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Presumed consent
Presumed Consent: What Does It Mean? T. Tottoczko
C
ONSENT FOR ORGAN donation is a generous contribution dictated by the heart, mind, and intellect of the donor, consistent with his or her personal convictions and beliefs. The donor bears no costs in terms of money, but an organ obtained for transplantation is a priceless gift, which may save the recipient’s life or improve its quality. Although many altruistic individuals perceive organ donation as a moral obligation, organs cannot be procured using a system that makes their donation mandatory even if this action is against a person’s wishes and remains in conflict with the moral principles by which he or she abides. The intentions of transplantation surgeons, who continuously seek new and more effective ways to harvest organs, although admirable, cannot find uncritical acceptance and unconditional support. Experiments with cloning warn us that scientists may acknowledge themselves as ultimate moral authorities. Proud of their profound specialist knowledge and technical skills, scientists may become convinced that they are equally capable of finding solutions to all moral dilemmas. I believe that they are honest in their intentions, but I know that, as all humans, they may err, whereas terminological confusion may be another source of mistaken notions and wrongful actions.
CONSENT
From the ethical point of view, any consent always should be conscious and intentional. There are numerous prerequisites for consent, but, if it is to be valid, consent must be given freely, without duress or deception and with sufficient mental capacity to give it.
benefits, and prognosis when the treatment does not occur. Thus, true agreement always fulfills the prerequisites for “informed consent” because it is granted with full knowledge of the consequences. Complete information should be given to all potential donors or groups of donors (eg, drivers) to ensure that they are made fully aware of all aspects of organ donation. If we want to get consent to use donors’ organs in the event of their deaths, it is necessary to formulate the questions pertaining to the agreement in a way that is both precise and understandable to everyone, so that there is no margin for doubt. If no questions are asked, one cannot expect answers, not to mention actual consent. Ethically, consent should be informed, whether it is expressed or presumed.2 EXPRESS OR EXPLICIT CONSENT
Express or explicit consent is always prospective informed consent and it does not raise any doubts. To obtain express consent, one should also clearly express one’s questions, providing all relevant information to the other party. The absence of express consent for organ donation means neither refusal nor consent to the use of organs for transplantation surgery and, when a person fails to sign a consent form or carry a donor card, it does not mean that he or she actually objects to organ donation. On the other hand, the notion of “unexpressed individual autonomous consent” is deceitful, being simply false from the logical and moral point of view. When no express, explicit consent has been obtained, it may indicate one of the three options implicit consent, actual objection, or indifference. PRESUMED OR IMPLICIT CONSENT
INFORMED CONSENT
In medicine, informed consent is the process by which a fully informed patient participates in deciding whether to choose the proposed treatment, operation, or diagnostic procedure.1 This legally documented agreement, which is also valid from the moral viewpoint, cannot be then obtained unless the patient is first thoroughly and honestly informed about all the pertinent facts, such as the nature of his or her illness or injury, the nature and purpose of the treatment, the risks and potential for death or injury during the procedure, the consequences of the proposed treatment, the probability of success, other treatment options and their associated risks and benefits, and the risks,
The notion of “presumption” refers to an attitude or belief based on reasonable evidence or grounds that have been already proven, but that have no value of explicit evidence. It refers to an idea that is taken to be true, although it is not known for certain. Accordingly, convincing, indirect evidence (proof by assumption) to confirm that consent has been given is a prerequisite for “presumed consent.” If, From the Department of General, Vascular and Transplantation Surgery, Warsaw Medical University, Warsaw, Poland. Address reprint requests to T. Tottoczko, Department of General, Vascular and Transplantation Surgery, Warsaw Medical University, 1a Banacha Str, 02-097 Warszawa, Poland.
