SMART IRB
BUSINESS ANALYSIS
USER RESEARCH
INTERACTION DESIGN
AGILE
Founded in 2008, Harvard Catalyst is one of 61 Clinical and Translational Science Centers (CTSC) in the United States. Funded by a NIH grant, Harvard University, and local hospitals, Harvard Catalyst's mission is to further clinical and translational research by providing clinical and translational researchers with training programs, grants, tools and technologies.
As the Design Lead on the Portal Team, I worked on multiple projects, including the SMART IRB initiative. SMART IRB aims to streamline the institutional review board (IRB) process for clinical studies by reducing the need for duplicative reviews. We built a web-based platform to identify a single IRB for multisite clinical studies in support of the recent NIH mandate for single IRB review of NIH funded research studies.
The SMART IRB team adopted an agile software development process in order to move quickly. While the majority of efforts have been focused on design, development, and QA, we made time to conduct user research as well.
My Role:
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Collaborate with stakeholders and internal team on design solutions
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Continuously refine Design process and deliverables to meet the needs of stakeholders and internal team
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Served as proxy Product Owner by prioritizing features and triaging tickets into and out of the Sprint
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Demo to external stakeholders
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Collect feedback from end users through surveys, usability testing, interviews
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Create training materials such as camtasia videos, knowledgebase articles and help documents
Key Milestones
Phase 1
Join IRBrely Project
Conducted 15 remote usability tests with potential users to evaluate IRBrely. View protocol
Get up to speed on IRB reliance and work done to date.
Usability testing
Harvard Catalyst joins IRBrely
IRBrely grant ends
Deliver code
With the close of the IRBrely grant, Catalyst handed off the code and specs to NCATS.
Phase 3
Phase 2
Refocus on local cede review system
Local cede review system
Building on work for IRBrely, we began re-writing our local system.
Interview Users
Onsite interviews with 11 local IRB Directors.
Catalyst wins SMART IRB grant
Going national
Refocused our development efforts to suit the needs of a national audience.
Working Group
Form Working Group comprised of stakeholders from across the nation.
Conduct 3 pilot studies to seek feedback.
Pilot Studies
Website + Joinder launch
SMART IRB launches website and Joinder
Launched SMART IRB website and Joinder tool, which allows institutions to sign onto SMART IRB.
2017
Online Reliance System (ORS) in Beta
ORS launched to Beta on May 4, 2017.
Online Reliance System Beta
Webinar series
Multiple webinar series to educate community about SMART IRB.
User Survey
Solicit feedback from active Beta users.
Prod. launch
Launch Online Reliance System to production Jan 23, 2018.
ORS Production launch
New feature development
Iterative enhancements based on user feedback.
Our Users
I’d like to collaborate on a study with my colleagues at Ridgeview Research Facility and Belledale Institute.
I want to make it easier for my investigators to conduct multi-site research by reducing the administrative burden of multiple IRB reviews.
Steps to building a new feature
1. Review list of priorities
Periodically review the list of priorities with the Working Group, product owner and internal team, and re-order the list as priorities change.
2. Meet with Working Group
One month prior to development of new feature, discuss the goals and problems that will be addressed by this feature.
3. Review with Product Owner
Regroup with the Product Owner to understand the concerns brought up by Working Group to establish the requirements for this new feature.
4. Review with development team
Check-in with the development team to let them know what we’ll be working on next. Developers provide feedback on early design ideas and suggest alternatives. QA help us to find gaps in design.
5. Iterate based on feedback
Feedback from Product Owner and development team is incorporated into draft wireframes. Sometimes multiple iterations are necessary.
6. Present final design
Present the final design to Product owner for sign off. Pass final wireframes and specs to developers and QA so they can begin their work.
Selected Artifacts
User Flows
Workflow diagram showing the entire process from submitting a IRB reliance request to receiving a reliance determintation.
Wireframes
An early wireframe showing a possible layout for the cede request form.
A wireframe of the cede request details page. This page would be updated as institutions submitted their reliance forms.
Mockups
A final mockup of the cede request details page, showing a final reliance determination has been made.