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.

Last Chance to Say Your Word on NPRM

I posted “Informed about Changes to Research Consents?” on 11/15/15. You now have until 1/6/2016 at 11:58pm EST to send your comments about the changes that will affect hundreds of thousands of patients, researchers and institutions (at least). PLEASE send in your comments!

Here’s how:

  1. Read my blog post on 11/15/15 to refresh yourself, and feel free to use any part for your comments.
  2. Look at the summary of changes, according to the US Office of Human Research Protections (OHRP).
  3. Read some of the public comments that have already been posted (so far, there are 957 comments). Here is an example of one of them from the Genetic Alliance – feel free to use any part for your comments.
  4. Click if you want Tips for Submitting Comments (go to bottom of page and click on .pdf file).
  5. Post YOUR Comments at this link!
  6. Feel free to share your comments below on this post if you want to discuss them.

I’m finishing my comments now and will post them… but don’t hold your breath – create your own comments NOW! GO FOR IT!

Informed about Changes to Research Consents?

Isolated patients need clearer informed consents to engage fully in research.

If not, you’ll be surprised soon. The Common Rule is changing – 1st time since 1991. The US NIH NINR says, “The Common Rule contains regulations that protect individuals who participate in research and is followed by 18 federal agencies.” Translation: these are the rules that apply to informed consent forms that patients sign to join research studies.

Your input (yes, you!) actually matters. Here is what you can do:

  1. Brush up on proposed changes: check out the summary, the full text in Federal Register, the public comments, and start thinking about yours as you read on.
  2. Comment by 1/6/2016 (was 12/7/15 originally) at the Notice of Proposed Rulemaking (NPRM). If you need the docket ID #, it’s HHS-OPHS-2015-0008.
    EDIT: the public comment period has been extended – post your comments before 1/6/2016.
  3. Be sure to remind them to STOP with this ‘research subject’ nonsense! People who join studies are trial participants, not subjects of some self-imposed royalty (or worse). And please ask them to require public study result summaries too.

If you want to post on your own, go for it. If you want to know my thoughts, read on…

“…bold moves to streamline the clinical trial process.”

Quorum Review IRB

Here is a quick summary of the proposed changes:

  • Tighter rules on explaining the study: shorter forms with key points highlighted for better patient understanding. Consent forms will become public. Hopefully, a step forward.
  • A written “broad” consent for all biological samples (e.g. leftover blood, surgery tissue) for any research, now or in the future. This includes samples that don’t have personal information attached, so each person won’t be identified.
  • Linking the level of risk with the type of Institutional Review Board (IRB) review.
    • Less risk = less review. A web-based decision tool will help figure this out.
  • More data security & privacy standards to protect trial participants’ confidentiality.
  • Requiring a single/central IRB for studies done at many sites.
  • Applying the Common Rule to all clinical trials in institutions that get federal funding.
  • Eliminate ongoing (continuing) reviews for some research.
Good review of Medical Ethics!

Good review of Medical Ethics!

For a quick refresher on ethical principles, please see the Belmont Report, and Medical Ethics for Dummies. It will make this much easier! This stuff matters – worth your effort.

So, what’s the big deal?

Many researchers think the new requirement of a written consent for all research samples will hinder medical advances. Until now, they collected samples from everyday medical care to use in research without each patient signing a form that says ‘yes, you can use my sample.’ Many of these samples had patient identifiers removed (called “de-identified” samples).

Translation: people working in the system chose which samples to take, and how use them. Some set up ethical methods, but patients weren’t involved in decisions (i.e., paternalistic).

Here are some arguments from the research perspective about changes (I’m paraphrasing):

  • This will negatively impact sample collections from the past (called “retrospective biobanks”). These samples are valuable because data (e.g., w/5 year follow-up) is useful now instead of waiting another 5 years if we start collecting now.
  • Changes only apply to physical samples, not data. Data also needs careful management to protect people from harm.
  • There is no oversight for the broad consent option, so how will we protect people from misuse? Issues like scarce samples, race and ethnicity, cultural norms, and harms to societal groups are not covered.
  • Changes create extra burden & cost on hospitals and clinics to use a broad consent form. Smaller places may opt out of research, which limits access to some communities.
  • Hesitancy to find patients for consent (or ask them about past samples), and the fear that many patients may not like being contacted.
  • Changes over-emphasize Autonomy (independent choice) vs. Beneficence (maximize benefit while doing no harm) and Justice (people affected should be offered access). See? I told you to check medical ethics first!

In a Perfect World…

This scenario may never happen since middlemen (like institutions) couldn’t make money off the data or samples, as many do now:

Patients would own their own samples, data AND electronic Medical Record (eMR/eHR). Healthcare professionals would interact with patients, but patients would be in total control of everything related to them. Flags in the record could be turned on for Y/N to donating research samples, data, etc.

BTW, how many current eMRs do you have? I’m up to 10 and many are wrong and/or incomplete!

My Take on NPRM Changes

I have worked directly with thousands of researchers for over 20 years, and I respect their dedication and efforts. Some have asked me if I can support their position on NPRM. After much contemplation, I have my own opinions regarding the proposed changes to the Common Rule (as usual). My current thoughts are:

  1. NPRM will change the way research samples are collected. It might reduce the number of samples that researchers have available if it is not explained well. That doesn’t mean, however, that people can’t decide for themselves.
  2. The arguments above represent a system averse to change, not on how to improve the research process and engage patients in new, open ways. Researchers are constrained by the old guard and fear extra burdens from the traditional research system.
  3. Modern social media and communication technologies can help find and engage patients. It takes new mindsets and methods, but old institutions don’t change easily. The NPRM should NOT be viewed in isolation, but rather WITH the rest of healthcare!
  4. Simple, direct plain-language consents can help people understand how samples have been used for years, and how they can continue to contribute to better care today. Some of us who create plain-language patient communications can help.
  5. New regulations (broad consent in this case) frequently allow for continuation (grandfathering) of older collections and procedures.
  6. NPRM must require specific oversight for the broad consent approval process. IRBs or usage committees should not be left out of this process, and a patient communication plan is CRITICAL.
  7. We should definitely include DATA (big, little & in-between) in the requirements. Data standards are desperately needed for research collections, which carry greater potential risk/harm than do body parts. Some groups are writing recommendation reports, but we need widespread action NOW.
  8. Extra burden? Every new initiative is an opportunity to make hospital procedures easier. Right now, patients give separate consents for any procedure they have done in a medical setting. While these are different from research informed consents, they are indistinguishable to most patients.

There are many more points, but I need to wrap up for now. Patients want to be more engaged, and this is an opportunity to better explain how the research community develops new treatments, procedures and tests that help people.

I frequently feel the need to remind ethicists not to “protect patients from themselves.” This is a step in the right direction (as long as they call us trial participants, of course!).

Involving those of us who represent patient voices in the implementation plans will help ensure that this works for patients AND those who serve them.

“…the ethical principle of respect for persons.”

NPRM 2015 Summary

All content © 2015 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.