July 16, 2013 - Yale University

Dear Dr. Rudczynski:

Thank you for your October 20 and December 9, 2011 responses to our September 22 and November 15, 2011 requests for information related to our evaluation of the Yale University (Yale) system for protecting human research subjects as part of our program to evaluate human subjects protection programs of institutions that receive Department of Health and Human Services (HHS) support for research.  We apologize for the delay in responding to your reports.  

A. Recommendations regarding your human subjects protection program:

HHS regulations at 45 CFR 46.116(d) require that the IRB make and document four findings when approving a consent procedure which does not include, or which alters, some or all of the required elements of informed consent or when waiving the requirement to obtain informed consent.  OHRP recommends that when approving such a waiver for research reviewed by the convened IRB, these findings be documented in the minutes of the IRB meeting, including protocol-specific information justifying each IRB finding.

B. Other findings:

We note that the Yale institutional review board reviewed and approved, and the institution conducted protocol #0410027163, The Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight Infants (the SUPPORT Trial).  Please see attached determination letter to University of Alabama Birmingham (UAB) related to determinations of noncompliance against that institution regarding the informed consent document for this study and a follow-up letter which notes that we have put on hold all compliance actions against UAB relating to the SUPPORT case, and plan to take no further action in studies involving similar designs until the process of producing appropriate guidance is completed.  

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.

OHRP appreciates the continued commitment of your institution to the protection of human research subjects.  Please feel free 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

Attachments: March 7, and June 4, 2013 letters to University of Alabama, Birmingham

cc:
Dr. Marianne  LaFrance, Chair, Human Investigation Committee #1, Yale University
Dr. Sandra Alfano, Chair, Human Investigation Committee #2 & 5, Yale University
Dr. Maurice Mahoney, Chair, Human Investigation Committee #3 & 4B, Yale University

Dr. Margaret Hamburg, Commissioner, Food and Drug Administration
Dr. Joanne Less, Food and Drug Administration
Dr. Sherry Mills, OER, National Institutes of Health
Dr. Joe Ellis, OER, National Institutes of Health