THOMAS JEFFERSON UNIVERSITY - DOC by QjDFZhPh

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									Thomas Jefferson University                                                              OHR8-
D
Principal Investigator:                                                                  7/2009
IRB Control:
Phone Number:
Page 1
                                 THOMAS JEFFERSON UNIVERSITY
                                  ADDENDUM TO CONSENT FORM



TITLE OF RESEARCH:

SPONSOR:

IRB CONTROL NUMBER:

Thomas Jefferson University [TJU] and __________________ have entered into an IRB
Authorization Agreement (IAA). This agreement enables the both institutions to enroll patients
into a study for which TJU is relying on the approval and regulatory oversight of the
__________________Institutional Review Board [IRB]. The __________________ IRB has
reviewed and approved the protocol and consent form for this study.

This addendum provides additional information for participants being enrolled at TJU, and that is
not included in the __________________consent form being used for this study.

If you have any questions and/or concerns about this research, you are free to ask the study
doctor or others as listed below.

Study doctor: (put contact information for PI and Co-Is here)




CONFIDENTIALITY
All information generated from this study will be maintained in the strictest of confidence. The
terms and conditions of confidentiality are the same at both institutions.

By signing this Addendum to Consent Form, you are allowing the research team at
______________________ to have access to your protected health information (PHI) collected
during the course of this study. The research team also includes the investigators listed on this
Addendum to Consent Form and the TJU Division of Human Subjects Protection. Your PHI will
also be shared, as necessary, with the __________________ IRB. These people and entities
are obligated to protect your PHI.

INDEMNIFICATION
The terms and conditions of indemnification included in the __________________consent form
will be the same terms and conditions applicable to TJU and participants enrolled at TJU.

DISCLOSURE OF FINANCIAL INTEREST
The sponsor of this clinical study, ________________, is paying Thomas Jefferson University to
conduct this study.
Thomas Jefferson University                                                                            OHR8-
D
Principal Investigator:                                                                                7/2009
IRB Control:
Phone Number:
Page 2


ADDITIONAL INFORMATION


Telephone number for questions          The Jefferson Institutional Review   215-503-8966
about your rights as a research         Board
participant
For questions, concerns or              The Principal Investigator,          Insert telephone number
complaints about the research, or if    Dr. _____________________
you suspect a research-related injury

If you have difficulty contacting the   Call the Jefferson Office of Human   215-503-0203
study staff                             Research during working hours




    By signing this consent form, you are not waiving any of your legal rights.




Signature of Participant                                                                      Date

____________________________________________________________________________
Signature of Person Conducting Consent Interview                 Date




Principal Investigator or Co-Investigator                                                     Date

								
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