Stephen J.LurieMD, PhD, Senior EditorIndividualAuthor
Copyright 2002 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2002
To the Editor: In his discussion of the institutional
review board (IRB) process, Mr Annas1 suggests
that consent forms initially intended to protect human research subjects have
been transformed into a tool to protect researchers and institutions. To the
extent that this transformation has occurred, the explanation may be straightforward.
Many research projects entail so little risk to patients that the only measurable
risk is that posed by the legal system or regulatory agencies to an institution
or researcher accused of violating process. Although the tort system may eventually
address its problem with so-called junk science,2
the IRB system currently seems to be enamored with process, which for some
research largely represents "junk regulation." Even for research where the
risk of harm to any patient is less than that of daily activities such as
discarding old tax returns or driving to the store, the IRB system soldiers
on as if it were preventing atrocities.
Foucar E. How Much Oversight Is Necessary to Protect Human Subjects?. JAMA. 2002;287(6):716-717. doi:10.1001/jama.287.6.711