Micromanagement of bioethics isn’t ethical

Author: Paul Krzyzanowski, 09/10/15

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Steven Pinker

Steven Pinker

Bioethicists have had ample time this summer for self-reflection, following Steven Pinker’s op-ed in The Boston Globe that’s informally become known as the “Get out of the way” article.

I’ve always found Pinker to be one of my favourite authors due to the fact his arguments are thoroughly reasoned, so I have been slightly taken aback at the discontent and general disagreement that’s followed his opinion piece. It’s a shame that more people haven’t considered Pinker’s assessment of the ethical review system and paused to think about exactly where getting out of the way might actually be a great idea.

However, some ethicists are standing by Pinker.

Julian Savulescu, from the University of Oxford, defends Pinker’s assessment that some parts of the ethical review system unnecessarily obstruct good, ethical research with bureaucracy. It’s this part of doing research in an academic setting that I personally have experienced and it’s one of the more demotivating factors in biomedical research today.

Recently, I blogged about an opt-in system of ethical review that would do away with the mundane, low risk, ethics reviews that I believe Pinker and Savulescu think the research system can do with less of. For the moment, forget about the potentially high-risk ethical choices related to gene editing, HIV research, or cell therapy clinical trials and think about the bread and butter of medical research – the tissue biobank.

Here’s a glimpse into one ethics review that I filed for my work a few years ago, which went through the expedited ethics review at the University of Toronto:

I was charged to use patient derived tissue from two biobanks in institutions other than my own. To get ethical approval to use material such as DNA or tissue slides, I had to complete a 14-page Research Ethics Board (REB) application regarding the project funding, peer review status, conflicts of interest, a project description, methods, describe participant consent and recruitment, complete a large section on data security, and much more. Total time invested: one day.

Next, I had to obtain the ethics review documents from the biobanks themselves, read through them to identify where the relevant information to my application was so that I could highlight the same to my REB. That’s one morning on top of several days it took to receive the papers from both banks.

I completed the application on a Wednesday, but had to wait until the following Monday for another weekly cycle of low-risk ethics review to start. Fair enough, that was my fault for not knowing this; it was my first ethics application.

A colleague told me that the turnaround time was rather quick – about 2-3 weeks – so all in all it was about a month before I could legally use banked DNA for sequencing, which was isolated from donors who had already given their unrestricted consent to the biobanks I contacted.

All in all, I was able to start work on these DNA samples about four weeks after they were available at the biobank.

While I’m sure this delay could have been reduced with better planning and more experience on my part, or if REB applications were handled by an ethics expert, but I suspect this kind of scenario plays out again and again every time a new research-ethics-novice-of-a-PhD student or postdoc begins a new project.

However you quantify it, it’s a burden on the research system, which is why I propose that Principal Investigator or department centred groups have ethical pre-approval for simple cases, especially if they have had comparable experience in the past. Pre-approvals to engage in various risky activities are granted throughout our lives; for example, we are granted driver’s licenses, credit cards and professional qualifications and are expected to behave responsibly, and without getting permission, for every risky event that we engage in.

I understand the need for research to operate in an ethical framework: to respect the dignity of human life; to reduce the potential harm to research subjects (be they human or animal); and even to use banked human tissues efficiently and for good research purposes. But with his op-ed, Steven Pinker raised a valid point:

Sometimes, the most ethical decision is for bioethicists to get out of the way.

Do you agree or disagree? I’d like to hear your thoughts.

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Paul Krzyzanowski

Paul is a computational biologist and writer living in Toronto. He's been a contributor to Signals for three years, writing articles for the general public about how biotechnology and biomedical research can be used to solve pressing medical problems. Alongside Paul's experience in computational biology,
 bioinformatics, and molecular genetics, he's interested in how academic research develops into real world, commercial technology, and what's needed for the Canadian biotech industry needs to grow. Paul is currently a Post-doctoral Fellow at the Ontario Institute of Cancer Research. Prior to joining the OICR, he worked at the Ottawa Hospital Research 
Institute and earned a Ph.D. from the University of Ottawa, specializing in computational biology. And finally, Paul earned an H.B.Sc. from the University of Toronto a long time ago. Paul's blog can be read at www.checkmatescientist.net
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