Guidelines for the Use of Fishes in Research



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2. General Considerations

Certain general considerations apply to nearly all research investigations on fishes, whether conducted in the field or in a laboratory setting. This section introduces concepts and procedures that can be adapted to the situation and circumstances for each investigator.


Research studies should have well-understood and justifiable objectives that address, within the context of the research discipline, basic needs for knowledge and understanding of the world in which we live and the particular resource under consideration. In cases where the biology of fishes proposed for study is well known, a study hypothesis should be articulated so that the use of fishes is focused on addressing that hypothesis. If the biology of a fish species is not well known, general sampling and other observational uses of fishes (i.e., not hypothesis-driven) may be warranted to guide the development of a good study hypothesis (see section 5.2 Field Collections). Research quality relies on the carefully communicated questions that can be addressed by scientific methods and on the development of research procedures that are quality controlled, publishable, and repeatable. Guidelines have been published for the improved reporting on animal research and for increased reproducibility (Kilkenny et al. 2010; see ARRIVE Guidelines, http://www.nc3rs.org.uk/page.asp?id=1357; see section 3.1 International Regulations and Guidelines).
The validity of research results is affected by the experimental design, the analytical procedures employed, and the quality and health status of the experimental subjects. The quality and appropriateness of the fishes used, both the species and the individuals, can seriously influence results and conclusions, thereby having dramatic effects on the number of animals needed and the number of times that the study is repeated. These effects, in turn, will have important animal welfare and financial implications. Research scientists have long recognized the importance of animal welfare considerations; however, formal guidelines for the use of fishes in research were not common in the United States prior to 1985, when requirements that research proposals obtain the approval of an IACUC were imposed (Public Law 99-158 1985, http://history.nih.gov/research/downloads/PL99-158.pdf). Although the principles and procedures described in these Guidelines have been designed to address requirements imposed by IACUCs in the United States, the general concepts are applicable to investigators around the globe.

2.1 Approval of Research Plans by IACUCs


When approval by an IACUC is required, investigators must prepare written statements or requests for animal use that ensure that all applications, proposals, and actual research will meet certain basic requirements (Silverman et al. 2007). Safeguards include limiting unneeded replications of research, use of appropriate species and number of animals, an adequate experimental design, and method of euthanasia or disposition of the animals after the completion of the study. Investigators must be familiar with the species to be studied, or with closely related surrogates, so as to be able to provide environmental conditions essential for the well-being of the experimental subjects and to be able to recognize their responses to disturbances, including capture, restraint, or other changes in environmental conditions that may be applicable to the particular study. Copies of IACUC-approved study plans are maintained by the IACUC from the sponsoring facility, as well as by the individual investigator.
Post-approval monitoring of protocols by the IACUC is required by federal laws, regulations, and policies; allows for the modification of research procedures/protocols; and ensures the well-being of the animals.

2.2 Project Quality Assurance Plans and Standard Operating Procedures


Project Quality Assurance Plans (PQAPs) and standard operating procedures (SOPs), while not required by many universities or nongovernmental institutions, are nevertheless recommended as useful tools for maintaining overall research quality. PQAPs and SOPs usually are required if research data and conclusions will be submitted to certain regulatory agencies, such as the U.S. Food and Drug Administration (FDA, http://www.fda.gov/) or the U.S. Environmental Protection Agency (EPA, http://epa.gov/).
A PQAP should include a description of the project design and approach to the problem, a statement of anticipated deliverables, and a description of how the data will be reported (for instance, as individual measurements or in a reduced form). The PQAP documents the principles, policies, organizational responsibilities, objectives, implementation actions, and accountability procedures that will ensure an appropriate quality process throughout a research project. Emergency contacts and contingency plans for animal care may be included in a PQAP. Importantly, the PQAP should describe actions that will be used to control/verify experimental procedures and ensure that results obtained are representative of the experimental parameters being evaluated. The PQAP should identify how unauthorized laboratory personnel or research project areas will be controlled and biosecurity maintained. For research involving field sampling, the PQAP should include a sampling plan outlining the methods, equipment, and procedures, as well as safety procedures for personnel. For laboratory research, sample preparation and analytical methods should be specified. SOPs for routine, specialized, or unpublished methods should be identified. Data quality objectives should be identified for each measured parameter, and quality control procedures to be used, whether in the field or under laboratory conditions, should be stated. Corrective actions should be specified should problems arise. Finally, a quality assurance (QA) report should be generated at the conclusion of the study. This report should include a summary of the PQAP, results of technical systems and performance evaluation audits, corrective actions taken and results of those actions, data quality assessments (precision, accuracy, representativeness, completeness, comparability, and reporting limits), a discussion of whether the QA objectives were met, and limitations on use of data collected during the research.
SOPs document routine or repetitive technical activities, or those that occur occasionally yet need to be followed in the exact fashion as the previous time. Ideally, SOPs ensure that work is done correctly the first time, thereby reducing unnecessary repetition and costs. If research data are generated in a setting where the same procedures are used yet personnel change with time, SOPs help maintain consistency. Some institutions require SOPs for assuring that job applicants can perform the needed tasks. SOPs also can form an essential part of effective training programs. General SOPs, not specific to individual studies, may be established as basic procedures for entire research laboratories or institutions. Examples of specific technical tasks for which SOPs are useful in conducting research with fishes include blood sampling, vaccination protocols, procedures for electrofishing, preparation of solutions for use as sedatives, and techniques for collecting meristic data. Policies requiring adherence to SOPs and PQAPs in research protocols are to allow for the development of new procedures and for the revision or expansion of established procedures whereby new study techniques are developed. Additional information on SOPs and PQAPs is available in guidance documents from the EPA (EPA 2007, Guidance for Preparing Standard Operating Procedures [SOPs], http://www.epa.gov/quality/qs-docs/g6-final.pdf, or EPA 2002, Guidance for Quality Assurance Project Plans, http://www.epa.gov/quality/qs-docs/g5-final.pdf) or the FDA (various questions and answers regarding quality assurance and SOPs are included in FDA 2007, Guidance for Industry—Good Laboratory Practices Questions and Answers, http://www.fda.gov/downloads/ICECI/EnforcementActions/BioresearchMonitoring/UCM133748.pdf) and from various manuals or texts that address quality assurance. Further, the U.S. Fish and Wildlife Service (USFWS, http://www.fws.gov/) Aquatic Animal Drug Approval Partnership (AADAP) Program (http://www.fws.gov/fisheries/aadap/home.htm) has online SOPs (http://www.fws.gov/fisheries/aadap/AADAP_Protocols_and_SOPs.htm).



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