A Plan for Real Research Improvements

Looks like 1,772 of us posted public comments about medical research informed consents to the NPRM docket! I realize this sounds obtuse, but bear with me through this post – please!

So, What’s the Big Deal?

The final regulation will affect millions of patients, researchers, institutions, and companies. These rules last changed in 1991. You know, before the internet existed for mere mortals. Just after my first cancer, while I was still a Silicon Valley computer executive. When Terminator 2 was new. Before my son was born. But I digress. Background on research informed consents is in this post.

Important Points for Patients

Unfortunately, informing patients about research has too often become a check box as CYA (cover your aspirations) for institutions. Big business. Instead of a straight-forward PROCESS that tells people what to expect so they can agree (consent) to take part in research (or not). Seems simple, right?

Rather than lament, my comments explain how systemic changes should happen. But don’t hold your breath. BTW, I had to write a preamble due to the 5000 character limit. That ticked me off (!), so I wrote this introduction:

“My individual comments are listed in the attached letter, although as founder of Patient Advocates In Research (PAIR), I have helped thousands of patient advocates partner with the research system for over 20 years (and am personally a survivor of multiple cancers).

Since you have received so many concerns from researchers and IRB members, it seems appropriate to add to the sparse patient perspective that appears in the NPRM public comments. Here are a few key points, in addition to my attached letter:

  • It is past time to embrace technology that can help deliver a modern approach to informed consent for trial participants, instead holding fast onto antiquated mindsets, procedures and reliance on paper forms.
  • This is too important to limit comments to 5000 characters, hence the attachment. I have participated in far too many informed consent committees to rely on an ‘executive summary’ approach to comprehensively address the NPRM.
  • Please eliminate the terms “human subject” and “research subject” from all federal regulations. My premise and recommendation is attached.
  • Informed consent is a process, and should be acknowledged as such in federal regulations. The form is a check box.
  • The NPRM, HIPAA, and any other related regulations should NOT be viewed in isolation, but rather WITH the rest of healthcare. Regulations should state that all agencies should work together in an adaptive infrastructure to ensure rules are kept up to date in our changing world.

Thank you for the opportunity to comment on the proposed changes to the Common Rule, which is of utmost importance in protecting research participants (i.e. people) while fostering research. In this historic shift to modernize the Common Rule, the NPRM should create an adaptive infrastructure that allows for evolving science while supporting responsible participant partnership, choice, and engagement. Please view my comments in the attached letter as a complete package.”

The Whole Letter

Pages from NPRM public comments 1-6-16PLEASE read the details in this pdf. It’s not long, and posits a new adaptive approach to create an open, welcoming research system. We can actually push this forward with your help!

So, What’s Next?

You can see the 1,772 comments here – if you know the Comment Tracking Number (mine is 1k0-8n8m-6xee), you don’t have to look through all of them.

I have no idea how the comments will be used, but they promise to read and consider them. The research community has waited for years to get changes to the Common Rule. No one knows when the final rule will take effect, but it’s a safe bet it won’t be before 2018.

Please join the discussion about making research accessible and open – make it REAL for PEOPLE!

All content © 2016 by Deborah Collyar unless otherwise specified. All rights reserved. Permission is granted to use short quotes provided a link back to this page and proper attribution is given to me as the original author.

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