1. Retention period(s) of samples/data Many jurisdictions, as well as hospitals and institutions, mandate retention periods for medical or research-related data and samples. Additionally, some types of research initiatives involve long-term retention of data and samples for research purposes, such as longitudinal studies or biobanking. The TCPS states that appropriate data retention periods vary depending on the research discipline, research purpose and the kind of data involved. Indefinite “DNA and immortalized cells will be kept at the biobank of the [institution] for as long as the principal investigator will be able to maintain it” (case # 30) “At the completion of the study, all blood samples including DNA and all clinical data will be securely held by the researchers for use in future studies” (case # 17) With time periods “The blood samples will be stored securely [at a laboratory] for 10 years. The information from your samples will be entered into a secured database. It will be kept for 20 years” (case # 15) Indefinite and with time periods “The questionnaire(s) and the sample(s)/data collected will be used for this study only and will be kept for 25 years after completion of the study as required by Health Canada. … Biologic samples from your child…will be frozen and stored in a laboratory of the investigators for twenty years… Some of these samples will remain in long term storage for later testing of factors that may become important as we learn about them in the future and develop new methods of testing” (case # 24) Access to data/samples Many concerns related to accessing the child’s data and samples exist, even when such access is authorised. The TCPS permits access to data and samples by authorised third parties, such as researchers or other institutions. However, the TCPS does not specifically address material and data transfer agreements, which are becoming increasingly common. Recent debate has centred on the time at which it is ethically permissible to disseminate samples and data to researchers (through properly approved mechanisms). No transfer “The DNA and cell lines used in these studies will be stored by the [research institute] at [the health centre]. These will be used solely for the study of rare diseases and related disorders. These samples (blood, DNA or cell lines) will be destroyed upon completion of our studies of rare diseases and related disorders. … None of the blood, DNA, tissue, or cell lines will be transferred or sold to a third party or returned to the subject or referring physician” (case # 20) Disclosure that data/samples may be transferred to another location “Some samples will be shipped to other specialized laboratories elsewhere in Canada, or in some cases the United States of America. Analyses of these samples, including DNA testing, allow us to understand the effects of both genetics and the environment on the development of the child” (case # 22) Disclosure and discussion of procedure for transfer of data/samples to another location “All data and samples will be shared with Canadian investigators who are members of the Consortium. However, before the data and samples are shared, they will be assigned a specific code and only the local investigator will have the “code key” which can link the codes back to the data/samples. These conditions are rare and there may be children outside of Canada who also suffer from the disorder in your family. For this reason, following approval from the…Consortium scientific committee and the relevant research ethics board, researchers from outside of Canada may be granted access to the coded data (in a controlled access database) or to coded biological samples, for research purposes related to the study of rare genetic disorders. Samples and data will be re-coded prior to such access” (case # 32)