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The U.S. Department of Health and Human Services has issued proposed rules to improve and modernize the legal ethical criteria that govern federally funded human research.  From the press release:

Revisions to the current regulations are now being considered because HHS believes these changes will strengthen protections for research subjects in a number of important ways. Comment is sought on the following:

  1. Revising the existing risk-based framework to more accurately calibrate the level of review to the level of risk.

  2. Using a single Institutional Review Board review for all domestic sites of multi-site studies.

  3. Updating the forms and processes used for informed consent.

  4. Establishing mandatory data security and information protection standards for all studies involving identifiable or potentially identifiable data.

  5. Implementing a systematic approach to the collection and analysis of data on unanticipated problems and adverse events across all trials to harmonize the complicated array of definitions and reporting requirements, and to make the collection of data more efficient.

  6. Extending federal regulatory protections to apply to all research conducted at U.S. institutions receiving funding from the Common Rule agencies.

  7. Providing uniform guidance on federal regulations.

I can think of two salutary changes that are very unlikely to be included, now or in the near future.

1. Apply the Common Rule standards to All Human Subject Research: Currently, the “Common Rule” for protecting human subjects only applies to federally funded research.  Many protections provided to animals in the Animal Welfare Act, in contrast, apply to all experimentation, regardless of the source of funding.  I think that is a good thing, and that human research protections should apply across the board, whether or not federal money is involved.

2. Stop the Outsourcing of Ethics in Human Experimentation:  Sometimes companies avoid ethical rules by taking their human subject research overseas where they can experiment under far laxer standards.  The USA should do what it can to stop this outsourcing of ethics (in William Hurlbut’s splendid term). To help prevent that, Common Rule protections should apply to experiments conducted internationally—again, however funded—as a condition of obtaining later FDA or other required government approvals for new drugs, products, or procedures.   If companies know that doing experiments overseas, which would be unethical if done here, will impede their entry into US markets, it could do a lot to protect destitute people from being preyed upon.

As for the proposed rules, they seem pretty technical.  Increasing efficiency is good.  But care needs to be taken that in so doing, that current standards be improved, not  lowered.

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