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.