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Posted by on Feb 10, 2018 in Bioethics, Privacy, Rare disease | 0 comments

Coming soon: National Health Ethics Week (10.02.2018)

Coming soon: National Health Ethics Week (10.02.2018)

The 4th edition of Canada’s National Health Ethics Week (NHEW), coordinated by the Canadian Bioethics Society, will take place the week of April 4-8, 2018. If you’re in Canada, keep an eye out for public events and education sessions at your local healthcare facility, hospital, or university!

Paper airplanes with message on wings for National Health Ethics Week

Image: Sandra WoodA

Once again I’ll mark the event by writing a couple of blog posts here. New for this year, I’ll try to combine the 3 different  topics I blog about into each post for NHEW:

  1. Biomedical ethics, also called bioethics
  2. Patient privacy protection
  3. Rare disease

In the meantime, I’ll share a very interesting article by Andrew Joseph at STAT(1). It’s about a surprising project being run – by a bioethicist – at McGill University here in Montréal:

“In unpublished research, McGill bioethicist Jonathan Kimmelman and colleagues asked cancer experts to forecast the probability of more than a dozen clinical trials hitting their primary endpoint. They found that the predictions overall were not very accurate, and, if anything, were too pessimistic.”(1)

Why would a bioethicist care about how optimistic or pessimistic researchers are about a specific clinical trial? So glad you asked! Because of a concept called risk-benefit analysis, that’s important in clinical (medical) research ethics.

Before any patient can be in a medical research project, the project has to be reviewed by a special type of committee. What these committees can do, and the type of people who can be part of them, is set by each country’s government. In Canada it’s called a Research Ethics Board (REB), while in the United States it’s called an Institutional (or Independent) Review Board (IRB).

I used to be part of an IRB/REB, so know that these committees spend a lot of time checking the information that will be given to patients. They have to make sure that information about research projects is accurate and balanced. A medical research project, for example, can’t promise a cure for a disease. This is because medical research is usually meant to find things out; if the doctors knew for sure what the answer would be, then there might be no point to the research!

Some of the information that these committees check most closely is about the potential (possible) benefits and potential risks of participating in a clinical trial. If a patient doesn’t have accurate information, then they can’t make a truly informed decision. And that’s really important, because no one can force a patient to take part in a research project. It’s up to the patient to decide. Except for

It’s good to keep in mind that potential harms aren’t only physical harm, like illness or injury. A risk can also be a breach of patient privacy. And that could be from hacking, or even from a simple human mistake. Here are some examples of types of information that most person might want to keep private:

  • Addiction issues, like problems with gambling
  • Criminal records
  • HIV/AIDS status
  • Paternity issues (genetic research might show that 2 people aren’t related, when they thought they were)
  • Reproductive history, including any children given up for adoption
  • Sexual history
  • Suicide attempts in the past

REBs/IRBs will usually check to see if informed consent forms or documents (ICFs or ICDs) for research talk about possible benefits in too positive a way. Or if they show possible harms in a way that makes them seem less negative. Making information seem too positive can make something called ‘positivity bias’ even worse.

Positivity bias is what happens when people tend to remember things that are nice, more than things that aren’t nice. If anyone reads a one-page document, they’ll probably remember more about the things they liked than the things they didn’t like.

So if a slide show or video about a medical research study shows possible benefits and possible harms, which ones are we more likely to remember? That’s right – the possible benefits! So the REBs/IRBs check to make sure that there’s not already too much of a positive spin in any medical research forms for patients.

But Dr. Kimmelman’s research is showing that IRBs/REBs may also have to do the opposite. If the doctors involved in the medical research projects tend to be too pessimistic in their views, that’s probably affecting the information given to patients. From his point of view:

“when we talk about informed consent with patients, we want to be able to give people accurate information about the prospect of benefit, and so your ability to have a good discussion about risk and benefit is only as good as your ability to accurately perceive risk and benefit. You don’t want to be overly optimistic and you don’t want to be overly pessimistic.”(1)

Dr. Kimmelman has a doctorate (a PhD) in Molecular Biophysics and Biochemistry. Topics of his research include testing new medical technologies in human beings, called translational research. He looks into this from the perspectives of ethics, health policy, and social sciences.(2)

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(1) Joseph, Andrew. STAT. How well can you predict the outcome of clinical trials? Not as well as you may think. 22 Jan 2018. Web:
https://www.statnews.com/2018/01/22/clinical-trials-forecasting-outcomes/?utm_source=STAT+Newsletters&utm_campaign=effcd01e8a-Daily_Recap&utm_medium=email&utm_term=0_8cab1d7961-effcd01e8a-149508509

(2) McGill University, Biomedical Ethics Unit. Jonathan Kimmelman. Web: https://www.mcgill.ca/biomedicalethicsunit/faculty/kimmelman

 

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