Office for Human Research Studies
DANA-FARBER / HARVARD CANCER CENTER
DFCI Protocol No.:
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OHRS USE ONLY
HRC: _______ AM #: _______
STATEMENT OF PRINCIPAL INVESTIGATOR
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STATEMENT OF SITE RESPONSIBLE INVESTIGATOR
Instructions:
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This form should be completed by the Overall Principal Investigator (PI) or Site Responsible Investigator.
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If any required training is incomplete or expired, this submission will be returned and/or disapproved.
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If Human Subject Protection training will expire within 30 days of this submission, the addition of this investigator will be
disapproved. Please re-submit when refresher human subject protection training has been completed.

Overall Principal Investigators are required to complete training as outlined in DF/HCC SOP EDU-105 Training Requirements for
New Overall Principal Investigators. Please contact the DF/HCC Clinical Trials Education Office (CTEO) for information regarding
required training at CTEO@partners.org.

If this investigator has any outside interest(s) to report in “Part D - Disclosure of Outside Interests”, the Outside Interest Log
must be submitted for IRB review. For questions about reporting outside interests, please contact Roberta Driscoll in the DFCI
Office of Faculty Activities, (617) 632-4557 or Roberta_Driscoll@dfci.harvard.edu.

Please contact the OHRS, (617) 632-3029 or ohrs@dfci.harvard.edu, with any other questions.
Part A – Study Information
Full Project Title:
Trial Sponsors(s):
Name of Investigator:
Degree(s):
Phone:
E-mail:
Disease/Discipline Program:
Partners User ID (if applicable):
Department:
Institution:
Part B – Statement of Assurance
By signing this form, I understand that as the Overall Principal Investigator, I have ultimate responsibility for the protection of the
rights and welfare of human subjects, conduct of the study and the ethical performance of the project as described below. If I am the
Site Responsible Investigator, I understand that I am responsible for the conduct of the research conducted at the DF/HCC Site for
which I am designated the Site Responsible Investigator as described below.
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I agree to conduct this research in accordance with the relevant, current protocol(s) and will only make changes in a protocol
after notifying the sponsor and the IRB, except when necessary to protect the safety, rights, or welfare of subjects.
I agree to personally conduct or supervise the described investigation(s).
I agree to inform all research subjects or legally authorized representative of the investigational nature of this project as required
in 21 CFR Part 50 and 45 CFR Part 46. This includes allowing subjects or legally authorized representatives sufficient opportunity
to review the consent document, to discuss the research with other people and to ask questions before signing the informed
consent document.
I will ensure that the requirements for obtaining informed consent are met per the regulations found at 21 CFR Parts 50 and 56,
and 45 CFR Part 46.
I agree to report to the sponsor, IRB, FDA, OHRP, NIH, all site-responsible investigators and any other required sponsor or
agency, the adverse experiences that occur in the course of the investigation(s).
I have read and understand the information in the investigator’s brochure, including the potential risks and side effects of the
drug(s) or device(s).
I agree to ensure that all associates, colleagues, and employees assisting in the conduct of the research are fully informed about
the protocol and their respective research related duties and functions.
I agree to maintain adequate and accurate records in accordance with the regulations and to make those records available for
inspection in accordance with the regulations.
I am responsible for submitting the materials for continuing review in a timely manner.
I will promptly report to the IRB all changes in the research activity and all unanticipated problems involving risks to humans or
others.
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Version: 06.30.14b
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I have completed the required human subject protection training (see EDU-102 Human Subject Protection Training
Requirements).
I have completed all DF/HCC required investigator training (see EDU-103 Good Clinical Practice Training Requirement for
New Clinical Trial Researchers).
I have completed all DF/HCC required investigator training (see EDU-105 Training Requirements for New Overall Principal
Investigators).
Part C – Declaration of Outside Interests
Declaration of Outside Interests is mandated by the conflict of interest policies of Harvard Medical School (HMS) and the Dana-Farber
Cancer Institute (DFCI) whose Institutional Review Board (IRB) reviews research on behalf of Dana-Farber/Harvard Cancer Center
(DF/HCC) consortium members.
HMS conflict of interest policy is available for reference at:
http://hms.harvard.edu/about-hms/integrity-academic-medicine/hms-policy/faculty-policies-integrityscience/interim-policy-statement-conflicts-interest-and-commitment
DFCI conflict of interest policy is available for reference at:
http://www.dfcionline.org/research/researchoffices/facultyactivities/conflict/
If you answer “Yes” to any of the questions below, please complete the Outside Interests Log Sheet and submit it along with this form
via OHRS submit.
Do you, your spouse, dependent children, or any associated entity:
a) Expect to receive, or have received in the past 12 months, any financial interests in exchange for providing
consulting or scientific advisory services, or participating in educational or speaking engagements, from any
entity having an interest in, sponsoring or providing support for this research?
No
Yes (if Yes, please complete the Outside Interests Log Sheet)
b) Own, expect to own, or owned in the past 12 months, stock, stock options or other ownership interests in any
entity having an interest in, sponsoring or providing support for this research?
No
Yes (if Yes, please complete the Outside Interests Log Sheet)
c)
Have or expect to receive, intellectual property rights in any entity having an interest in, sponsoring or
providing support for this research?
No
Yes (if Yes, please complete the Outside Interests Log Sheet)
d) Serve on the Board of Directors of any entity having an interest in, sponsoring or providing support for this
research, currently or in the past five years?
No
Yes, currently (if Yes, please complete the Outside Interests Log Sheet)
Yes, previously within the past 5 years (if Yes, please complete the Outside Interests Log Sheet)
e) Hold an Executive Position in any entity having an interest in, sponsoring or providing support for this
research, currently or in the past five years?
No
Yes, currently (if Yes, please complete the Outside Interests Log Sheet)
Yes, previously within the past 5 years (if Yes, please complete the Outside Interests Log Sheet)
Statement of Principal Investigator / Site Resp. Investigator
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I hereby declare that the above declaration of Outside Interests accurately represents any and all such interests held
by me, my spouse, and my dependent children. I further agree that I will promptly update this declaration should the
relevant Outside Interests of myself, my spouse, my dependent children and other persons living in my household
change during the conduct of this research, or within one year following the completion of this research.
I understand and acknowledge that these disclosures are mandated by the Conflict of Interest policies of
HMS, DFCI and/or my institution.
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Signature of Investigator
_________
Date
Name:
Statement of Principal Investigator / Site Resp. Investigator
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