© 2003 by Elsevier Science Inc. 360 Park Avenue South, New York, NY 10010-1710
0041-1345/03/$–see front matter doi:10.1016/S0041-1345(03)00191-X
Transplantation Proceedings, 35, 1195–1197 (2003)
1195
1196
while alive, the deceased consented to donate organs, but did not register his or her will to do so, or if such will can be demonstrated to be in keeping with his or her views, then consent can be recognized as “presumed.” “Presumed” consent must be based on the proof or well-founded assumption that the person had been properly informed about the consequences of his or her decision. As such it is “presumed informed” consent.2 Consent can be “presumed” only when people were properly informed and also given a genuine opportunity to opt out.3 When a prospective donor was not properly informed or there is no evidence of his or her will to donate, his or her hypothetical agreement cannot be recognized as presumed consent. The procurement practices must meet stringent, rigorous, widely known criteria of “presumed informed consent” accepted by the ethics committee, which is an independent body, not linked to the procurement and transplantation teams. When express consent is missing, these criteria should differentiate between “implicit consent,” which indicates the will to donate organs for transplantation surgery in the event of a potential donor’s death, and “implicit lack of consent” or event “implicit refusal.” One should add that the criteria should be inflexible and must not be dictated by current needs and circumstances. GUESSED OR CONJECTURAL CONSENT
When there is no direct or indirect evidence, one may only guess whether the deceased would or would not have given his or her consent to use his or her organs for transplantation surgery. “To guess,” however, is not the same as “to presume.” A presumption is based on the validity of arguments and evidence, which support it, whereas guesswork is a “hit-and-miss” affair. “Presumed consent” when not based on widely known and accepted criteria means free choice in interpretation and decision making. That is why, in the event of the death of an individual who has not been registered as a potential donor, the absence of “express consent” does not necessarily mean “implicit consent.” The very fact of death does not automatically give us the right to harvest organs from the deceased because that would be based on “guessed consent.” CONSENT GIVEN BY THE DECEASED DONOR’S NEXT OF KIN
Consent given by the deceased donor’s next of kin cannot be recognized as explicit consent. It is only a highly probable “presumed consent.” The statement of the deceased donor’s next of kin is the testimony of the witness, and does not have the value of the proven truth. When there is evidence of express consent while the next of kin claim that before his or her death the potential donor changed his or her decision and withheld his or her consent, this should be treated as presumed lack of consent rather than just lack of consent.
TOTTOCZKO
OBJECTION
In no circumstances, does lack of consent require a person to notify any authority of their refusal or to register the refusal. Accordingly, the absence of refusal cannot signify actual consent.
EDUCATION
What we need is a public education campaign combined with implementation of an efficient system to obtain and record consent for organ donation. Public relations experts should be able to tell us how to make the general public aware of the benefits of a widespread system of informed consent to donate their organs for transplantation surgery in the event of their death. People should become aware that this is a duty dictated by reason and heart. Donation of organs is the ultimate gift.1 Energetic educational campaigns and enhanced public and professional education to increase awareness about the merits of organ donation can increase the supply of donor organs.
SILENCE
The silence of an individual who has been neither asked to give their consent nor properly informed signifies nothing, and it cannot be interpreted as either consent or refusal. It gains significance when the person has been requested to give consent after being fully informed. But what is the meaning of silence of a properly informed person asked to give their consent? Why should their will, which was never recorded, be interpreted either as consent or objection to donate their organs? The silence of such people may indicate more about their ambivalent attitude to organ donation than anything else.4 To assume that silence of the noninformed person is “unexpressed but autonomous will” is a typical instance of wishful thinking. This is not only a logical error, but also moral infringement. However, it is highly probable that most of the “silent” people, if properly informed, would give their consent to donate their organs in the event of their death, because people tend to notify authorities of their refusal rather that of their agreement. That is why when an ethics committee has confirmed that all members of a given social or occupational group (eg, drivers) have been informed about the aims, principles, and outcome of express consent for organ donation and been made aware of its benefits to society at large, we may conclude that a “silent” potential organ donor from this group was likely to give his or her implicit consent. Only meeting the criteria of presumed consent would provide intellectual, logical, and moral grounds to recognize “silence” as consent to harvest the organs after the donor’s death. Accordingly, it would be necessary to formulate such criteria and start a widespread campaign to inform and educate the public.
PRESUMED CONSENT
CONCLUSIONS
Ethically, any consent should be informed, whether it is expressed or presumed, ie, people should be given all relevant information before giving consent. The person asked to give his or her consent must be fully aware of all relevant facts and have a genuine opportunity to opt out if he or she change his or her mind. The widespread campaign to inform and educate people to persuade them that consent to donate organs may save lives of a few donors will
1197
be long, laborious, and expensive. This arduous task will target people’s hope.
REFERENCES 1. 2. 3. 4.
