Yes, based on a study-specific review, we may permit such language based on the principle of autonomy.  In these situations, we require specific language in the consent document and process explaining that the research subject will be at risk for financial harms if third party payors (insurers and CMS) do not pay for such injuries.  We also require that the PI explain the probability of such physical injury and the associated financial risks.  Finally, in the consent we include two check boxes for the subject to complete:
[] I have discussed participation in this trial with my insurance company.
[] I do not have health insurance.

Steven Lascher, DVM, MPH, PhD
Vice President, Research
Saint Vincent Catholic Medical Centers of New York
170 W.12th Street - Staff House
New York, NY 10011
(v) 212-604-7470
(f) 212-604-7159
Email: xxxxxx@svcmcny.org

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@hrinet.org] On Behalf Of Jamie Kauwell
Sent: Wednesday, June 10, 2009 2:30 PM
To: xxxxxx@hrinet.org
Subject: [RESADM-L] Subject Injury Language in ICF/CTA

Good Afternoon,
Would you ever include CTA & ICF language that specifies risks that would be included or excluded from subject injury coverage? Specifically, risks related to procedures that would be considered standard of care.

Thank you,
Jamie

Jamie Kauwell MHA CCRC
Administrative Research Coordinator
Geisinger Center for Clinical Studies
Henry Hood Center for Health Research
100 N. Academy Ave
Danville, PA  17822-4400
Phone# 570-214-9405
Fax# 570-271-6944
xxxxxx@geisinger.edu

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