171 Helsinki Protocol for Human Research

Introduction

The “Declaration of Helsinki as a statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Medical research involving human subjects includes research on identifiable human material or identifiable data.” (Reference https://www.who.int/bulletin/archives/79(4)373.pdf accessed 3/23/2022). The document was adopted by the World Medical Association (WMA) meeting in Helsinki, Finland in June 1964. It received updates in later meetings such as the 52nd WMA meeting in Edinburgh, Scotland in 2000.

 

Content

It has opening statements in the introduction pointing out areas of concern and importance, e.g.:

  • It states that “In medical research on human subjects, considerations related to the well-being of the human subject should take precedence over the interests of science and society.”
  • It also states that “Medical research is subject to ethical standards that promote respect for all human beings and protect their health and rights. Some research populations are vulnerable and need special protection. The particular needs of the economically and medically disadvantaged must be recognized. Special attention is also required for those who cannot give or refuse consent for themselves, for those who may be subject to giving consent under duress, for those who will not benefit personally from the research and for those for whom the research is combined with care.”

The Helsinki declaration then presents basic principles for all medical research. Some are listed here:

  • It is the duty of the physician in medical research to protect the life, health, privacy, and dignity of the human subject.
  • The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol. This protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence. This independent committee should be in conformity with the laws and regulations of the country in which the research experiment is performed. The committee has the right to monitor ongoing trials. The researcher has the obligation to provide monitoring information to the committee, especially any serious adverse events. The researcher should also submit to the committee, for review, information regarding funding, sponsors, institutional affiliations, other potential conflicts of interest and incentives for subjects.
  • In any research on human beings, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail. The subject should be informed of the right to abstain from participation in the study or to withdraw consent to participate at any time without reprisal. After ensuring that the subject has understood the information, the physician should then obtain the subject’s freely-given informed consent, preferably in writing. If the consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.

Ethical questions:

  • Did the Tuskegee experiment violate concerns or basic principles outlined in the Helsinki declaration?
  • Which sections of the Helsinki declaration are maybe addressing problems and concerns with the Tuskegee experiment?
  • What additional improvements could you suggest for the Helsinki declaration?

 

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Biology 2e Part I, 2nd edition Copyright © 2022 by LOUIS: The Louisiana Library Network is licensed under a Creative Commons Attribution 4.0 International License, except where otherwise noted.

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