Biomedical Research Institute of America
a non-profit corporation
June 7, 2002
Mr. Charles Wallach
18727 Ventura Blvd
Tarzana, CA 91356
Termination of Study
Dear Mr. Wallach:
The IRB committee has reviewed additional information regarding the above listed protocol. This information included data requested by the IRB and recently submitted by investigators involved in this study. The committee has also examined the web sites for Bio-Energy Services.
Upon review of this data at the June 5. 2002, meeting of the IRE, the committee unanimously voted to terminate approval for Protocol BDS PAP001 for all investigators. The reasons for this termination include;
- Noncompliance in reporting serious adverse events to the IRB (Initial 1RB Approval Notification dated May 24,2001)
Noncompliance in adhering to the conditions set forth in the Informed Consent document [21CFR 50.25(b)(3)]
- Making misleading claims on the web site regarding the device [21CFR 812.7]
- Commercialization of an investigational device [21CFR 812.7]
- Use of an investigational device outside the research arena [21CFR 812.7J
- Use of material unapproved by the IRB on the web site for subject recruitment [21CFR 812.7]
- Selection of subjects. is inequitable in that subjects were dropped from the study when they lost the ability to pay for the visits [21 CFR 56.111]
Effective immediately, all research activity with this device must cease [21 CPR. 56.1 03 (a)]. In addition, you must remove the unapproved web site from the Internet immediately.
As the sponsor you are responsible for terminating the study at all approved sites. You are also responsible for the return or disposal of all study devices [21CFR812.7(e)].
If you have further questions regarding this issue, please feel free to contact our office.
Edward Juskelis, M.D.
IRB Medical Chairman
copy: Mr. John Isele, CDHR/FDA
This page was posted on December 3, 2007.