Accidental Research Subjects
I read an article In the San Francisco Chronicle this week that raised a prickly question, namely – should patients know that they are research subjects?’ http://bit.ly/WqXpR7. The fact is, most people haven’t a clue.
A patient’s participation in research is usually mentioned in standard hospital consent forms. You give a blood sample because your doctor wants to check something, and any spare blood can be used [anonymously] to check lab procedures, or for research.
But in some clinical consent forms, the research question isn’t even a question – it is just assumed that unless you say otherwise, your blood sample can be used. In other cases, you may be asked specifically if you want to opt out.
Whatever the situation, the research is not usually defined. What the patient actually consents to is just ‘research,’ full stop. This could mean allowing a junior member of the lab staff the opportunity to practice loading samples into a shiny new robot that extracts DNA, or it could be that your sample gets entered as a ‘control’ into a DNA sequencing project. Either way, you would never be the wiser.
So, would you want to know if you are research subjects? Is it enough that your spare bits are donated willingly, and for the good of science? Or would you like to know what sorts of projects your bits will kindly participate in before given the opportunity to consent or decline?
Whilst it would cripple researchers if they had to feed back individual results for every sample, would it be nice to at least have some idea of where your sample ends up? Or perhaps you’d like to know what steps are actually taken to ensure that your sample remain anonymous?
This is particularly pertinent for DNA sequencing projects, where your DNA – the unique barcode that is personal to you (and your identical twin, if you have one) – is never published in the findings of any research project in a way that could reveal your identity. This is important in light of a paper in Science (http://bit.ly/YdCT3R) showing that participants who had taken part anonymously in genomic research studies could be identified using publically available genealogy databases.
I have no problem whatsoever in any of my spare blood being used in ‘research’ – take a bucket full if it helps advance science. That said, I’d just like the request for my involvement to be upfront – don’t hide the pertinent details in the small print of a hospital consent form. In fact don’t even give me a consent form that is more than a page long, I won’t likely read it. I’d also like the request to use ‘anonymous me’ in research to be a direct one, together with some idea of the kinds of research I’ll be taking part in. I can then make an informed decision about whether I want to participate.
Consent issues relating to genome reseach is something we cover in our Genomethics study. If you’d like to take part in this, learn abit about genomics and ethics, have a voice and be heard, then ‘Click Here‘
So, do you want a short concise consent form or to know exactly what may happen to your sample? Having designed a lot of consent forms, I can tell you it’s pretty much impossible to have both.
I think a page long (or less) is sufficient and should be enough to give an idea of what is going to happen to the sample. Given that no consent form is provided in many situations then anything would be better than nothing. But consent doesn’t always have to be written, even a conversation would be better (and consent implied as implicit if the recipient holds their arm out for blood to be taken). What I would like is to be treated as an equal partner in the decision making process about me and my health. Not much to ask. Also having designed consent forms myself for clinical genetic testing I know it isn’t too hard to do.