Human experiments

The Journal of Physiology and Experimental Physiology requires that all experiments conducted in humans meet the highest standards of safety and ethics. Legislation and accepted practice concerning human experimentation vary from country to country and consequently it is difficult to define absolute requirements. However, work with human subjects should conform to the standards set by the Declaration of Helsinki (last modified in 2013), the Medical Research Council's online guidance on the use of human tissue, and the guidelines set out below. The objectives must be to ensure that all risks are minimized and that subjects are not injured and do not feel they have been abused as a result of participating in the study. Any definition of abuse will include excessive or unexpected pain or discomfort experienced during the experiment. Note, in the case of experiments involving minors, any risks must have been considered absent or minimal, and evidence must be presented that the experiments were performed with the understanding and consent of the legal guardian.

All manuscripts must contain statements indicating that (i) informed consent has been obtained, preferably in writing, (ii) studies conformed to the standards set by the latest version of the Declaration of Helsinki or the version that was in place at the time of the experiments), NOTE: If the research study was registered (clause 35 of the Declaration of Helsinki) the registration database should be indicated, else the lack of registration should be noted as an exception (e.g. The study conformed to the standards set by the Declaration of Helsinki, except for registration in a database.);  and (iii) the procedures have been approved by the local ethics committee.

1. The acceptability of procedures used will depend on the age and health of the subjects. Manuscripts should state the age, sex, health status and, where necessary, fitness of participants.

2. 'Informed' consent means that subjects have been told not only of the procedures and risks from the experiment but also that they are free to withdraw at any time without jeopardy. Experiments with children must have, in addition to the acquiescence of the child, the informed consent of the parent or guardian.

3. Experiments must be conducted by suitably qualified personnel with medical support where appropriate. The possible adverse physical and psychological effects of invasive procedures, painful stimuli, the stress of physical performance, sleeplessness, confinement or sensory deprivation must be borne in mind.

4. Monetary or other rewards are commonly provided in physiological studies that involve discomfort. Such rewards should not be so large as to induce subjects to participate against their better judgement. Particular care should be taken to ensure that students and junior laboratory personnel are not inadvertently coerced to participate by senior staff.

5. When drugs are to be given to a subject, their usual actions and potential side-effects must be explained verbally and, when appropriate, in writing.

6. It is the duty of the experimenter to minimize the physical risks to the subject. Such precautions will depend on the type of experiment: examples include having stops on mechanical devices, limiting the electric current provided by nerve stimulators and providing resuscitation facilities where necessary. Where procedures involve the sampling of body fluids suitable aseptic conditions must be used.

7. Procedures involving exposure to radiation should be detailed separately in the manuscript and include a statement of the dose given.

8. The identity of subjects must remain confidential; only with the written consent of the subject may his or her name be revealed.

9. Where patient photos are published, a statement confirming that consent to publish was obtained must be included.

10. Before human biopsy or post-mortem tissue is taken for study, consent must be obtained from the subject, or relatives where appropriate. This should be stated in the manuscript.

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