IRB-Investigator/IRB-Investigator/Research Coordinator Mtg.Research Coordinator Mtg.

““What You Can Do to Facilitate an Efficient What You Can Do to Facilitate an Efficient

IRB Review”IRB Review”

January 13, 2004January 13, 2004

George GasparisGeorge Gasparis

ObjectivesObjectives

1)1) Provide Information to Assist in the Provide Information to Assist in the Submission of Research Proposals Submission of Research Proposals to the IRB and Tips to Facilitate an to the IRB and Tips to Facilitate an Efficient IRB Review Efficient IRB Review

2)2) Provide a Basic Understanding of Provide a Basic Understanding of IRB Requirements for ApprovalIRB Requirements for Approval

Human Research at Human Research at Columbia University Columbia University

Health SciencesHealth Sciences

Governed by Ethical Principles Governed by Ethical Principles and the Requirements of and the Requirements of

HHS and FDA Regulations HHS and FDA Regulations and NY State Lawand NY State Law

DEPARTMENT OFDEPARTMENT OFHEALTH & HUMAN HEALTH & HUMAN

SERVICESSERVICES

Food and Drug Food and Drug Administration (FDA) Administration (FDA)

RegulationsRegulations

21 CFR 50 - Informed Consent21 CFR 50 - Informed Consent

21 CFR 56 - IRB21 CFR 56 - IRB

21 CFR 312 – IND, Sponsor21 CFR 312 – IND, Sponsor

21 CFR 600 – Biologics21 CFR 600 – Biologics

21 CFR 812 - Devices21 CFR 812 - Devices

45 CFR Part 4645 CFR Part 46

HHS Regulations for the HHS Regulations for the Protection of Protection of

Human SubjectsHuman Subjects

45 CFR Part 4645 CFR Part 46

Subpart A -- Basic ProtectionsSubpart A -- Basic Protections

Subpart B -- Pregnant Women,Subpart B -- Pregnant Women, Fetuses, and NeonatesFetuses, and Neonates

Subpart C -- PrisonersSubpart C -- Prisoners

Subpart D -- ChildrenSubpart D -- Children

ABCs of 45 CFR 46ABCs of 45 CFR 46

Each performance site needs:Each performance site needs:

A.A. Assurance of Compliance Approved by Assurance of Compliance Approved by OHRP (not required by FDA regulations)OHRP (not required by FDA regulations)

B.B. Board Approval (i.e., IRB, REB, ethics Board Approval (i.e., IRB, REB, ethics cmte.)cmte.)

C.C. Consent Obtained from Each Subject, Consent Obtained from Each Subject, UnlessUnless

Waived by the IRBWaived by the IRB

Columbia University Columbia University Health SciencesHealth Sciences

Federalwide Assurance Federalwide Assurance (FWA):(FWA):

FWA00002636FWA00002636

-Applies the -Applies the Belmont ReportBelmont Report and the and the Common RuleCommon Rule to all of its Human to all of its Human SubjectsSubjectsResearch Regardless of SupportResearch Regardless of Support

New York Presbyterian New York Presbyterian HospitalHospital

Federalwide Assurance Federalwide Assurance (FWA):(FWA):

FWA00002635FWA00002635

-Applies the -Applies the Belmont ReportBelmont Report and the and the Common RuleCommon Rule to all of its Human to all of its Human SubjectsSubjectsResearch Regardless of SupportResearch Regardless of Support

When Does Human Subjects When Does Human Subjects Research Need IRB Review?Research Need IRB Review?

Not Human Subjects No IRB Review Research Needed

HHS RegulationsHuman Subjects Research

that is not exempt

Needs IRB Review

Exempt Research Needs Determination of Status Exempt Research Needs Determination of Status by Someone Other Than The Investigatorby Someone Other Than The Investigator

When does Human Subjects Research When does Human Subjects Research Need IRB Review?Need IRB Review?

