Indwelling Catheter QI Procedures: (July 30, 2008)

July 30, 2008 Letter to Dr. Peter Provonost Regarding Indwelling Catheter Procedures

The Office for Human Research Protections (OHRP) has posted its recent letter to Dr. Peter Pronovost at the Johns Hopkins University School of Medicine, in the belief that others may find OHRP’s analysis of his planned activities useful for understanding the applicability of the regulations to certain types of quality improvement activities.

On April 8, 2008, Dr. Pronovost sent a letter to OHRP requesting clarification regarding whether the Department of Health and Human Services (HHS) regulations for the protection of human subjects in research would apply to certain planned activities involving the implementation of a program designed to reduce catheter-related infections at a number of hospitals across the country. OHRP requested additional information about the planned activities, to which Dr. Pronovost responded. OHRP then sent a letter to Dr. Pronovost with an analysis of whether the HHS regulations would apply to the planned activities described by Dr. Pronovost. Dr. Pronovost has agreed to the posting of this letter.

The link below provides a copy of OHRP’s letter to Dr. Pronovost. OHRP welcomes comments on its analysis. Comments on this or other subjects may be submitted to OHRP by email at ohrp@hhs.gov. Please include the term “Pronovost letter” in the subject field. Alternatively, comments may be submitted by mail to:

Office for Human Research Protections
1101 Wootton Parkway
The Tower Building, Suite 200
Rockville, MD 20852

Comments received, including any personal information provided, will be made available to the public upon request.

See Indwelling Catheter QI Procedures: Letter, July 30, 2008 (also available in PDF format).