Ethics: Dynamic consent in the digital age of biology: online initiatives and regulatory considerations

Broad Consent for Research With Biological Samples: Workshop Conclusions

“…For example, a large number of donors withdrawing consent after approval of a type of research might signal that such research conflicts with donors’ values or expectations, and may suggest adding that category to the list of triggers for further independent review. A robust system for ongoing communication mirrors in some respects “dynamic consent” models but without asking participants for new consent for each new study (Wee R et al 2013; Kaye J et al 2014). …”

Redefining Genomic Privacy: Trust and Empowerment

“…Active research on this topic is underway (e.g., [21],[22]), and commercial offerings like PatientsLikeMe and 23andMe are currently using dynamic consent models [23]. The BCF's dynamic consent mechanism emphasizes reciprocity (also discussed in [14]) and agency, giving participants greater information on researchers and their studies.…”

Biobank consent models – are we moving toward increased participant engagement in biobanking?

“…In that way, it is possible to facilitate more autonomous choices within large-scale biobank research and respect the decision-making process of the individual. 7,15,21,24,27,44 The whole point of the dynamic consent model is of course to be dynamic. That means that donors should have control over their consent, be able to track and inspect it, as well as change it whenever it suits the individual donors.…”

“…That means that donors should have control over their consent, be able to track and inspect it, as well as change it whenever it suits the individual donors. 15,24 Proponents of such a consent model also argue that by being able to exercise a dynamic, flexible, and ongoing consent, research participants have control over samples and data. 7,24,25,34,40,45 If participants get tired and burdened by a study-by-study consent, but still want to endorse biobank research, then they should be able to change their consent preference to a broad(er) consent, thereby ensuring all preferences are met.…”

“…So, even if broad consent has solved some problems for the research biobank(s), it has on the other hand triggered renewed consent debates based on its shortcomings. 4,6,7,12,15,17,[23][24][25][26][27] Better information and communication routines would be one plausible and simple response to this challenge. However, some would argue that this is not enough; that we have to rethink the relationship between researchers and research participants is one of the claims.…”