Hi Alex
I appologize for not getting back to you sooner but I am currently in Italy
You sent me some interesting emails about vacation time and grants. There are some changes in so far as charging benefit time to grants. The rules have relaxed in this area whereby it is permissable to charge time
I will tell you more when I get back
Larry
________________________________
Da: Research Administration List per conto di Schoen, Alexander
Inviato: ven 05/10/2007 10.44
A: xxxxxx@hrinet.org
Oggetto: Re: [RESADM-L] Institutional Policy on Subject Injury during research
If the injury is caused by the study drug or the "properly performed" study procedures, the costs should rest with the sponsor. Of course, if the injury is caused by the PI or study site, then the sponsor should not have to pay. Also - many sponsors want to carve out injuries that can be traced back to existing conditions/diseases that the patient had prior to entering the study.
You also have to watch out for lots of other language that the sponsors try to add in order to water down the section.
-----------------------------------------
Alexander Schoen
Director, Office of Sponsored Programs
Winthrop-University Hospital
222 Station Plaza North, Suite 510
Mineola, NY 11501
Phone: (516) 663-4931
Fax: (516) 663-9718
xxxxxx@winthrop.org
-----Original Message-----
From: Research Administration List [mailto:xxxxxx@hrinet.org] On Behalf Of Espinosa, Dora
Sent: Thursday, October 04, 2007 4:55 PM
To: xxxxxx@hrinet.org
Subject: [RESADM-L] Institutional Policy on Subject Injury during research
Dear Colleagues:
I would like to know if you have an institutional policy that addresses payment to a subject for injury during research. If so, does your institution require that sponsors paid for everything, or does it allow sponsor to pay only for those expenses that are not covered by the subject's insurance or Medicare? Our institution followed the suggestion of the AAMC (Clinical Trial Contracts: A discussion of four selected Provision) in that financial responsibility for payment of treatment to trial participants resulting from an injury during the course of the trial should rest with the Sponsor. We are partnering with a local hospital and they think that our language is too strict. We are analyzing this subject again before we respond to them.
Also, do you know if hospitals are less strict than medical institutions regarding subject injury language? If yes, do you know the reason?
Dora
Dora G. Espinosa, MBA
Director
Office of Sponsored Research
Rosalind Franklin University of Medicine and Science
Ph: (847) 578-8524
Fax: (847) 775-6555
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