adam mills human subjects office september 18, 2015 irb basics

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Adam Mills Human Subjects Office September 18, 2015 IRB Basics

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Adam Mills

Human Subjects Office

September 18, 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 affiliated)

• IU has 7 IRBs between Indianapolis and Bloomington to review all student, faculty, staff research

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WHY ARE THERE REGULATIONS?

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

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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

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 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

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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

[email protected]

812-856-3753

Senta Baker, Associate

[email protected] 812-855-

0945

Adam Mills, Associate [email protected]

4687Casey Mumaw,

[email protected]

812-855-1741

Screening and Review

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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

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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)

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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

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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

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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

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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

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Exempt Submission Materials

• Study information sheet (If Applicable)

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

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Expedited Submission

• Informed Consent Template

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

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Kuali Coeus (KC-IRB)

• Online submission database

• KC-IRB can be accessed through onestartoSoon to be one.iu.edu

• Required for all submission types

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Q & A