Thursday, August 4, 2011

Cutting Clinical Trial Red Tape

A news story came out recently in the Washington Post, discussing the federal government's proposed sweeping revisions to the rules governing scientific research on human subjects. Apparently, this is the first change in two decades to the "Common Rule" that governs nearly all human-clinical research financed by taxpayers and it protects those in the trenches doing this work while also streamlining the oversight and paperwork required of scientists.

Here's a news release on that from the HHS on this rule revision. That release says this:

The current regulations governing human subject research were developed years ago when research was predominantly conducted at universities, colleges, and medical institutions, and each study generally took place at only a single site. Expansion of human subject research into many new scientific disciplines and venues and an increase in multi-site studies have highlighted ambiguities in the current rules and have led to questions about whether the current regulatory framework is effectively keeping up with the needs of researchers and research subjects.

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.
Honestly, most of that went over my head. I truly don't understand what it means, for those researching, conducting clinical trials, or participating on the other side of that research. Curious about the impact of this in the diabetes research arena, I took the question to a someone I know who has a better idea what this might mean to us.

That is Indiana University researcher Patrick T. Fueger in the Department of Pediatrics, whose diabetes research focuses on pancreatic beta cells and islet proliferation.

He says, "This could be a great thing. I’d have to read the proposal in its entirety to be certain of that. The whole process to get a study approved is filled with red tape. The proposal seems to minimize that while maintaining the protection of human subjects. The biggest benefit will be streamlining research that uses surveys and interviews. Right now, you have to get your survey approved and if you change one question (even just deleting it) you have to get a new approval. You have to talk about the risks of filling out a survey. I think I did one once and listed paper cuts as a potential risk to the study participants. Most researchers are pretty ethical and police each other in many ways. Streamlining the approval process and cutting out some red tape is a welcome update to this facet of research."

Nothing is final at this point. Published on July 25 in the Federal Register, public comments are being accepted for a 60-day period. It's listed as an Advance Notice of Proposed Rulemaking (ANPRM), entitled Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. Comments can be submitted here, using the ID number HHS-OPHS-2011-0005.

3 comments:

Meagan said...

Thanks for getting him to put it into simpler terms. I really hope it does make research easier, and approval faster.

P.S. I'm ready to be a guinea pig!!! :)

Lubna said...

he biggest benefit will be streamlining research that uses surveys and interviews. Carlmontpharmacy Online Brilliant.

Berthold Hanisch said...


Saved as a favorite, I really like your web site! gmail email login