1BOM-Posted on Wednesday 13 March 2013
Now think what could be done in those field trials-the drug trials outside of institutions…the trials we never hear about.
“” …”de-identified electronic health record data representing more than 40 million patients” will get one’s attention. And how do they get that kind of access?””
1BOM-” the light of day…”
“This is one of the reasons for the mandatory push to patient electronic records in the US.
A large database thar can be deidentified if required, from which statistical data can he pulled.”
“Guidance on Engagement of Institutions in Human Subjects Research”
“Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.”
“Institution is defined in 45 CFR 46.102(b) as any public or private entity or agency (including federal, state, and other agencies).
For purposes of this document, an institution’s employees or agents refers to individuals who: (1) act on behalf of the institution; (2) exercise institutional authority or responsibility; or (3) perform institutionally designated activities. “Employees and agents” can include staff, students, contractors, and volunteers, among others, regardless of whether the individual is receiving compensation.”
Emphasis on the private entity as being an “institution”.
flip to Henery K. Beecher-1966
“In addition to documenting the extent of problems in human subject research, Beecher was instrumental in formulating the solutions. One common aspect to many of Beecher’s cases was that some experimental subjects, such as military personnel and mentally handicapped children in institutions, were not in a position to freely decline consent. Beecher believed that rules requiring informed consent were not by themselves sufficient, as truly informed consent was an unattainable ideal. He worked both in defining the rules and conditions for informed consent and in establishing institutional review boards as an additional layer of oversight regarding research protocols.”
40 million out of a country of 315
is about 1 in 7 people.So the question is how do you fit the patient to the clinical trial?
Complicating the HSR issue is this idea of patents:
FDA Matters -The Grossmen FDA Report “FDA’s E-Mail Scandal: First Impressions”
“According to the New York Times, FDA collected more than 75,000 employee e-mails in an effort to identify leaks of confidential trade secret information. At some point, a narrow, possibly legitimate inquiry into a handful of scientists at the Center for Devices and Radiological Health (CDRH) turned into a massive e-mail surveillance of selected individuals and their contacts.”
The last complication is a biggie,how much of our economy is absolutely dependant on this research? Are the risks really worth the benefits?
“Empires do not suffer emptiness of purpose at the time of their creation. It is when they have become established that aims are lost and replaced by vague ritual.’
FRANK HERBERT, Dune Messiah