CTSC:TTIC.111009

Back to Collaboration:Harvard_CTSC

Agenda:

1. Meeting with the Catalyst Regulatory team and Suzanne Churchill from SHRINE

Harvard Translational Imaging Consortium Meeting Minutes November 10, 2009

In attendance:

• Valerie Humblet
• Bill Hanlon
• Gordon Harris
• Ron Kikinis
• Annick Van den Abbeele
• Randy Gollub
• Stephan Voss
• Simon Warfield
• Yong Gao
• Gordon Williams
• Clare Tempany
• Laura Alice
• Sabune Winkler (Harvard Catalyst Regulatory)
• Susanne Churchill (SHRINE)
• Lara Brotheim (Harvard Catalyst Regulatory)
• Charles Guttmann
• Jeff Yap

1. Harvard Catalyst Regulatory Department.

• Sabune Winkler, Director of Regulatory Affairs Operations for the Harvard Catalyst, presented herself to the group. She gave an overview of her responsibilities. She wanted to learn about the consult program (goals, scope, access, work flow, who is in the program, etc.) and identify aspects of the consult program that overlap with IRB/regulatory to proactively any regulatory/legal issues. She also wanted to identify whether aspects of the consult programs meet the OHRP definition of "engagement". The Imaging consortium was able to answer a lot of her questions but was running out of time to cover all the subjects. Valerie and Randy will meet individually with Sabune later to finish the discussion.

2. SHRINE.

• Susanne Churchill, i2b2 Executive Director and Liaison to the Catalyst Regulatory Committee, presented the document: SHARING CLINICAL DATA ACROSS HARVARD CATALYST INSTITUTIONS FOR RESEARCH PURPOSES, business policies (download). This document provides a framework intended to insure that the primary goal of SHRINE – catalyzing research collaborations among Harvard investigators by sharing clinical data across the participating institutions - is realized in an ethical, respectful and transformative fashion.
• There are a lot of similitudes between SHRINE and Medical Imaging Informatics Bench to Bedside (mi2b2), the project funded by an Administrative Supplement to the Harvard Catalyst through the federal stimulus package aka ARRA. This project will enable clinical imaging data to be used, with appropriate human subject and institutional protections, for secondary research purposes.
• There are also so big differences between SHRINE and mi2b2. For example, for the clinical data there is already an electronic system at each institution (e.g. RPDR for Partners).
• SHRINE key concepts:
  • Initial goal: share aggregate data. It went live on October 1st at CHB, BIDMC, MGH and BWH. It is in beta testing mode for demographic and diagnosis and is accessible by invitation only.
  • Second step: share limited data sets.
  • SHRINE is for research only. There was some concerns from the institutions that some aggregate numbers could be used in a competitive fashion (e.g. number of abortion). The use of the data are very well controlled.
  • SHRINE access is limited to faculty members, one must be employed by one institution that agreed to share data. An ecommons username is needed to register. The IT people have created a registration software that could also be used for the mi2b2 project. When a PI registers, he also signs an agreement (document to be provided by Sabune) that was approved by all the Senior Vice-Presidents for Research and the General Counsels. People without a direct appointment need a principal collaborator who is the person who will do the query. (example: HSPH is not producing data but might want to use SHRINE).
  • Any request gets looped to a data steward who will decide before approving the request if it is appropriate research. It could be the same person for mi2b2.
• Advices from the SHRINE experience:
  • It is very important to have all the players at the table, everybody must be able to voice their concern. The project must be absolutely transparent.
  • At each individual institution, it is crucial to get approval from the Senior Vice-President for Research. They meet once a month with the Catalyst leadership. Randy will contact Laura Weisel to get on the next meeting (November 19) agenda.
  • The business plan developed for SHRINE can be used as a model to create one for mi2b2.
  • A first draft of the business plan (with input from the technical people involved) must be shared with the different IRBs to talk about their concerns about patient privacy etc. It is also important to learn from the IRBs how they define medical imaging data and how much information are linked to them.
  • The General Counsel at each institution will also have to vet the project.