Brown Bag Series on Research Faculty Protection of Human Subjects in Research February 10, 2012 Gerberding Hall 142, University of Washington

Brown Bag Series on Research Faculty Speaker Karen Moe, PhD Director and Assistant Vice Provost for Research Human Subjects Division Associate Research Professor, Psychiatry & Behavioral Sciences

Brown Bag Series on Research Faculty Help, policies, guidance, forms HSD HSD Phone HSD website

Brown Bag Series on Research Faculty What is the Human Subjects Division (HSD)? Human subjects compliance Supports UW Institutional Review Boards (IRBs) About 40 people

Brown Bag Series on Research Faculty The UW IRBs: n=7 Committee A: biomedical Committee B: biomedical Committee C: social/behavioral/humanities Committee D: biomedical Committee G: social/behavioral/humanities Committee J: social/behavioral/humanities Committee K: hybrid (mostly biomedical)

Brown Bag Series on Research Faculty The UW IRBs Structure IRB members & HSD support team “Minimal Risk” = IRB subcommittees of HSD staff Timing Bi-weekly meetings Materials sent to IRB 5-7 days in advance

Brown Bag Series on Research Faculty Other IRBs used for UW research Western IRB (WIRB) for industry-initiated-and-funded clinical trials Cancer Consortium IRB (CC-IRB, or “Hutch” IRB) for cancer-related research Cooperative agreements: avoid “dual review” WA state IRB: must be used for any research involving records, specimens, or clients of most state agencies Seattle Children’sBenaroya/Virginia Mason Group HealthSwedish

Brown Bag Series on Research Faculty How do I start?

Brown Bag Series on Research Faculty Time, money, frustration, non-compliance

Brown Bag Series on Research Faculty Your activity 1.Is it research? 2.Does it involve human subjects? 3.Does it qualify for exempt status? 4.Which IRB does the review? 5.What type of review is required? 6.Any related compliance requirements?

Brown Bag Series on Research Faculty Is it research? Definition: A systematic investigation, including development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Includes research development, testing, and evaluation. “Publication” is not part of the definition.

Brown Bag Series on Research Faculty Activities that may not be “research” Case report or case study Program evaluation Oral history Quality assurance/quality improvement

Brown Bag Series on Research Faculty How do I know? Ask HSD Phone Look at HSD’s form: “Case Report Research Self- Determination” for analysis of the definition of research. No need to submit the form.

Brown Bag Series on Research Faculty HSD home page: Go to “Forms”

Brown Bag Series on Research Faculty HSD Forms List: Case Report

Brown Bag Series on Research Faculty Case Report Self-Determination Form Has definitions of: Systematic investigation Designed Generalizable This is a self-determination form. It does not need to be submitted to HSD.

Brown Bag Series on Research Faculty Why does this matter? If it is not “research”, IRB review is not required, even if you are studying humans.

Brown Bag Series on Research Faculty Does it involve human subjects? Definition: An individual about whom a researcher obtains Data through intervention or interaction with the individual, or Identifiable private information Not sure? Ask HSD, or see the Policy & Procedure document “Human Subject Definition”

Brown Bag Series on Research Faculty HSD home page

Brown Bag Series on Research Faculty HSD List: Policies & Procedures

Brown Bag Series on Research Faculty Remember…. Records and specimens can be “human subjects”, even if you are not obtaining them directly from the individuals

Brown Bag Series on Research Faculty When your research does not involve direct contact with humans Use this HSD form to self-determine whether “human subjects” are involved: Use of Non-identifiable Specimens/Data

Brown Bag Series on Research Faculty When your research does not involve direct contact with humans

Brown Bag Series on Research Faculty Public data sets: Not “human subjects”

Brown Bag Series on Research Faculty Exempt Status Certain types of human subjects research are “exempt” from the regulations Requires HSD administrative review Median turnaround time: 6 business days Forms List on the HSD website Initial application form: Exempt Status Request

Brown Bag Series on Research Faculty Human Subjects Research: Which IRB? Type of researchIRB Industry clinical trialsWestern IRB (WIRB) Cancer-related researchFred Hutch IRB WA state records or clientsWA State IRB Research at Seattle Children’sSeattle Children’s IRB All otherUW IRB

Brown Bag Series on Research Faculty “Minimal Risk” review Some types of research do not require review by the full IRB committee. Advantage: faster (median=24 business days) All requirements for approval are the same as for full IRB review.

Brown Bag Series on Research Faculty Minimal Risk review How do I know if I qualify? Instructions and guidance on the front of the standard Human Subjects application form: Human Subjects Review Application UW How do I apply? Human Subjects Review Application UW 13-11, or Medical Records Review form

Brown Bag Series on Research Faculty

Brown Bag Series on Research Faculty Full IRB Review What form do I use? Human Subjects Review Application UW Repository Application How long does it take? Median = 56 business days

Brown Bag Series on Research Faculty Most frequent reasons for delay Incomplete applications (e.g., did not attach a complete copy of the grant) Requested inappropriate type of review (e.g., exempt application) Insufficient information about procedures Unanswered questions Lack of differentiation between what is the research and what is not

Brown Bag Series on Research Faculty Funding and IRB approval “Just in Time” Plan ahead! NIH compared with NSF Industry clinical trials “LAD” status: Limited Activities Determination

Brown Bag Series on Research Faculty IRB Metrics: Link on HSD home page

Brown Bag Series on Research Faculty Detailed Quarterly Report

Brown Bag Series on Research Faculty Working with Other Institutions Every institution that is “engaged” in a human subjects project must do an IRB review, unless arrangements are made for one IRB to rely upon the other IRB: Institution-specific Cooperative Agreement or Study-specific IRB Authorization Agreement

Brown Bag Series on Research Faculty Other HSD/IRB responsibilities HIPAA and research Registration of clinical trials (clinicaltrials.gov) Comparing contract, consent, and budget for industry clinical trials Confidentiality agreements UW Injury Compensation Plan

Brown Bag Series on Research Faculty Confidentiality Agreement WA State Law: the use of state-owned records for research, without the consent of the individual, requires a formal Confidentiality Agreement between the state agency and the researcher. UW records: medical, student, personnel, etc. Required even when UW physician-researcher is using own patient records.

Brown Bag Series on Research Faculty HSD Forms: Confidentiality Agreement

Brown Bag Series on Research Faculty UW Injury Compensation Plan For medical problems caused by UW research: – Up to $10K reimbursement for expenses – Free medical care at UW Medicine A “no fault” program Research location is irrelevant HSD administers the program

Brown Bag Series on Research Faculty Requests for your research data Examples From a research subject An attorney, or a subpoena Public records request Immediately forward the request to HSD, the UW Public Records office, or the UW Attorney General’s office. Do not respond on your own.

Brown Bag Series on Research Faculty HSD Strategic Goals Encourage research by facilitating fulfillment of ethical and compliance responsibilities Achieve operational excellence Create a wonderful place to work Add value to the UW