Obtaining Informed Consent

The following statement is adapted from the Standards for Tissue Banking Manual published by the American Association of Tissue Banks and is the basis of Tissue Bank Manitoba’s Standard Operating Procedure 200-040, The Process of Informed Consent for Tissue and Eye Donation.

Human organ and tissue transplantation has become an important and growing part of modern medical practice. Advances in medical science have made it possible for millions of North Americans to receive these life-saving and life-enhancing gifts. None of this would be possible, however, were it not for the tens of thousands of donors and donor families who give their organs and tissue to help their fellow men and women.

The decision to donate must, therefore, be an informed consent, and it must be conducted under circumstances that are sensitive to the consenting person’s situation. Information concerning the donation should be presented in language and in terms that are easily understood by the consenting person. The consent should be obtained under circumstances that provide an opportunity to ask questions and receive informative responses. An offer should be made regarding the availability of a copy of the signed consent form, and information should be provided regarding ways to reach the recovery organization following donation. Consent should be obtained in accordance with federal, state, provincial and/or local laws and/or regulations. The person seeking the consent should be trained to appropriately answer any questions that the consenting person may have. In addition, coercion should not be exerted in any manner, nor monetary inducement offered to obtain consent for donation. The identification of who may be the appropriate person to consent to donation, and whether the consent of any person in addition to the donor needs be obtained, should be evaluated in accordance with the applicable laws and organizational policy and is not addressed in this statement.

The following list of "Basic Elements of Informed Consent" is intended to highlight the information that may be considered critical to informed decision making by a family member or other legally authorized person, who is being approached for consent to organ and/or tissue donation. This listing, whether communicated verbally or included on consent forms, is not intended to preempt any applicable federal, state, provincial or local laws or regulations that may require more or less information to be disclosed for informed consent to be legally effective.

Basic Elements of Informed Consent

In seeking informed consent, the following information should be provided to the person(s) being approached for consent:

1. A confirmation/validation of the donor’s identity and his or her clinical terminal condition.
   
2. A general description of the purposes (benefits) of donation.
   
3. Identification of specific organs and/or tissues (including cells) that are being requested for donation (with subsequent information provided on specific gifts recovered).
   
4. An explanation that the retrieved organs/tissues may be used for transplantation, therapy, scientific research, or educational purposes.
   
5. A general description of the recovery process (including timing, relocation of donor if applicable, contact information, etc.).
   
6. An explanation that laboratory tests and a medical/social history will be completed to determine the medical suitability of the donor, including an explanation that blood samples from the donor will be tested for certain transmissible diseases.
   
7. An explanation that the spleen, lymph nodes, and blood may be removed, and cultures may be performed, for the purposes of determining donor suitability and/or used to determine compatibility of donor and recipient.
   
8. A statement granting access to the donor's medical records, and that the medical records may be released to other appropriate parties.
   
9. An explanation that costs directly related to the evaluation, recovery, preservation and placement of the organs and tissues will not be charged to the family.
   
10. An explanation regarding the impact the donation process may have on burial arrangements and on appearance of the body.
    
11. Any additional information required by federal, state, provincial and/or local laws and/or regulations.

Additional Elements of Informed Consent

In some situations, there may be additional information that should be known by the consenting person(s), or that might be helpful for family decision-making. At a minimum, if the donor family inquires about any of these or additional matters, explanations should be provided.

The guiding principle for the use of these "Additional Elements of Informed Consent" is to advance simplicity and reasonableness in seeking informed consent, i.e., include these elements or additional comments if they are appropriate and might clarify any exigencies. For example, if there is the likelihood that the patient will become a Medical Examiner's case, then it should be appropriate to so inform the family. If it is unlikely that donated tissue is going to be used for aesthetic surgery, then it would not be reasonable to address this issue in the family approach.

One or more of the following elements of information may also be appropriate for communication to the person(s) being approached for consent, depending upon the circumstances surrounding the donation and the potential gift(s):

1. A description of any involvement by the Medical Examiner and/or Coroner, including an explanation that an autopsy may be performed.
   
2. An explanation that transplantation may include reconstructive and aesthetic surgery.
   
3. A reference to the possibility that the final gift may take a different form than originally recovered.
   
4. An explanation that multiple organizations (nonprofit and/or for profit) may be involved in facilitating the gift(s).
   
5. Reference to the possibility that tissue and/or organs may be transplanted abroad.

Reference

Model Elements of Informed Consent for Organ and Tissue Donation. American Association of Tissue Banks, Standards for Tissue Banking, 10th edition, 2002, Appendix III.