Principles and Practice of Pharmaceutical Medicine

Ethics committees and IRBs may sanction specific
methods for the documentation of oral informed
consent. This is a very rare clinical situation.

Surrogate informed consent

Some patients are incapable of providing informed
consent, whether written or not. These patients are
often in demographic subgroups which are medi-
cally underserved. Consequently, these are patients
for whom there is encouragement to the pharma-
ceutical industry by governments, activists and
others to increase research into experimental thera-
pies. Children, those with various types of neuro-
logical disease (e.g. Alzheimer’s disease), and
emergency patients (e.g. unconscious head injury,
stroke, multiple trauma, etc.) are good examples.
Many of these patients have a very poor prognosis,
and they epitomize the concept of unmet medical
need. For these patients, clinical research would be
impossible if written informed consent was an
essential prerequisite.
For children, most ethics committees agree that
provision of written informed consent by a parent
orguardian is acceptable. If the child is of sufficient
age, then his or her concurrence may also be
sought; although this is not sufficient evidence of
informed consent, the refusal to provide concur-
rence by a child that is likely to be competent to
understand the clinical trial conditions should be
sufficient to exclude the child from a study.
In the case of studies in incompetent adults,
again most Ethical Committees will accept a
legal guardian or custodianin lieuof the patient
himself or herself, provided that there is sufficient
evidence that the custodian has abona fideand
independent interest in the patient’s welfare.
Again, forms of concurrence can be employed
when possible. The ordering of a patient’s partici-
pation in a clinical trial by a Court Order would
usually be a form of duress and could thus violate
the concept of autonomy described above.

When informed consent is impossible

Emergency patients have as much right to taking

For example, patients with acute head injury and a

low Glasgow Coma Score have a dismal prognosis,

and therapeutic interventions (if ever likely to be

successful) must be instituted quickly. Under

these conditions, there is often not even the time

to find relatives to provide surrogate informed

consent. Even if relatives can be found quickly

enough, then their emotional state may not be

suited to becoming truly informed before giving

consent.

Experiments are now under way to investigate

whether some substitute for informed consent may

be used. One set of guidelines suggests that such

clinical trials can be conducted when

1. there is clinical and public agreement that the
   disease merits clinical investigation with the
   investigational therapy;


2. there has been advertising and publicity in the
   likely catchment area of suitable patients that
   such a study is being undertaken;


3. the ethics committee or the IRB has approved,
   in detail, the methods used in pursuit of local
   publicity;


4. an independent, clinically experienced indivi-
   dual will confirm that the patient is a member of
   the well-defined population that is the subject of
   the clinical research, and that it is not unreason-
   able to include the patient in the study for any
   other reason;


5. no relative (if any is available in a timely fash-
   ion) objects.

It is likely that these guidelines will be refined,

possibly on an international basis, in the near

future.

7.5 Responsibility of parties

to informed consent

It is the responsibility of all parties to the informed

consent that all parties remain within its ethical

7.5 RESPONSIBILITY OF PARTIES TO INFORMED CONSENT 77