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Slide 2 THE UW HEALTH SCIENCES IRB S OVERVIEW PRACTICAL REGULATORY ISSUES IN HUMAN SUBJECTS RESEARCH Slide 3 The UW HS IRBs Process Is IRB Review Needed? The Institutional Review Board The UW HS IRBs Resources TOPIC OVERVIEW Slide 4 THE UW HS IRB S PROCESS Slide 5 Institutional Review Board Protects the rights and welfare of human research subjects Helps ensure compliance with rules and regulations: federal state university Criteria for IRB Approval 45 CFR 46.111 (DHHS), 21 CFR 56.111 (FDA), and 38 CFR 16.111 (VA) KB 19230 Human subjects research SHOULD NOT commence without prior IRB approval or exemption WHAT IS AN IRB? Slide 6 UW IRBs HS-IRB MR-IRB SBS ED IRB irb.wisc.edu ALL UW IRBs USE ARROW External IRBs Western IRB (WIRB) for most industry-sponsored research kb.wisc.edu/wirbgateway NCI CIRB IRB for some cancer trials kb.wisc.edu/hsirbs/19695 Meriter Hospital for some OB- GYN research kb.wisc.edu/hsirbs/21707 Aurora in Milwaukee, Medical College of Wisconsin and Marshfield Clinic through the Wisconsin IRB Consortium (WIC) kb.wisc.edu/hsirbs/21707 CAMPUS IRBs Shared office. Slide 7 Full Board Expedited Exempt CATEGORIES OF IRB REVIEW Slide 8 SUBMISSION PROCESS OVERVIEW FULL BOARD Slide 9 Initial Review Application: Full Review Any study that poses more than minimal risk Minimal risk research that is not exempt or not a medical records review Initial Review Application: Non-Exempt Medical Records Review For studies of medical records or images (e.g., those that retain identifiers) Initial Review Application: Exemption Must be minimal risk Some survey and interview studies Some evaluations of educational activities, curricula Use of existing data (e.g., some medical records research), specimens that are unidentifiable (e.g., residual tissue) APPLICATION TYPES Slide 10 SUBMISSION PROCESS OVERVIEW 1.Exemption Apps 2.Expedited Review Non-Exempt Medical Record Review Apps Slide 11 IS IRB REVIEW NEEDED? Slide 12 Quality Improvement/Program Evaluation projects do not need to be submitted for IRB review Many Resources to help researchers make determination Research Decision Tool Research Decision Tool Research Decision Tree Research Decision Tree Characteristics of Research, Quality Improvement and Program Evaluation Activities Characteristics of Research, Quality Improvement and Program Evaluation Activities RESEARCH vs. QUALITY IMPROVEMENT AND PROGRAM EVALUATION Slide 13 RESEARCH, QI, PE TABLE Slide 14 Exempt status is determined by the IRB office, not researchers, via an exemption application An exemption means the IRB determines that the project is exempt from further IRB review Exempt research does not require ongoing oversight by an IRB Six categories of exemption allowed under the Common Rule; three categories are common: Categories Categories HIPAA still applies to exemptions using PHI EXEMPTIONS Slide 15 De-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. limited identifiers under HIPAA 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? Slide 16 Category 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 Slide 17 Category 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 Slide 18 Category 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 Slide 19 THE INSTITUTIONAL REVIEW BOARD Slide 20 COMPOSITION OF AN IRB Click to watch video. Slide 21 Continuing Review Reportable Events Changes Initial Reviews Actions the Board can take Approved as Submitted Approved with Administrative Hold Modifications Requested Deferred WHAT HAPPENS AT AN IRB MEETING Slide 22 THE UW HS IRB S RESOURCES Slide 23 WEBSITE http://kb.wisc.edu/hsirbs Knowledge Base Site Link to ARROW Searchable Contact Information FAQs Guidance Slide 24 HS-IRBs Office is located at 800 University Bay Drive, Suite 105 Questions? Point of Contact System: Staff Reviewer is on call for questions each day Call the Main Line at (608) 263-2362 to be transferred Email: asktheirb@medicine.wisc.eduasktheirb@medicine.wisc.edu IRB Consultation Set up a consultation with a staff reviewer by completing the HS-IRBs Consultation Request Form: https://kb.wisc.edu/hsirbs/18204https://kb.wisc.edu/hsirbs/18204 Recommended for new investigators and researchers who have a research question developed but would like additional guidance before formally submitting a study for review ARROW Technical Assistance Email: askarrowirb@medicine.wisc.eduaskarrowirb@medicine.wisc.edu To contact a Staff Reviewer directly Individual Contact Information: https://kb.wisc.edu/hsirbs/page.php?id=17016https://kb.wisc.edu/hsirbs/page.php?id=17016 WHO TO CONTACT AND WHEN