Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3
Once sponsors decide to capture/share expanded access-derived data above and beyond that needed, what should IRBs do?
IRB
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Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 3 -
Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2 Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 2
In some cases there may be value in collecting “real world data” from Expanded Access.
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Read more: Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1 Everything You Wanted to Know About Expanded Access but Were Afraid to Ask, Part 1
Expanded access allows patients who lack other treatment options to try unapproved medical products in development.
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Read more: A Proposal for Localized Review to Safeguard Genetic Database Privacy A Proposal for Localized Review to Safeguard Genetic Database Privacy
We must take action to make genetic data sharing more secure and increase the public’s perception of its importance and safety.
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Read more: Black Lives Matter To Human Research–Lessons From ‘On The Run’ Black Lives Matter To Human Research–Lessons From ‘On The Run’
The problem here is not simply one for Goffman, who admitted in hindsight, “I’m glad that I learned what it feels like to want a man to die…to feel it in my bones, at an emotional level eclipsing my own reason or sense of right and wrong,” but the broader academy, which for too long…