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Full disclosure of the potential risks to people who volunteer to be test subjects for biomedical research has been a bedrock of ethical protections for decades. Now, a fresh question has come to the fore: how best to protect human subjects in trials that examine the effectiveness of existing therapies that are already in widespread use.
On 28 August, the US office charged with protecting human research subjects will hold an unusual public meeting in Washington DC to tackle this contentious, complex issue, which has polarized the biomedical community in recent months. The Office for Human Research Protections (OHRP), part of the Department of Health and Human Services, is asking for input on how institutional ethics committees — the advisory boards that decide whether proposed trials can go ahead — should assess the risks to people in randomized studies that investigate the risks and benefits of existing treatments for the same condition. Such ‘standard of care’ trials are likely to become more widespread after being mandated in the 2010 health-care law, so a lot is riding on what the OHRP...
On 28 August, the US office charged with protecting human research subjects will hold an unusual public meeting in Washington DC to tackle this contentious, complex issue, which has polarized the biomedical community in recent months. The Office for Human Research Protections (OHRP), part of the Department of Health and Human Services, is asking for input on how institutional ethics committees — the advisory boards that decide whether proposed trials can go ahead — should assess the risks to people in randomized studies that investigate the risks and benefits of existing treatments for the same condition. Such ‘standard of care’ trials are likely to become more widespread after being mandated in the 2010 health-care law, so a lot is riding on what the OHRP...