Difference between revisions of "CTSC:TTIC.111009"
From NAMIC Wiki
| Line 29: | Line 29: | ||
| − | 1. Harvard Catalyst Regulatory Department.<br> | + | '''1. Harvard Catalyst Regulatory Department.'''<br> |
* 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. | * 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. | ||
| Line 35: | Line 35: | ||
<br> | <br> | ||
| − | 2. | + | '''2. SHRINE.''' <br> |
| + | |||
| + | * 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. 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. | ||
Revision as of 19:21, 13 November 2009
Home < CTSC:TTIC.111009Back to Collaboration:Harvard_CTSC
Agenda:
- 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. 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.
