Brown Bag Series on Research Faculty Protection of Human Subjects in Research February 10, 2012...
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Transcript of Brown Bag Series on Research Faculty Protection of Human Subjects in Research February 10, 2012...
Brown Bag Series on ResearchFaculty
Protection of Human Subjects in Research
February 10, 2012Gerberding Hall 142, University of Washington
Brown Bag Series on ResearchFaculty
Speaker
Karen Moe, PhD Director and Assistant Vice Provost for Research
Human Subjects [email protected]
543-0098
Associate Research Professor, Psychiatry & Behavioral Sciences
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Help, policies, guidance, forms
HSD Email [email protected] Phone 206-543-0098HSD website www.washington.edu/research/hsd/
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What is the Human Subjects Division (HSD)?
• Human subjects compliance• Supports UW Institutional Review Boards (IRBs)• About 40 people
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The UW IRBs: n=7
Committee A: biomedicalCommittee B: biomedicalCommittee C: social/behavioral/humanitiesCommittee D: biomedicalCommittee G: social/behavioral/humanitiesCommittee J: social/behavioral/humanitiesCommittee K: hybrid (mostly biomedical)
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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
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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 agenciesSeattle Children’s Benaroya/Virginia Mason
Group Health Swedish
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How do I start?
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Time, money, frustration, non-compliance
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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?
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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.
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Activities that may not be “research”
• Case report or case study• Program evaluation• Oral history• Quality assurance/quality improvement
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How do I know?
Ask HSD• Email [email protected]• Phone
Look at HSD’s form: “Case Report Research Self-Determination” for analysis of the definition of research. No need to submit the form.
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HSD home page: Go to “Forms”
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HSD Forms List: Case Report
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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.
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Why does this matter?
If it is not “research”, IRB review is not required, even if you are studying humans.
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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”
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HSD home page
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HSD List: Policies & Procedures
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Remember….
Records and specimens can be “human subjects”, even if you are not obtaining them directly from the individuals
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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
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When your research does not involve direct contact with humans
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Public data sets: Not “human subjects”
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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
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Human Subjects Research: Which IRB?
Type of research IRB
Industry clinical trials Western IRB (WIRB)
Cancer-related research Fred Hutch IRB
WA state records or clients WA State IRB
Research at Seattle Children’s Seattle Children’s IRB
All other UW IRB
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“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.
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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 13-11
How do I apply?• Human Subjects Review Application UW 13-11, or• Medical Records Review form
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Full IRB Review
What form do I use?• Human Subjects Review Application UW 13-11• Repository Application
How long does it take?Median = 56 business days
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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
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Funding and IRB approval
• “Just in Time”Plan ahead!
• NIH compared with NSF• Industry clinical trials• “LAD” status: Limited Activities Determination
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IRB Metrics: Link on HSD home page
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Detailed Quarterly Report
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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
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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
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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.
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HSD Forms: Confidentiality Agreement
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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
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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.
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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