Quality Assurance Program

1 PURPOSE

1.1 This document describes the internal Quality Assurance program conducted by the University of
Washington (UW) Human Subjects Division (HSD).

2 POLICIES

2.1 The purpose of the Quality Assurance (QA) program is to assess and ensure the compliance of HSD and
its Institutional Review Boards (IRBs) with applicable federal and state regulations, University policies,
HSD policies, and HSD and IRB standard operating procedures (SOPs).

2.2 The QA program is a permanent and ongoing part of HSD operations.

3 PROGRAM DESCRIPTION

3.1 Scope. The scope of the QA program includes all HSD and IRB activities described in HSD’s written SOPs
(as implemented and posted on HSD’s website).
3.1.1 The SOPs describe all HSD and IRB procedures and responsibilities as they are outlined in federal
regulations, state regulations, and University policy statements.
3.1.2 In scope examples:
3.1.2.1 IRB determinations about waivers of consent
3.1.2.2 HSD determinations about whether a research study qualifies for exempt status
3.1.3 Out of scope examples:
3.1.3.1 The accuracy of HSD website content
3.1.3.2 The content of consultation and education provided by HSD staff to researchers

3.2 Management. The QA program is managed by the HSD Regulatory Affairs team, drawing upon expertise
and assistance from all of HSD (and from outside of HSD) as needed and appropriate for the scope, size,
and subject matter of projects.

3.3 Activities. The QA program activities are:

3.3.1 Assess HSD and IRB actions. This may include assessment and monitoring activities that are
ongoing and permanent (e.g., the weekly lapsed approval report distributed to all IRB teams) or
QA projects that have a specific start and endpoint.
3.3.2 Analyze findings for root causes and contributing factors.
3.3.3 Report findings and outcomes.
3.3.3.1 Findings are saved in the electronic HSD Compliance files.
3.3.4 Develop and implement corrective action plans , to address any observed non-compliance.

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3.4 Relationship with HSD change efforts. The QA program focuses on compliance. Analysis of QA findings
may suggest changes in system (e.g., forms, SOPs, processes), which could lead to the initiation of a
project through the HSD change management system (i.e., the DOES team).
3.4.1 Example: The root cause of a non-compliance finding is found to be ambiguous instructions on a
form used to document IRB determinations. The corrective action plan includes revising the
instructions on the form (i.e., a systems change).
3.4.2 Any QA findings that might incidentally identify the need or opportunity to improve process
efficiency, assistance to researchers, or other strategic goals not related to compliance will be
shared with the Management Team and the DOES team. However, such changes will not be the
responsibility of the QA program.

3.5 Relationship with individual performance evaluation . The results of the QA program are not intended to
be routinely incorporated into the performance evaluations of individual HSD staff members. However,
repeated findings or patterns of findings could become a performance issue.

4 DEFINITIONS

4.1 None

5 PROCEDURES: Assessment and Monitoring

5.1 Identification of possible QA activities. Suggestions for possible QA activities may arise through a variety
of mechanisms, including (but not limited to):
5.1.1 External requests or requirements. Example: A FDA audit results in a finding about UW IRB
minutes, based on a small sample of minutes. A possible QA activity would be to examine more
of the minutes, to determine the extent and cause of the finding and thereby develop an
appropriate corrective action plan.
5.1.2 Internal requests from HSD or an IRB. Example: An IRB requests an assessment of its recent
determinations about parental permission in research involving children.
5.1.3 Complaints or concerns expressed by HSD staff or IRB members.
5.1.4 Informal observations by members of the management team, regulatory affairs team, post-
approval monitor, or education & training team. These may or may not be actively solicited by
the regulatory affairs team.
5.1.5 National trends in regulatory oversight and focus. For example, national communications from
the federal human subjects regulatory agencies may make it clear that they are currently
focusing on issues related to children in research.
5.1.6 New information about specific risks. For example, highly publicized complaints by individuals
about the use of their research samples for genetic analyses in unrelated studies across the
country might suggest that the QA program examine the information provided to subjects in
consent forms for UW genetics research.