Goss RM: BMJ 321:102, 2000 Hill DJ, Palmer TC, Evans DW: BMJ 318:1490, 1999 Wilks M: Lancet 352:151, 1998 Webster GC: Can Med Assoc J 159:135, 1998
C
ONSENT FOR ORGAN donation is a generous contribution dictated by the heart, mind, and intellect of the donor, consistent with his or her personal convictions and beliefs. The donor bears no costs in terms of money, but an organ obtained for transplantation is a priceless gift, which may save the recipient’s life or improve its quality. Although many altruistic individuals perceive organ donation as a moral obligation, organs cannot be procured using a system that makes their donation mandatory even if this action is against a person’s wishes and remains in conflict with the moral principles by which he or she abides. The intentions of transplantation surgeons, who continuously seek new and more effective ways to harvest organs, although admirable, cannot find uncritical acceptance and unconditional support. Experiments with cloning warn us that scientists may acknowledge themselves as ultimate moral authorities. Proud of their profound specialist knowledge and technical skills, scientists may become convinced that they are equally capable of finding solutions to all moral dilemmas. I believe that they are honest in their intentions, but I know that, as all humans, they may err, whereas terminological confusion may be another source of mistaken notions and wrongful actions.
CONSENT
From the ethical point of view, any consent always should be conscious and intentional. There are numerous prerequisites for consent, but, if it is to be valid, consent must be given freely, without duress or deception and with sufficient mental capacity to give it.
benefits, and prognosis when the treatment does not occur. Thus, true agreement always fulfills the prerequisites for “informed consent” because it is granted with full knowledge of the consequences. Complete information should be given to all potential donors or groups of donors (eg, drivers) to ensure that they are made fully aware of all aspects of organ donation. If we want to get consent to use donors’ organs in the event of their deaths, it is necessary to formulate the questions pertaining to the agreement in a way that is both precise and understandable to everyone, so that there is no margin for doubt. If no questions are asked, one cannot expect answers, not to mention actual consent. Ethically, consent should be informed, whether it is expressed or presumed.2 EXPRESS OR EXPLICIT CONSENT
Express or explicit consent is always prospective informed consent and it does not raise any doubts. To obtain express consent, one should also clearly express one’s questions, providing all relevant information to the other party. The absence of express consent for organ donation means neither refusal nor consent to the use of organs for transplantation surgery and, when a person fails to sign a consent form or carry a donor card, it does not mean that he or she actually objects to organ donation. On the other hand, the notion of “unexpressed individual autonomous consent” is deceitful, being simply false from the logical and moral point of view. When no express, explicit consent has been obtained, it may indicate one of the three options implicit consent, actual objection, or indifference. PRESUMED OR IMPLICIT CONSENT
INFORMED CONSENT
In medicine, informed consent is the process by which a fully informed patient participates in deciding whether to choose the proposed treatment, operation, or diagnostic procedure.1 This legally documented agreement, which is also valid from the moral viewpoint, cannot be then obtained unless the patient is first thoroughly and honestly informed about all the pertinent facts, such as the nature of his or her illness or injury, the nature and purpose of the treatment, the risks and potential for death or injury during the procedure, the consequences of the proposed treatment, the probability of success, other treatment options and their associated risks and benefits, and the risks,
The notion of “presumption” refers to an attitude or belief based on reasonable evidence or grounds that have been already proven, but that have no value of explicit evidence. It refers to an idea that is taken to be true, although it is not known for certain. Accordingly, convincing, indirect evidence (proof by assumption) to confirm that consent has been given is a prerequisite for “presumed consent.” If, From the Department of General, Vascular and Transplantation Surgery, Warsaw Medical University, Warsaw, Poland. Address reprint requests to T. Tottoczko, Department of General, Vascular and Transplantation Surgery, Warsaw Medical University, 1a Banacha Str, 02-097 Warszawa, Poland.
