For research that involves human participants or animals to be published in the International
Journal of Sports Medicine (IJSM), it must have been conducted in accordance with
recognised ethical standards and national/international laws. Authors are required
to confirm that these standards and laws have been adhered to by formally citing this
editorial within the methods section of their own manuscript. In this editorial, we
synthesise the standards and laws into one source for convenience to authors of IJSM
submissions. We outline the principles of the World Medical Association Declaration
of Helsinki [1] and the Institute for Laboratory Animal Research of the National Research Council's
Guide for the Care and Use of Laboratory Animals [2]. We highlight ethical issues included in national/international law and provide
guidance on ethical issues common to Sport and Exercise Science.
Authors who cite this editorial confirm that research using human participants has
been conducted ethically according to the principles of the Declaration of Helsinki.
The Declaration is intended to be read as a whole and every principle is equally important,
but those points most-commonly considered by sport and exercise scientists are summarised
below.
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Basic principles. Respect the rights and welfare of participants which must take precedence over all
other interests.
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Ethical review. Before research begins and before amendments are applied, research must be reviewed
and approved by an appropriate ethics committee.
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The research protocol. The study, research design and statistical analysis must be clearly described, justifiable
and appropriate. In drawing up the research protocol, the researcher must;
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consider ethical issues in accordance with the Declaration of Helsinki,
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provide information regarding funding, sponsors, institutional affiliations, other
potential conflicts of interest,
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consider the contribution to new knowledge and consider the environment,
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include details of any incentives for participants and provisions for treating and/or
compensating participants who are harmed as a consequence of participation in the
research study,
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describe the arrangements for post-study access by all participants to interventions
identified as beneficial in the study or access to other appropriate care or benefits.
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Consent. Informed consent/assent should be provided freely by the participant and should ideally
be in writing. If written consent/assent cannot be obtained, or is not appropriate,
then oral consent/assent should be formally documented and witnessed. Research that
involves children or other populations that cannot consent (e. g. vulnerable populations)
should seek consent from an appropriate person and assent from the participant. Research
involving participants who are physically or mentally incapable of giving consent
may be undertaken only if the physical or mental condition that prevents giving informed
consent is a necessary characteristic of the research population. Informed consent/assent
must include the;
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aims of the research,
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methods,
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sources of funding,
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conflicts of interest,
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institutional affiliations,
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anticipated benefits and potential risks,
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potential discomfort and
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right to refuse to participate or withdraw consent without reprisal.
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Conduct. Research must be conducted;
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in accordance with appropriate risk management
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by appropriately qualified researchers and support staff
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with skill and care
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in an appropriate setting
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in order to protect the privacy of participants and confidentiality of their personal
information
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in accordance with laws and regulations of the country or countries in which the research
is to be performed as well as international norms and standards. Specific laws relevant
to research ethical may regulate the collection, use and/or storage of human tissue;
the protection of individuals that lack the capacity to consent; data protection;
and the use of drugs in research.
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Governance. Serious adverse events occurring during the study must be reported to the ethics
committee that ethically reviewed and approved the research.
Authors who cite this editorial confirm that research involving animals has been conducted
ethically according to the principles of the Guide for the Care and Use of Laboratory
Animals of the Institute for Laboratory Animal Research [2]. Again, the guide is intended to be read as a whole, but the basic obligations on
the researcher are summarised below. The researcher must;
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Ensure the appropriateness of experimental methods.
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Legally acquire animals.
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Ensure that animals are properly housed and fed to ensure safe, hygienic and comfortable
living conditions.
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Maintain a record of animal care.
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Ensure that animal maintenance and research are carried out by qualified personnel,
following all legal statutes and regulations.
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Administer appropriate pain management to minimize suffering, discomfort and pain.
Specific issues relevant to Sports Medicine:
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Retrospective ethics. Data are routinely collected from individuals for various purposes. For example,
sport scientists may monitor physiological function of an athlete in order for him
or her to gain an edge over their rivals. Data collected exclusively for one purpose
cannot be used for another purpose (research) unless consent for the use in research
is subsequently given and the research ethically approved. An exception to this would
be where the data collected for the primary purpose is anonymised prior to use in
a research study (second purpose) which has ethical approval. Retrospective ethical
approval cannot be granted for any research study.
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The use of placebo. The inclusion of a placebo group in a research study may challenge the principle
of equipoise. Ideally, participants should be randomly assigned to experimental or
placebo groups. In healthy volunteers, where possible, the type of treatment should
be blinded, for example, comparator (control) participants could be given a fitness
or lifestyle information sheet. After a finite length of time those participants in
the comparator group could be offered the experimental condition, or an experiment
could be halted if at any point it became clear that the placebo group was fairing
more poorly [4]. In more medical research where participants are patients or clients extreme care
must be taken to avoid the abuse of placebo. In this type of research, the use of
placebo is acceptable when no current proven intervention exists, or when the participant
will not be at risk of serious or irreversible harm.
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Deception. The use of deception in research (e. g. in a pacing strategy study in which time
trial distance is deceived) must be merited such that there are no reasonable alternatives
for obtaining the data, as long as there is no reasonable expectation to cause pain
or severe emotional distress. If deception is to be used, then the participants must
be accurately informed of the risks and be debriefed at the conclusion of the study
with the option to withdraw their data [5].
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Good research practice. The UK Medical Research Council has outlined some basic principles of good research
practice which may help to ensure that research is conducted ethically. These include
planning, conduct, recording data, reporting results, applying the results [3]. Relevant issues not specifically raised in the Declaration of Helsinki include
the use, calibration and maintenance of equipment, COSHH, documentation of standard
operating procedures, retention of data, publication policy, authorship, correction
of errors and retraction of published findings and intellectual property rights.