5.2 Prioritization and selection.

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5.2.1 The regulatory affairs team meets periodically to collate and discuss possible QA activities.
About once per quarter, the team develops a slate of recommendations about QA needs,
priorities, scope of specific QA activities, and resource needs.
5.2.1.1 Prioritization criteria include (but are not limited to):
5.2.1.1.1 External requirements
5.2.1.1.2 Risk of serious non-compliance
5.2.1.1.3 Risk of harm to subjects
5.2.1.1.4 Institutional risk
5.2.1.1.5 The extent of a possible problem across HSD or the IRBs
5.2.2 About once per quarter, the recommendations are presented to the management team for
discussion. The recommendations are generally accepted except when:
5.2.2.1 There are resource constraints.
5.2.2.2 The HSD Director has identified an urgent need that requires a higher priority.
5.2.3 The quarterly QA plan can be revised in response to urgent issues.
5.2.4 The QA plan may or may not change from one quarter to next, depending upon size and length
of specific projects and other demands on the regulatory affairs team.

5.3 Methods of assessment and monitoring. The regulatory affairs team draws upon a variety of methods
for assessment and monitoring. These include (but are not limited to):
5.3.1 Reports and data from the HSD database and Zipline, the electronic submission system
5.3.2 Examination of IRB study files and other IRB documents (e.g., meeting minutes)
5.3.3 Examination of HSD files and documents
5.3.4 Interviews with HSD staff or IRB members
5.3.5 Observation of IRB meetings

5.4 Who conducts assessment and monitoring? The regulatory affairs team does much of the assessment
and monitoring but may draw upon other HSD staff (and from outside of HSD), as needed and
appropriate for the scope, size, and subject matter of projects.

6 PROCEDURES: Analysis and Corrective Action Plan

6.1 The regulatory affairs team identifies the likely cause(s) of findings, as well as contributing factors.
6.1.1 The analysis may require additional monitoring, observation, or interviews.
6.1.2 The analysis considers the possible contributions of:
6.1.2.1 People (e.g., individuals, specific teams, or IRBs)
6.1.2.2 Policy (e.g., ambiguity; conflicting policies)
6.1.2.3 Process and system (e.g., procedures with gaps; templates that do not require
necessary information; imbalance of workload distribution)

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6.2 The regulatory affairs team applies the definitions and procedures of the SOP IRB Non-compliance to
determine whether the QA findings meet the definition of non-compliance, serious non-compliance,
continuing non-compliance, or none of these.
6.2.1 When IRB non-compliance is discovered, the regulatory affairs team follows the procedures
described in the SOP IRB Non-compliance.

6.3 The regulatory affairs team devises an appropriate corrective action plan to:
6.3.1 Correct the specific findings
6.3.2 Prevent the finding from occurring
6.3.3 Assign responsibility for implementation and oversight of the plan
6.3.4 Assess the success of the corrective action plan

7 PROCEDURES: Report

7.1 The regulatory affairs team prepares an internal report in a format and length that is appropriate to a
specific QA project. It describes:
7.1.1 Purpose of the QA activity
7.1.2 Brief description of the QA activity (methods, records examined, etc.)
7.1.3 Findings or (for permanent ongoing assessments) recent trends
7.1.4 Whether the findings constitute non-compliance, serious non-compliance, continuing non-
compliance, or none of these
7.1.5 Causal analysis of any findings
7.1.6 Recommended corrective action plan, including the points described in 6.3

7.2 The report is presented to the management team for discussion, possible refinement, and decisions
about implementation (timing, resources, etc.).

7.3 The HSD Director may share the report (or portions of it) with others as appropriate or required,
including (but not limited to):
7.3.1 HSD staff
7.3.2 UW human subjects Institutional Official
7.3.3 Vice Provost for Research
7.3.4 UW Internal Audit
7.3.5 Federal regulatory offices such as the Office of Human Research Protections or the Food and
Drug Administration

7.4 Federal regulations require institutions to report serious or continuing non-compliance. When findings
are determined to be serious or continuing non-compliance, the regulatory affairs team follows the
procedures described in SOP Federal Reporting to report the findings to all appropriate federal
authorities.

8 PROCEDURES: Documentation and Records

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8.1 All of the following are considered HSD records and are managed as such by the regulatory affairs team.
8.1.1 The quarterly QA program (i.e., list of planned QA activities)
8.1.2 The report prepared for each QA project
8.1.3 The assessment and monitoring data that result from specific QA projects

9 MATERIALS

9.1 SOP IRB Non-compliance

9.2 SOP Federal Reporting

10 REFERENCES

10.1 None

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