Declaration of Helsinki

The Declaration of Helsinki was issued by the World Medical Association in 1964 and has since been revised several times. It is a foundational document in medical research ethics, but its requirements for informed consent and review of research projects by an independent committee have profoundly influenced research ethics and regulation outside the biomedical field, including in many fields of social science research. This entry looks at the development of the Declaration of Helsinki, its main principles, objections to its requirements, and the incompatibility of the declaration with certain practices used in education research.

The declaration came into being because of a number of papers and books appearing in the early 1960s, showing that medical researchers were often using vulnerable patients in risky research projects without consent. An American military tribunal in Nuremberg issued the Nuremberg Code in 1947 as part of the judgment in the so-called Doctors’ Trial where Nazi doctors and administrators who participated in war crimes and crimes against humanity in the Nazi concentration camps were prosecuted. Some of the crimes committed involved medical research on concentration camp prisoners.

The code required consent from research participants as a necessary condition for research to proceed, but in the early 1960s, it became evident that it was not generally followed and the World Medical Association decided to issue the Helsinki Declaration to improve the ethical standard of medical research. The 1964 declaration and its subsequent revisions have had significant impact on the development of research ethics because it was the first widely accepted international set of rules and principles for medical research involving human subjects. Principles first enunciated in the declaration have since been implemented in national laws and in binding international guidelines.

The following are the four main principles of the declaration:

• 1.
  The interests of society and science can never outweigh the interests of the participants.
• 2.
  Research participants can only participate in research if they have given their voluntary fully informed consent. If research participants are unable to consent because of lack of legal competence, someone else must provide proxy consent.
• 3.
  Research participants have an unconditional right to withdraw from research at any time.
• 4.
  Research projects need to be reviewed by an independent committee and can only begin if the committee approves the project.

The requirement for informed consent entails that the prospective participants must be fully informed about the purpose of the research, what [Page 478]their involvement will entail, and any risks involved as well as information about funding and possible conflicts of interest on the part of the researchers. After having received this information and having had a chance to ask questions and have them answered, the persons must then give their voluntary consent to participation.

The declaration puts the decision-making capacity and responsibility solely with the individual participant, except where the participant is incompetent. It does not allow consent from community leaders or family members on behalf of competent potential participants. In relation to minors, it recognizes the need to consult them about participation, if possible, and to respect any refusal to participate, but it places no weight on the assent of a minor.

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