adam mills human subjects office september 18, 2015 irb basics

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Regulatory Overview January 22, 2011

Adam MillsHuman Subjects OfficeSeptember 18, 2015IRB BasicsWhat is an IRB?Institutional Review Board (responsible to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated) IU has 7 IRBs between Indianapolis and Bloomington to review all student, faculty, staff research


ExamplesTuskegeeStanford Prison SponsorPublic Health Service(1932-1972)US Office Naval Research(1946-1948)PurposeDocument disease progression, justify future treatment optionsConflicts Between Guards and PrisonersSubject PopulationBlack malesMale StudentsInterventionsMedical examsPrison SimulationBenefitsFree meals, burial insuranceNo Direct BenefitUnethical ConductLack of informed consent, failure to treat, deceptionPhysical and Mental HarmHISTORY OF RESEARCH ETHICSNational Research Act (1974)Created due to publicity from the Tuskegee Syphilis StudyCreated the National Commission for the Protection of Human Subjects of Biomedical and Behavioral ResearchDrafted the Belmont Report


Belmont Report (1979)A statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects3 basic ethic principles:Respect for persons BeneficenceJustice6HISTORY, cont

Respect for PersonsIndividuals should be treated as autonomous (independent) agentsPersons with diminished autonomy are entitled to protectionBeneficenceHuman subjects should not be harmedResearch should maximize possible benefits and minimize possible harmsJusticeThe benefits and risks of research must be distributed fairly

7Role of HSO and IRBIRB Review Process contd

Team 3Sara Brand, Associate 812-856-3753Senta Baker, 812-855-0945Adam Mills, Associatemillsa@iu.edu812-856-4687Casey Mumaw, 812-855-1741Screening and Review9Questions to ask:Is it research?Does it involve human subjects?Scope of the Regulations10Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledgeSystematic Investigation typically involves a predetermined method for studying a specific topic, answering a specific question, testing a specific hypothesis, or developing theory.Develop or contribute to generalizable knowledge typically requires that results (or conclusions) of the activity are intended to be extended beyond a single individual or an internal program.Intervention includes both physical procedures (e.g. venipuncture) and manipulations of the living individuals or the living individuals environments.Interaction includes communication or interpersonal contact between the investigator (or research team) and the living individual.Information is considered identifiable if (1) the identity of the individual from whom the information was obtained is ascertained or may be readily ascertained by the investigator; or (2) the identity of the individual from whom the information was obtained is associated or may be readily associated with the information.Private information includes information about behavior that occurs in a context in which the individual can reasonably expect that no observation or recording is taking place or information that has been provided for specific purposes that the individual can reasonably expect will not be made public (e.g. medical records, employee or student records).

11Levels of IRB ReviewExempt review (minimal risk, 6 categories*)Expedited review (minimal risk, 7 categories) Full Board review (Greater that minimal risk)

Minimal Risk: the risks of harm anticipated in the proposed research are not greater considering the probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams or tests

ExamplesExemptCommon Educational PracticesEducational Tests, Survey Procedures, Interview Procedures, Public ObservationsPre-Existing (identifiable) DataExpeditedSurveys, interviewsProspective collection of data (Non-Research)Research on individual or group characteristics, Language, CommunicationResearch employing oral history, focus groups, or program evaluationFullExperimental drug or device studiesMost invasive proceduresSurveys/interviews that include sensitive questions or questions that are likely to be stressful to the subject, or that involve illegal behaviorMany types of research involving children, pregnant women and fetuses, cognitively impaired, and prisoners

Flex Exempt CategoriesFlex Category 6 (Traditional Expedited 6)Flex Category 7 (Tradtional Expedited 7) What qualifies? Non-Federal FundingNon FDA Regualted Non VA RegulatedChildren 14+No Other Vulnerable PopulationsPre-Submission Requirements:IU PolicyComplete the required IU Conflict of Interest Disclosure form (COI)*Complete the required Collaborative Institutional Training Initiative human subject test (CITI)Eligible Principal Investigator (PI)

14CITI TestRequired human subject test for investigators who are interacting with subjects are receiving identifiable data. There are two educational tracks: Biomedical or Social and Behavioral. You would choose the Social Behavioral Researcher Stage 1Missing CITI will hold processing Log In: 15CITI cont.A passing score of 80% is requiredSign onto the site with your IU email addressMake sure that you affiliate yourself with IUBTutorial and the test will immediately followModules will be about Regulations, Informed Consent, Privacy and Confidentiality

16ONLINE COI FORMThe University requires annual disclosures of "significant financial interests" by all faculty/ staff members and any other key personnel involved in the design, conduct or reporting of research or sponsored program activities. This is a brief online form that is required every year.Log in page: 17Eligible PIStudents are not eligible to serve as Principal InvestigatorFaculty Members/ Advisors List of eligible PIs: 18Exempt Submission MaterialsStudy information sheet (If Applicable)

Include all research instruments, e.g. recruitment materials, surveys, questionnaires, etc. as applicable19Expedited Submission Informed Consent Template

Include all research instruments, e.g. recruitment materials, surveys, questionnaires, etc. as applicable

20Kuali Coeus (KC-IRB)Online submission database

KC-IRB can be accessed through onestartSoon to be

Required for all submission types

21Q & A


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