Guidelines for Clinical Investigations
In order to aid physicians in fulfilling their responsibilities when they engage in the clinical investigation of new drugs and procedures,
the WSMA has established the following guidelines for clinical investigations:
A physician may participate in clinical investigation only to the extent that those activities are a part of a systematic program
competently designed, under accepted standards of scientific research, to produce data which are scientifically valid and significant.
In conducting clinical investigation, the investigator should demonstrate the same concern and caution for the welfare, safety and comfort
of the person involved as is required of a physician who is furnishing medical care to a patient independent of any clinical
In clinical investigation primarily for treatment –
The physician must recognize that the physician-patient relationship exists and that professional judgment and skill must be
exercised in the best interest of the patient.
Voluntary written consent must be obtained from the patient, or from a legally authorized representative if the patient lacks the
capacity to consent, following: a) disclosure that the physician intends to use an investigational drug or experimental procedure;
b) a reasonable explanation of the nature of the drug or procedure to be used, risks to be expected, and possible therapeutic
benefits; c) an offer to answer any inquiries concerning the drug or procedure; and d) a disclosure of alternative drugs or
procedures that may be available.
In exceptional circumstances and to the extent that disclosure of information concerning the nature of the drug or
experimental procedure or risks would be expected to materially affect the health of the patient and would be detrimental to
his/her best interests, such information may be withheld from the patient. In such circumstances, such information shall be
disclosed to a responsible relative or friend of the patient where possible.
Ordinarily, consent should be in writing, except where the physician deems it necessary to rely upon consent on other than
written form because of the physical or emotional state of the patient.
Where emergency treatment is necessary, the patient is incapable of giving consent, and no one is available who has authority
to act on his/her behalf, consent is assumed.
In clinical investigation primarily for the accumulation of scientific knowledge –
Adequate safeguards must be provided for the welfare, safety, and comfort of the subject. It is fundamental social policy that the
advancement of scientific knowledge must always be secondary to primary concern for the individual.
Consent, in writing, should be obtained from the subject, or from his/her legally authorized representative if the subject lacks the
capacity to consent, following: a) a disclosure of the fact that an investigational drug or procedure is to be used; b) a reasonable
explanation of the nature of the procedure is to be used and risks to be expected; and c) offer to answer any inquiries concerning
the drug or procedure.
Minors or mentally incompetent persons may be used as subjects only if:
- The nature of the investigation is such that mentally competent adults should not be suitable subjects.
Consent, in writing, is given by a legally authorized representative of the subject under circumstances in which an informed
and prudent adult would reasonably be expected to volunteer him/herself or his/her child as a subject.
- No person may be used as a subject test against his/her will.
The overuse of institutionalized persons in research is an unfair distribution of research risks. Participation is coercive and not
voluntary if the participant is subjected to powerful incentives and persuasion. (JC 2.07-87) (Reaffirmed A-17)
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Abbreviations for House of Delegates report origination:
EC – Executive Committee; BT – Board of Trustees; CPA – Council on Professional Affairs; JC – Judicial Council; CHS – Community and Health