Hugh Davies explains that the key rules for experiments on people are set out in the Declaration of Helsinki. “Although the primary goal of medical research is to generate new knowledge, this goal can never override the rights and interests of individual research subjects,” he says. Based on this, the trials should avoid increasing the risks to those involved, as Khan says.
Still, ethics researchers debate whether that should always be true, says Davies. The risk that drugs potentially increase suicide rates in general could be a case where societal interests are also a factor, especially if measures like those the Iltis team suggests mitigate the risks to individuals.
So, prompted by Khan’s claim, I asked 16 members of the Oxford Davies Research Ethics Board chairs how they balance these considerations when deciding whether to approve a trial. I asked them if they would allow people at risk of suicide to participate in the trials. I also asked if they supported a strategy like the one proposed by Iltis and his colleagues.
Of the eight members who responded, most agreed that questionnaires like the C-SSRS were essential for measuring a person’s risk of suicide. They would also like to know at what stage of the drug development process the trial was and what the risk of suicide was.
For example, drugs tested for the first time in humans should exclude people at risk of suicide. “Certainly, if the target population were to include vulnerable individuals (those with a medical history of severe depression, psychosis, etc.), I would expect not only a screening process, but a strategy for managing those at risk. risk,” writes Christine Montague-Johnson. , a senior pediatric research nurse at the University of Oxford and one of the committee members. But under those conditions, a majority agreed that if a strategy similar to that proposed by Iltis was in place, they would allow a trial to include people at risk of suicide to proceed.
Of course, these are the opinions of a single, UK-based ethics committee answering hypothetical questions. But it does provide some insight into the kind of decisions people approving clinical trials must weigh before allowing them to go ahead.
And even with better protection of patients at risk during trials, as Iltis has identified in its strategy, not all research groups will be equipped to deal with the potential consequences.
“He’s a brave researcher saying, ‘I’ll include these people who are at risk for suicide in a study where the drug might make it worse,'” Davies says. “They need to come to the research ethics board and say, we’re brave and make the benefits very obvious. Then you need opinions from all groups with a legitimate interest and a long debate. It’s a brave committee who subscribes to this.”
But the benefits should not be ignored either. Inclusion in trials can help patients like me who participate, but it can also clarify the risks of antidepressant treatments. This may mean safer drugs for patients more widely.
And at a time when Covid-19 has largely deteriorated mental health, this could be more important than ever.
As Davies points out, it will take bold action by researchers, regulators and pharmaceutical companies if the way trials are conducted is to change.
“But sometimes I think we have to be brave,” he adds.
If you or someone you know is affected by the issues raised in this story, the International Association for Suicide Prevention has a list of global agencies that may be able to provide immediate support. You can also contact Friends all over the world.
In the UK and Ireland: The Samaritans are open 24 hours a day. Call 116 123 or email [email protected]
In the United States: If you are in crisis, please call National Suicide Prevention Lifeline at 1-800-273-TALK (8255) or contact Crisis text line by texting TALK to 741741.
In Australia: Call safety rope on 13 11 14 or chatting on the internetevery night seven days a week.
In Canada: If you are in crisis, call 1-833-456-4566 (4357) or text 45645. For more information on suicide prevention, visit Suicide Prevention Center.
In India: You can call AASRA at 91-982-046-6726 or visit their website.
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