Emedinews:Insights on Medicolegal Issues:World Medical Association (WMA) guidelines for medical doctors in biomedical research involving human subjects

• Doctors should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Doctors should cease any investigation if the hazards are found to outweigh the potential benefits.
• In publication of the results of his or research, the doctor is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.
• In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort, it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The doctor should then obtain the subject’s freely given informed consent, preferably in writing.
• When obtaining informed consent for the research project the doctor should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a doctor who is not engaged in the investigation and who is completely independent of this official relationship.
• In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation.
• The research protocol should always contain a statement of the ethical consideration involved and should indicate that the principles enunciated in the present Declaration are complied with.

(Ref: 18th World Medical Assembly, Helsinki, Finland, 1964 and revised by the 29th World Medical Assembly, Tokyo, Japan, 1975).

Emedinews:Insights on Medicolegal Issues:World Medical Association (WMA) guidelines for medical doctors in biomedical research involving human subjects

• Doctors should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Doctors should cease any investigation if the hazards are found to outweigh the potential benefits.
• In publication of the results of his or research, the doctor is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.
• In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort, it may entail. He or she should be informed that he or she is at liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The doctor should then obtain the subject’s freely given informed consent, preferably in writing.
• When obtaining informed consent for the research project the doctor should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a doctor who is not engaged in the investigation and who is completely independent of this official relationship.
• In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation.
• The research protocol should always contain a statement of the ethical consideration involved and should indicate that the principles enunciated in the present Declaration are complied with.

(Ref: 18th World Medical Assembly, Helsinki, Finland, 1964 and revised by the 29th World Medical Assembly, Tokyo, Japan, 1975).

Emedinews:Insights on Medicolegal Issues:'WMA declaration of Malta on hunger strikers

Medicolegal Update
(Dr Sudhir Gupta, Additional Prof, Forensic Medicine & Toxicology, AIIMS)

Such difficult ethical situations in medical practice and the guidelines to deal with them have been addressed thoroughly in the revised WMA Declaration of Malta on hunger strikers with principles of Duty to act ethically, in 2006. All physicians are bound by medical ethics in their professional contact with vulnerable people, even when not providing therapy. Whatever their role, physicians must try to prevent coercion or maltreatment of detainees and must protest if it occurs. The other important component is respect for autonomy. Physicians should respect individuals’ autonomy. This can involve difficult assessments as hunger strikers’ true wishes may not be as clear as they appear. Any decisions lack moral force if made involuntarily by use of threats, peer pressure or coercion. Hunger strikers should not be forcibly given treatment they refuse. Forced feeding contrary to an informed and voluntary refusal is unjustifiable. Artificial feeding in form of intravenous fluid/nutrition with the hunger striker’s explicit or implied consent is ethically acceptable.

WMA declaration of Malta on hunger strikers – Guidelines for medical management

The doctor must assess the mental capacity of the individual. This involves verifying that an individual intending to fast does not have a mental impairment that would seriously undermine the person’s ability to make health care decisions. Individuals with seriously impaired mental capacity cannot be considered to be hunger strikers. They need to be given treatment for their mental health problems rather than allowed to fast in a manner that risks their health.

As early as possible, physicians should acquire a detailed and accurate medical history of the person who is intending to fast. The medical implications of any existing condition should be explained to the individual. Physicians should verify that hunger strikers understand the potential health consequences of fasting and forewarn them in plain language of the disadvantages. Physicians should also explain how damage to health can be minimized or delayed by, for example, increasing fluid intake. Since the person’s decisions regarding a hunger strike can be momentous, ensuring full patient understanding of the medical consequences is critical. Consistent with best practices for informed consent in health care, the physician should ensure that the patient understands the information conveyed by asking the patient to repeat back what they understand.