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 (45 CFR, Part 46), 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 Manuscripts that report on clinical trials may not be sent out for peer review and will not be published until registry information is provided.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. Curarizing agents are not anesthetics; if these were used, evidence must be provided that anesthesia of suitable grade and duration was employed. Authors may want to review guidelines provided by the Institute for Laboratory Animal Research (National Academy of Sciences), Guidance for the Description of Animal Research in Scientific Publications, and those of the National Centre for the Replacement, Refinement and Reduction of Animals in Research, Animals in Research: In Vivo Experiments for additional guidance to determine what items are relevant to their study. Editors/Associate Editors reserve the right to judge the appropriateness of the use of animals and humans in experiments submitted for publication and will refuse papers in which evidence of the adherence to these principles is not apparent. Differences of opinion will be adjudicated by the Publications Committee.
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, "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. The PHS Policy requires institutions to use the Guide for the Care and Use of Laboratory Animals to develop and implement an institutional animal care and use program. Analgesics and other techniques should be used to minimize discomfort and pain except when the intervention would compromise experimental goals. Appropriate anesthetics must be used to eliminate sensibility to pain during all surgical procedures. Drugs that produce muscle paralysis are not anesthetics. They must never be used alone for surgical restraint, only when animals are under anesthesia. If the study requires the death of an animal, humane endpoints should be identified, and an approved method of euthanasia stipulated in the American Veterinary Medical Association's Guidelines on Euthanasia should be used. Death is acceptable as the endpoint of a study only where euthanasia would compromise scientific outcomes and an IACUC or similar oversight body has approved the exception. Animals used in research and education must be housed, fed, and maintained in a manner appropriate for their species and their condition. They should also be given appropriate veterinary care. Personnel who care for or perform procedures on animals must receive training for these tasks. When students or trainees use animals in educational activities or for the advancement of science, such work shall be conducted under the direct supervision of an experienced teacher, investigator, or veterinarian.
- Office for Human Research Protections (OHRP) policy and guidance US Public Law 103-43
- Title 45, U.S. Code of Federal Regulations, Part 46, Protection of Human Subjects
- Declaration of Helsinki
- U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training
- Guide for the Care and Use of Laboratory Animals
- American Veterinary Medical Association's Guidelines on Euthanasia
- Ethical Guidelines for the Use of Animals in Research