Guiding principles for research involving animals and human beings (download pdf)
1. About the guidelines
2. SPC Guiding Principles for the Care and Use of Vertebrate Animals in Research and Training
B: Basic principles for all medical research.
C. Additional principles for medical research combined with medical care.
D: SPC guiding principles in the care and use of animals
1- About the guidelines
In Progress in Chemical and Biochemical Research, when reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2013(1). If doubt exists whether the research was conducted in accordance with the Helsinki Declaration, the authors must explain the rationale for their approach and demonstrate that the institutional review body explicitly approved the doubtful aspects of the study. When reporting experiments on animals, authors should indicate whether the institutional and national guide for the care and use of laboratory animals was followed.
The research described in papers submitted to any of the SPC publications that involve the use of human beings, including healthy volunteers, should be conducted according to high standards of safety and ethics. We expect that all studies adhere to the requirements of the U.S. Federal Policy for the Protection of Human Subjects, and support the general ethical principles of the Declaration of Helsinki. In particular, protocols involving human subject studies must be reviewed and approved by a research ethics committee (IRB) prior to starting the study, and the subjects or legally authorized representatives must provide written informed consent. These two statements must be affirmed in the Methods section of the manuscript. Clinical trials must be registered in an English language public database. The clinical trial number and registry site must be reported in the Methods section of the manuscript. Manuscripts that report on clinical trials may not be sent out for peer review and will not be published until registry information is provided.
Research involving animals must adhere to SPC's Guiding Principles in the Care and Use of Vertebrate Animals in Research and Training (see below) and a statement of protocol approval from an IACUC or equivalent must be included in the Methods section of the paper. The description of animal procedures in the manuscript should be sufficient to permit readers to evaluate the quality of the data presented and to replicate the experiments, if needed. Studies involving surgeries or other painful procedures must include an explanation of steps taken to mitigate pain and distress, including the types and dosage of anesthetics and post-operative analgesics that were used.
2- SPC Guiding Principles for the Care and Use of Vertebrate Animals in Research and Training
As noted in the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training(2), "Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society." The use of animals is also justified to provide scientific, veterinary, and medical training that is not possible through other mechanisms. Investigators should consider the appropriateness of the experimental procedures, the species of animals used, and number of animals required. Prospective approval of procedures on animal subjects should be obtained from an institutional animal care and use committee (IACUC) or similar oversight body as required under the relevant regulatory authorities. This review should also consider whether the use of animals in a given protocol could be replaced by other experimental approaches such as in vitro studies or computer modeling. Only animals that are lawfully acquired shall be used in research and teaching. The procurement, transport, maintenance, and use of animals must in all cases comply with federal, state and local laws and regulations. In the United States, animal research may be subject to the Animal Welfare Act, the Public Health Service Policy on Humane Care and Use of Laboratory Animals, or other guidelines established by funding agencies (3,4).
1) 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.
2) 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.
3) 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.”
4) Medical progress is based on research which ultimately must rest in part on experimentation involving human subjects.
5) 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.
6) 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.
7) In current medical practice and in medical research, most prophylactic, diagnostic and therapeutic procedures involve risks and burdens.
8) 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.
9) 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.
B: Basic principles for all medical research.
10) It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject.
11) 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.
12) 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.
13) 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.
14) 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.
15) 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.
16) 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.
17) 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.
18) 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.
19) 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.
20) The subjects must be volunteers and informed participants in the research project.
21) 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.
22) 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.
23) 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.
24) 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.
25) 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.
26) 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.
27) 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.
C. Additional principles for medical research combined with medical care.
28) 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.
29) 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. To further clarify the WMA position on the use of placebo-controlled trials, the WMA Council issued, during October 2001, the following note of clarification on article 29: The WMA is concerned that paragraph 29 of the revised Declaration of Helsinki (October 2000) has led to diverse interpretations and possible confusion. It hereby reaffirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapy. However, a placebo-controlled trial may be ethically acceptable, even if proven therapy is available, under the following circumstances: Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic, diagnostic or therapeutic method; or Where a prophylactic, diagnostic or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm. All other provisions of the Declaration of Helsinki must be adhered to, especially the need for appropriate ethical and scientific review.
30) 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.
31) 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.
32) 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 judgement 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.
D: SPC Guiding Principles In The Care And Use Of Animals (5)
Animal experiments are to be undertaken only with the purpose of advancing knowledge. Consideration should be given to the appropriateness of experimental procedures, species of animals used, and number of animals required.
Only animals that are lawfully acquired shall be used in the laboratory, and their retention and use shall be in every case in compliance with federal, state and local laws and regulations, and in accordance with the Institute for Laboratory Animal Research (ILAR)Guide for Care and Use of Laboratory Animals.(6)
Animals used in research and education must receive every consideration for their comfort; they must be properly housed, fed, and their surroundings kept in a sanitary condition.
The use of animals must be in accordance with the ILARGuide for Care and Use of Laboratory Animals. Appropriate anesthetics must be used to eliminate sensibility to pain during all surgical procedures. Drugs that produce muscle paralysis are not anesthetics, and they must not be used alone for surgical restraint, but may be used in conjunction with drugs known to produce adequate anesthesia. The care and use of animals shall be such as to minimize discomfort and pain. All measures to minimize pain and distress that would not compromise experimental results may be employed.
If the study requires the death of an animal, the most humane euthanasia method consistent with the study must be used.
When animals are used by students for their education or the advancement of science, such work shall be under the direct supervision of an experienced teacher or investigator.
- World Medical Association (2013). "Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects". JAMA. 310 (20): 2191–2194. doi:10.1001/jama.2013.281053. PMID 24141714.
- Based on principles formulated in 1909 by Walter B. Cannon. APS Council first adopted the Guiding Principles in 1953. Latest revision approved July 2000.
- Institute for Laboratory Animal Research. National Research Council. Guide for the Care and Use of Laboratory Animals. Washington, DC: National Academy Press, 1996.