PRINCIPAL
INVESTIGATOR’S RESPONSIBILITIES
A.
General Responsibilities of Principal Investigators
The
principal investigator (PI) is responsible for personally
conducting or supervising the conduct of human-subjects
research and for protecting the rights, safety, and welfare
of the subjects enrolled in the research. The PI must
ensure that all human-subjects research is conducted in
an ethical manner and in accordance with all federal,
state, and local laws and regulations, institutional policies,
and requirements or determinations of the PHRC.
1.
Supervising the conduct of human-subjects research
The
PI may delegate study-related tasks, but must adequately
supervise study personnel to whom tasks are delegated.
When supervising the conduct of human-subjects research,
the PI must ensure that:
-
Study personnel are qualified by training and experience
to perform study-related tasks that have been delegated
to them;
-
Study personnel have an adequate understanding of
the research; and
-
Study personnel follow the IRB-approved protocol,
including the recruitment and consent procedures described
in the protocol summary.
The
PI should have a plan for supervision and oversight
of the research. The intensity of the supervision should
take into consideration the study personnel conducting
the research, the nature of the research, and the subject
population. For more information refer to PHRC guidance
Principal
Investigators and Delegation of Study-related Tasks
to Co-investigators and Study Staff.
2. Protecting the rights, safety, and welfare of research
subjects
The
PI or other identified qualified individual(s) must
be available to provide study subjects with reasonable
medical care for any medical problems that arise during
participation in the research that are, or could be,
related to the research. Additionally, when participation
in the research might impact the subject’s health and/or
medical care, the PI should inform the subject’s primary
care physician about the subject’s participation in
the research if the subject has a primary care physician
and if the subject agrees to the primary care physician
being informed.
When
protecting the rights, safety, and welfare of research
subjects, the PI must ensure that:
-
S/he or other identified, qualified individual(s)
provides study subjects with reasonable medical care
for any adverse events, including clinically significant
laboratory values, related to the research;
-
S/he or another specific qualified individual is available
to study subjects to answer questions or provide care
during the conduct of the research; and
-
S/he and all research staff conducting the study adhere
closely to the research plan, such as inclusion/exclusion
criteria, safety assessments, safety monitoring and
reporting of unanticipated problems, and procedures
to protect privacy of subjects and confidentiality
of identifiable data, in order to minimize risks to
subjects.
The
PI should not commence the research without adequate
resources to protect subjects participating in the research
and should stop the research if the resources necessary
to protect subjects become unavailable. These resources
might include research personnel, space, equipment,
time, and availability of medical or psychological care
for problems that arise during participation in the
research.
B. More Specific Responsibilities of Principal Investigators
The
PI must ensure that:
-
PHRC approval is obtained prior to initiation of the
research;
-
The research is conducted in accordance with the PHRC-approved
protocol, including, when applicable, the approved recruitment
and consent procedures;
-
When informed consent is required, informed consent
is obtained prior to the initiation of any study-related
procedures;
-
When written informed consent is required, informed
consent is obtained and documented using the current
PHRC-approved research consent form;
-
When drugs, biological products, and devices are being
investigated or used, they are managed and controlled
as required by institutional policy and, when applicable,
FDA regulations 21
CRF 312 and 21
CFR 812;
-
Changes to the PHRC-approved protocol and/or the research
consent form are not initiated without prospective PHRC
approval unless necessary to eliminate apparent immediate
hazards to the subject;
-
Unanticipated problems involving risks to subjects or
others (including adverse events) are reported promptly
to the PHRC in accordance with PHRC
policy
-
When applicable, Data and Safety Monitoring Board/Data
Monitoring Committee or other monitoring group reports
are submitted promptly to the PHRC for review;
-
Continuing review is conducted prior to expiration of
PHRC approval in accordance with PHRC
Policy;
-
Should PHRC approval lapse, research procedures, such
as recruitment and enrollment of subjects, study procedures
on currently enrolled subjects, review of health/medical
records, collection of tissue or other samples, or analysis
of data, are not conducted until the PHRC re-approves
the research or until special permission is obtained
from the PHRC to continue previously enrolled subjects
because it is in their best interests to do so;
-
When the research has been completed or is being closed
out prior to completion, a final continuing review report
is submitted to the PHRC;
-
Adequate and accurate research records are kept and
retained as required by the PHRC
and, when applicable, by the sponsor or FDA; and
-
Research records are made available to the PHRC, Partners
Quality Improvement Program (QI Program), the sponsor,
and when applicable, the Office for Human Research Protections
(OHRP), and the Food and Drug Administration (FDA) upon
request for monitoring and oversight of the research.
Guidance
based on United States. U.S. Dept. of Health and Human
Services, Food and Drug Administration, et al. Guidance
for Industry: Protecting the Rights, Safety, and Welfare
of Study Subjects – Supervisory Responsibilities of Investigators.
Draft Guidance May 2007
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