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
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
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