1、Adam Mills Human Subjects Office September 4, 2015,IRB Basics,What 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 affiliat
2、ed) IU has 7 IRBs between Indianapolis and Bloomington to review all student, faculty, staff research,2,WHY ARE THERE REGULATIONS?,HISTORY OF RESEARCH ETHICS,National Research Act (1974) Created due to publicity from the Tuskegee Syphilis Study Created the National Commission for the Protection of H
3、uman Subjects of Biomedical and Behavioral Research Drafted the Belmont Report,5,HISTORY OF RESEARCH ETHICS, cont,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 subject
4、s 3 basic ethic principles: Respect for persons Beneficence Justice,6,HISTORY, cont,Respect for Persons Individuals should be treated as autonomous (independent) agents Persons with diminished autonomy are entitled to protection Beneficence Human subjects should not be harmed Research should maximiz
5、e possible benefits and minimize possible harms Justice The benefits and risks of research must be distributed fairly,7,Role of HSO and IRB,IRB Review Process contd,Screening and Review,9,Questions to ask: Is it research? Does it involve human subjects?,Scope of the Regulations,11,Levels of IRB Revi
6、ew,Exempt 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
7、in daily life or during the performance of routine physical or psychological exams or tests,Examples,Exempt Common Educational Practices Educational Tests, Survey Procedures, Interview Procedures, Public Observations Pre-Existing (identifiable) Data Expedited Surveys, interviews Prospective collecti
8、on of data (Non-Research) Research on individual or group characteristics, Language, Communication Research employing oral history, focus groups, or program evaluation Full Experimental drug or device studies Most invasive procedures Surveys/interviews that include sensitive questions or questions t
9、hat are likely to be stressful to the subject, or that involve illegal behavior Many types of research involving children, pregnant women and fetuses, cognitively impaired, and prisoners,Flex Exempt Categories,Flex Category 6 (Traditional Expedited 6) Flex Category 7 (Tradtional Expedited 7) What qu
10、alifies? Non-Federal Funding Non FDA Regualted Non VA Regulated Children 14+ No Other Vulnerable Populations,Pre-Submission Requirements: IU Policy,Complete the required IU Conflict of Interest Disclosure form (COI)* Complete the required Collaborative Institutional Training Initiative human subject
11、 test (CITI) Eligible Principal Investigator (PI),14,CITI Test,Required 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 Sta
12、ge 1 Missing CITI will hold processing Log In: http:/researchcompliance.iu.edu/eo/eo_citi.html,15,CITI cont.,A passing score of 80% is required Sign onto the site with your IU email address Make sure that you affiliate yourself with IUB Tutorial and the test will immediately follow Modules will be a
13、bout Regulations, Informed Consent, Privacy and Confidentiality,16,ONLINE COI FORM,The 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 a
14、ctivities. This is a brief online form that is required every year. Log in page: http:/researchcompliance.iu.edu/coi/coi_disclosure.html,17,Eligible PI,Students are not eligible to serve as Principal Investigator Faculty Members/ Advisors List of eligible PIs: http:/researchcompliance.iu.edu/hso/hs_
15、inv_req.html,18,Exempt Submission Materials,Study information sheet (If Applicable)Include all research instruments, e.g. recruitment materials, surveys, questionnaires, etc. as applicable,19,Expedited Submission,Informed Consent TemplateInclude all research instruments, e.g. recruitment materials, surveys, questionnaires, etc. as applicable,20,Kuali Coeus (KC-IRB),Online submission database KC-IRB can be accessed through onestart Soon to be one.iu.eduRequired for all submission types,21,Q & A,
