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EXPERIMENTAL PROCEDURES AND THE DYING

 

Explanation of Terms and Procedures 

Medical experimentation "refers to relatively untested and usually more innovative medical and surgical procedures which…are applied…primarily as a means of contributing to the common good in the interests of humanity through anticipated progress in medical science." (1) A procedure is deemed experimental "because it has not been accepted by the medical community as a standard treatment for a specific disease or disorder, or for a subclass of patients, e.g., infants, the elderly." (2)

  

Policy 

In the case of the dying patient, it is permissible to undertake experimental procedures which may carry a risk of harm, provided that other effective treatments are not available and that free and informed consent is obtained. 

It is also permissible to withdraw these procedures if the investment of resources proves disproportionate to the results or if the burdens imposed on the patient prove disproportionate to the benefits gained by him/her, provided that free and informed consent for withdrawal is obtained. 

 

Sources of Policy 

The basic position was articulated by Pius XII in an address to the World Medical Association in 1954: 

In desperate cases when a patient is certain to die unless his case is given due attention, and there exists a remedy, a treatment, an operation which, without precluding all danger, nonetheless retains a certain possibility of success, a just and thoughtful person acknowledges without further discussion that a doctor may, with the explicit or tacit consent of the patient, proceed with application of the treatment. (3) 

This position was reiterated and further developed in the Vatican Declaration on Euthanasia (1980): 

If there are no other sufficient remedies, it is permitted, with the patient's consent, to have recourse to the means provided by the most advanced medical techniques, even if these means are still at the experimental stage and are not without a certain risk. By accepting them, the patient can even show generosity in the service of humanity.
 

It is also permitted, with the patient's consent, to interrupt these means, where the results fall short of expectations. But for such a decision to be made, account will have to be taken of the reasonable wishes of the patient's family, as also of the advice of the doctors who are specially competent in the matter. The latter may in particular judge that the investment in instruments and personnel is disproportionate to the results foreseen; they may also judge that the techniques applied impose on the patient strain or suffering out of proportion with the benefits which he or she may gain from such techniques. (4) 

The Ethical and Religious Directives for Catholic Health Care Services reaffirms the requirement of free and informed consent:

No one should be the subject of medical or genetic experimentation, even if it is therapeutic, unless the person or surrogate first has given free and informed consent.  In instances of nontherapeutic experimentation, the surrogate can give this consent only if the experiment entails no significant risk to the person's well-being.  Moreover, the greater the person's incompetency and vulnerability, the greater the reasons must be to perform any medical experimentation, especially nontherapeutic. (no. 31) 

 

1. Orville N. Griese, Catholic Identity in Health Care: Principles and Practice (Braintree: MA: Pope John Center, 1987), p. 321. 

2. Ibid., p. 486. 

3. Pius XII, "Moral Problems in Medicine," Allocution to the Eighth Congress of the World Medical Association, Sept. 30, 1954 in The Human Body: Papal Teachings (Boston: Daughters of St. Paul, 1960), p. 314. See also Pius XII, "The Intangibility of the Human Person" in The Human Body: Papal Teachings, p. 207. 

4. Congregation for the Doctrine of the Faith, Declaration on Euthanasia IV (Washington, D.C.: United States Catholic Conference, 1980), p. 9. 

5. National Conference of Catholic Bishops, Ethical and Religious Directives for Catholic Health Care Services (Nov. 1994)  (Washington, DC: United States Catholic Conference, 1995).

 

