Concordance of International Regulation of Pediatric Health Research.

OBJECTIVE: To assess the comparability of international ethics principles and practices used in regulating pediatric research as a first step in determining whether reciprocal deference for international ethics review is feasible. Prior studies by the authors focused on other aspects of international health research, such as biobanks and direct-to-participant genomic research. The unique nature of pediatric research and its distinctive regulation by many countries warranted a separate study. STUDY DESIGN: A representative sample of 21 countries was selected, with geographical, ethnic, cultural, political, and economic diversity. A leading expert on pediatric research ethics and law was selected to summarize the ethics review of pediatric research in each country. To ensure the comparability of the responses, a 5-part summary of pediatric research ethics principles in the US was developed by the investigators and distributed to all country representatives. The international experts were asked to assess and describe whether principles in their country and the US were congruent. Results were obtained and compiled in the spring and summer of 2022. RESULTS: Some of the countries varied in their conceptualization or description of one or more ethical principles for pediatric research, but overall, the countries in the study demonstrated a fundamental concordance. CONCLUSIONS: Similar regulation of pediatric research in 21 countries suggests that international reciprocity is a viable strategy.

Biobanking of human biological material and the principle of noncommercialisation of the human body and its parts.

The prohibition of commercialisation of the human body and its parts is not applied consistently and suffers from many exceptions in the human biological material (HBM) market. Examples include the possibility of patenting certain HBM-derived products and their commercial marketing or payments for blood donations. Thus, the current practice of marketing HBM-derived products makes the altruistic donor most vulnerable to exploitation while being deprived of benefits. There seem to be two ways to improve this state of affairs. The first is to apply consistently the prohibition of commercialisation of the body and its parts to commercially marketed tissue and cell products as well. This would require limiting the possibility of financial gain associated with the processing, distribution and sale of HBM-based products. Such a solution, however, does not seem to gain wide acceptance or have a chance of implementation in the near future. Therefore, introducing more transparent rules and greater donor empowerment seems more reasonable by exempting HBM from the ban on commercialisation under certain conditions and with clear limitations.

Recommendations for Creating Codes of Conduct for Processing Personal Data in Biobanking Based on the GDPR art.40.

Personal data protection has become a fundamental normative challenge for biobankers and scientists researching human biological samples and associated data. The General Data Protection Regulation (GDPR) harmonises the law on protecting personal data throughout Europe and allows developing codes of conduct for processing personal data based on GDPR art. 40. Codes of conduct are a soft law measure to create protective standards for data processing adapted to the specific area, among others, to biobanking of human biological material. Challenges in this area were noticed by the European Data Protection Supervisor on data protection and Biobanking and BioMolecular Resources Research Infrastructure-European Research Infrastructure Consortium (BBMRI.ERIC). They concern mainly the specification of the definitions of the GDPR and the determination of the appropriate legal basis for data processing, particularly for transferring data to other European countries. Recommendations indicated in the article, which are based on the GDPR, guidelines published by the authority and expert bodies, and our experiences regarding the creation of the Polish code of conduct, should help develop how a code of conduct for processing personal data in biobanks should be developed.