Physicians involved with post-mortem organ and tissue donations may be concerned about informed consent—particularly, who can provide it and how it should be obtained. Physicians may also worry about exposing themselves to complaints or legal actions when taking part in harvesting and transplanting organs and tissue. By gaining an understanding of the regulatory requirements governing organ and tissue donation, physicians can be confident they are effectively meeting their obligations to patients and their families, and potentially helping to increase the limited supply of transplantable organs.
Physicians who act in good faith and are reasonably satisfied that valid consent has been given are unlikely to face medico-legal difficulties. Indeed, the CMPA is not aware of any legal actions or regulatory authority (College) complaints arising from organ and tissue donations in Canada in the past 10 years.
Consent to opt in or out
Requirements for consent to donate organs and tissue are addressed in provincial and territorial statutes (in Québec, consent for such donations is addressed in the Civil Code).1
All provinces and territories except Nova Scotia operate opting-in systems. In the opting-in systems, the express consent of the donor or other specified individual is required. Such consent can commonly be given when a prospective donor registers with a provincial donor registry such as BC Transplant or Ontario’s Trillium Gift of Life Network, or when renewing one’s health card or driver’s license, or can be given more contemporaneously by the patient or substitute decision-maker (SDM).
In the opting-out system, currently employed in Canada only in Nova Scotia,2 individuals may register their consent or refusal to donate in the provincial donor registry, which is to be consulted before any transplantation activity. If the individual has not recorded their decision in the provincial registry and they were 19 years of age or older and met certain other conditions before death, their consent to donation will be deemed (i.e. presumed). Where the patient’s SDM has information that would lead a reasonable person to conclude the patient would have made a different decision than the deemed decision or the one recorded in the registry, the SDM may consent or refuse the donation on behalf of the patient.
Legislation in many provinces also allows family members and SDMs to consent at the time of death or when death is imminent. In general, consent may be given in priority order by next of kin or other specified individuals when certain conditions are met such as the absence of personal knowledge that the donor would have refused to give consent.3
Presumed (deemed) consent and mandated choice
In an effort to increase the availability of organs, some advocates call for a system of presumed (deemed) consent or mandated choice. In an opting-out system, consent is deemed to have been given unless the person’s refusal is recorded in a registry, there is evidence the person would have made a different decision, or specified exceptions apply. A mandated-choice system means all citizens would be required to declare whether they wish to donate.
Suitability for organ and tissue donation
An ongoing challenge for physicians and organ procurement organizations is finding ways to reduce barriers to organ and tissue donation, thus narrowing the gap between supply and demand. While Canadian regulations4 identify many contraindications5 to organ and tissue donation, such as infections and some neurological disorders, they do allow for exceptions to be made on a case-by-case basis. Indeed, one recent study found that about one-third of deceased donors in Ontario were such exceptions.6 Suitability is typically assessed by the organ procurement organization and the decision whether to proceed is ultimately made by the transplant physicians.
Physicians may be subject to additional obligations. In Alberta, for example, physicians who make a determination of death are required to consider and document in the patient record the medical suitability of the deceased person’s organs for transplantation.7 For more information physicians should refer to the applicable College guidelines and to policies such as the Canadian Medical Association’s Policy on Organ and Tissue Donation and Transplantation.8 As well, some provincial donor registries and organ procurement organizations offer resources and advice from transplant specialists; in many hospitals transplant physicians may also be available for consultation.
Providing care in good faith
Provincial legislation on organ and tissue donation provides immunity from civil liability for physicians who act in good faith and without negligence in removing tissue for post-mortem donation.9 Such legislation is grounded in the general principle that physicians will not be found liable when acting according to the appropriate standard of care applicable in the circumstances, which is based on medical knowledge and prevailing practices at the time.
Communicating with donor patients and their families
Physicians are encouraged to provide prospective donors with “meaningful, understandable information” concerning donating their organs and tissue. Preferably this information is part of ongoing care and provided in advance of any crisis requiring an urgent decision or when the patient’s capacity to consent might be compromised.8 Such information may normally include the following: benefits and risks of donation and transplantation, procedures on the determination of death, testing of organs and tissues to determine their suitability for transplantation, measures that may be required to preserve organ function until death is determined, what will happen to the body once death has been declared, what organs or tissues are being donated, and the protocol that will be followed in the event the family objects.8
Physicians should encourage prospective donors to discuss their choice with their family or SDM. This can provide greater certainty and avoid possible later conflict.
