Principles and Practice of Pharmaceutical Medicine

7.3 Written informed consent

The large majority of clinical trials use a written
informed consent document. In the absence of any
special circumstances, the essential elements of
such a document are as follows:

1. A clear statement that the study is a research
   procedure.


2. A clear statement that participation is volun-
   tary and that there will be no repercussions
   either in the patient’s relationship with the
   investigator, or with the patient’s other care
   givers, should the patient decide not to take
   part in the study;


3. A description of the scope and aims of the
   research, and whether or not there may be
   benefits to patients exposed to the test medica-
   tions. The foreseeable risks and discomforts
   should also be disclosed. The possibility of
   placebo treatment and the probability of
   being treated with each test therapy should
   be stated.


4. Clear descriptions of alternative therapies or
   standard therapies or procedures (if any), in
   order that the patient can judge whether to
   enter the study.


5. The methods for compensation that may be
   available in the case of injury (these often
   have marked international variations).


6. Name and telephone number of persons that
   the patient may contact in case of anydifficulty
   during the study. Also, the identity of person(s)
   of whom the patient may ask questions during
   the day-to-day conduct of the study and an
   expression of willingness on the part of the
   investigator to provide answers to any ques-
   tions that the patient may have.


7. A confidentiality statement. This should
   include the degree to which the patient’s iden-
   tity could be revealed to an inspecting regula-
   tory authority, and whether information from

municated to the patient’s primary care or

referring physician. In any case, there should

be an assurance that no patient identity infor-

mation will be made public.

8. A statement of the circumstances under
   which the patient will be withdrawn from the
   study (e.g. noncompliance with test procedures).


9. A clear statement that the patient may with-
   draw from the study at any time and for any
   reason, again without repercussions to his or
   her relationship with any clinical care giver.


10. A statement that the patient will be required to
    give a full and accurate clinical and treatment
    history on study entry and periodically there-
    after (according to the study design).


11. Assurance that any new information that arises
    (e.g. in other studies) and which may alter the
    assessment of hazard of study participation
    will be communicated to the patient without
    delay.


12. A statement about the number of patients tak-
    ing part in the study, and a brief summary of
    how many patients in the past have been
    exposed to the test medication.

Written informed consent documents should be

signed by both the patient and the investigator,

and ideally the patient should sign before an impar-

tial witness. Informed consent documents should be

written in a language that is understandable to the

patient, and ideally at a level of complexity that

could be understood by a young adolescent of

average intelligence from the same community as

the patient. There should be adequate time for the

patient to review the document. All written infor-

med consent documents should be approved by an

ethics committee or an institutional review board

(IRB).

7.4 Unwritten informed consent

Informed consent, in law, must be informed but

76 CH7 INFORMED CONSENT