- Posted October 20, 2013 by
This iReport is part of an assignment:
- MORGAN LEWIS RESPONSE TO THE SENATE FINANCE COMMITTEE CONFIRMING THE FACT THAT THE OUTCOMES REGISTRY HAD NOTHING TO DO WITH THE MYXO ETLOGIX CLINICAL TRIAL
- 150 years later, newspaper retracts editorial panning Gettysburg Address
- OHRP FDA REGULATIONS FOR INFORMED CONSENT CLASSIFIES INVESTIGATIONAL DEVICES SUCH AS THE MYXO ETLOGIX MODEL 5100 UNDER THE LAWS WHICH REQUIRE FULL INFORMED CONSENT:
- FDA CONGRESSIONAL OFFICE ON JULY 16, 2009 OFFICIALLY CATAGORIZES THE MYXO ETLOGIX MODEL 5100, MANUFACTURED BY EDWARDS LIFESCIENCES AS INVESTIGATIONAL AND OF SIGNIFICANT RISK
- Northwestern University and Northwestern Memorial Hospital Elements of Informed Consent : HIPPA WAIVER DOES NOT APPLY TO FDA STUDIES subject to the FDA regulations at 21 CFR 50
In 2013: The Board of Trustees of Northwestern University has the Institutional Responsibility for the oversight over the Human Experimentation and Lack of Informed consent
From 2009-to 2013 Dr. Rajamannan continues to inform the Board of Trustees, and the Audit office to fulfill the responsibilities of the reporting and to get the proper health care for the patients who are the human subjects and who have the guarantee from HHS under the federal wide assurance for full informed consent and for proper health care.
A copy of the Organizational Chart for the Audit and Advisory office, the ORI Misconduct policy is included in this report.
The Board of Trustees of Northwestern University has the Institutional Responsibility for the oversight over the Human Experimentation and Lack of Informed consent to test the McCarthy Annuloplasty Ring Model 5100.
In 2009 Dr. Rajamannan wrote the Board of Trustees and the Audit office for Northwestern University to get help for the patients who were suffering from the illegal surgical experiments.
The Board of Trustees of Northwestern University establishes policies for the governance of the University and is responsible for general oversight of the management of the institution. The major responsibilities of the Board include:
1) advancement of the University;
2) protection and enhancement of assets;
3) preservation of institutional integrity;
4) Board/President relations; and
5) functioning of the Board.
Obtaining informed consent is a basic ethical obligation and a legal requirement for researchers.
This requirement is founded on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Belmont Report. The principle of respect for persons requires that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected.
The requirement for informed consent is one of the central protections defined by:
• Department of Health & Human Services (HHS) regulations at 45 CFR part 46
• Food and Drug Administration (FDA) regulations at 21 CFR part 50
Potential subjects must be provided with information about the research project that is understandable and that permits them to make an informed and voluntary decision about whether or not to participate. The amount of information and the manner of presentation will vary depending on the complexity and risk involved in the research study. Informed consent is an ongoing educational interaction between the investigator and the research subject that continues throughout the study.
Audit Services helps ensure that the wide range of University processes operate in an accurate, timely and reliable fashion. We assess:
• efficiency of operations
• adequacy of internal controls
• reliability of financial information
• effectiveness of asset safeguards
• compliance with University policies and procedures
A copy of the letter sent to the Audit office and the Board of Trustees for Northwestern University is attached in this report
Evidence as Documented in CNN ireporter:NRajamannan