COMMENTARY
EXPERIMENTAL PROCEDURES AND THE DYING
 

In medical research and experimentation it is mandatory to seek free and informed consent for use of an experimental procedure. (For a discussion of informed consent, see the entry MEDICAL RESEARCH AND EXPERIMENTATION ON HUMAN SUBJECTS: GENERAL PRINCIPLES, Commentary, "Principles Found in Ecclesiastical Statements," no. 4.) If the patient is competent, he/she properly gives or withholds consent. Thus Pius XII speaks of the "consent of the patient" (1) as does the Vatican Declaration on Euthanasia (2). However, in the case of a patient who is not able to give consent (e.g., an incapacitated adult, a child), it falls to an appropriate proxy decisionmaker to give or withhold consent. (For further discussion of proxy decisionmaking in the context of medical research and experimentation, see the entry MEDICAL RESEARCH AND EXPERIMENTATION ON HUMAN SUBJECTS: GENERAL PRINCIPLES, Commentary; "Principles Found in Ecclesiastical Statements," no. 4.)  In the treatment of dying adults who are incapacitated, one should ascertain if a proxy decisionmaker has been legally appointed through the execution of a durable power of attorney for health care. (See entry ADVANCE DIRECTIVES:  THE LIVING WILL AND DURABLE POWER OF ATTORNEY FOR HEALTH CARE.) 

Some healthcare professionals and patients have the impression that once a treatment is initiated, it cannot be stopped or withdrawn. This is incorrect. The Vatican Declaration on Euthanasia makes explicit two conditions under which experimental treatments in particular can be stopped: if the investment of resources proves disproportionate to the result or if the burdens imposed on the patient prove disproportionate to the benefits gained by him/her. The second condition uses the principle of weighing benefits and burdens, the standard principle for making decisions about using or forgoing life-sustaining treatments. (See the entry  GENERAL POLICY ON THE USE OF LIFE-SUSTAINING TREATMENTS.) This second condition views the experiment from the perspective of the patient undergoing the treatment, since it is the patient (or his/her proxy decisionmaker) who must assess the benefits and burdens of a treatment. The first condition, on the other hand, represents the more objective perspective of the researcher, but also involves a concept of proportionality. 

Withdrawal from an experiment is also a recognized part of informed consent. (See the entry MEDICAL RESEARCH AND EXPERIMENTATION ON HUMAN SUBJECTS: GENERAL PRINCIPLES, Commentary, "Principles Found in Ecclesiastical Statements," no. 4.) 

A distinction is made between therapeutic and nontherapeutic research and experimentation.  Research and experimentation is considered therapeutic if it holds out a reasonable expectation of improving the health status of the patient-subject.  Research and experimentation  is classified as nontherapeutic if it is not expected to improve the health of the patient-subject, but will yield information and knowledge which will benefit other people. (3)  The statement of Pius XII that "In desperate cases when a patient is certain to die unless his case is given due attention, and there exists a remedy, a treatment, an operation which...retains a certain possibility of success..." (italics added), suggests the use of experimental procedures which would be therapeutic for the patient.  However, unlike the case of experimental procedures on living embryos and fetuses, the Ethical and Religious Directives for Catholic Health Care Services does not explicitly rule out the participation of the dying in experiments of a nontherapeutic nature. (4)  In fact, the Directives do address the case of proxy consent for nontherapeutic experimentation (5), and some cases of nontherapeutic experimentation on the dying could fall under this category. 

On the topic of experimental procedures and the dying, see also the entries THE DISEASE AIDS:   ETHICAL   QUESTIONS   AND   GUIDELINES   WITH   RELATED   GOVERNMENTAL REGULATIONS,  "Treatment   Decisions"   and   RESEARCH   AND   EXPERIMENTATION INVOLVING EMBRYOS AND FETUSES, Commentary.

 

 1. Pius XII, "Moral Problems in Medicine," Allocution to the Eighth Congress of the World Medical Association, Sept. 30, 1954 in The Human Body: Papal Teachings (Boston: Daughters of St. Paul, 1960), p. 314. 

2. Congregation for the Doctrine of the Faith, Declaration on Euthanasia IV (Washington, DC: United States Catholic Conference, 1980), p. 9. 

3. For this distinction see, for example, Benedict M. Ashley, O,P. and Kevin D. O'Rourke, O.P., Healthcare Ethics, 3rd ed. (St. Louis: Catholic Health Association, 1989), p. 236. 

4. National Conference of Catholic Bishops, Ethical and Religious Directives for Catholic Health Care Services (Nov. 1994)  (Washington, DC: United States Catholic Conference, 1995), no. 51. 

5. Ibid., no. 31, quoted in SOURCES OF POLICY above.

 


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