Action Needed: Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care

Rare Disease Patients and their families will be dramatically impacted by the Draft Guidance on Disclosing Reasonably Foreseeable Risks in Research Evaluating Standards of Care recently released for comment by the Office of Human Research Protections. We are writing to ask that you allow us additional time in which to offer comments in response to this draft guidance you announced on October 24, 2014.

 

To be included in this request, please send your name, organization, and city/state to Kyle McEvilly (kmcevilly@geneticalliance.org) by 5 PM on November 17, 2014. Please also indicate whether you are signing on as an organization or individual. You may also sign on online. If you have any questions please contact (sterry@geneticalliance.org).