Transcript Slide 1

NYU School of Medicine HRPP PI Lecture Series
Getting to Yes*
Helping to Get Your Protocol Approved
Thomas Diflo, MD, FACS
IRB Chairman
NYU SoM PI Lecture Series 2010
*With Thanks to Roger Fisher
The Old Days
NYU SoM PI Lecture Series 2010
The Old Days
NYU SoM PI Lecture Series 2010
IRB
Chair
PI
NYU SoM PI Lecture Series 2010
Criteria for IRB Approval of
Research
• Risks to subjects are minimized - Indicate How
• Risks to subjects are reasonable in relation to
anticipated benefit
(please specify reason for risk determination)
• Selection of subjects is equitable - Indicate How
• Informed consent will be obtained
• Informed consent will be documented
• Adequate monitoring to ensure safety
• Privacy is protected - Indicate How
• Vulnerable populations have been additionally
safeguarded
Informed Consent
NYU SoM PI Lecture Series 2010
Informed Consent
• A description of any reasonably
foreseeable risks or discomforts to the
subject.
NYU SoM PI Lecture Series 2010
Informed Consent
• A description of any reasonably
foreseeable risks or discomforts to the
subject.
• Participation is voluntary without
negative consequences if you don’t
participate
NYU SoM PI Lecture Series 2010
Informed Consent
• A description of any reasonably
foreseeable risks or discomforts to the
subject.
• Participation is voluntary without
negative consequences if you don’t
participate
• A process, not a paper form
NYU SoM PI Lecture Series 2010
Code of Federal Regulations
TITLE 45
PUBLIC WELFARE
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 46
PROTECTION OF HUMAN SUBJECTS
NYU SoM PI Lecture Series 2010
The Nitty-Gritty
NYU SoM PI Lecture Series 2010
The Nitty-Gritty
• What does the IRB need?
NYU SoM PI Lecture Series 2010
The Nitty-Gritty
• What does the IRB need?
• How can the PI give it to us?
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
a) In order to approve research covered by this policy the
IRB shall determine that all of the following
requirements are satisfied:
1. Risks to subject are minimized:
– (i) By using procedures which are consistent with
sound research design and which do not
unnecessarily expose subjects to risk, and
– (ii) whenever appropriate, by using procedures
already being performed on the subject for diagnostic
or treatment purposes
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
Risks to Subjects are Minimized
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
2. Risks to subjects are reasonable in relation to
anticipated benefits, if any, to subjects, and the
importance of the knowledge that may reasonably be
expected to result. In evaluating risk and benefits, the
IRB should consider only those risks and benefits that
may result from research (as distinguished from risks
and benefits of therapies subjects would receive even if
not participating in the research).
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
Risks are Reasonable
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
The IRB should not consider possible long-range
effects of applying knowledge gained in the
research (for example, the possible effects of the
research on public policy) as among those
research risks that fall within the purview of its
responsibility.
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
3. Selection of subjects is equitable. In making
this assessment the IRB should take into
account the purposes of the research and the
setting in which the research will be conducted
and should be particularly cognizant of the
special problems of research involving
vulnerable populations, such as children,
prisoners, pregnant women, mentally disabled
persons, or economically or educationally
disadvantaged persons.
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
Subject selection is Equitable
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
• Equitable Subject Selection
– The special case of non-English speakers
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
4. Informed consent will be sought from each
prospective subject or the subject’s legally
authorized representative, in accordance with,
and to the extent required by 46.116.
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
• The Process
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
• The Process
– Who
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
• The Process
– Who
– How
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
• The Process
– Who
– How
– Competency
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
• The Process
– Who
– How
– Competency
– Need for Surrogate
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
• The Process
– Who
– How
– Competency
– Need for Surrogate
– Assent for children
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
• The Process
– Who
– How
– Competency
– Need for Surrogate
– Assent for children
– How many parents need to sign
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
5. Informed consent will be appropriately
documented, in accordance with 46.117.
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
6. When appropriate, the research plan makes
adequate provision for monitoring the data
collection to ensure the safety of subjects.
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
6. When appropriate, the research plan makes
adequate provision for monitoring the data
collection to ensure the safety of subjects.
Patient Safety
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
6. When appropriate, the research plan makes
adequate provision for monitoring the data
collection to ensure the safety of subjects.
Patient Safety
The Role of Data Safety Monitoring
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
7. When appropriate, there are adequate
provisions to protect the privacy of the subjects
and to maintain the confidentiality of the data.
NYU SoM PI Lecture Series 2010
45 CFR 46.111 – Criteria for IRB Approval
of Research
NYU SoM PI Lecture Series 2010
PI
Co-I
Research
Team
Hierarchy of Research
The PI is the leader of the research team.
NYU SoM PI Lecture Series 2010
Human Research Protection Program
4-point
Responsibility in Research Plan
1. Accountability
NYU SoM PI Lecture Series 2010
Human Research Protection Program
4-point
Responsibility in Research Plan
2. Renew Commitment
NYU SoM PI Lecture Series 2010
Human Research Protection Program
4-point
Responsibility in Research Plan
3. Training and Development
NYU SoM PI Lecture Series 2010
Human Research Protection Program
4-point
Responsibility in Research Plan
4. Transparency
NYU SoM PI Lecture Series 2010
Criteria for IRB Approval of
Research
• Risks to subjects are minimized - Indicate How
• Risks to subjects are reasonable in relation to
anticipated benefit
(please specify reason for risk determination)
• Selection of subjects is equitable - Indicate How
• Informed consent will be obtained
• Informed consent will be documented
• Adequate monitoring to ensure safety
• Privacy is protected - Indicate How
• Vulnerable populations have been additionally
safeguarded
NYU School of Medicine
PI Lecture Series 2010
• June 16th – “How Can You Recruit for Your Project”
– Frederick G. More, DDS, IRB Chairman
• September 16th – “Get to Know Your HRPP”
–
–
–
–
Kenneth Delany, SPA
Elan Czeisler, IRB
Jeanie Gatewood, OCT
Keisha Lightbourne, Regulatory Compliance
• December 2nd – “Areas PI Find Vexing”
– Frederick G. More, DDS, IRB Chairman
– Sylvia Adams, MD, Co-IRB Chairwoman
NYU SoM PI Lecture Series 2010