Biological sample collections from minors for genetic research: a systematic review of guidelines and position papers

Abstract

Stored tissue samples are an important resource for epidemiological genetic research. Genetic research on biological material from minors can yield valuable information on the development and genesis of earlyonset genetic disorders and the early interaction of environmental and genetic factors. The use of such tissue raises some specific ethical and governance questions, which are not completely covered by the discussion on biological materials from adults. We have retrieved 29 guidelines and position papers pertaining to the storage and use of biological tissue samples for genetic research, originating from 27 different organizations. Five documents have an international scope, three have an European scope and 21 have a national scope. We discovered that 11 of these documents did not contain a section on biological materials from minors. The content of the remaining 18 documents was categorized according to four themes: consent, principles of non-therapeutic research on vulnerable populations, ethics committee approval and difference between anonymous and identifiable samples. We found out that these themes are not consistently mentioned by each document, but that documents discussing the same themes were mostly in agreement with their recommendations. However, a systematic reflection on the ethical and policy issues arising from the participation of minors in biobank research is missing.

Are the kids really all right? Direct-to-consumer genetic testing in children: are company policies clashing with professional norms?

“…Second, the fact that many companies test for adult onset disorders (and may, therefore, perform research on these disorders using samples from minors) clashes with the principles that research should only be done in minors if (i) it benefits persons of the same age or condition, (ii) it can have direct benefit to the participant and (iii) the same research can not be carried out on adults. 29 Foremost, our data confirm that a large majority of companies selling GT DTC are testing minors. In attempting to keep the questionnaire short, questions regarding the nature of the tests being performed were not posed.…”

“…18 Above and beyond this, the fact that research is being performed on DNA samples originating from minors may also raise important issues. A review of guidelines on the topic by Hens et al 29 shows that there is no systematic agreement on all relevant themes. However, if we simply look at two of the important themes the review discusses, the need for ethics committee approval and the principles of nontherapeutic research on vulnerable populations, conflicts become likely.…”

An exploratory survey of professionals on the use of stored tissue samples from minors for genetic research

“…This is in accordance to the ethics literature on the subject (Hens et al, 2009b). Holm (2005), for example, argues that as children have not been able to autonomously consent and give up the right to withdraw at the moment of donation, the right to withdraw for children is more important than for adults.…”

“…We created a structured questionnaire based on a review of the ethics literature on stored tissue samples (Hens et al, 2009b). The survey was reviewed by one medical doctor, one researcher in genetics and one researcher in biochemistry.…”

Clarifying assent in pediatric research

“…12 With regard to the different types of pediatric biobanks, the prevailing view is that assent should be obtained when possible. 3,[13][14][15][16][17][18][19] However, though many emphasize the importance of assent, few explain how they understand the concept and few have elaborated on the underlying grounds of assent and its role in pediatric biobanks. 20 This is not surprising as no consensus exists about how assent should be interpreted and implemented in biomedical research.…”