Phil B.FontanarosaMD, Deputy EditorIndividualAuthorStephen J.LurieMD, PhD, Contributing EditorIndividualAuthor
Copyright 2000 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2000
To the Editor: I suspect that many investigators
were surprised by Dr Woodward's1 claim that
human research subjects are now threatened with increasing risks because of
pressures to reduce the protections offered by current procedures for reviewing
and approving research protocols. On the contrary, the system created to assure
that we protect human research subjects is increasingly difficult to navigate,
with little evidence of a commensurate increase in the protection of human
subjects. Furthermore, I believe it is the manner in which existing regulations
are being interpreted and enforced that is creating some of the problems described
by Woodward, particularly the increasing inability of IRBs to handle the avalanche
of protocols they now receive.
Reingold AL. Protection for Human Subjects in Medical Research. JAMA. 2000;283(18):2387-2390. doi:10.1001/jama.283.18.2387