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International Society for Developmental Psychobiology's Principles for the Use of Animals in Research (ISDP's Principals)
The Helsinki Declaration
Association for the Accreditation of Human Research Protection Programs (AAHRPP)
The purpose of the Society is to promote research and communicate research results on the development of behavior in order to advance knowledge and alleviate suffering for the benefit of mankind. We pledge to acquire, care for, use, and dispose of all animals in compliance with all relevant laws and regulations. Where such regulations are inadequate for the very young animals, we will use special procedures that minimize discomfort, pain and distress.
:
(1) Animals are used to enable researchers to answer questions and solve problems that cannot realistically be addressed without their use.
(2) Animals are treated humanely during all phases of research. When experimental
procedure requires stressful stimulation, it will be applied judiciously to meet the objective of the experiment while minimizing distress.
(3) Healthy animals are the best subjects for studies on live animals; they give the most reliable data, thereby reducing the overall number of animals needed to
provide meaningful and reliable experimental findings.
(4) The primary investigator responsible for day-to-day conduct of the research is
responsible for appropriate care and use of each animal. Personnel working with animals should be supervised by well-trained and experienced scientists who are familiar with government regulations and aided by a veterinary staff, trained animal care technicians and appropriate institutional facilities and policies.
Members of ISDP subscribe to the guidelines for use of animals developed by organizations such as the American Psychological Association, Animal Behavior Society, and Society for Neuroscience. However, members of ISDP frequently apply treatments to or make measurements on fetal and neonatal animals. We recognize that very young animals have limited behavioral and physiological special needs for maintenance of body temperature, adequate nutrition, and social development. Therefore, we will use additional vigilance to ensure that conditions for the care and use of very young animals minimize discomfort.
A copy of these principles should be posted in laboratories where members of ISDP conduct research.
Adopted by the 18th WMA General Assembly Helsinki, Finland, June
1964 and amended by the
29th WMA General Assembly, Tokyo, Japan, October
1975
35th WMA General Assembly, Venice, Italy, October 1983
41st WMA General Assembly, Hong Kong, September 1989
48th WMA General Assembly, Somerset West, Republic of South Africa, October 1996
52nd WMA General Assembly, Edinburgh, Scotland, October 2000
A. Introduction,
B. Basic Principles for all Medical Research,
C. Additional Principles for Medical Research Combined with Medical Care.
The World Medical Association has developed the Declaration of Helsinki
as a statement of ethical principles to provide guidance to physicians
and other participants in medical research involving human subjects.
Medical research involving human subjects includes research on identifiable
human material or identifiable data.
It is the duty of the physician to promote and safeguard the health
of the people. The physician's knowledge and conscience are dedicated
to the fulfillment of this duty.
The Declaration of Geneva of the World Medical Association binds
the physician with the words, "The health of my patient will
be my first consideration," and the International Code of Medical
Ethics declares that, "A physician shall act only in the patient's
interest when providing medical care which might have the effect of
weakening the physical and mental condition of the patient."
Medical progress is based on research which ultimately must rest
in part on experimentation involving human subjects.
In medical research on human subjects, considerations related to
the well-being of the human subject should take precedence over the
interests of science and society.
The primary purpose of medical research involving human subjects
is to improve prophylactic, diagnostic and therapeutic procedures
and the understanding of the aetiology and pathogenesis of disease.
Even the best proven prophylactic, diagnostic, and therapeutic methods
must continuously be challenged through research for their effectiveness,
efficiency, accessibility and quality.
In current medical practice and in medical research, most prophylactic,
diagnostic and therapeutic procedures involve risks and burdens.
Medical research is subject to ethical standards that promote respect
for all human beings and protect their health and rights. Some research
populations are vulnerable and need special protection. The particular
needs of the economically and medically disadvantaged must be recognized.
Special attention is also required for those who cannot give or refuse
consent for themselves, for those who may be subject to giving consent
under duress, for those who will not benefit personally from the research
and for those for whom the research is combined with care.
Research Investigators should be aware of the ethical, legal and
regulatory requirements for research on human subjects in their own
countries as well as applicable international requirements. No national
ethical, legal or regulatory requirement should be allowed to reduce
or eliminate any of the protections for human subjects set forth in
this Declaration.
It is the duty of the physician in medical research to protect the
life, health, privacy, and dignity of the human subject.
Medical research involving human subjects must conform to generally
accepted scientific principles, be based on a thorough knowledge of
the scientific literature, other relevant sources of information,
and on adequate laboratory and, where appropriate, animal experimentation.
Appropriate caution must be exercised in the conduct of research
which may affect the environment, and the welfare of animals used
for research must be respected.
The design and performance of each experimental procedure involving
human subjects should be clearly formulated in an experimental protocol.
This protocol should be submitted for consideration, comment, guidance,
and where appropriate, approval to a specially appointed ethical review
committee, which must be independent of the investigator, the sponsor
or any other kind of undue influence. This independent committee should
be in conformity with the laws and regulations of the country in which
the research experiment is performed. The committee has the right
to monitor ongoing trials. The researcher has the obligation to provide
monitoring information to the committee, especially any serious adverse
events. The researcher should also submit to the committee, for review,
information regarding funding, sponsors, institutional affiliations,
other potential conflicts of interest and incentives for subjects.
