AHS Research Process Map - Business Process Redesign
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AHS Research Process Map
Business Process Redesign
What do AB researchers say?
Alberta Clinical Research Consortium (ACRC)
conducted survey of Alberta Clinical Researchers
(September 2013):
• 47% were Dissatisfied with the Clinical Research
environment in Alberta
• Researchers spend 30% of their time on Clinical
Research administration
2
What do AB researchers say?
Researchers comments revealed the need for:
- Administrative approval time
- Trial initiation workload
- Clarity on approval processes
- Accountability: tracking mechanism
for status of approvals
3
What is getting in the way?
Existing processes inhibit initiation of effective AHS
research
• Inconsistent process, not broadly applied, not understood
• Inefficient
• Re-work: ethics, operational approvals, data requests
• Missed opportunities for alignment with SCN priorities
• Inconsistent assessment of operational impacts
• No mechanism to gather questions of importance from
the front line
4
What action have we taken?
Process and systems redesign to facilitate AHS
research:
– Convened a SWAT team after seeking input and
feedback from all stakeholder groups
– Performed detailed analysis of current state, issues
for all processes and sub-processes
– Redesigned process from multiple perspectives
5
What was the timeline?
November
October 2014 -
2014 - Edmonton
August Calgary
2014 -
Edmonton
July 2014
- Calgary
June
2014 -
Calgary
6
What results do we expect?
Improved processes will:
• Reduce re-work
• Promote alignment, engagement, team
competencies
• Address data needs
• Address operational requirements
• Track research progress and provide metrics
• Increase quality of research output
• Be agile to support innovation
7New AHS Research Features and
Processes Benefits
Idea Incubator Creates Searchable Registry (post-ethics)
Assessment & Review Possible partnership with AHS and accompanying
of Idea support (if desired by researcher)
Proposal Data availability, operational feasibility, and other
Development Support internal/external supports
Research Facilitation AHS Way-finding, Knowledge Translation,
Services Biostatistics, Data Analytics, etc.
Expert Panel & Peer
AHS Alignment; Possible seed funding
Review
Post-Ethics Approvals Decreased time to administrative approval
8AHS Research Process - Idea Incubator
Early Research
Registration SCN Review
Engagement Plan
Features and Benefits:
Electronic portal registration
Searchable Registry (post-ethics approval)
Collects information for review of idea
Provides access to SCN and RF supports
9AHS Research Process – SCN Review
SCN Review SCN
Results and
Researcher Determines
Leadership Feedback to
Selects SCN Level of
team + ASD Researcher
Commitment
Features and Benefits:
Systematic SCN review (if desired)
Possible SCN partnership or endorsement
Early feedback to avoid wasted effort
Prioritization for Support
11Proposal Development
AHS Research Process – Support
Researcher RF Navigates to
Identifies Internal/External Consultation
Support Needs Services
Features and Benefits:
Access to: Proposal Development Support
Data availability, AHS purchased
services, ethics, budget, data capture
options, legal, privacy, etc.
Address issues prior to submission to
ethics/granting agencies
13Research Facilitation
AHS Research Process - Services
Minimal
Research Substantial
Support
Navigator Support
(templates, Proposal
Assesses (Work
brief
Requests Agreement)
consult)
Features and Benefits:
Access to AHS Way-finding, Knowledge
Translation, Biostatistics and Data Analytics
Cost recovery for substantial support
15AHS Research Process – Expert Panel and
Peer Review
Expert Panel Peer Review
(SCN-partner) (SCN-endorsed)
Possible Seed Funding Feedback provided
Letter of Support for Grant Improved Quality of
funding Proposal for funding agency
Features and Benefits:
Expert Panel – zones, operations, science, benefits
realization, KT, SCNs
Possible seed funding
Enhanced quality of Research Proposals
Additional support per panel recommendations
Increased AHS awareness of SCN priority projects
17AHS Research Process – Post-ethics Approvals
E-Portal
Operational
uploads from Operational Research Administrative
Advisor
IRISS and Approvals Agreement Approval
assessment
REMO
Features and Benefits:
Seamless transfer of documents from ethics to
AHS Research operations
E-portal will automatically create research
agreement schedules
Decreased time to administrative approval
19What’s in it for researchers?