When a patient has died, a good practice is to call on the hospital’s organ donation coordinator (or equivalent), who may access the donor registry and who is well versed in communicating information about the donation process with the family. Communicating effectively with the family to obtain their consent has been shown to improve rates of authorization for organ and tissue donation as well as the overall quality of the donation experience.9 When requesting consent from family members in the absence of the donor’s express consent, it may be helpful to keep in mind that families are more likely to regret refusing to donate their loved one’s organs and tissue rather than feeling remorseful about giving permission.10
When the patient’s wishes are known and there is no reason to believe the patient changed his or her mind to donate, physicians are not obligated from a legal perspective to seek additional consent from family members or the SDM. While family members and SDMs are encouraged to respect their loved one’s expressed wishes, consensus may not always be easily achieved. For physicians, it may not be prudent to proceed without first having a tactful, considerate discussion with the family or SDM to review the donor’s wishes and secure the family’s consent. Such a discussion will serve to avoid potential disagreements, help grieving survivors cope with their loss, and reduce the possibility of medico-legal difficulties for the physicians involved.
The bottom line
- Physicians who act in good faith and are reasonably satisfied that valid consent has been given (or, in Nova Scotia, the conditions have been met to deem consent) to harvest a deceased person’s organs or tissue are unlikely to face medico-legal difficulties.
- Information concerning donating organs and tissue is best provided to patients as part of ongoing care and in advance of any crisis that might give urgency to the decision.
- When a patient’s wishes are not known, legislation generally allows next of kin to consent to donate, or refuse to donate, under specified conditions.
- When a patient’s wishes are known, a discussion with the family to confirm the donor’s wishes may help avoid possible disagreements and medico-legal difficulties for physicians.
- art. 10, 11 CCQ
- Human Organ and Tissue Donation Act, Chapter 6, Acts of 2019. Available from: https://nslegislature.ca/sites/default/files/legc/PDFs/annual%20statutes/2019%20Spring/c006.pdf
- For example, in Alberta, Human Tissue and Organ Donation Act. Chapter H-14.5, 2006 (http://www.qp.alberta.ca/documents/Acts/h14p5.pdf). In Ontario, Trillium Gift of Life Network Act, R.S.O. 1990, c. H.20
- Government of Canada. Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR/2007-118). Canada Gazette Part II. June 27, 2007. 141(13): 1216-1274
- Canadian Standards Association. CAN/CSA-Z900.1-12 - Cells, tissues, and organs for transplantation: General requirements. Ottawa: CSA, 2012
- Deceased Organ Donor Potential in Canada [Internet]. Ottawa: Canadian Institute for Health Information; 2014 Dec [cited 2015 Mar 22]. 36 p. Available from: https://www.cihi.ca/web/resource/en/organdonorpotential_2014_en.pdf
- Human Tissue and Organ Donation Act. Chapter H-14.5, 2006. Available from: http://www.qp.alberta.ca/documents/Acts/h14p5.pdf
- CMA Policy, Organ and Tissue Donation and Transplantation [Internet]. Ottawa: Canadian Medical Association; 2015 [cited 2016 Mar 22]. 9 p. Available from: https://www.cma.ca/Assets/assets-library/document/en/advocacy/cma_policy_organ_and_tissue_donation_and_transplantation_update-2015_pd16-02-e.pdf#search=organ%20donation%20policy
- Siminoff LA, Traino HM, Genderson, MW. Communicating effectively about organ donation: A randomized trial of a behavioral communication intervention to improve discussions about donation. Transplantation Direct [Internet]. 2015 Mar [cited 2016 Mar 22]. Available from: http://journals.lww.com/transplantationdirect/Fulltext/2015/03000/Communicating_Effectively_About_Organ_Donation___A.6.aspx#P81 doi: 10.1097/TXD.0000000000000513
- Tymstra TJ, Heyink JW, Pruim J, Slooff MJH. Experience of bereaved relatives who granted or refused permission for organ donation. Fam Pract [Internet]. 1992 [cited 2016 Mar 22]; 9 (2): 141-144. Available from: http://fampra.oxfordjournals.org/content/9/2/141.short doi: 10.1093/fampra/9.2.141