research EthicsChris FlippJanuary 13, 2014(7 min.)http://www.youtube.com/watch?v=Zbi7nIbAuMQEthical Basis (Belmont Report):

Respect for PersonsAutonomous individuals are entitled to be protected, are fully informed and freely volunteer to participate

BeneficenceDo no harm! Maximize benefits while minimizing risks

JusticeBurdens and benefits are appropriately distributed between subjects and beneficiaries; no coercion to participate59/15/20155Special Classes of Subjects (Vulnerable Populations)

Federally DesignatedChildren and MinorsFetuses and Pregnant WomenPrisonersWPU DesignatedAnyone who perceives that their participation will hav a negative impact on themCognitive or development disabilityNot fluent in EnglishOther limitations that prevent them from understanding or responding to the terms or conditions of participation

69/15/20156The IRB Does Not ReviewClassroom demonstrations, exercises and/or experiments designed for the exclusive purpose of education.Pedagogical research done in the investigators own classroom.Oral history interviews done for historical research but not any social/behavioral or biomedical purposes.Research conducted by the University (or parts thereof) concerning its activities and with its own constituencies.Library research, archival research, or the use of publicly accessible databases7Undergraduate and Masters Degree Student ResearchOnly reviews research where:The outcomes will be shared outside the classroomThe research involves a special class or subjectsThe research collects identifying information on the research subject beyond a signatureThe research concerns a highly sensitive subjectThe research may elicit a negative psychological or physical response by the subject OR have a potential physical risk for the researcherBased on department and topic of researchDecided by instructor/mentor89/15/20158The IRB ReviewsEverything else that fits the definition for research involving human subjects

Initial Reviews

Continuing ReviewsAnnual, an unanticipated event, a significant change, or when research is completed

IRB can suspend or terminate a protocol if it determines thatcontinuation would not be in the best interest of subjects the information in a protocol or continuing review is wrong or misleading.9Certification of TrainingMust be renewed every three yearsIRB Policy requires investigators, instructors of students actively engaging subjects in research, IRB members and others to certify that they have received ethics training related to the use of human subjects in researchFlexibility for investigators who completed it somewhere elseCertification for professor covers everyone in her/his students that she/he is supervisingWPUNJ Training Page10Four types of Informed Consent Statements at WP

Sample Statements:http://www.wpunj.edu/osp/irb/irb-forms.dot

1. Passive consent

Participation is subjects statement of consent to participate in the research

Limited to anonymous surveys119/15/2015112. Active consent

Signature requiredFor interviews and physical contact with subjects, collection of personally identifying information, and ongoing contact with subjectParent/guardian consent required for children and minors as well as others who may not be able to decide or communicate decisionWitness included for special classes of subjects and special situations129/15/2015123. AssentFor anyone for whom an Active Consent was signed by a parent or guardian on their behalfChildren and Minors Adults with cognitive or physical challenges that prevented them from either understanding the consent document or communicating their consentMethod of obtaining verbal consent will vary by one population and situationMinors may provide an assent signature on the Active Consent Statement their parents signed139/15/2015134. Waiver of ConsentProvided by IRB when obtaining active or passive consent is impracticableUsed for observation of public behavior and emergency treatment situations

Permission to use a site does not provide consent for the subjects at that site, subjects still must also agree to participate149/15/201514Areas of Particular Interest

Data ManagementWhat data will be maintained Coding system used to protect subject identityHow data and code key will be stored separatelyHow long data will be maintained and how it will be protectedLocation of ResearchBe Specific; disclose you affiliations with locationSubject RecruitmentBe specific: Who will they be & how will you contact them. Why are they the right subjects?159/15/201515Faculty, Staff and Doctoral Student Protocols contain:IRB Protocol Face SheetNarrativePurposeDurationSubject Recruitment/SelectionProtection of SubjectsConsent ProceduresLocation of ResearchBackgroundResearch PlanStorage and Disposition of Data and RecordingsPotential Risks and Benefits169/15/201516Informed consentRecruitment lettersData InstrumentsOther attachments as neededTraining certificationConflict of Interest Disclosure if neededProtocol Face Sheet179/15/201517Student Research ProtocolA. Contact InformationB. The research planHypothesisResearch DesignWhat information will be collected?How will it be collected?How will information be stored?How will it be analyzed?189/15/201518The Research Plan, continuedHuman SubjectsWho will they be?How will they recruited?How with their personal information be protected?OutcomesBenefits, RisksScheduleStudent Protocol Form199/15/201519C. Attach:

Informed Consent Statement(s)

Data Collection ToolsSurvey or questionnaireOriginal or AcquiredInterview QuestionsObservation sheet, other items

Recruitment ResourcesFlyer or PosterEmailAnnouncement for Social Media209/15/201520Questions . . . ContactLiane RobertsonIRB Chair and Assistant Professor, EnglishRobertsonL10@wpunj.eduMartin WilliamsIRB Administrator and Director, Office of Sponsored ProgramsWilliamsM@wpunj.eduMaureen PetersProgram Assistant, Office of Sponsored ProgramsPetersM@wpunj.edu

Phone: 973-720-2852Location: Raubinger Hall, Room 309Website:http://www.wpunj.edu/osp/irbAll Forms Available On Website!219/15/201521