The UW health sciences irb s Overview Practical regulatory issues in human subjects research

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

2. Topic overview • The UW HS IRBs Process • Is IRB Review Needed? • The Institutional Review Board • The UW HS IRBs Resources

3. The UW HS IRBs Process

4. What is an IRB? • 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

5. Campus IRBs UW IRBs 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 • HS-IRB • MR-IRB • SBS ED –IRB • irb.wisc.edu • ALL UW IRBs USE ARROW Shared office.

6. Categories of irb review

7. Submission Process Overviewfull board

8. Application Types • 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)

9. Submission Process Overview • Exemption Apps • Expedited Review • Non-Exempt Medical Record Review Apps

10. Is IRB review needed?

11. Research vs. quality improvement and program evaluation • 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 Tree • Characteristics of Research, Quality Improvement and Program Evaluation Activities

12. Research, QI, PE table

13. Exemptions • 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 • HIPAA still applies to exemptions using PHI

14. What is the difference between "de-identified", "anonymous", and "coded" data? • 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.  • 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.

15. Category 1 • 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.

16. Category 2 • 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.

17. Category 4 • 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.

18. The institutional review board

19. Composition of an IRB Click to watch video.

20. What happens at an irb meeting • Continuing Review • Reportable Events • Changes • Initial Reviews • Actions the Board can take • Approved as Submitted • Approved with Administrative Hold • Modifications Requested • Deferred

21. The uwhsirbs resources

22. Website http://kb.wisc.edu/hsirbs • Knowledge Base Site • Link to ARROW • Searchable • Contact Information • FAQs • Guidance

23. Who to contact and When • 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.edu • IRB Consultation • Set up a consultation with a staff reviewer by completing the HS-IRBs Consultation Request Form: https://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.edu • To contact a Staff Reviewer directly • Individual Contact Information: https://kb.wisc.edu/hsirbs/page.php?id=17016