ACN - 101321555 Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)
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Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

Sample and data sharing barriers in biobanking: consent, committees, and compromises (Paper: Flora Colledge MA, et al | December 2013)0

Posted by Admin in on January 2, 2020


The discussion in this paper is not particularly new or surprising but it does highlight yet again that HRECs can often be out of touch with donors wishes.  We have included links to ten other papers on consent and biobanking.

The ability to exchange samples and data is crucial for the rapidly growth of biobanking. However, sharing is based on the assumption that the donor has given consent to a given use of her or his sample. Biobanking stakeholders, therefore, must choose 1 of 3 options: obtain general consent enabling multiple future uses before taking a sample from the donor, try to obtain consent again before sharing a previously obtained sample, or look for a legally endorsed way to share a sample without the donor’s consent. In this study, we present the results of 36 semistructured qualitative interviews with Swiss biobanking stakeholders regarding these options and the role of ethics committees in the process of authorizing sharing. Our results show that despite a lack of legal or guideline-based barriers to general consent, some stakeholders and ethics committees have reservations about this method of consent. In most cases, however, a general consent form is already in use. Many interviewees describe processes involving the ethics committees as time-consuming and cumbersome and their requirements as too demanding for donors/patients. Greater awareness of donors’ opinions and preferences and the content of guidelines and recommendations could therefore be helpful for a better justified perspective of biobanking stakeholders and ethical committee members, equally. Finally, it may be necessary to differentiate between procedures governing future samples, where general consent is clearly desirable, and the use of old yet still relevant samples, where the option of using them without consent can be highly beneficial for research.

Biobank, Informed consent, Ethics committee, Data sharing, Sample sharing

Colledge F, Persson K, Elger B, Shaw D. (2014) Sample and data sharing barriers in biobanking: consent, committees, and compromises. Annals of Diagnostic Pathology 18:78-81

Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation? (Papers: Dara Hallinan & Michael Friedewald | 2015)0

Posted by Admin in on August 22, 2019

This article focuses on whether a certain form of consent used by biobanks – open consent – is compatible with the Proposed Data Protection Regulation. In an open consent procedure, the biobank requests consent once from the data subject for all future research uses of genetic material and data. However, as biobanks process personal data, they must comply with data protection law. Data protection law is currently undergoing reform. The Proposed Data Protection Regulation is the culmination of this reform and, if voted into law, will constitute a new legal framework for biobanking. The Regulation puts strict conditions on consent – in particular relating to information which must be given to the data subject. It seems clear that open consent cannot meet these requirements. 4 categories of information cannot be provided with adequate specificity: purpose, recipient, possible third country transfers, data collected. However, whilst open consent cannot meet the formal requirements laid out by the Regulation, this is not to say that these requirements are substantially undebateable. Two arguments could be put forward suggesting the applicable consent requirements should be rethought. First, from policy documents regarding the drafting process, it seems that the informational requirements in the Regulation are so strict in order to protect the data subject from risks inherent in the use of the consent mechanism in a certain context – exemplified by the online context. There are substantial differences between this context and the biobanking context. Arguably, a consent transaction in the biobanking does not present the same type of risk to the data subject. If the risks are different, then perhaps there are also grounds for a reconsideration of consent requirements? Second, an argument can be made that the legislator drafted the Regulation based on certain assumptions as to the nature of ‘data’. The authors argue that these assumptions are difficult to apply to genetic data and accordingly a different approach to consent might be preferable. Such an approach might be more open consent friendly.

Hallinan, D. and M. Friedewald (2015). “Open consent, biobanking and data protection law: can open consent be ‘informed’ under the forthcoming data protection regulation?” Life Sciences, Society and Policy 11(1): 1.
Publisher (Open Access):

Participants’ Understanding of Informed Consent for Biobanking: A Systematic Review (Papers: Elizabeth R. Eisenhauer, et al | 2017)0

Posted by Admin in on August 7, 2019

Nurses are increasingly asked to obtain consent from participants for biobanking studies. Biobanking has added unique complexities to informed consent. The purpose of this systematic review was to evaluate participants’ level of understanding of the information presented during the informed consent process unique to the donation of biological specimens for research. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were utilized to conduct the review. PubMed, EMBASE, CINAHL, PsycINFO, Scopus, Web of Science, and ProQuest bibliographic databases were searched. Results indicated that elements of informed consent unique to biobanking were poorly understood. Most studies had authors or funding associated with a biobank. Only one study disclosed and assessed participants’ understanding of moral risks. Increased disclosures, values-clarification, and presenting information via multiple modalities may facilitate understanding. There is a need to improve the quality of informed consent for biobanking studies by utilizing standardized instruments, definitions, and encouraging research about informed choice outside the biobanking industry.

biological specimen banks, biobanking, informed consent, moral risks, understanding

Eisenhauer, E. R., Tait, A. R., Rieh, S., Y. & Arslanian-Engoren, C., M. (2017) Participants’ understanding of informed consent for biobanking: a systematic review. Clinical Nursing Research. 28(1) pp30-51

Incorporating Exclusion Clauses into Informed Consent for Biobanking (Papers: Zubin Master and David B. Resnik)0

Posted by Admin in on August 7, 2019

Determining how best to obtain valid consent for the use of human biological samples collected for research is a challenging issue for investigators, sponsors, and institutional review boards (IRBs) because the goals of maximizing participants’ autonomous decisionmaking and advancing scientific research may conflict. Some participants want control over their samples to avoid research projects that they find morally objectionable. In this article, we argue that the use of exclusion clauses in informed consent can minimize risks to participants and social groups and promote accountability and trust without significantly deterring research.

Exclusion clauses are written statements used during informed consent to (1) exclude the use of biological samples and personal health information for certain types of research and (2) limit sharing of biological samples and personal health information with specific researchers, biobanks, or organizations—for example, investigators working on certain types of research projects, insurance companies, government or law enforcement agencies, advocacy organizations, and private companies, that is, employers. Exclusion clauses are meant to capture contentious research that could risk discrimination or stigmatization of individuals or groups and sharing with organizations the public perceives as less trustworthy. Exclusion clauses are statements included in consent forms by the researchers on areas of contentious research in which they will not take part in the future and organizations they are unlikely to share with. Although exclusion clauses may limit unrestricted use and global sharing, they can be useful for smaller biobanks with specific purposes.

Biobanking and Informed Consent
Biobanking involves the collection of human biological materials and health information that are used for a current study and stored for future research. Samples can be tested to detect the presence of cell types, proteins, metabolites, antibodies, DNA sequences, and other biomarkers in a given population.1 With the accompanying health information of participants, investigators can analyze data derived from biological samples (such as genomic information), as well as other types of data (such as demographic and health information), to discover statistical relationships between various factors and diseases and patterns of heritability within families and populations. Sharing of biological samples is important for promoting scientific progress, because investigators can take advantage of one another’s labor and resources and can access diverse populations and include more samples in their studies. Sometimes, samples come from populations where individuals are thought to have unique genetic predispositions or environmental exposures.

MASTER, Z., & RESNIK, D. (2013). Incorporating Exclusion Clauses into Informed Consent for Biobanking. Cambridge Quarterly of Healthcare Ethics, 22(2), 203-212. doi:10.1017/S0963180112000576