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As the individual responsible for the implementation of the research, the principal
investigator bears ultimate responsibility for protecting every research subject.
Each investigator is obliged to be personally certain that each subject is adequately
informed and freely consents to participate in the investigator's research. The
investigator must personally assure that every reasonable precaution is taken
to minimize any risk to the subject. The investigator also assumes responsibility
for compliance with all Federal, State, and institutional rules and regulations
related to research involving human subjects and human-subject-derived information
and materials.
As a principal investigator you must:
- Accept responsibility for the scientific
and ethical conduct of this research study
- Obtain prior review from
the IRB before implementing any protocol amendments and/or changes to approved
research, except where necessary to eliminate apparent immediate hazards
to the study subjects
- Immediately report to the IRB any serious adverse reactions
and/or unanticipated effects on subjects which occur as a result of this
study
- submit a progress report prior to expiration of specified approval
period
- Report any significant changes to the study site and significant deviations
from the research protocol
- Report all deaths of subjects enrolled in the research
project
- Upon completion,
termination, or non-renewal of the project, submit a protocol termination form
- Train study personnel in the proper conduct of human subject research
- Prepare and maintain adequate and accurate case histories that record
all observations and other data pertinent to the investigation on each individual
administered the investigational drug/device or employed as a control
in the investigation
- Case histories include the case report forms and supporting data such as, signed and dated consent forms and medical records containing progress notes of the physician, the individual's hospital chart(s), and nurses' notes. The case history must have documented evidence from each individual that informed consent was obtained prior to participation in the study.
- Assure peer review of the protocol
- submit an indemnification agreement
for the protocol for industry sponsored protocols taking place in Mount Carmel
facilities
- assure coordination with Mount Carmel departments, including,
but not limited to:
- staff in-servicing with the appropriate nursing units
- coordination
of drug accountability with the pharmacy
- coordination with radiology
department, pathology department, laboratory department, and/or other
departments as applicable
It is the responsibility of the investigator to assure that only individuals
who are licensed or otherwise qualified perform procedures in a study and that
those procedures are performed with the appropriate level of supervision under
the laws of the state of Ohio and the polices of Mount Carmel. The principal
investigator may delegate some tasks and responsibilities, but retains ultimate
responsibility for the ethical conduct of the research.
Per Federal regulations, the investigator obtaining informed consent must
note in the source documents, including the hospital medical record, the subject's
willingness to participate and the volunteering of informed consent prior to
any study related procedures. This is required for all studies. The continuing
informed consent should also be noted. The documentation of informed consent
must be maintained in compliance with institutional policies, FDA regulations,
OHRP regulations, and ICH regulations or contractual obligations as applicable.
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