International Ethical Guidelines for Biomedical Research
Involving Human Subjects
(CIOMS, WHO, Geneva, 1993)
(Basic guidelines only, without
commentary)
Guideline 1: Individual informed consent
For all biomedical research involving
human subjects, the investigator must obtain the informed consent
of the prospective subject or, in
the case of an individual who is not capable of giving informed consent,
the proxy consent of a properly authorized representative.
Guideline
Guideline 2: Essential information for prospective research subjects
Before
requesting an individual’s consent to participate in research,
the investigator must provide the individual with the following information,
in language that he or she is capable of understanding:
— that each individual is invited to participate as a subject in research,
and the aims and methods of the research;
—
the expected duration of the subject’s participation;
— the benefits that might reasonably be expected to result to the subject
or to others as an outcome of the research;
— any foreseeable risks or discomfort to the subject, associated with
participation in the research;
— any alternative procedures or courses of treatment that might be as
advantageous to the subject as the procedure or treatment being tested;
— the extent to which confidentiality of records in which the subject
is identified will be maintained;
—
the extent of the investigator’s responsibility, if any, to
provide medical services to the subject;
— that therapy will be provided free of charge for specified types of
research-related injury;
—
whether the subject or the subject’s family or dependants will
be compensated for disability or death resulting from such injury;
and
— that the individual is free to refuse to participate and will be free
to withdraw from the research at any time without penalty or loss
of benefits to which he or she would otherwise be entitled.
Guideline 3: Obligations of investigators regarding informed consent
The
investigator has a duty to:
— communicate to the prospective subject all the information necessary
for adequately informed consent;
— give the prospective subject full opportunity and encouragement to
ask questions;
— exclude the possibility of unjustified deception, undue influence and
intimidation;
— seek consent only after the prospective subject has adequate knowledge
of the relevant facts and of the consequences of participation, and
has had sufficient opportunity to consider whether to participate;
— as a general rule, obtain from each prospective subject a signed form
as evidence of informed consent; and
— renew the informed consent of each subject if there are material changes
in the conditions or procedures of the research.
Guideline 4: Inducement to participate
Subjects may be paid for inconvenience
and time spent, and should be reimbursed for expenses incurred, in
connection with their participation
in research; they may also receive free medical services. However,
the payments should not be so large or the medical services so extensive
as to induce prospective subjects to consent to participate in the
research against their better judgment (“undue inducement”).
All payments, reimbursements and medical services to be provided
to research subjects should be approved by an ethical review committee.
Guideline 5: Research involving children
Before undertaking research
involving children, the investigator must ensure that:
— children will not be involved in research that might equally well be
carried out with adults;
— the purpose of the research is to obtain knowledge relevant to the
health needs of children;
— a parent or legal guardian of each child has given proxy consent;
—
the consent of each child has been obtained to the extent of the child’s
capabilities;
—
the child’s refusal to participate in research must always
be respected unless according to the research protocol the child
would
receive therapy for which there is no medically-acceptable alternative;
— the risk presented by interventions not intended to benefit the individual
child-subject is low and commensurate with the importance of the
knowledge to be gained; and
— interventions that are intended to provide therapeutic benefit are
likely to be at least as advantageous to the individual child-subject
as any available alternative.
Guideline 6: Research involving persons with mental or behavioural
disorders
Before undertaking research involving individuals who by reason
of mental or behavioural disorders are not capable of giving adequately
informed consent, the investigator must ensure that:
— such persons will not be subjects of research that might equally well
be carried out on persons in full possession of their mental faculties;
— the purpose of the research is to obtain knowledge relevant to the
particular health needs of persons with mental or behavioural disorders;
—
the consent of each subject has been obtained to the extent of that
subject’s capabilities, and a prospective subject’s refusal
to participate in non-clinical research is always respected;
— in the case of incompetent subjects, informed consent is obtained from
the legal guardian or other duly authorized person;
— the degree of risk attached to interventions that are not intended
to benefit the individual subject is low and commensurate with the
importance of the knowledge to be gained; and
— interventions that are intended to provide therapeutic benefit are
likely to be at least as advantageous to the individual subject as
any alternative.
Guideline 7: Research involving prisoners
Prisoners with serious illness or at risk of serious illness should
not arbitrarily be denied access to investigational drugs, vaccines
or other agents that show promise of therapeutic or preventive benefit.
Guideline 8: Research involving subjects in underdeveloped communities
Before undertaking research involving subjects in underdeveloped communities,
whether in developed or developing countries, the investigator must
ensure that:
— persons in underdeveloped communities will not ordinarily be involved
in research that could be carried out reasonably well in developed communities;
— the research is responsive to the health needs and the priorities of
the community in which it is to be carried out:
— every effort will be made to secure the ethical imperative that the consent
of individual subjects be informed; and
— the proposals for the research have been reviewed and approved by an
ethical review committed that has among its members or consultants persons
who are thoroughly familiar with the customs and traditions of the community.
Guideline 9: Informed consent in epidemiological studies
For several types of epidemiological research individual informed
consent is either impracticable or inadvisable. In such cases the
ethical review committee should determine whether it is ethically
acceptable
to proceed without individual informed consent and whether the
investigator’s
plans to protect the safety and respect the privacy of research
subjects and to maintain the confidentiality of the data are adequate.
Guideline 10: Equitable distribution of burdens and benefits
Individuals or communities to be invited to be subjects of research
should be selected in such a way that the burdens and benefits of the
research will be equitably distributed. Special justification is required
for inviting vulnerable individuals and, if they are selected, the
means of protecting their rights and welfare must be particularly strictly
applied.
Guideline 11: Selection of pregnant or nursing (breastfeeding) women
as research subjects
Pregnant or nursing women should in no circumstances be the subjects
of non-clinical research unless the research carries no more than minimal
risk to the fetus or nursing infant and the object of the research
is to obtain new knowledge about pregnancy or lactation. As a general
rule, pregnant or nursing women should not be subjects of any clinical
trials except such trials as are designed to protect or advance the
health of pregnant or nursing women or fetuses or nursing infants,
and for which women who are not pregnant or nursing would not be suitable
subjects.
Guideline 12: Safeguarding confidentiality
The investigator must establish secure safeguards of the confidentiality
of research data. Subjects should be told of the limits to the
investigators’ ability
to safeguard confidentiality and of the anticipated consequences
of breaches of confidentiality.
Guideline 13: Right of subjects to compensation
Research subjects who suffer physical injury as a result of their
participation are entitled to such financial or other assistance as
would compensate them equitably for any temporary or permanent impairment
or disability. In the case of death, their dependants are entitled
to material compensation. The right to compensation may not be waived.
Guideline 14: Constitution and responsibilities of ethical review
committees
All proposals to conduct research involving human subjects must be
submitted for review and approval to one or more independent ethical
and scientific review committees. The investigator must obtain such
approval of the proposal to conduct research before the research is
begun.
Guideline 15: Obligations of sponsoring and host countries
Externally sponsored research entails two ethical obligations:
• An external sponsoring agency should submit the research protocol to
ethical and scientific review according to the standards of the country of
the sponsoring agency, and the ethical standards applied should be no less exacting
than they would be in the case of research carried out in that country.
• After scientific and ethical approval in the country of the sponsoring
agency, the appropriate authorities of the host country, including a national
or local ethical review committee or its equivalent, should satisfy themselves
that the proposed research meets their own ethical requirements.