I read the letter by Davis and Walsh1 and the response by Lawlor et al2 in the January 21, 2001, issue of the ARCHIVES. Davis and Walsh are correct in pointing out that any mention of oversight by a research review body was missing from the original article. The explanation given by Lawlor and colleagues, that the research was not more than is usually done in the clinical setting and therefore was not subject to review when the study was developed, was an insufficient reason for failure to obtain approval of the research protocol prior to its implementation and regular (at least annual) oversight on an ongoing basis.
Moran MB. Clinical Research Requires IRB Review. Arch Intern Med. 2001;161(17):2151. doi: