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> ----------------------------------------- This message and its attachments may contain confidential and/or legally-sensitive information that is intended for the sole use of the addressee(s). Any unauthorized review, use, disclosure, or distribution of the information contained in this message and its attachments is prohibited. If you have received this message or any of its attachments in error, please destroy all originals and copies of the same and notify the sender immediately. ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== -- 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 ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================