Not Human Subjects Research (No IRB Review)

Oral History EvaluationOral History Evaluation

Polling QAPolling QA

Gray Area

Human ResearchHuman ResearchIRB ReviewIRB Review

Ethnography Ethnography Pedagogical Res.Pedagogical Res.

Types of IRB ReviewTypes of IRB Review

1)1) Determination if human Determination if human subjects researchsubjects research

2)2) ExemptExempt

3)3) Expedited ReviewExpedited Review

4) Full Committee Review4) Full Committee Review

IRB Review and Approval IRB Review and Approval (46.111)(46.111)

This section of the regulations provides the This section of the regulations provides the criteria for IRB approval of research. It criteria for IRB approval of research. It includes requirements, such as:includes requirements, such as:

-risks to subjects are minimized,-risks to subjects are minimized,

-risks are in relation to anticipated benefits,-risks are in relation to anticipated benefits,

-selection of subjects is equitable,-selection of subjects is equitable,

-informed consent will be sought from each -informed consent will be sought from each subject,subject,

and will be appropriately documented,and will be appropriately documented,

IRB Review and Approval (46.111)IRB Review and Approval (46.111)(cont’d)(cont’d)

This section of the regulations provides This section of the regulations provides the the

criteria for IRB approval of research. Itcriteria for IRB approval of research. Itincludes requirements, such as:includes requirements, such as:

-the research plan makes adequate provision -the research plan makes adequate provision for monitoring of data,for monitoring of data,

-adequate provisions for privacy/confidentiality -adequate provisions for privacy/confidentiality of subjects,of subjects,

-when subjects are likely to be vulnerable – -when subjects are likely to be vulnerable – adequate safeguards have been includedadequate safeguards have been included

IRB Review and Approval IRB Review and Approval (46.111)(46.111)

Risks to subjects are minimized:Risks to subjects are minimized:

First, must identify risks:First, must identify risks:

Examples:Examples:-Emotional distress-Emotional distress -Psychological -Psychological traumatrauma-Invasion of privacy-Invasion of privacy -Embarrassment-Embarrassment-Loss of social status-Loss of social status -Loss of -Loss of employmentemployment-Stigmatization-Stigmatization

Which Regulations Apply?Which Regulations Apply?

HHS

FDA

Informed Consent:Informed Consent:Differences Between FDA and HHS Differences Between FDA and HHS

RegulationsRegulations

WAIVER OF CONSENTWAIVER OF CONSENT

HHS - Provides for Waiver of Consent or HHS - Provides for Waiver of Consent or

Elements of Consent for Minimal Risk ResearchElements of Consent for Minimal Risk Research

(45 CFR 46.1116d)(45 CFR 46.1116d)

FDA - Does Not Have Such a ProvisionFDA - Does Not Have Such a Provision

Informed Consent: Informed Consent: Differences Between FDA and HHS Differences Between FDA and HHS

RegulationsRegulations

HHS - Provides for Waiver of HHS - Provides for Waiver of

Documentation of Consent Documentation of Consent

FDA - Does Not Have Such a ProvisionFDA - Does Not Have Such a Provision

IRB-Investigator/IRB-Investigator/Research Coordinator Mtg.Research Coordinator Mtg.

““What You Can Do to Facilitate an Efficient What You Can Do to Facilitate an Efficient

IRB Review”IRB Review”

January 13, 2004January 13, 2004

““What You Can Do to Facilitate an What You Can Do to Facilitate an Efficient IRB Review”Efficient IRB Review”

Definition of Human Subjects ResearchDefinition of Human Subjects Research

Tips to Facilitate Efficient IRB ReviewTips to Facilitate Efficient IRB Review

IRB Terminology Related to Data CollectionIRB Terminology Related to Data Collection

Criteria for IRB ApprovalCriteria for IRB Approval

Categories of Exempt ResearchCategories of Exempt Research

Categories of Expedited ReviewCategories of Expedited Review

Criteria for Waiver of the Elements of Criteria for Waiver of the Elements of ConsentConsent

Criteria for Waiver of Written Criteria for Waiver of Written Documentation of Informed ConsentDocumentation of Informed Consent