Ever wondered what happens to the biological material you leave behind when you check out of the hospital? Nothing much, is the usual answer. However, the little bits of blood, tissue, and urine are potentially valuable for medical research; miniscule amounts of it may already allow sophisticated analyses, including genetic ones. Thus, in an approach termed ‘healthcare-embedded biobanking’, healthcare providers have started collections of leftover patient materials to create resources for future research.
However, unlike traditional research, healthcare-embedded biobanking is not done with a clear research question in mind. The materials are simply left-overs from diagnosis or treatment and, at the time of collection, the scientific projects for which they may be used eventually are entirely unclear.
This approach leads to an ethical conundrum. Established research ethics frameworks found here and here require that patients be asked for their consent and that they are given all the information they need to make an informed decision about whether to donate their material (and its associated data) or not. This includes, in particular, the research goals as well as the potential benefits and risks. However, this provision of information is not possible in healthcare-embedded biobanking: the risks and benefits can only be described in very broad terms, and the goals and timing of future research are usually unknown. Indeed, the materials may even not be used at all.
How, then, can we develop an acceptable consent policy for healthcare-embedded biobanking? Ask patients to donate with only broad information given about what might happen to their sample? Would patients even consider donating under such circumstances?
The University Medical Center Schleswig-Holstein, with 150,000 patients per year, is currently establishing healthcare-embedded biobanking at its Kiel Campus. During the implementation process, we wanted to assess whether the new consent policy—specifically developed for this program—was acceptable to patients and what they thought about it. The policy was the result of several years of debate among researchers in Kiel and beyond and consultation with with the local Institutional Review Board (IRB). It includes a succinct brochure (in German) informing patients of the most important aspects of the undertaking, including its overall goal (“biomedical research”), the undetermined length storage, the potential benefits to research and future patients (but no personal benefits), potential risks to donors (informational harm), ownership issues, and the exclusion of commercial use. The consent policy explicitly excludes the provision of any individual research results, even if these might be relevant to the patient’s health.
In a representative sample of 760 patients, recruited randomly during admission, we inquired about the individual reasons to consent and tested whether patients had understood the information we gave them. Our findings were encouraging: nearly 75% of patients completed the consent process properly, and a large majority of these (87%) consented to the future scientific use of their material and associated data under the circumstances described. Thus, our study implies that patients generally accept a broad consent policy in the context of medical research, when proposed.
We also tested objective understanding of the process, with mixed results. After rewriting the information material for greater clarity, however, understanding improved significantly in the second half of the study. Moreover, an even higher percentage of patients (92%) gave consent in phase two. This was particularly surprising in view of another result: we also asked if patients found the no-feedback policy on individual patient-related findings appropriate, and if they would have wanted to receive such results. In both phases of our study, patients generally disagreed with the no-feedback policy. In phase two, where objective understanding was better, they voiced even stronger opposition. However, this opposition did not translate into corresponding lower rates of consent, because the willingness to consent increased as well.
One potential explanation for this apparent contradiction is provided by the reasons patients gave for consenting. Overwhelmingly, patients stated pro-social motives, ranging from altruism to solidarity to gratitude. Self-interest played a decidedly minor role. Thus, even if patients are not happy with some aspects of how healthcare-embedded biobank is conducted (i.e. no feedback), they still consider the endeavor to be overall important and valuable enough to participate.
When it was first discussed for more traditional forms of biobanking, broad consent was quite controversial. Our study shows that at least when it comes to healthcare-embedded biobanking, we might not have to worry so much about overburdening patients with this decision, or hurting their interests unduly. Obviously, we need to design robust governance and well-designed information materials for this kind of research. But when the indefinite collection of materials and data concerns ‘leftovers’ from the clinic, patients are very likely to consent for their use for unspecified future medical research purposes. Encouragingly, they do not do so for fear of disadvantages, nor for self-interested reasons, but because they want to support a type of research they deem, overall, valuable.
Excellent work thank you.
Thanks! Glad you like it.
Offering patients a valid reason to contribute to a biobank will lead to a “yes” unless they hold strong religious beliefs that oppose that practice. Most patients would savor a chance to help others and boost scientific knowledge, but first, they need to be told why their biological gift is of value. Asking them for permission allows them to have control over the decision which is a gesture of respect (in what might have already felt like an out-of-control hospitalization or illness). If they agree, they have the privilege of donating a personal, precious “gift.” Whatever they have endured to be a patient in your care is erased for a brief moment as they sign the consent form. And that, too is a special gift…
I think you are right. Gratitude was a really important motivation in our sample as well, so this fits with what you say. Thanks for the comment!
Hi Alena,
This is really interesting, and supports the idea that patients may prioritise different ethical issues to those of ‘the publics’ – the latter being concerned and interested in the most commonly discussed ethical issues related to biobanking (what the data would be used for/privacy/confidentiality etc); the former being more concerned with alturism/helping others and themselves etc.
The results could also be explained with notions of trust – ie patients trust hospitals more than biobanks??
In terms of accepting broad consent as an option -did you hypothetically propose to patients what the research might be used for after they had given consent. There is some research which suggests that people are happy with broad consent until they actually find out what samples might be used for, and then they realise that actually they do have specific choices about how their sample should be used???
Hi Gabby,
glad you like the work! Thanks for your comment. We did not look into trust, although that would have been very interesting. And I believe you are probably right, and that patients do indeed trust hospitals more than biobanks. One of the leading motives for donating in our sample was ‘being grateful to my doctors’. It is not the same as trust, but again, trust is probably a precondition for the practice: you would probably not express your gratitude by giving samples to the institution where you were just diagnosed and/or treated without trusting the institution in the first place. We will run more studies into motivation and I will definitely include this.
Re: the second point – very interesting, but unfortunately we did not do this systematically. This would be so interesting to test in our patients – would you happen to have a reference? Thanks so much!
All best, Alena