Kathy Kasten
on theNuremberg Human
Experimentation Directives
From Kathy Kasten - kkasten@pathology.medsch.ucla.edu
February 1997
In addition to the Nuremberg Code, there are United States Federal regulations which further define a human subjects rights - these go a little further than the Nuremberg Code.
For example, a human subject has the right at any time to refuse to participate in the research, without providing a reason to the Principal Investigator, and without retribution for doing so. For example, if compensation is to paid for participation in the study, the length of time the individual is calculated and the requisite amount of monies paid to the subject.
There is no research conducted on humans which is not therapeutic. There is always a lot of arguments in Human Subject Protection Committee meetings regarding "control subjects." A control subject is one who is administered a placebo/no drug looking substance. Therefore, the Committee usually will ask the P.I., if the experimental therapy works, to "cross-over" all control subjects who wish/ask for the experimental treatment.
If there is risk/side effects from the study treatment, the potential subjects are apprised before beginning the study. That is why there is an Informed Consent Form; it is contain all information pertaining to the study as described under both the Nuremberg Code and the Federal regulations.
If the individual is hospitalized because of a response to therapy, it is the institution sponsoring the study should be monetarily responsible.
Responsibility for all research studies performed in the United States - no matter where - were watched over by the NIH until 1994, when the government decided that local control would be more feasible, efficient and perform the watch dog stance better. UCLA's has become a model for all institutions within the United States - and Dr. Neal of the NIH has so stated.
So, it is important to know the name of the P.I., the institution, etc. and then approach the local Institutional Review Boards. I when to the NIH because I wanted the policy dictum stating that no covert research would be done with tax payers' monies. I still send information I think pertinent to Dr. Neal at the NIH. Whether he responds directly to me is not important. At this time, I provide him with the website/e-mail address of the people I discover are possibility involved in covert research projects.
I guess Dr. Neal should be apprised of John Alexander and the group in Las Vegas. Anybody have their e-mail address/website? I can provide the information I have put together so far, and send it on to Dr. Neal.
Kathy