The Principal Investigator's Responsibilities in Research

The Principal Investigator’s
Responsibilities in Research
Morning Presenter: David Rizzieri, MD
Associate Professor, Cancer Center
Afternoon Presenter: Edward Suarez, PhD
Associate Professor, Department of Psychiatry

David Rizzieri, MD
Associate Professor, Cancer Center
Dr. Rizzieri is an Associate Professor of Medicine and involved in
the hematologic malignancy program, writing and conducting
over 50 studies of novel agents in the treatment of leukemia and
lymphoma. In addition, he is funded as a 'Clinical Scholar of the the
Leukemia and Lymphoma Society' for his work using
mismatched immune systems in hematopoietic stem cell
transplantation and introducing new post transplant immune
modulatory
strategies.

Duke University Health System
PI Responsibilities & The IRB
Duke Policy states that ALL human subjects’
research done at Duke or done by Duke faculty,
staff or students anywhere in the world MUST
have DUHS IRB review and approval prior to
initial human subject contact.

DUHS PRINCIPAL
INVESTIGATOR (PI)
AGREEMENT
New DUHS PI Agreement of 22 Statements
To Be Signed Annually by Researchers
Implementation date to be announced by Dr.
Oddone

DUHS PI Agreement
Commitment of a DUHS PI or Co-PI Co PI to
Institutional Human Subject Protection
Policies & IRB Oversight Under Federal- Federal
Wide Assurance, FWA # 00009025

DUHS PI Agreement
Preamble
Declaration of intent to participate in
research subject to initial and continuing review
by the IRB.

DUHS PI Agreement
Preamble continued
Understanding that a condition of doing
research is to acknowledge and accept
responsibilities of the DUHS Investigator
Agreement to comply with institutional policies,
applicable federal, state, & local laws and
regulations, ethical guidelines and other policies
and principles as described in the document.

1. Familiar with:
-HHS 45 CFR 46:
DUHS PI Agreement
-FDA 21 CFR 50 & 56:
54, 312, 314:
601:
812:
814:
Protection of Human Subjects
Protection of Human Subjects
Good Clinical Practice
Licensing of Biologics
Investigational Device Exemptions
Pre-market Approval of Medical Devices
-HIPAA 45 CFR 46, 160 and 164

DUHS PI Responsibilities
2. I recognize the authority of the DUHS
IRB
oversee human subject research, as
described in the FWA, and I will abide by
all decisions of the IRB

DUHS PI Responsibilities
3. Assume overall administrative responsibilities
for all aspects
of each protocol approved under
this Agreement. Will maintain appropriate
oversight
of the research protocol and my
research staff and appropriately delegate
research responsibilities.

4.
DUHS PI Responsibilities
I will ensure that all members of my research staff, and
all others directly involved in the conduct of the
study, are qualified by education, training, and
experience to perform their research
responsibilities.
I will inform my staff of any pertinent changes during the
course of a study, and arrange for education or
additional training of staff as needed.

DUHS PI Responsibilities
5. If I arrange with a source outside of DUHS to
provide information critical to the study, I will
take steps to ensure that the outside source can
verify the integrity of data and records
provided to me.

DUHS PI Responsibilities
6. Will employ sound study design
in accordance
with the standards of my discipline.

DUHS PI Responsibilities
7. Will recruit participants in a fair and equitable
manner, manner,
weighing the potential benefits of the
research to the participants against their
vulnerability and the risks to them.

DUHS PI Responsibilities
8. I will notify the IRB when I wish to enroll a
prospective subject who does not meet
inclusion/exclusion criteria as specified in the
protocol, and I will do so prior to enrollment
of the person.

DUHS PI Responsibilities
9. For more than minimal risk research will
provide the IRB with an adequate data and
safety monitoring plan for promptly detecting
harm and mitigating potential injuries.

DUHS PI Responsibilities
10. I have determined, before conducting the
research study, that the resources necessary to
appropriately protect participants are present.

DUHS PI Responsibilities
11. I will comply with the IRB’s prompt reporting
requirements.

DUHS PI Responsibilities
12. Will seek, document, and maintain records of
informed consent and HIPAA authorization
from
each research participant or the participant’s legally
authorized representative as required under HHS
regulations and stipulated by the IRB.
Will
develop an informed consent process
emphasizing the importance of participant
comprehension and voluntary participation.

DUHS PI Responsibilities
13. I will ensure that the informed consent process is led
only by individuals who have appropriate training and
knowledge of the research, including any
investigational product involved, in order to discuss
the risks and benefits of the study with prospective
subjects.
Only appropriate staff listed as “Key Personnel” in
my IRB submission will be authorized by me to
conduct the consent process with prospective
subjects.

DUHS PI Responsibilities
14. I agree to cooperate with the IRB as it conducts initial
and continuing review, including providing required
information, records, reports, and certifications.
I will ensure that the periodic continuing review of my
research will occur within the time frame stipulated
by the IRB, and no research will continue beyond the
designated approval period.

DUHS PI Responsibilities
15. Will conduct research involving FDA-regulated FDA regulated products
under an IND application or IDE,
Will comply with all applicable FDA regulations and fulfill
all investigator responsibilities [or investigator-sponsor
investigator sponsor
responsibilities, where appropriate], including those
described at 21 CFR 312 and 812, the text of which is
found at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr
/cfrsearch.cfm

DUHS PI Responsibilities
16. I Will NOT enroll participants in research prior to the review
and approval of the research by the IRB.
I Will report promptly to the IRB proposed changes in the
research conducted under this Agreement.
I Will NOT initiate changes in research activities without
prior review and approval by the IRB, except when necessary
to eliminate immediate hazards to the research participants.

DUHS PI Responsibilities
17. Understand that emergency medical care may
be delivered without IRB review and approval
to the extent permitted under applicable
Federal regulations and State law.

DUHS PI Responsibilities
18. I (and my research staff) will respond in a
timely manner to participants’ complaints or
requests for information.
If I am unable to resolve the complaint
satisfactorily, then it is my responsibility to
report the complaint to the IRB.

DUHS PI Responsibilities
19. I will generally be available (by phone or other
electronic communication) to subjects during the
study. If I will be unavailable during the study, I will
delegate study responsibility to a specific qualified
person who will be available in my absence. I will
inform the IRB of this delegation of authority, via a
protocol amendment, as a change in the research
activity requiring IRB review.

DUHS PI Responsibilities
20. Understand if there is a change in my status
as PI, it is my responsibility to inform the IRB
of the change & to seek IRB approval for a
new principal investigator to continue the
project,
or to request closure of the protocol.

DUHS PI Responsibilities
21. I will cooperate with any inquiry by the Duke
University School of Medicine Compliance Office
concerning any research with humans in which I
participate.
In the event that institutional officials determine that
I have failed to comply with this Agreement, I agree
to take recommended action (s), including but not
limited to termination of my participation in
designated research activities.

DUHS PI Responsibilities
22. In the event I am found to have failed to comply of
with any of these requirements, the IRB will report
such noncompliance to institutional officials, the
Office of Human Research Protections (OHRP), the
compliance officer of any other sponsoring federal
department or agency, such as the FDA, and the non-
federal sponsor of the research, as appropriate.

DUHS Investigator Agreement &
Responsibility
23. I acknowledge that my primary responsibility as a
PI or Co-PI Co PI is to safeguard the rights and welfare of
each research subject, and that the subject’s rights and
welfare must take precedence over the goals and
requirements of the research.