If you plan to publish a study involving animals, missing information about ethical approval and animal welfare can delay peer review and even result in rejection of your manuscript. Proper reporting of this information allows other researchers to replicate the work and also allows the editor and reviewers to evaluate the animal welfare and ethical aspects of the submission. However, if it is your first time publishing in an international journal, you may have questions about what information is commonly required by journals. We have answered some of the most common questions that researchers ask about reporting their animal studies.
What animal studies require animal ethics statements and what information is required?
For studies involving vertebrates or field studies of wild animals, authors are commonly asked to state that their study received animal ethics committee approval (and to name the committee) or complies with relevant legislation. The exact content and structure can vary between journals, and the editor has the final say as to whether the study will be published.
What organizations monitor laboratory animal welfare?
At an institutional level, animal breeding, care, and experiments are generally overseen by an animal ethics committee (commonly known as an “institutional animal care and use committee” (IACUC) in the United States). In some countries, a national office may handle ethical approvals (e.g., the "Home Office" in the United Kingdom). Most countries have national oversight and legislation as well. For example, in the US, the majority of animal research is monitored by the NIH via the Office of Laboratory Animal Welfare. Although the laws and policies may vary in different countries, many countries have similar systems to meet journal reporting standards. If the animal protocols and/or approval process in your institution or country do not align with the journal's standards, you should explain the legislation or national policies that govern animal research.
What is covered in an animal protocol?
In the US, protocols are extremely detailed documents that provide information about animal husbandry (housing, food, water, light/dark cycles, environmental enrichment), veterinary care, analgesia, euthanasia, tissue harvesting (i.e., from living animals or postmortem), surgeries, drug treatments, staff training, and breeding. These protocols are completed by investigators and must be submitted to the animal ethics committee for approval before a study can be performed. If an investigator plans a procedure that is not included in the current protocol, an amendment must be approved before the procedure can be performed. Consider researching the procedures you plan to use before writing your protocol to ensure that they comply with the current standards in your field and potential target journals.
What can happen if a researcher does not follow approved protocols or there are animal welfare issues?
The investigator or the entire institution can have their research programs suspended or receive fines and other punishments.
What if an institution/company doesn't have its own ethics committee?
There are independent committees that can be contracted to evaluate and approve protocols in situations like this. Colleagues or journal editors may be able to recommend organizations that perform this function.
Are there exceptions to the requirement for ethics committee approval for vertebrates?
Depending on the circumstances, the field, and relevant legislation, a journal may have exceptions to the reporting standards outlined above. For instance, if a non-mammal vertebrate embryo (chick, fish, Xenopus) is used, ethical approval is often needed if the embryo is more than halfway through development. Chicken eggs hatch in 21 days, so experiments done after 10-11 days development should have approval. Experiments performed earlier in development may not need approval. In the UK, if animals are only euthanized (no other manipulations involved) in an approved manner at a designated establishment, then often no ethics approval/home office license is required. Depending on the journal, you may need to provide details to the editor about regulations specific to your institution or country. Before you design your study, consider reviewing the institutional, national, and journal guidelines for animal research to ensure your study complies with all relevant regulations.
Are there any studies that require additional details about the experimental protocol?
There are some animal studies in which serious morbidity or mortality would be the expected outcome without intervention (also known as "lethal challenge", "lethal infection" or "survival studies"). In these cases, it is generally expected that the protocol will include "humane endpoints": predefined criteria for humane euthanization (e.g., when the animals lose a certain percentage of their body weight or a tumor reaches a certain size). For these types of experiments, authors often need to specify whether the animals died as a direct result of the intervention or whether humane endpoints were used during the survival study. The journal may also require information such as the criteria used to determine when the animals should be humanely euthanized, how frequently the condition of the animals was monitored, how suffering of the animals was minimized using analgesics and anaesthetics, and the method of euthanasia.
For more information about guidelines for animal research, please visit:
National Centre for the Replacement, Refinement & Reduction of Animal Research