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ResourcesHuman Research Ethics(US) A new NIH rule won’t be enough to make clinical research more inclusive – STAT (Louise Aronson | January 2019)

Australasian Human Research Ethics Consultancy Services Pty Ltd (AHRECS)

(US) A new NIH rule won’t be enough to make clinical research more inclusive – STAT (Louise Aronson | January 2019)

 


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A quiet but revolutionary new national health policy goes into effect this week, ushering in changes that could lead to important medical discoveries that benefit most Americans. There’s just one problem. Implementing the change will require that our country’s health researchers make some fundamental changes in how they do business.

The exclusions of some sections of society from clinical trials is not merely a matter of justice (fair access to research opportunities) it can seriously limit the usefulness of the research and conceal problems with the treatment. As populations in the global north are getting older this limitation becomes more significant.  This STAT piece reflects on why the regulatory move by the NIH won’t help.

Under the National Institutes of Health’s new Inclusion Across the Lifespan policy, federally supported medical research must include patients of all relevant ages or explain their exclusion. Since most studies already include adults, and a mandate to include children has existed since 1998, the novelty in this policy is the stipulation that clinical research include people age 65 and older.
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That’s a big group. It currently includes both Donald Trump and Nancy Pelosi, Ruth Bader Ginsberg and Clarence Thomas, as well as the 50 million other older Americans, along with the rest of us who get lucky enough down the road to make it into elderhood.
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Read the rest of this discussion piece



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