I can understand if maybe you missed the big announcement on September 8.
Perhaps you were out apple-picking with your kids, or were getting ready for a hot date that night. Or maybe you failed to scroll through your entire Twitter feed that day.
If that’s the case, brace yourself. This is a big one. Years from now, this will be akin to the day that president Kennedy was shot, or the day the Space Shuttle exploded. People will ask you “Where were you when …?”
On September 8, 2015, the Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services published in the Federal Register its Notice of Proposed Rulemaking on Federal Policy for the Protection of Human Research Subjects!
Have you totally fainted to the floor? Shall I administer some smelling salts?
Or better yet, perhaps I should explain what the heck this means, and why we should care.
This notice suggests revising the Common Rule, the federal policy protecting human subjects who engage in basic, translational, and clinical research. It has been codified in separate regulations by 18 federal departments and agencies. Our institutional review boards (IRBs) follow the Common Rule, as do our compliance committees.
Some of the suggested changes make a lot of sense. For example, improving informed consent documentation to facilitate the ability to understand these documents.
That’s one of my favorites. Have you ever read through the 10 or 12 pages of an informed consent document? Have you ever read through those pages placing yourself in the position of a potential trial participant? Imagine you’re 80 years old, you forgot your glasses at home because you didn’t know you’d need them at the doctor’s office, you’re fasting because you thought the bloodwork the doctor was getting that day might require 12 hours of fasting, and you’re also trying to absorb information about your cancer and treatment options while reading through these forms.
Have you ever wondered whether our patients truly understand the informed consent documents they sign, and thus are truly informed about potential risks, benefits, and alternative options?
I have, and I’m all for making informed consent easier to read and understand, even if our patients may not get the chance to absorb the fact that there is a less-than-1 percent chance that the investigational treatment might make the nail on their left big toe turn a shade of green.
Another change mandates a single IRB review of cooperative research conducted at U.S. institutions.
Again, I’m giving this one the green light. Cooperative group trials pass through multiple committees staffed by plenty of smart people before they ever reach our individual institutions. I’ve been the primary investigator on a couple of these studies and, in my experience, I was on conference calls every couple of weeks for months re-presenting my protocol to yet another committee for feedback about its design, endpoints, subject inclusion criteria, and the informed consent. The change proposed in the NPRM will eliminate redundant reviews and allow under-resourced institutional IRBs to focus on less-vetted research.
An additional suggestion would eliminate continuing review for certain minimal-risk studies. I’m going to take a moment now to shed a tear… I will miss those continuing review forms for chart reviews long-abandoned by internal medicine residents whose dedication to those nagging research questions evaporated as soon as the fellowship match results are announced, much like my kids seem to evaporate when I ask whose turn it is to clear the dinner table.
All of this sounds great, right? Well, then there’s another suggestion that involves expanding the definition of “human subject.”
The proposed change widens the definition to include all biospecimens, regardless of identifiability, and to almost always require informed consent for secondary use of biospecimens.
Wait, what’s that noise I hear? Are those the gears of research grinding to a halt?
You see, there are a few cancer centers around the country that have tried to be prescient in collecting and banking samples for future studies, anticipating that those studies will advance science, cure cancer, and a lot of other good things. This provision would still allow that – as long as broad, informed consent is obtained.
What it would not allow, however, is use of leftover tissue specimens, which are commonly obtained from pathology after a tissue diagnosis has been made, or from the hematology lab after blood counts have come in. The NPRM prohibits their use, even if those samples are de-identified and even though we don’t need the excess tissue or fluids.
It sounds like one of those problems that some worrywarts far removed from actually conducting research or from working in a living, breathing cancer center thought in theory could bug a couple of people of the tens or hundreds of thousands whose samples might be available for valuable research over the next few decades.
For the record, in front of the ASH Clinical News readership and everyone, I would like to hereby give my consent for anyone to use my leftover tissue specimens. Go ahead. Have a party.
Wow – that was liberating.
Have you ever thought through what it would take to create the sort of broad consent that would be necessary to use leftover specimens in a large institution?
A couple of years ago, as a member of a task force at my institution, we developed the data and specimen flow diagrams, the interactions of automated and manual information systems, the infrastructure required to manage all of these data, the data- and specimen-tracking mechanisms, and the “opt-in” and “opt-out” contingencies for informed consent.
All of this can be yours for the low, low price of tens of millions of dollars. My institution doesn’t have that kind of cash floating around, and I’m guessing that most reading this essay don’t either.
Which means that institutions won’t institute a process for broad consent for leftover tissue specimens, and, in turn, means that the research that has stemmed from those specimens – the advancement in the understanding of cancer and inroads into therapies for those conditions – won’t happen.
As a society, do we appease the worrywarts to avoid the unknown possibilities? Or do we serve the common good of conducting the research that will cure disease?
I know how I’d vote.
The comment period on these proposed changes ends at 5:00 p.m. on January 6, 2016. Let OHRP know how you feel.
To weigh in on the changes proposed in the NPRM, visit www.hhs.gov/ohrp/humansubjects/regulations/nprmhome.html.
The content of the Editor’s Corner is the opinion of the author and does not represent the official position of the American Society of Hematology unless so stated.
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