The UW health sciences irbs OverviewPractical regulatory issues in human subjects research

1The UW HS IRBs ProcessIs IRB Review Needed?The Institutional Review BoardThe UW HS IRBs Resources

Topic overview

2The UW HS IRBs Process

3Institutional Review BoardProtects the rights and welfare of human research subjectsHelps ensure compliance with rules and regulations:federal stateuniversity Criteria for IRB Approval45 CFR 46.111 (DHHS), 21 CFR 56.111 (FDA), and 38 CFR 16.111 (VA) KB 19230Human subjects research SHOULD NOT commence without prior IRB approval or exemptionWhat is an IRB?

4UW IRBsHS-IRBMR-IRB

SBS ED IRBirb.wisc.edu

ALL UW IRBs USE ARROWExternal IRBsWestern IRB (WIRB) for most industry-sponsored researchkb.wisc.edu/wirbgatewayNCI CIRB IRB for some cancer trialskb.wisc.edu/hsirbs/19695Meriter Hospital for some OB-GYN researchkb.wisc.edu/hsirbs/21707Aurora in Milwaukee, Medical College of Wisconsin and Marshfield Clinic through the Wisconsin IRB Consortium (WIC)kb.wisc.edu/hsirbs/21707

Campus IRBsShared office.

5Categories of irb review

6Submission Process Overviewfull board

7Initial Review Application: Full ReviewAny study that poses more than minimal riskMinimal risk research that is not exempt or not a medical records reviewInitial Review Application: Non-Exempt Medical Records ReviewFor studies of medical records or images (e.g., those that retain identifiers)Initial Review Application: ExemptionMust be minimal riskSome survey and interview studiesSome evaluations of educational activities, curriculaUse of existing data (e.g., some medical records research), specimens that are unidentifiable (e.g., residual tissue)Application Types

8Submission Process Overview

Exemption AppsExpedited ReviewNon-Exempt Medical Record Review Apps

9Is IRB review needed?

10Quality Improvement/Program Evaluation projects do not need to be submitted for IRB reviewMany Resources to help researchers make determinationResearch Decision ToolResearch Decision TreeCharacteristics of Research, Quality Improvement and Program Evaluation Activities

Research vs. quality improvement and program evaluation

11Research, QI, PE table

12Exempt status is determined by the IRB office, not researchers, via an exemption applicationAn exemption means the IRB determines that the project is exempt from further IRB review Exempt research does not require ongoing oversight by an IRBSix categories of exemption allowed under the Common Rule; three categories are common:CategoriesHIPAA still applies to exemptions using PHI

Exemptions

13De-identified data: refers to data that have been stripped of all subject identifiers, including all 18 HIPAA identifiers. This means that there can be no data points that are considered limited identifiers under HIPAA, i.e. geographic area smaller than a state, elements of dates (date of birth, date of death, dates of clinical service), and age over age 89. If the data set contains any limited identifiers, it is considered a limited data set under HIPAA. If the data includes an indirect link to subject identifiers (e.g. via coded ID numbers), then the data is considered by the IRB to be coded, not de-identified. Anonymous data: essentially the same thing as de-identified data, this refers to data that have been stripped of all subject identifiers and that have no indirect links to subject identifiers. There should be no limited identifiers in anonymous data set.Coded data: this refers to data that have been stripped of all direct subject identifiers, but in this case each record has its own study ID or code, which is linked to identifiable information such as name or medical record number. The linking file must be separate from the coded data set. This linking file may be held by someone on the study team (e.g. the PI) or it could be held by someone outside of the study team (e.g. researcher at another institution). A coded data set may include limited identifiers under HIPAA. Of note, the code itself may not contain identifiers such as subject initials or medical record number.What is the difference between "de-identified", "anonymous", and "coded" data?

14Category 1: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 1

15Category 2: Research involving the use of educational tests, survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of harm. NOTE: The exemption for survey and interview research does not apply to research in which the subjects are children, except for research involving observation of public behavior if the investigator does not participate in the activities being observed.

Category 2

16Category 4: Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.

Category 4

17The institutional review board

18Composition of an IRB

Click to watch video.

19Continuing ReviewReportable EventsChangesInitial Reviews

Actions the Board can takeApproved as SubmittedApproved with Administrative HoldModifications RequestedDeferred

What happens at an irb meeting

20The uw hs irbs resources

Website

http://kb.wisc.edu/hsirbsKnowledge Base Site

Link to ARROWSearchableContact InformationFAQsGuidance

22HS-IRBs Office is located at 800 University Bay Drive, Suite 105Questions?Point of Contact System:Staff Reviewer is on call for questions each dayCall the Main Line at (608) 263-2362 to be transferredEmail: asktheirb@medicine.wisc.eduIRB Consultation Set up a consultation with a staff reviewer by completing the HS-IRBs Consultation Request Form: https://kb.wisc.edu/hsirbs/18204Recommended for new investigators and researchers who have a research question developed but would like additional guidance before formally submitting a study for reviewARROW Technical AssistanceEmail: askarrowirb@medicine.wisc.eduTo contact a Staff Reviewer directlyIndividual Contact Information: https://kb.wisc.edu/hsirbs/page.php?id=17016Who to contact and When

23To the IRB for triage

Communication with Research Team

OR

Communication with Research Team

OR

APPROVAL

APPROVAL

Cancer Center Scientific Review

Institute of Clinical & Translational Research (ICTR) Scientific Review

IRB Review

Pre-Review by IRB Staff

No institutional scientific review needed

Health Sciences IRBs Submission Process May 28, 2009

Communication with Research Team

Communication with Research Team

Modifications requested

APPROVAL

Submission of New Protocol by Research Team

To the IRB for triage

Communication with Research Team

OR

Communication with Research Team

OR

APPROVAL

APPROVAL

Cancer Center Scientific Review

Institute of Clinical & Translational Research (ICTR) Scientific Review

IRB Review

Pre-Review by IRB Staff

No institutional scientific review needed

Health Sciences IRBs Submission Process May 28, 2009

Communication with Research Team

Communication with Research Team

Modifications requested

APPROVAL

Submission of New Protocol by Research Team