From: Borror, Kristina C. (OPHS) [mailto:KBorror@OSOPHS.DHHS.GOV]
Sent: Friday, March 03, 2006 1:46 PM
Cc: Schwetz, Bernard A. (OPHS); Carome, Michael A. (OPHS); Lin, Melody (OPHS); Stith-Coleman, Irene E. (OPHS); Hicks, Shirley (OPHS)
Subject: RE: AHRP Files Complaint with OHRP Re: Non-Consensual "Blood Substitute" Experiment on Trauma Patients
Dear Ms. Sherav:
The Office for Human Research Protections (OHRP) has received your March 2, 2006 email concerning the Polyheme trial.
As you know, OHRP has responsibility for oversight of compliance with the U.S. Department of Health and Human Services (HHS) regulations for the protection of human research subjects (see 45 CFR Part 46 athttp://www.dhhs.gov/ohrp/humansubjects/guidance/45cfr46.htm ). In carrying out this responsibility, OHRP evaluates all substantive allegations of noncompliance involving human subject research projects conducted or supported by HHS or that are otherwise subject to the regulations (see OHRP memorandum dated December 4, 2000 at http://www.dhhs.gov/ohrp/compliance/ohrpcomp.pdf for an explanation of OHRP’s jurisdiction).
Neither of these conditions appear to be met by the circumstances described in your emails. Therefore, OHRP will not be able to pursue the matter on your behalf.
The research that you describe appears to be subject to the jurisdiction of the U.S. Food and Drug Administration (FDA). Therefore, OHRP will forward a copy of your email to the Acting FDA Commissioner and FDA’s Office for Good Clinical Practice for further review. The Office for Good Clinical Practice can be reached at the following address:
Office for Good Clinical Practice HF-34
Office of the Commissioner
Food and Drug Administration
5600 Fishers Lane (HF-34)- Suite 9C24
Rockville, MD 20857
OHRP appreciates your concern about the protection of human research subjects. Please feel free to contact me if you have additional questions about this matter.
Kristina C. Borror, Ph.D.
Division of Compliance Oversight
Office for Human Research Protections
1101 Wootton Parkway, Suite 200
The Tower Building
Rockville, MD 20852
Phone: (240) 453-8132
Fax: (240) 453-6909
Dear Dr. Borror,
Thank you for your quick response to our letter of complaint (posted at: http://www.ahrp.org/cms/ ).
Attached is a list of sites at which the non-consensual PolyHeme experiment is being conducted.
Among the sites listed at clinicaltrials.gov are the following: University of California, San Diego; Denver Health Medical Center; Medical Center of Central Georgia; Loyola University Medical Center; University of Kansas Medical; University of Kentucky Medical Center; Mayo Clinic, Rochester, Minn; Duke University Medical Center; University of Cincinnati Medical Center; St. Luke’s Regional Resource Trauma Center; University of Texas Health Science Center; Brooke Army Medical Center, Fort Sam Houston, Texas; University of Utah Health Sciences Center, Virginia Commonwealth University Medical Center;
These institutions have a DHHS federal wide assurance (FWA )–a license to conduct research involving human beings on the basis of a contractual promise to adhere to federal regulations known as The Common Rule (45 CFR 46). Foremost among these regulations is the right to informed consent by the individual human subjects.
If institutions having a federal license recruit human subjects in the community, the community expects that a federally licensed medical institution will abide by federal protections for human subjects.
OHRP should not be so quick to claim lack of jurisdiction inasmuch as the license it issues is being used as a license to conduct an experiment that fails to meet federal regulations under the Federal license.
If the experiment were being conducted in the sponsor’s basement, it may be argued that OHRP has no jurisdiction under current law. However, the PolyHeme experiment is being conducted at facilities licensed and overseen by HHS-OHRP, and was approved by an IRB accredited by a government agency–the Veterans administration.
The community was thus misled into believing that the artificial blood experiment was fully compliant with ethical standards.
Inasmuch as complaints had been filed with OHRP about the PolyHeme experiment at least as early as one year ago, did OHRP conduct an investigation and did OHRP issue a report of its findings?
If so, may we have a copy of the OHRP letter / report ?
Research involving human subjects is fraught with risks for the subjects involved. Human subject protections is a serious responsibility that must not fall between agency jurisdictional chairs.
Even a cursory examination of the public record shows that the FDA has demonstrated an utter lack of regard for the life safety of citizens who are exposed to harmful drugs and medical products–often with an FDA seal of approval–without disclosure of the known and potential harms. Thus, research conducted at DHHS-OHRP licensed facilities cannot be relegated to the FDA whose priority is approving medical products as quickly as possible.
Contact: Vera Hassner Sharav