exempt research mary banks bs, bsn irb director crc irb and bumc irb
TRANSCRIPT
Exempt ResearchExempt Research
Mary Banks BS, BSNMary Banks BS, BSN
IRB DirectorIRB Director
CRC IRB and BUMC IRB CRC IRB and BUMC IRB
Exempt from Further IRB Exempt from Further IRB Review Review
Studies are Exempt from further IRB review Studies are Exempt from further IRB review when:when:
• The The IRB determinesIRB determines that the project does not meet that the project does not meet the definition of human subjects research the definition of human subjects research
– there are by definition there are by definition NO HUMAN SUBJECTSNO HUMAN SUBJECTS– the study does not meet the regulatory the study does not meet the regulatory
definition of definition of RESEARCH RESEARCH • Categorical Exemption: the Categorical Exemption: the IRB determinesIRB determines that the that the
study fits into one or more exempt categories study fits into one or more exempt categories defined in the regulationsdefined in the regulations
• BU investigators areBU investigators are not engaged not engaged in the researchin the research• BU investigators are engaged in the research but BU investigators are engaged in the research but
there isthere is an authorization agreement an authorization agreement for IRB review for IRB review by another IRBby another IRB
Human SubjectsHuman Subjects
Human subjectHuman subject means a means a livinglivingindividual individual about whomabout whom an aninvestigator conducting researchinvestigator conducting researchobtains obtains 1.1. Data through intervention or Data through intervention or
interaction with the interaction with the individual, ORindividual, OR
2.2. Identifiable private Identifiable private informationinformation
45CFR 46.102(f)45CFR 46.102(f)
ResearchResearch
“ “ A A systematic systematic investigationinvestigation (including research (including research development, testing and development, testing and
evaluation), evaluation), designed designed to develop or to develop or contribute to contribute to generalizable generalizable knowledge.”knowledge.”
45CFR 46.102(d)45CFR 46.102(d)
Examples of NHSR Examples of NHSR (not human subjects (not human subjects
research)research)• Analysis of anonymous biological Analysis of anonymous biological
samples previously collected (for samples previously collected (for examples blood obtained from the Red examples blood obtained from the Red Cross)Cross)
• Program evaluation determined by the Program evaluation determined by the IRB to not meet the definition of researchIRB to not meet the definition of research
• Analysis of publically available, Analysis of publically available, anonymous data setsanonymous data sets
Categorical ExemptionsCategorical Exemptions Under the Regulations Under the Regulations
Exempt Exempt StudiesStudies
45CFR 45CFR 46.101(b)46.101(b)
Studies are Exempt Studies are Exempt UnlessUnlessHuman subjects can Human subjects can
be identifiedbe identified
ANDAND
Disclosure could Disclosure could place the subject place the subject at riskat risk
RisksRisks
• Physical RisksPhysical Risks
• Other RisksOther Risks– Criminal / civil liabilityCriminal / civil liability– Damaging to financial Damaging to financial
standing, employability, standing, employability, or reputationor reputation
Very Important PointVery Important Point
Unless otherwise Unless otherwise required… required… Exemption applies Exemption applies to research activities to research activities in which the in which the ONLYONLY involvement of involvement of human subjects will human subjects will be in one or more of be in one or more of the following the following categoriescategories
45 CFR 46.101 (b) (1)45 CFR 46.101 (b) (1)
• Research conducted in Research conducted in established educational established educational settingssettings
• Involving normal Involving normal educational practiceseducational practices– Regular/special ed Regular/special ed
strategiesstrategies– Effectiveness of / Effectiveness of /
comparison among comparison among instructional techniques, instructional techniques, curricula, classroom curricula, classroom management methodsmanagement methods
45 CFR 46.101 (b) (2)45 CFR 46.101 (b) (2)
• Research involving use of Research involving use of educational testseducational tests
• Research usingResearch using survey survey procedures, procedures, interview interview procedures, observation of procedures, observation of public behavior public behavior
• Except:Except:– If subjects can be identified If subjects can be identified
directly or through identifiers directly or through identifiers linked to subjects ANDlinked to subjects AND
– Disclosure of responses could Disclosure of responses could place subjects at risk (i.e. civil place subjects at risk (i.e. civil or criminal liability, financial or criminal liability, financial standing, etc.)standing, etc.)
