High-quality biobanks have become essential resources for medical research. However, because of this growth, biobanks need to look closely at their consent procedures and provide meaningful reports of their ethics procedures. Chin et al. (2016) note that some biobanks seek broad consent from their donors so that they can use specimens for research beyond the scope of the original project, while other biobanks use project-specific consent procedures, tying specimens to a particular project.1
The authors call for biobanks using broad consent to differentiate between the different models of this type of consent. Under broad consent, the biobank itself can be approved, meaning that participants agree to have that particular biobank use their samples for any future research. There is also a process by which the same oversight body of the biobank, or another governing body, can approve specific projects that require particular biomaterials and data to be released. Chin et al. argue that meaningful biobank reporting needs to define whether ethics approval relates to the biobanking and its use of biosamples, or if it is only referring to one of these.
To investigate this further, the authors screened ethics statements from 120 articles reporting on analyses of human biospecimens published between 2014 and 2015 in four different journals: PLOS Genetics (n = 30), The New England Journal of Medicine (n = 30), Nature Genetics (n = 30) and Nature Medicine (n = 30). The majority of the articles, 87% (n = 104), reported at least some information on consent. Of these, 41% (n = 43) reported additional details such as proxy consent, timing of consent, consent obtained from another study or project, and data protection specifications. However, only 8% (n = 8) of the studies with consent reporting provided information indicating whether the consent was broad or project-specific.
A total of 93% (n = 112) of the articles reported at least some information on ethics approval. Of these, 79% (n = 89) reported additional details, such as the name of the institutional review board or the approval protocol number. Only 9% (n = 10) provided information indicating whether approval related to the banking of specimens for future research, for a specific project or for both.
Although most of the papers Chin et al. reviewed did report on consent and approval, only a very small number provided meaningful details about either. The authors make a number of recommendations to the journals themselves to improve reporting:
- Require more meaningful information on the type of consent
- Ask for information on whether there is approval for the biobank itself, whether there is approval for the project (and by whom) and whether any other biobanks are involved (including details)
- Ask whether research groups whether they store or discard remaining samples
They also recommend that the biobanks themselves include an ethics reporting template with their material transfer agreements to avoid variations in reporting by studies linked to the same biobank.
Finally, Chin et al. recommend a unified approach from researchers, journal editors, ethicists and other relevant stakeholders in the form of a consensus statement.
1. Chin, W.W., et al. (2016) “Ethics reporting in biospecimen and genetic research: Current practice and suggestions for changes,” PLOS Biology, 14(8) (e1002521), doi: 10.1371/journal.pbio.1002521.