July 22, 2013 - Dignity Health

Dear Dr. Wiebe:

Thank you for your March 29, 2012 report in response to our March 5, 2012 request that Catholic Healthcare West evaluate allegations of noncompliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46).  

The complainant alleged the following:

That subjects in the above-referenced studies were not provided with informed consent information in language understandable to the subject or the subject’s legally authorized representative (for example, for Sri Lankan and Persian subjects), as required by HHS regulations at 45 CFR 46.116, and that study staff members did not explain the studies to subjects.   

We acknowledge that members of the research team speak the languages of the subjects and translated the informed consent information verbally.  We acknowledge your April 16, 2013 report indicating that the principal investigator has closed the study at your site due to noncompliance by a study coordinator.  OHRP makes no finding regarding this allegation.  Please see our guidance “Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English” at http://www.hhs.gov/ohrp/regulations-and-policy/guidance/obtaining-and-documenting-infomed-consent-non-english-speakers/index.html.

At this time, there should be no need for further involvement by our office in this matter.  Please notify us if you identify new information which might alter this determination.

We appreciate the continued commitment of your institution to the protection of human research subjects.  Please do not hesitate to contact me should you have any questions.

Sincerely,

Kristina C. Borror, Ph.D.
Director, Division of Compliance Oversight
1101 Wootton Parkway, Suite 200
Rockville, Maryland  20852
Telephone: 240-453-8132
FAX: 240-453-6909
E-mail: Kristina.Borror@hhs.gov

cc:
Mr. Matthew Rydman, Director, Human Subjects Protections Office, Catholic Healthcare West
Dr. Miriam Cotler, Chairperson, Catholic Healthcare West IRB #11
Dr. Mehrdad Ariani, Northridge Hospital and Medical Center

Dr. Margaret Hamburg, Commissioner, Food and Drug Administration (FDA)
Dr. Joanne Less, FDA
Dr. Susan Shurin, Director, National Heart, Lung, and Blood Institute, National Institutes of Health
Dr. Michelle Bulls, Director of OPERA, Office of Extramural Research, NIH
Ms. Sarah Carr, Office Science Policy, NIH