Human Subject Protection in Research - School of Humanities

,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,*,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,Human Subject Protection in Research,Val Sanchez,MA,CCRP,IRB Administrator,November 14,2021,UCI Office of Research,Led by:,Vice Chancellor for Research(John Hemminger),Associate Vice Chancellor for Research(James Hicks),Two Divisions:,Sponsored Projects,Research Protections,Human Research Protections(HRP),Animal Care and Use,Human Stem Cell,DHHS(OHRP)Definition,45 CFR 46.102(d)Research-,a,(1),systematic investigation,including research development,testing and evaluation,(2),designed to develop or contribute to generalizable knowledge.,A,systematic investigation,involves a plan which incorporates collection of data,either quantitative or qualitative,or specimens;and analysis to answer a question.,Activities,designed to develop or contribute to generalizable knowledge,are those activities designed to draw general conclusions(i.e.,knowledge gained from a study may be applied to populations beyond the specific study population),inform policy,or generalize findings.,DHHS(OHRP)Definition,45 CFR 46.102(f)Human Subject,-a,living individual about whom,an investigator(faculty,staff,or student)conducting research obtains,(1),data through intervention or interaction with the individual,or,(2),identifiable private information.,Intervention,includes both physical procedures by which data are gathered and manipulations of the subject or the subjects environment that are performed for research purposes.,Interaction,includes communication or interpersonal contact between researcher and subject.,Private information,includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place,and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public(for example,a medical record information).Private information must be individually identifiable,.,Individually identifiable,includes where the identity of the subject is or may be ascertained by the researcher or associated with the information.,Research Ethics Timeline,Research Ethics Timeline,Belmont Principles(1979),Respect for Persons,(Be Respectful),Individuals should be treated as autonomous agents,Individuals with limited autonomy are entitled to protection,Beneficence,(Be Nice),Do no harm,Minimize risk/maximize benefits,Justice,(Be Fair),Fair distribution of risks and benefits of research,Criteria for Approval,BENEFICENCE,JUSTICE,RESPECT FOR PERSONS,Experimental Design Risk/Benefit AnalysisData Safety,Qualifications of Researchers,46.111,56.111,Privacy&Confidentiality Vulnerable Populations,Informed Consent,Surrogate Consent,Parent Permission/Assent,Subject Selection,Inclusion/Exclusion,Recruitment,Fair Distribution,Institutional Review Board,UCI has four IRB Committees:,IRBs“A and“B review biomedical research,IRB“C reviews social/behavioral/educational,Team“D minimal risk biomedical research,IRB“E reviews non-compliance issues,IRB C,Led By:,Chair,Elizabeth Cauffman,PhD-Psychology&Social Behavior,Vice Chair,JoAnn Prause,PhD Psychology&Social Behavior,Transaction Types:,New Applications,Modifications/Amendments to approved studies,Continuing Review of approved studies,Adverse Events,Meetings:,Full-Committee:Monthly(3,rd,Friday),Subcommittee:Weekly(every Friday morning),Level of Risk Generally,Determines,Level of Review,Exempt*,SubC,Admin,Sr.Analyst,Expedited*,Subcommittee,Convened IRB Meeting,Full Committee,Minimal Risk,RISK,*,defined by lists in regulations,Virtually No Risk,Minimal Risk,Exempt Review,See,Category 1.School Based Research,research in an educational setting(classroom,dojo),(a)instructional strategies or,(b)comparing instructional techniques,curricula or classroom management methods.,Category 2.Interviews,Surveys,Observation of Public Behavior,Cannot identify subject(anonymous or de-identified),or,Data is identifable,but subject is not at risk of criminal or civil liability or be damaging to the subjects financial standing,employability or reputation.,Category 3.Public Officials,Interviews or observation of public behavior of elected or appointed public officials or candidates for public office,Category 4.Records Review,Collection of,existing,data,recorded such that subjects cannot be identified,Expedited Review,Category 4.fMRI,-Collection of data thru noninvasive means,including studies using cleared medical devices,Category 5.Records Review,involving materials collected for non research purposes that have been collected or,will