Surveillance

Canadian Paediatric Surveillance Program
Ethical Approval

Overview

Collecting data on rare paediatric disorders appears to be a conundrum: how can one hope, when numbers are so few, to find enough cases of a rare disorder to produce sufficient data for meaningful analysis, without identifying individual patients and compromising their inherent right to patient confidentiality? 

Yet, in accordance with the United Nations Convention on the Rights of the Child, which first specified the rights to individual privacy and professional secrecy more than 12 years ago, the Canadian Paediatric Surveillance Program (CPSP) achieves the above goal.

Because patient confidentiality is of tantamount importance to the success of the program, all new CPSP studies must receive ethical approval from a certified research ethics board before commencing, and then the studies can only collect non-nominal data that are related to the condition under surveillance. 

Only the reporting physician is aware of the patient’s identity; on the initial reporting form, the paediatrician provides the date of birth and the sex of the child to allow the program coordinator to identify and eliminate duplicate cases. The CPSP ensures that only aggregate pan-Canadian data are published and presented.  The commitment to patient confidentiality is capitalized on by providing study investigators with invaluable, anonymous research material on which to build knowledge that will ultimately help children and youth afflicted by rare diseases and conditions. 

Even though the reporting paediatrician does not have to inform the family or obtain consent because no identifying information is ever revealed, he or she may wish to introduce the CPSP and the importance of its research to families who would welcome additional insight into these rare conditions. However, a principal investigator may wish to follow-up a cohort of patients over time. In such a case, the principal investigator must secure the consent of the patient or the patient’s parents before conducting any follow-up.

Rights to individual privacy and professional confidentiality – A Canadian Paediatric Society Program ongoing commitment

Paediatr Child Health 2004;9(8):535

Whether you are a treating physician, a research ethics board member or a parent of a child with a severe, rare condition, you might have wondered: “Does the Canadian Paediatric Surveillance Program (CPSP) respect patient confidentiality?” The answer is definitely yes. The CPSP is dedicated to improving the health of Canadian children and youth by gathering valuable epidemiological public health data on uncommon high impact conditions without compromising patient confidentiality.    

• The CPSP Steering Committee has scrupulously endeavoured to balance the goal of data collection for the common good against the essential need to respect the privacy and confidentiality of patients.
  
  
• A review of the Compendium of Canadian Legislation Respecting the Protection of Personal Information in Health Research, prepared by the Canadian Institute of Health Research, states that information can be used or disclosed for research purposes if it is non-nominal and nonidentifiable, as is the case with the CPSP studies. This is also in agreement with the Canadian Medical Association and the Tri-Council guidelines.
  
  
• To further ensure accordance with published guidelines, an independent Canadian research ethics board (REB) must approve a new study before its addition to the program. So far, CPSP studies have been approved by REBs from the following universities and hospitals: University of British Colombia, University of Calgary, University of Manitoba, McGill Univeristy, McMaster University, Memorial University, Children’s Hospital of Eastern Ontario, Hamilton Health Sciences Corporation, Hôpital Sainte Justine, The Hospital for Sick Children, IWK Health Centre, Ottawa Hospital, North York General Hospital, and Health Canada’s REB. 
  
  
• Because CPSP studies only ask for the date of birth and sex, patient confidentiality is maintained. Every attempt is made to ensure the child’s right to privacy, especially because these are very rare conditions; in fact, neither the CPSP nor the study investigator could link a specific child to any report. Similarly, the CPSP ensures that only aggregate pan-Canadian data are published and presented.
  
  
• CPSP’s primarily concern is collecting and analyzing pre-existing epidemiological scientific health data for advancing knowledge on rare diseases. The health impact of such surveillance research is beneficial not only to the individual patient but also to the community at large.