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:
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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.
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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
investigation.
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In clinical investigation primarily for treatment –
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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.
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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.
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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 their 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.
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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.
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Where emergency treatment is necessary, the patient is incapable
of giving consent, and no one is available who has authority to
act on their behalf, consent is assumed.
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In clinical investigation primarily for the accumulation of scientific
knowledge –
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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.
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Consent, in writing, should be obtained from the subject, or from
their 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.
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Minors or mentally incompetent persons may be used as subjects only
if:
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The nature of the investigation is such that mentally competent
adults should not be suitable subjects.
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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 their child as a subject.
- No person may be used as a subject test against their will.
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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-23)
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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
Services