Informed Consent.

 Robert J. Levine’s article Informed Consent: Some Challenges to the Universal Validity of the Western Model (1991) Beauchamp & Walters (2008) p.132-137.  In this article the author states that “Informed consent holds a central place in the ethical justification of research involving human subjects” (p. 132) In order for it to be informed consent four points need to be made it must be “voluntary”, the patient must be “legally competent’, “informed” and able to “comprehend” what is being advised.  The purpose of research on humans must be used to improve the lives of others, either through improving the ability to diagnose a problem, the use of therapeutic and prophylactic procedures and finally understanding of the disease or the pathogens of disease. Special considerations must be obtained when the research involves the environment and animals. 

The Declaration of Helsinki (1964) http://www.cirp.org/library/ethics/helsinki/ 

Lists the Basic Principles as:

1.      Biomedical research involving human subjects must conform to general accepted scientific principles and should be based on adequate preformed laboratory and animal experimentations and on a thorough knowledge of scientific literature.

2.      The design and performance of each experiment procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted to a specially appointed independent committee for consideration.

3.      Biomedical research involves human subjects should be conducted only by scientifically qualified persons.  The responsibility for the human subject must rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.

4.      Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in the proportion to the inherent risk to the subject.

5.      Every biomedical research project involves human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interest of the subject must always prevail over the interest of science and society.

6.      The right of the research subject to safeguard his or her integrity must always be respected.  Every precaution should be taken to respect the privacy of the subjects and to minimize the impact of the study on the subject’s physical and mental integrity and the personality of the subject.

7.      Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable.  Physicians should cease any investigation if the hazards are found to outweigh the benefits of the study.

8.      In publication of the results of his or her research, the physician is obligated to preserve the accuracy of the results.  Report of experimentation not in accordance with the principles laid down in the Declaration should not be accepted for publication.

9.      In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potentional 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 with draw visor her consent to participate at any time.  The physician should then obtain the subject’s freely given informed consent, preferably inheriting.

10.  When obtaining informed consent for the research project the physician should be cautious if the subject is in dependent relationship to him or her or may consent under duress.  In that case the informed consent should be obtained by a physician who isn’t engaged in the investigation and who is completely independent of this official relationship.

11.  In cases 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 the national legislation.  Whenever the minor child is in fact able to give consent the minor’s consent must be obtained in addition to the consent of the minor’s legal guardian.

12.  The research protocol should always contain a statement of the ethical consideration involved and should indicate that the principles enunciated in the declaration are complied with.

This document has been cited in the article many times and I felt that it was important to clarify exactly what are the Declaration of Helsinki’s Principles.

            It is felt by the Universalists that this Declaration of Helsinki is a widely excitable universal standard for biomedical research and it is used in many countries.  These are the principles that are used to conduct research universally.

            The Pluralists feel that the Declaration of Helsinki shows a Western view and that it does not guide the investigators to show the respect to others in the world.

            The author came to four ideas to provide informed consent to all people in all nations:

1. All plans to conduct research involving humans subjects should be reviewed and approved by a research ethics committee.
2. Proposals to employ consent procedures that do not conform to the international standard should be justified by the researcher and submitted for review and approved by a national ethics review body.
3. There should be established an international ethics review body to provide advice, consultation and guidance to national ethics review bodies when such is requested.
4. In the case of externally sponsored research: Ethics review should be conducted in the initial country.

This article was a bit confusing to exactly what they were trying to point out.  After I made the reference the Declaration of Helsinki it made more sense to me once I knew what they were talking about.  He needed to make more of a reference to that than he did to Immanuel Kant, who seems to be one of his favorites.  I apologize for the length of this posting but it needed to be clarified.