Post on 04-Jan-2016
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 affiliated)
• IU has 7 IRBs between Indianapolis and Bloomington to review all student, faculty, staff research
2
Examples Tuskegee Stanford Prison
Sponsor Public Health Service(1932-1972)
US Office Naval Research
(1946-1948)
Purpose
Document disease progression, justify
future treatment options
Conflicts Between Guards and Prisoners
Subject Population Black males Male Students
Interventions Medical exams Prison Simulation
Benefits Free meals, burial insurance No Direct Benefit
Unethical ConductLack of informed consent, failure to treat, deception
Physical and Mental Harm
HISTORY OF RESEARCH ETHICS
• National Research Act (1974)oCreated due to publicity from the
Tuskegee Syphilis StudyoCreated the National
Commission for the Protection of Human Subjects of Biomedical and Behavioral Research• Drafted the Belmont Report
5
HISTORY OF RESEARCH ETHICS, con’t
• Belmont Report (1979)oA statement of basic ethical
principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects
o 3 basic ethic principles:• Respect for persons • Beneficence• Justice
6
HISTORY, con’t
o Respect for Persons• Individuals should be treated as
autonomous (independent) agents• Persons with diminished autonomy are
entitled to protectiono Beneficence
• Human subjects should not be harmed• Research should maximize possible
benefits and minimize possible harmso Justice
• The benefits and risks of research must be distributed fairly
7
Role of HSO and IRB
Human Subjects Office
• Provides administrative support to IRBs and guidance to investigators
IRB • Makes final determination
IRB Review Process cont’d
Team 3Sara Brand, Associate
Dir.slbenken@indiana.edu
812-856-3753
Senta Baker, Associate
skbaker@iu.edu 812-855-
0945
Adam Mills, Associate millsa@iu.edu812-856-
4687Casey Mumaw,
Consultantkmumaw@iu.edu
812-855-1741
Screening and Review
9
RESEARCH:
Systematic
investigation to
develop or contribute
to generaliza
ble knowledge
HUMAN SUBJECT:Research about a living
individual either
through intervention/ interaction
or identifiable
private information
IRB Review
Questions to ask:– Is it research?– Does it involve human subjects?
Scope of the Regulations
11
Levels of IRB Review
1.Exempt review (minimal risk, 6 categories*)
2.Expedited review (minimal risk, 7 categories)
3.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
Examples• Exempt
o Common Educational Practiceso Educational Tests, Survey Procedures, Interview Procedures, Public
Observationso Pre-Existing (identifiable) Data
• Expeditedo Surveys, interviewso Prospective collection of data (Non-Research)o Research on individual or group characteristics, Language, Communicationo Research employing oral history, focus groups, or program evaluation
• Fullo Experimental drug or device studieso Most invasive procedureso Surveys/interviews that include sensitive questions or questions that are likely
to be stressful to the subject, or that involve illegal behavioro 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 qualifies? o Non-Federal Fundingo Non FDA Regualted o Non VA Regulatedo Children 14+o 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 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 Stage 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 about 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 activities. 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 PI’s: http://
researchcompliance.iu.edu/hso/hs_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 Template
• Include 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 onestartoSoon to be one.iu.edu
• Required for all submission types
21