For publication in the International Journal of Sports Medicine (IJSM), studies involving
human participants or animals must have been conducted in accordance with recognised
ethical standards and national/international laws. At the very first submission stage,
authors are required to confirm that these standards and laws have been adhered to
by reading, and formally citing, this editorial within the methods section of their
own manuscript. Authors who do not provide any information regarding ethical approval
will have their manuscripts rejected before it enters the peer-review process, without
any option to resubmit.
In the original 2009 IJSM editorial [3], we described the ethical considerations embedded into national/international laws
and provided specific guidance on the ethical issues which commonly arise in Sports
Medicine research. In 2011, this information was updated to recognise the ethical
principles of other professional associations and treaties when conducting research
involving human participants [4]. Additional information was also provided on the use of Laboratory Animals in research,
and on the links between sample size and research ethics. In our new update for 2014
onwards, we elaborate on,
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A. The ethical issues relating to the investigation of doping agents
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B. The use of animals for answering research questions that appear to be solely focussed
on the enhancement of athletic performance
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C. Sample size and the issue of the burden to individual research participants.
Research Using Human Participants
Research Using Human Participants
Authors who cite this editorial confirm that research using human participants has
been conducted ethically according to the principles of the Declaration of Helsinki
[2]. 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 and
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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 may conduct their research in accordance with principles detailed by professional
associations and treaties other than the World Medical Association Declaration of
Helsinki such as the International Sociological Association’s (ISA) Code of Ethics
[11]. This update recognises that differences in ethical principles may exist between
professional associations. For example, the ISA’s code of Ethics states that “The consent of research subjects and informants should be obtained in advance. Covert
research should be avoided in principle, unless it is the only method by which information
can be gathered, and/or when access to the usual sources of information is obstructed
by those in power.” [11]. Suggesting that consent in sociological research is less stringent than in experimental
research [7]. Authors are required to confirm whether aspects of their research abides by ethical
principles proclaimed by professional associations or treaties that differ in status
to the Declaration of Helsinki.
By reading and citing this editorial the author confirms the following [7]:
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Consent to participation was valid, such that the participants were provided with
adequate information, the consent was given voluntarily and that those providing consent
were competent to do so.
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If research was carried out on participants who were vulnerable or not competent to
give consent then the authors confirm that the participants were appropriately identified,
there was justification for carrying out the research on these individuals and additional
measures were put in place to ensure the research was ethical.
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Issues of privacy and confidentiality have been considered beyond what is legally
required. Where “privacy is the protection of control over information about oneself; control over
access to oneself, both physically and mentally; and control over ones ability to
make important decisions about family and lifestyle in order to be self expressive
and to develop varied relationships” [7]. And confidentiality is when the “participant discloses to the researcher information which the participant regards
as confidential or secret [default assumption]; and the researcher undertakes (implicitly or explicitly) not to reveal this information
to anyone who does not already possess it.” [7].
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Researchers have considered their legal and ethical obligations to breach privacy
and confidentiality.
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If information provided confidentially as part of a research study has been used for
other purposes that confidentiality has been preserved by anonymising the information
or by seeking the participant’s consent.
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Risks relating to harm, inconvenience, time and money and benefits to the participant,
to other individuals, to the researchers and organisations have been considered, balanced,
communicated to the participants and appropriately managed when relevant.
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Participants have not been exploited and particular groups discriminated from participating
in the research.
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There are appropriate governance arrangements and structures in place if participants
are asked to donate biological material for use in future research, such as a biobank.
This should involve appropriate consideration of broad consent, privacy and confidentiality,
feedback to the participant of incidental findings, storage of material, commercial
involvement, donor involvement and intellectual property rights.
Research Involving Animals
Research Involving Animals
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 [8]. 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
The eighth edition of the Guide for the Care and Use of Laboratory Animals [9], published in 2010, includes expanded coverage of the ethics of laboratory animal
use; components of effective Animal Care and Use Programs; and new guidelines for
the housing, environment, and enrichment of terrestrial and aquatic animals, and for
veterinary and clinical care [10]. Specifically:
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The core foundation of the guide — replacement, refinement, and reduction.
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An Animal Care and Use Program
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The performance standards approach for animal care and care practices
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The care and use of fish and other aquatic species
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Housing space and enclosures for animals’ social needs
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Environmental enrichment got the enhancement of animal well-being to provide sensory
and motor stimulation and promote psychological health
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Discussion of animal biosecurity practices
Update. Exercise protocols in animal research
Update. Exercise protocols in animal research
A useful document for any researcher interested in studying animals in an exercise
context is the Resource Book of the American Physiological Society [12]. It is clear that the study of animals can help elucidate the mechanisms of exercise-related
benefits to both human and animal health. Nevertheless, any animal study that has
been specifically designed to answer a research question solely on the enhancement
of human athletic performance should include a clear explanation as to why such a
study is necessary, and why it could not be undertaken on humans. This is important
not just from an ethical perspective but is in keeping with the aim of maximising
external validity in any study.
Specific issues relevant to Sports Medicine
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 [14]. 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 [15].
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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 [13]. 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.
Update. Athletes as participants in studies on doping agents
Update. Athletes as participants in studies on doping agents
In principle, recreational and elite athletes should not be recruited to participate
in research that exposes them to violations of the World Anti-Doping Code. However,
the value of research into doping in sport is recognised – as well as the need to
use athletes as participants. Investigators who wish to recruit athletes as participants
in research involving prohibited performance enhancing substances and methods should
consider the following:
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Consultation with appropriate and relevant authorities (specific to each individual
athlete) such as research ethics committees, WADA, international sport federations
and national anti-doping organisations – to help protect recreational athletes, elite
athletes and sport.
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An unfair advantage should not be afforded to a recreational or elite athlete participating
in the research.
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“Adequate precautions should be taken so that the results of research are not misused
and applied for doping” [16]
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Append the WADA letter entitled “Scientific research using elite athletes: WADA point
of view” [6] to the participant information sheet to help fully inform participants who are recreational
or elite athletes
Update. Ethics and sample size
Update. Ethics and sample size
Statistical power should be considered by all authors submitting to IJSM. Ideally
an a priori estimation of the minimal sample size for adequate statistical power and/or adequate
precision of a confidence interval should be reported. Authors and reviewers of IJSM
manuscripts should be aware of the following important points:
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The minimal sample size for adequate statistical power should be considered alongside
the burden of the study procedures on individual participants/animals and the predicted
importance of the study findings to the knowledge base as well as to the impact on
real-world practice [1]. An unethical scenario is where many participants or animals have been substantially
burdened by the study procedures, but the study findings have dubious clinical/practical
importance. A “small” study might not be unethical, especially if participant burden
is low and clinical/practical importance of the study findings are high, even if “statistical
significance” has not been realised.
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For the importance of a study to be judged, it is imperative that the minimal clinically/practically
important magnitude of change or difference is rationalised clearly and reported by
authors [5]. We encourage authors to report the associated confidence interval(s), at least
for the primary study outcomes. Authors who rely solely on statistical significance
to judge clinical/practical importance will have their manuscripts rejected.
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It is inappropriate for a reviewer to criticise a study on the basis of a perceived
small sample size without considering the above issues of participant burden and clinical/practical
importance.
