Northwestern University
Biomedical IRB Social and Behavioral Sciences IRB
750 North Lake Shore Drive 600 Foster Street
Suite 700 Chambers Hall, Second Floor
Chicago, Illinois 60611 Evanston, Illinois 60208
312-503-9338 847-467-1723
Media Relations Overview and Instructions
Version Date: 4/5/2012 (Replaces version dated 5/24/11)
OVERVIEW
Federal regulatory bodies view media relations material as a form of subject recruitment and an element of the informed consent process. Media relations material includes press releases, scripted broadcasts, non-scripted interviews or information distributed on the Internet.
The media relations form and materials must be submitted to the IRB:
· When the material pertains to a study that is still open at NU (data lock is not in place and medical records may still be accessed for research purposes); or
· When the activity involves a non-scripted interview of a study subject who is currently enrolled and actively participating in the research study. The interview is considered an extension of the consent and will require IRB review. The subject should sign a revised consent form or an addendum to the consent.
The media relations form and materials do not need to be submitted to the IRB
· When the material pertains to a study that is closed at NU (data lock is in place and includes no further access to medical records for research purposes)
· When the activity involves a non-scripted interview of a study subject who has already completed participation in the research study. The study subject should be reminded that the study data is still being collected and/or analyzed and that statements claiming efficacy of the treatment should be avoided. The University will provide the subject with a Multimedia Release Form to sign, granting Northwestern University and its agents the right to record the subject’s appearance and participation on videotape, audiotape, film, photograph or any other medium.
Note: This form should not be submitted with subject recruitment material unrelated to a media relations piece. Such recruitment material requires IRB approval, but may be submitted to the IRB without this form.
INSTRUCTIONS
Before submitting the form to the IRB, the Principal Investigator must obtain assistance and approval from the following offices before submitting the media relations material to the IRB Office:
Research funded through or conducted at NU:
Northwestern University Media Relations
· Chicago: (312) 503-8928
· Evanston: (847)491-4887
Research conducted at an NMH site:
NMH Office of Research:
(312)926-2598
For external non-federally-funded projects:
Office for Sponsored Research (OSR) must review media relations material for externally funded projects to ensure that the material is consistent with the contract between NU and the external funding source. Written sponsor approval may be submitted in place of the OSR approval. Contact OSR at:
· Chicago: (312) 503-4666
· Evanston: (847) 491-4236
To submit the form and materials to the IRB, a Revision form must be completed under the applicable study in eIRB. If the media relations material applies to multiple studies, a Revision form must be submitted for each individual project. The following documents should be uploaded into the Revision form:
1) The Media Relations Form with Sections III, IV, and V completed,
2) The text of all material that is intended to be seen or heard by prospective subjects,
3) For external, non-federally funded projects, written approval from the sponsor or OSR of the media relation materials,
4) For non-scripted interviews of subjects who are currently participating in the applicable study, a copy of the consent form that the subject will sign agreeing to participate in the interview.
To expedite approval, after the Revision form is submitted in eIRB, a separate email should be sent to both, Debra G. Tice at and Dr. Dennis West at notifying them of the submission of the media relations form.
Institutional Review Board OfficeNorthwestern University
Biomedical IRB Social and Behavioral Sciences IRB
750 North Lake Shore Drive 600 Foster St.,
Suite 700 Chambers Hall, 2nd Floor
Chicago, Illinois 60611 Evanston, Illinois 60208
312-503-9338 847-467-1723
Media Relations Form
Version Date: 4/5/2012 (Replaces version dated 5/24/11)
I. STUDY INFORMATION
Principal Investigator:
IRB Project number:
Media Relations Preparer/Contact:
II. MEDIA RELATIONS MATERIAL: Select the type of medium to be used:
Press Release
Internal Communication, Specify:
External Communication, Specify:
III. FINANCIAL CONFLICT OF INTEREST INFORMATION
Please review Items 1–6 below to determine if the Principal Investigator or any authorized research personnel have a financial conflict of interest*.
Top of Form
1. Within the past 12 months or anticipated for the next 12 months, will you and/or any member of your immediate family**, or any authorized research personnel and/or any member of such personnel’s immediate family, receive payments from the research sponsor in excess of $10,000 including salary, consulting fees, royalty or licensing payments from intellectual property, honoraria and/or gifts (excluding salary and other payments received from Northwestern University)? Yes No
If yes, please provide the details, including the nature of the personal compensation and describe any plan in place for managing this conflict.
Bottom of Form
2. Do you and/or any member of your immediate family, or any authorized research personnel and/or any member of such personnel’s immediate family, have an equity interest worth more than $10,000 or more than 5% of the business entity with the sponsor of this study as determined by reference to its publicly listed price (excluding mutual funds)? Yes No
If yes, please provide the name of the business and describe any plan in place for managing this conflict.
3. Do you and/or any member of your immediate family, or any authorized research personnel and/or any member of such personnel’s immediate family, have any equity interest with the sponsor of this study if the value cannot be determined by reference to publicly listed prices (e.g., start-up companies)? Yes No
If yes, please provide the details on the nature of the business and describe any plan in place for managing this conflict.
4. Do you and/or any member of your immediate family, or any authorized research personnel and/or any member of such personnel’s immediate family, have a position of management (Director, Officer, Partner, Trustee, Employee, or any other executive or management position) with a company that is sponsoring the research? Yes No
If yes, please provide details, including the nature and term of the official position or board membership, and describe any plan in place for managing this conflict.
5. Do you and/or any member of your immediate family, or any authorized research personnel and/or any member of such personnel’s immediate family, have patent rights or royalties from such rights whose value may be affected by the outcome of the research, including royalties under any royalty-sharing agreements involving Northwestern University or an external entity?
Yes No
If yes, please provide the details, including the nature and magnitude of the royalties and describe any plan in place for managing this conflict.
6. Do you and/or any member of your immediate family, or any authorized research personnel and/or any member of such personnel’s immediate family, have ownership interest (equity or stock options) for any amount when the value of the interest would be affected by the outcome of this research? Yes No
If yes, provide the details, including the nature of the ownership and describe any plan in place for managing this conflict.
*Financial conflicts of interest in research involve situations in which an investigator or research team member, or the investigator or research team member’s immediate family, has a significant financial interest that may compromise or have the appearance of compromising professional judgment in the design, conduct, or reporting of research.
**Immediate family consists of a spouse, domestic partner, dependent children, and/or any member of their household.
Significant financial interest means a financial interest as described below in a sponsor of research, or intellectual property (patents, copyrights, or trade secrets) held by an investigator or research team member or the investigator or research team member's immediate family individually or in aggregate. Please note, significant financial interest does not include ownership interests such as mutual funds that are managed by an independent third party.
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