– If subjects are children there If subjects are children there are limitations on the are limitations on the research research
45 CFR 46.101 (b) (3)45 CFR 46.101 (b) (3)
• Educational tests, survey / Educational tests, survey / interview procedures, interview procedures, observation of public observation of public behavior not covered in #2 behavior not covered in #2 if :if :
• Subjects are elected or Subjects are elected or appointed public officialsappointed public officials
• Federal statues require Federal statues require without exception that the without exception that the confidentiality of information confidentiality of information will be maintained will be maintained throughout the research and throughout the research and thereafterthereafter
45 CFR 46.101 (b) (4)45 CFR 46.101 (b) (4)
• Collection or study of Collection or study of EXISTING EXISTING data, data, documents, records, documents, records, specimens specimens (diagnostic/pathological)(diagnostic/pathological)
• If sources are publicly If sources are publicly available available
• If data will be If data will be recordedrecorded so so that subjects that subjects cannotcannot be be identified either directly or identified either directly or through identifiers linked through identifiers linked to subjectsto subjects
Clarification :Existing Clarification :Existing DataData
Data must exist prior Data must exist prior to the IRB to the IRB submissionsubmission
Does not apply to Does not apply to studies where data studies where data or specimens will be or specimens will be collected in the collected in the futurefuture
Subjects Can Not Be Subjects Can Not Be IdentifiedIdentified
• Data collection sheets must use Data collection sheets must use unique identifiers and there can unique identifiers and there can be be NO MASTER CODE list NO MASTER CODE list that links those identifiers that links those identifiers back to the subjectsback to the subjects
• Application must include Application must include information regarding information regarding – how the data will be collected how the data will be collected – If there are any links to subjectsIf there are any links to subjects– Copies of the data collection toolsCopies of the data collection tools
45 CFR 46.101 (b) (5)45 CFR 46.101 (b) (5)
• Research and Research and demonstration projectsdemonstration projects
• Conducted by/Approval of Conducted by/Approval of governmental governmental department heads department heads which are designed to which are designed to evaluate/ examineevaluate/ examine– Public benefit or service Public benefit or service
programsprograms– Procedures for obtaining Procedures for obtaining
benefits/servicesbenefits/services– Changes/ alternativesChanges/ alternatives– Methods of paymentMethods of payment
45 CFR 46.101 (b) (6)45 CFR 46.101 (b) (6)
• Taste and food Taste and food quality evaluationquality evaluation
• Consumer Consumer acceptanceacceptance– Wholesome foods Wholesome foods – Without additivesWithout additives– Safe by FDASafe by FDA– Approved by EPAApproved by EPA
Which Categories Most Which Categories Most Frequently Apply to BU Frequently Apply to BU
Researchers?Researchers?• Anonymous surveys Anonymous surveys
(Category 2)(Category 2)
• Interviews Interviews (Category 2)(Category 2)
• Research Use of Research Use of ExistingExisting Data Data (Category 4)(Category 4)– DatabasesDatabases– Chart reviewsChart reviews– SpecimensSpecimens
ExemptionsExemptions do NOT apply do NOT apply to:to:• Research involvingResearch involving
– Pregnant womenPregnant women– FetusesFetuses– Human in-vitro fertilizationHuman in-vitro fertilization– PrisonersPrisoners
• Survey/interview exemptionSurvey/interview exemption– Does not apply to childrenDoes not apply to children
• Observation of public behaviorObservation of public behavior– Does not apply to research with Does not apply to research with
children (except when investigator children (except when investigator does not participate)does not participate)
Review Process for Review Process for ExemptExempt
• Exempt proposal reviewed by IRB Administrative Exempt proposal reviewed by IRB Administrative Staff Staff
• Determination of ExemptionDetermination of Exemption• Exempt letter generatedExempt letter generated• No further review by IRB needed unless a change No further review by IRB needed unless a change
is made to the protocolis made to the protocol• Administrative oversight-ensure research remains Administrative oversight-ensure research remains
within the “bounds” of the Exempt category- if within the “bounds” of the Exempt category- if anything changes must be resubmitted for new anything changes must be resubmitted for new Exempt determination Exempt determination
ProcessProcess
• Investigator presents the research to the Investigator presents the research to the IRB via Exempt applicationIRB via Exempt application
• Presentation includes clear documentation Presentation includes clear documentation of how the study meets the Exempt criteria of how the study meets the Exempt criteria or does NOT meet the definition of human or does NOT meet the definition of human subjects researchsubjects research
• IRB office makes the determination of IRB office makes the determination of ExemptExempt