© 2003 by Elsevier Science Inc. 360 Park Avenue South, New York, NY 10010-1710
0041-1345/03/$–see front matter doi:10.1016/S0041-1345(03)00191-X
Transplantation Proceedings, 35, 1195–1197 (2003)
1195
1196
while alive, the deceased consented to donate organs, but did not register his or her will to do so, or if such will can be demonstrated to be in keeping with his or her views, then consent can be recognized as “presumed.” “Presumed” consent must be based on the proof or well-founded assumption that the person had been properly informed about the consequences of his or her decision. As such it is “presumed informed” consent.2 Consent can be “presumed” only when people were properly informed and also given a genuine opportunity to opt out.3 When a prospective donor was not properly informed or there is no evidence of his or her will to donate, his or her hypothetical agreement cannot be recognized as presumed consent. The procurement practices must meet stringent, rigorous, widely known criteria of “presumed informed consent” accepted by the ethics committee, which is an independent body, not linked to the procurement and transplantation teams. When express consent is missing, these criteria should differentiate between “implicit consent,” which indicates the will to donate organs for transplantation surgery in the event of a potential donor’s death, and “implicit lack of consent” or event “implicit refusal.” One should add that the criteria should be inflexible and must not be dictated by current needs and circumstances. GUESSED OR CONJECTURAL CONSENT
When there is no direct or indirect evidence, one may only guess whether the deceased would or would not have given his or her consent to use his or her organs for transplantation surgery. “To guess,” however, is not the same as “to presume.” A presumption is based on the validity of arguments and evidence, which support it, whereas guesswork is a “hit-and-miss” affair. “Presumed consent” when not based on widely known and accepted criteria means free choice in interpretation and decision making. That is why, in the event of the death of an individual who has not been registered as a potential donor, the absence of “express consent” does not necessarily mean “implicit consent.” The very fact of death does not automatically give us the right to harvest organs from the deceased because that would be based on “guessed consent.” CONSENT GIVEN BY THE DECEASED DONOR’S NEXT OF KIN
Consent given by the deceased donor’s next of kin cannot be recognized as explicit consent. It is only a highly probable “presumed consent.” The statement of the deceased donor’s next of kin is the testimony of the witness, and does not have the value of the proven truth. When there is evidence of express consent while the next of kin claim that before his or her death the potential donor changed his or her decision and withheld his or her consent, this should be treated as presumed lack of consent rather than just lack of consent.
TOTTOCZKO
OBJECTION
In no circumstances, does lack of consent require a person to notify any authority of their refusal or to register the refusal. Accordingly, the absence of refusal cannot signify actual consent.
EDUCATION
What we need is a public education campaign combined with implementation of an efficient system to obtain and record consent for organ donation. Public relations experts should be able to tell us how to make the general public aware of the benefits of a widespread system of informed consent to donate their organs for transplantation surgery in the event of their death. People should become aware that this is a duty dictated by reason and heart. Donation of organs is the ultimate gift.1 Energetic educational campaigns and enhanced public and professional education to increase awareness about the merits of organ donation can increase the supply of donor organs.
SILENCE
The silence of an individual who has been neither asked to give their consent nor properly informed signifies nothing, and it cannot be interpreted as either consent or refusal. It gains significance when the person has been requested to give consent after being fully informed. But what is the meaning of silence of a properly informed person asked to give their consent? Why should their will, which was never recorded, be interpreted either as consent or objection to donate their organs? The silence of such people may indicate more about their ambivalent attitude to organ donation than anything else.4 To assume that silence of the noninformed person is “unexpressed but autonomous will” is a typical instance of wishful thinking. This is not only a logical error, but also moral infringement. However, it is highly probable that most of the “silent” people, if properly informed, would give their consent to donate their organs in the event of their death, because people tend to notify authorities of their refusal rather that of their agreement. That is why when an ethics committee has confirmed that all members of a given social or occupational group (eg, drivers) have been informed about the aims, principles, and outcome of express consent for organ donation and been made aware of its benefits to society at large, we may conclude that a “silent” potential organ donor from this group was likely to give his or her implicit consent. Only meeting the criteria of presumed consent would provide intellectual, logical, and moral grounds to recognize “silence” as consent to harvest the organs after the donor’s death. Accordingly, it would be necessary to formulate such criteria and start a widespread campaign to inform and educate the public.
PRESUMED CONSENT
CONCLUSIONS
Ethically, any consent should be informed, whether it is expressed or presumed, ie, people should be given all relevant information before giving consent. The person asked to give his or her consent must be fully aware of all relevant facts and have a genuine opportunity to opt out if he or she change his or her mind. The widespread campaign to inform and educate people to persuade them that consent to donate organs may save lives of a few donors will
1197
be long, laborious, and expensive. This arduous task will target people’s hope.
REFERENCES 1. 2. 3. 4.
Goss RM: BMJ 321:102, 2000 Hill DJ, Palmer TC, Evans DW: BMJ 318:1490, 1999 Wilks M: Lancet 352:151, 1998 Webster GC: Can Med Assoc J 159:135, 1998