document is essentially an agreement between
ethics committee, investigator and patient. How-
ever, for example, an investigator is responsible for
the patient’s role in the informed consent; if the
investigator suspects that the patient is not truly
informed, even in the absence of any deficiency on
the part of the investigator, then the investigator
should nonetheless police the patient’s part of
the agreement. This is entirely different from
the notion of a contract, where each party to the
contract is responsible only for fulfilling its own
commitments (see Meisel and Kuczewski, 1996).
Audit of some of the elements listed above
may also form part of the duty of a regulatory
authority. For example, in the United States, FDA
will audit IRBs and issue citations if the IRB is
not ensuring that written informed consent docu-
ments are complete and appropriate. FDAwill also
audits study sites, and disciplines investigators
(including prosecution), who do not ensure that
appropriate informed consent procedures are
being followed. Some FDA reviewing divisions
will ask for, and require changes to, informed con-
sent document prior to allowing an IND to become
active.
Although under law it is not the primary respon-
sibility of the typical pharmaceutical company,
it nonetheless behoves pharmaceutical physicians
to ensure that appropriate informed consent is
being obtained in all company-sponsored studies.
Many companies recognize this within their own
Standard Operating Procedures, and creation of
patient files that require a copy of the signed
informed consent. Investigators will often be
grateful if the company will draft an informed
consent document that complies with the guide-
lines, which the investigator can submit to the
ethics committee or IRB.References
Applebaum PS, Lidz CW, Meisel A. 1987.Informed
Consent: Legal Theory and Clinical Practice.
Oxford University Press: New York.
Marsh BT. 1990. ‘Informed consent’.J. R. Soc. Med.
83 : 603–606.
Meisel A, Kuczewski M. 1996. ‘Legal and ethical
myths about informed consent’. Arch. Intern.
Med. 156 : 2521–2526.78 CH7 INFORMED CONSENT