Searchable Way- Proposal Data Research Expert Operational
Registry finding Dev. Access Facilitation Panel Approval/
Support Consult Services (seed Research
Services funding) Agreement
Navigation
SCN
Partner
Projects
Non-SCN
projects
(cost-
recovery)
Student
projects
(Limited)
Industry
Funded
RCTs
21Next Steps
• Stakeholder Engagement and Feedback
• Social Design
– Staffing/Job Transitions
– Training Requirements
– Organizational Boundaries
• Implementation Plans
– IT Requirements
• Tool Development
• Implementation
22Thank you
For more information, please contact
Peter Faris
Email: peter.faris@albertahealthservices.ca
Tel: 403-944-0705
Rose Farrell
Email: RoseMarie.Farrell@albertahealthservices.ca
Tel: 403-944-3140
23Another Hoop AND a Chance to Help
Researchers Navigate the AHS System
January 2015
Cindy Gerdes
Senior Consultant, Research Operations
Innovation & Research Operations PortfolioResearch and AHS Research is essential to our ability to provide leading edge care to the patients we serve. AHS role: • Custodians of the health delivery system and the safety of our patients • Facilitate and engage with the work of our academic partners and other researchers • Protect the privacy of our patients • Accommodate research without impeding service delivery • Mitigate/manage organizational risk
Summer 2012 AHS Privacy advises that AHS must become compliant with the Health Information Act Memo from VP Research indicating that research agreements are needed for all studies that require the use or disclosure of health information for Research Purposes
Implementation HIA S54 Research Agreement template developed and linked to the AHS research web page. Researchers asked to download template, complete it and find the AHS repository holder to sign on behalf of AHS.
Issues for Researchers • How to find the repository holder? Look at the PIA, ask IT? • Get a name and send them an agreement. But, • Repository holder has no idea what that means and won’t sign.
Issues for Researchers • Researcher needs data/charts from more than one source/zone. • no one to coordinate repository holders • No one to coordinate data matching between sources so, • Multiple research agreements + time ++
Issues for Researchers
• Researchers indicate on their ethics application
that they will use data from AHS sources but
have no idea which sources or what form the
data is in.
• Researchers ask for access to Netcare which has
specific rules – essentially if study is not
prospective with a close link to patient care – no
go. Then what?On the Other Side of the Equation
• Repository holders aren’t clear about what their
responsibilities are and don’t have time to find
out because of the pressure of clinical concerns.
• No mechanism to coordinate between repository
holders for data matching – multiple data
products (often with identifiers) disclosed to
researchers.
• If the researcher doesn’t know where the data is
or assumes incorrectly that they can get it from
Netcare – then what?On the Other Side of the Equation
• Operational leaders are consumed with patient
care pressures and often have limited
time/experience reviewing research for impacts
and providing meaningful approval.So What’s the Plan? • Since we need a lot of information about each study to draft the Research Agreements why not use that information to facilitate, multiple repositories, data matching, data access and operational approval?
So What’s the Plan? • One of the main issues has been ensuring that we have REB approved document on which to base the research agreement. • The Health Research Ethics Harmonization Initiative created 3 HIA designated REBs supported by 2 IT platforms.
So What’s the Plan? • All of the REBS have agreed to provide documents from their platforms to the AHS Research Administration process so that we have approved documents and researchers are not required to resubmit materials to AHS after ethics approval.
So What’s the Plan?
• Research Administration Advisors ( 2 in Edmonton
and 2 in Calgary) review the documents for each file
and contact the researcher /designate to fill in any
gaps. This usually consists of:
• Names of research personnel who need access to
identifiable information.
• List of data elements (if not articulated in protocol)
• List of preferred data sources
• Clarification of research procedures and their
operational impact.So What’s the Plan?
Using this information the advisors:
• Assess study for privacy and security risks and identify
mitigation strategies – consulting with AHS privacy and/or It
Governance Risk Compliance as needed.
• Draft the research agreement and coordinate data matching
and/or sign off amongst repository holders.
One research agreement per study regardless
of how many AHS repository holders.So What’s the Plan?
Using this information the advisors:
• Review data requirements and arrange direct system access
(Netcare and others) as appropriate.
• Identify data sources if expected sources have not been
identified or planned sources are not available.
There are 1200 clinical databases and 600 corporate
databases in AHS. We are working to catalogue those
that are most likely to be useful to researchers
including understanding research uses specified in
privacy impact assessments and information manager
agreements.So What’s the Plan? Using this information the advisors: • Create a “briefing note” for operational leaders so that they can quickly assess impact and respond with their meaningful approval or identify issues that need to be sorted out. • Work with researchers and operational leads to negotiate adjustments needed to allow AHS to support the study. One operational approval regardless of how many AHS sites or zones.
So the Hoop becomes a Help As noted in the opening slide AHS depends on research but is built to provide patient care. Through the new AHS Research Administration Pathway developed in the service of research agreements (the hoop) we hope to become better research partners in Alberta and bring our vast clinical and data resources to the research enterprise (the help).
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