The research protocol should always contain a statement of the ethical
considerations involved and should indicate that there is compliance
with the principles enunciated in this Declaration.
Medical research involving human subjects should be conducted only
by scientifically qualified persons and under the supervision of a
clinically competent medical person. The responsibility for the human
subject must always rest with a medically qualified person and never
rest on the subject of the research, even though the subject has given
consent.
Every medical research project involving human subjects should be
preceded by careful assessment of predictable risks and burdens in
comparison with foreseeable benefits to the subject or to others.
This does not preclude the participation of healthy volunteers in
medical research. The design of all studies should be publicly available.
Physicians should abstain from engaging in research projects involving
human subjects unless they are confident that the risks involved have
been adequately assessed and can be satisfactorily managed. Physicians
should cease any investigation if the risks are found to outweigh
the potential benefits or if there is conclusive proof of positive
and beneficial results.
Medical research involving human subjects should only be conducted
if the importance of the objective outweighs the inherent risks and
burdens to the subject. This is especially important when the human
subjects are healthy volunteers.
Medical research is only justified if there is a reasonable likelihood
that the populations in which the research is carried out stand to
benefit from the results of the research.
The subjects must be volunteers and informed participants in the
research project.
The right of research subjects to safeguard their integrity must
always be respected. Every precaution should be taken to respect the
privacy of the subject, the confidentiality of the patient's information
and to minimize the impact of the study on the subject's physical
and mental integrity and on the personality of the subject.
In any research on human beings, each potential subject must be adequately
informed of the aims, methods, sources of funding, any possible conflicts
of interest, institutional affiliations of the researcher, the anticipated
benefits and potential risks of the study and the discomfort it may
entail. The subject should be informed of the right to abstain from
participation in the study or to withdraw consent to participate at
any time without reprisal. After ensuring that the subject has understood
the information, the physician should then obtain the subject's freely-given
informed consent, preferably in writing. If the consent cannot be
obtained in writing, the non-written consent must be formally documented
and witnessed.
When obtaining informed consent for the research project the physician
should be particularly cautious if the subject is in a dependent relationship
with the physician or may consent under duress. In that case the informed
consent should be obtained by a well-informed physician who is not
engaged in the investigation and who is completely independent of
this relationship.
For a research subject who is legally incompetent, physically or
mentally incapable of giving consent or is a legally incompetent minor,
the investigator must obtain informed consent from the legally authorized
representative in accordance with applicable law. These groups should
not be included in research unless the research is necessary to promote
the health of the population represented and this research cannot
instead be performed on legally competent persons.
When a subject deemed legally incompetent, such as a minor child,
is able to give assent to decisions about participation in research,
the investigator must obtain that assent in addition to the consent
of the legally authorized representative.
Research on individuals from whom it is not possible to obtain consent,
including proxy or advance consent, should be done only if the physical/mental
condition that prevents obtaining informed consent is a necessary
characteristic of the research population. The specific reasons for
involving research subjects with a condition that renders them unable
to give informed consent should be stated in the experimental protocol
for consideration and approval of the review committee. The protocol
should state that consent to remain in the research should be obtained
as soon as possible from the individual or a legally authorized surrogate.
Both authors and publishers have ethical obligations. In publication
of the results of research, the investigators are obliged to preserve
the accuracy of the results. Negative as well as positive results
should be published or otherwise publicly available. Sources of funding,
institutional affiliations and any possible conflicts of interest
should be declared in the publication. Reports of experimentation
not in accordance with the principles laid down in this Declaration
should not be accepted for publication.
The physician may combine medical research with medical care, only
to the extent that the research is justified by its potential prophylactic,
diagnostic or therapeutic value. When medical research is combined
with medical care, additional standards apply to protect the patients
who are research subjects.
The benefits, risks, burdens and effectiveness of a new method should
be tested against those of the best current prophylactic, diagnostic,
and therapeutic methods. This does not exclude the use of placebo,
or no treatment, in studies where no proven prophylactic, diagnostic
or therapeutic method exists.
At the conclusion of the study, every patient entered into the study
should be assured of access to the best proven prophylactic, diagnostic
and therapeutic methods identified by the study.
The physician should fully inform the patient which aspects of the
care are related to the research. The refusal of a patient to participate
in a study must never interfere with the patient-physician relationship.
In the treatment of a patient, where proven prophylactic, diagnostic
and therapeutic methods do not exist or have been ineffective, the
physician, with informed consent from the patient, must be free to
use unproven or new prophylactic, diagnostic and therapeutic measures,
if in the physician's judgment it offers hope of saving life, re-establishing
health or alleviating suffering. Where possible, these measures should
be made the object of research, designed to evaluate their safety
and efficacy. In all cases, new information should be recorded and,
where appropriate, published. The other relevant guidelines of this
Declaration should be followed.
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