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Protection of Human Subjects in Research

February 10, 2012Gerberding Hall 142, University of Washington

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Speaker

Karen Moe, PhD Director and Assistant Vice Provost for Research

Human Subjects Divisionkemoe@uw.edu

543-0098

Associate Research Professor, Psychiatry & Behavioral Sciences

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Help, policies, guidance, forms

HSD Email hsdinfo@uw.eduHSD 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 hsdinfo@uw.edu• 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 IRBIndustry clinical trials Western IRB (WIRB)Cancer-related research Fred Hutch IRBWA state records or clients WA State IRBResearch at Seattle Children’s Seattle Children’s IRBAll 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