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.