• IRB generates Exempt letterIRB generates Exempt letter
• Annual Review not required- no expiration Annual Review not required- no expiration datedate
• Changes must be submitted to IRBChanges must be submitted to IRB
Application Application for Exempt Studiesfor Exempt Studies
Simplified applicationSimplified application Submissions still must be Submissions still must be
signed by the department signed by the department Chair or Faculty AdvisorChair or Faculty Advisor
Student research must be Student research must be signed off by faculty advisor- signed off by faculty advisor- faculty advisor must be listed faculty advisor must be listed as a co-investigatoras a co-investigator
Human subjects protection Human subjects protection training for all investigators is training for all investigators is requiredrequired
HIPAAHIPAA
• Be aware that HIPAA regulations Be aware that HIPAA regulations could apply (i.e. if study involves could apply (i.e. if study involves medical record review) for exempt medical record review) for exempt researchresearch
• www.bumc.bu.edu/hipaawww.bumc.bu.edu/hipaa
• Many will require a Many will require a HIPAAHIPAA Waiver of Waiver of AuthorizationAuthorization
• No HIPAA Authorizations (because No HIPAA Authorizations (because research is anonymous)research is anonymous)
• Contact CRC IRB office with HIPAA Contact CRC IRB office with HIPAA questionsquestions
Important NotesImportant Notes
• IRB office IRB office – Will review the applicationWill review the application– Make determination regarding Exempt status Make determination regarding Exempt status
(criteria met)(criteria met)– Make HIPAA determinationMake HIPAA determination– ““Approve” it (i.e. mark it as Exempt) or return Approve” it (i.e. mark it as Exempt) or return
it for modifications)it for modifications)
• Research may not start until IRB approval Research may not start until IRB approval obtainedobtained
• Once it is deemed Exempt the study will Once it is deemed Exempt the study will be “closed” so no further action is be “closed” so no further action is requiredrequired
• No renewals needed No renewals needed
Exempt “Approval” LetterExempt “Approval” Letter
• Acknowledges that the research is Acknowledges that the research is Exempt Exempt becausebecause1.1. The IRB determined that the study was Not Human The IRB determined that the study was Not Human
Subject Research Subject Research OROR2.2. Exempt because it fits into one or more exemption Exempt because it fits into one or more exemption
categories- letter indicates which Exemption categories- letter indicates which Exemption category/ categories applycategory/ categories apply
3.3. States that it is exempt from further review at this States that it is exempt from further review at this institution because BU is not engagedinstitution because BU is not engaged
4.4. States that it is exempt from further review at BU States that it is exempt from further review at BU because there is an Authorization with XXX because there is an Authorization with XXX institution.institution.
• Indicates that approval does NOT necessarily mean Indicates that approval does NOT necessarily mean HIPAA is approved HIPAA is approved
• Reminds the PI to notify IRB of any changes Reminds the PI to notify IRB of any changes (Changes must be made by copying the protocol (Changes must be made by copying the protocol and resubmitting it to IRB as a new submission so and resubmitting it to IRB as a new submission so the IRB can re-evaluate the Exempt determination) the IRB can re-evaluate the Exempt determination)
PI Responsibilities for Submitting an PI Responsibilities for Submitting an IRB Protocol as ExemptIRB Protocol as Exempt
Prior to submission make sure Prior to submission make sure all all of of the research activities in the study the research activities in the study
a.a. Fit into one or more of the Exempt Fit into one or more of the Exempt categories prior to submission categories prior to submission OROR
b.b. Type A:The study (by definition) Type A:The study (by definition) does NOT involve human subjects does NOT involve human subjects researchresearch
c.c. Type C: Review the Engagement Type C: Review the Engagement memo [insert link] and describe memo [insert link] and describe research activities –why investigator research activities –why investigator is NOT engaged in the researchis NOT engaged in the research
d.d. Type D: Attach single IRB review Type D: Attach single IRB review request for studies where request for studies where Authorization Agreements neededAuthorization Agreements needed
PI ResponsibilitiesPI Responsibilities
Submit to the IRB Exempt Submit to the IRB Exempt protocol PRIOR to starting protocol PRIOR to starting the researchthe research
Wait for IRB approval Wait for IRB approval before beginning the before beginning the researchresearch
Verify that all investigators Verify that all investigators have had human subjects have had human subjects protection training and protection training and submitted a Conflict of submitted a Conflict of Interest (COI) Project Interest (COI) Project Specific Disclosure (PSD)Specific Disclosure (PSD)
If you have questionsIf you have questions
Email the IRB Email the IRB office atoffice at
617-358-6115617-358-6115