Re: Another Clinical Trial Survey Ellen Hyman-Browne 13 Feb 2007 14:27 EST

Susan,
I think of the OHRP template as a starting point, and adapt it to add
whatever agreements are necessary. For example, I would add an agreement
to allow monitoring of study records by the institution. So billing
policies and conflicts policies can be addressed.
Ellen

-----Original Message-----
From: xxxxxx@MSJ.ORG
To: "xxxxxx@MSJ.ORG".GWIA1.MERCURY
"xxxxxx@hrinet.org".GWIA1.MERCURY
BCC: Ellen Hyman-Browne <xxxxxx@email.chop.edu>
Creation Date: 2/13 1:06 pm
Subject: Re: [RESADM-L] Another Clinical Trial Survey

Ellen,
Thanks for providing the link.  The OHRP Agreement specifically
addresses compliance with regard to IRB related issues.  How do you
ensure compliance with other research issues (billing, conflict of
interest, research integrity, etc) and institutional policies ?
-Susan

-----Original Message-----
From: Research Administration List [mailto:xxxxxx@hrinet.org]On Behalf
Of Ellen Hyman-Browne
Sent: Monday, February 12, 2007 4:12 PM
To: xxxxxx@hrinet.org
Subject: Re: [RESADM-L] Another Clinical Trial Survey

Below is the link for the individual investigator agreement template on
the OHRP website. In case you have problems with that link, below it is
the OHRP page with the link to the agreement.

http://www.hhs.gov/ohrp/humansubjects/assurance/unaflsup.rtf

http://www.hhs.gov/ohrp/assurances/assurances_index.html

Elle

Ellen Hyman-Browne
Deputy Compliance Officer - Research
The Children's Hospital of Philadelphia
3535 Market Street - Suite 1371
Philadelphia, PA 19104
(267)426-6046
xxxxxx@email.chop.edu

To report compliance concerns anonymously, contact the Compliance
Hotline 1-866-246-7456 or www.mycompliancereport.com

n
>>> xxxxxx@WI.MIT.EDU 2/12/2007 2:51:17 PM >>>

Ellen,
I think it would help us all if you could direct the group to the OHRP
website that holds the independent investigators agreement.
Thanks,
Rich

Ellen Hyman-Browne wrote:

This is not much of an issue at my current institution, but I've dealt
with this at two other hospitals. We did allow doctors with privileges
to conduct research, requiring them to sign an independent investigators
agreement (there's one on the OHRP web site) and requiring any contract
to go through our clinical trials office. We did not require use of a
hospital coordinator.
Ellen

Ellen Hyman-Browne
Deputy Compliance Officer - Research
The Children's Hospital of Philadelphia
3535 Market Street - Suite 1371
Philadelphia, PA 19104
(267)426-6046
xxxxxx@email.chop.edu

To report compliance concerns anonymously, contact the Compliance
Hotline 1-866-246-7456 or www.mycompliancereport.com

>>> xxxxxx@MSJ.ORG 2/12/2007 1:40 PM >>>

Happy Monday !

Hope you all will help me by answering a short survey.  I'll be happy to
tally the results if others are interested.
Many Thanks!

Do you allow community physicians with hospital privileges, but who are
not employed by your institution, to conduct clinical trials in your
hospital?

If yes, do you also allow their research coordinators to coordinate the
trials or do you mandate the use of hospital employed coordinators?

------------------------------------------------------
Susan E. Sutherland, Ph.D.
Director, Research Institute
Mission Hospitals, Inc.
509 Biltmore Avenue
Asheville, NC 28801
ph: 828. 213-7038
fax: 828.213-7052
www.missionhospitals.org/research.htm <
http://www.missionhospitals.org/research.htm>

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--

Richard Chiriatti, CRA

Associate Director

Office of Sponsored Programs

Whitehead Institute for Biomedical Research

5 Cambridge Center, Room 780

Cambridge, MA  02142-1493

Phone: (617) 258-5018

Fax: (617) 258-6184

E-mail:  xxxxxx@wi.mit.edu

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