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Home  » About Us  » Research  » Project Responsibility

Project Responsibility

Investigators who conduct research under the auspices of Methodist Healthcare are guided by the ethical principles regarding research in human subjects as set forth in the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled Ethical Principles and Guidelines for the Protection of Human Subjects of Research and by Methodist Healthcare policies governing research. Both investigators and institutions are bound by federal guidelines regarding the use of human subjects in research.

General responsibilities of investigators are outlined in the FDA form 1572, the Code of Federal Regulations and the Statement of Investigators by device companies. The investigator is directed to the Methodist Healthcare Institutional Review Board (MHIRB) guidelines.

Research Study Submission
The investigator will submit under his/her signature a research study in accordance with MHIRB guidelines. Any supporting documentation the investigator deems important to the project should be submitted to the MHIRB at the time of project submission.

For additional information, please call the MHIRB Administration Office at 901.516.2323.

Adverse Events 
  A report must be in the MHIRB office within five days of discovery of an Adverse Event using MHIRB Adverse Event Report Form.
Advertisements and Inducements for Research Subjects 
  MHIRB complies with these guidelines for the advertisements and inducements for research subjects.
Continuing Review of Research Study 
  The investigator must submit documentation to the MHIRB of the research study to be considered for re-approval.
Documentation 
  The investigator is expected to maintain all documentation required by the sponsor of the study including case report forms and all other clinical site documentation.
Informed Consent 
  The investigator must obtain informed consent from each subject, or the subject's legally authorized representative, before study related procedures may begin.
Research Study Closure 
  The investigator must notify the IRB within three months of closing a study.
Research Study Revisions 
  The investigator must obtain informed consent from each subject, or the subject's legally authorized representative, before study related procedures may begin.
Safety Reports 
  In the case of multi-center studies using an investigational drug or device, it is understood that the investigator will be receiving from the sponsor safety reports sent to the FDA from all centers participating in any study involving that drug or device.
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