Parental Views On Consent, Tissue Taking and Tissue Banking in Pediatric Oncology Patients.

Ethical challenges associated with tissue banking in pediatric populations include consent, privacy and confidentiality, conflicts of interest, return of summary and individualized results and logistical issues. A gap in the literature exists in applying theoretical claims because of a paucity of empirical evidence with respect to parental attitudes towards tissue banking for their children. The purpose of this study was to investigate parental attitudes to ethical issues in tissue banking while acting as surrogate decision-makers for pediatric malignant hematology and oncology populations. Methods. A validated questionnaire was developed through literature review, an expert content validity exercise and a pilot study. The final questionnaire and 2 reminders with return postage were sent to parents of 104 consecutively diagnosed, pediatric oncology patients treated at the IWK Health Centre in Halifax, Nova Scotia, from January 2006 to December 2007. The questionnaire examined ethical domains related to consent, tissue acquisition for banking and subsequent use, as well as patient and parent demographics. Results. Fifty four parents (including 10 of 16 parents of children who were deceased) completed the questionnaires. The majority of the respondents were Caucasian (98%, n=53) and primarily spoke English (83%, n=45). 35% of patients were diagnosed with acute lymphoid leukemia or acute myeloid leukemia at an average age of approximately 8 years old. Most respondents (n=46, 85%) stated that they would agree to have tissue obtained in order to classify the cancer. 48 parents (89%) reported that they would agree to have their child's tissue sent anywhere in the world for research purposes. If a severe underlying health condition existed, 98% of parents (n=53) would want genetic research to be done if it might improve the immediate or future health of their child. 45 respondents (83%) stated that they would want genetic research to be done, if it might improve their personal health, and 76% of parents (n=41) agreed that they would still want genetic research to be undertaken, even if it would not improve their child's health. In a situation where a child is refusing a very painful procedure strictly for research purposes, 41% of parents said that they would not go through with the procedure, while 15% said they would do so regardless of the child's dissent. 54% of parents (n=29) feel that they should be asked for consent if previously stored tissue is to be used for a new research purpose. When a patient reaches the age of majority, 98% of parents agree that their child should be given the opportunity to confirm consent and 71% feel that the now mature child should be able to then withdraw consent. Only 2% of respondents believe stored tissue should be destroyed in the event that a patient (who is now the age of majority) cannot be contacted to confirm consent. 40 parents (74%) believed that they have few or no rights to any money gained as a result of research using their child's tissue; and 83% believed that the money should be used to fund childhood cancer research. In the setting where approximately two thirds of children would be offered research participation, 26% of respondents (n=14) cannot remember if their child was offered research participation, and 30% of parents (n=16) cannot recall if they provided consent. 3 parents reported that they did not understand the consent forms and 30% of parents (n=16) felt that they were not given adequate time to read the forms. While most parents agree that all their research participation questions were thoroughly addressed, 35% reported (n=19) that more time would have been helpful. Conclusions. Most parents are willing to participate in tissue research providing the child is not exposed to extra pain. Most parents felt that they had sufficient information to provide consent but a significant minority would like more time. Parents generally do not feel a right to monetary gains from tissue research or express concerns about sending tissue internationally for research purposes. In addition, parents are not apprehensive about genetic research being conducted on banked tissues, even if it cannot directly help the health of their child or themselves. This information may help Institutional Review Boards in assessing parentally perceived risks of research participation, and researchers in providing consent elements that parents require to make fully informed choices.

No relevant conflicts of interest to declare.