OHRP Responds to Open Letter on Xiao's Procedure

Back in March, we sent an open letter on Xiao's Procedure, with supporting material, to several government offices and related hospitals. Of them, the Office of Research Integrity of Department of Health and Human Services, had previously responded to decline an investigation.

Today, an email arrived from a different office, the Office for Human Research Protections, indicating that they are taking actions on this issue:

From: Borror, Kristina C (HHS/OASH)

To: Eddie Cheng

CC: Menikoff, Jerry (HHS/OASH)

Subject: "Xiao Procedure"

Dear Mr. Cheng:

The Office for Human Research Protections (OHRP) has received your letter concerning research conducted at William Beaumont Hospital. I apologize for the delay in responding to you.

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 at http://www.dhhs.gov/ohrp/humansubjects/guidance/45cfr46.htm). In carrying out this responsibility, OHRP evaluates, at OHRP's discretion, 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 October 14, 2009 at http://www.hhs.gov/ohrp/compliance/ohrpcomp.pdf for an explanation of OHRP's jurisdiction).

OHRP has initiated an evaluation of the matter referenced in your letter. We notified the funding agency of your allegations and they have stopped enrollment into the study. We will advise you when the evaluation has been completed.

OHRP appreciates your concern about the protection of human research subjects. Please do not hesitate to contact me at any time should you have any questions or wish to provide additional information.

Sincerely

Kristina C. Borror, Ph.D.

Director

Division of Compliance Oversight

Office for Human Research Protections

1101 Wooton Parkway, Suite 200

The Tower Building

Rockville, MD 20852

(Note: email address and phone number are also included in the above email. Although they are public records, they are omitted here to limit spam.)