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by David Massengill

Survey Results: Top 5 Regulatory Challenges

The regulatory landscape is becoming increasingly rugged. Some of those involved with human subjects research are pushing through the thorny vines of joint U.S. Food and Drug Administration (FDA) and Office for Human Research Protections (OHRP) guidance on electronic informed consent (eIC). Others are navigating the boulders of the 21st Century Cures Act, while the cliffs of the revised Common Rule loom in the distance. (Everyone thought they were closer than they are, but nobody seems to possess the proper pair of binoculars.) Much traversing and scaling is ahead in 2018, but let’s take some breaths, recharge our electrolytes, and see what a recent survey reveals about our trek.

During our recent webinar “2017 in Review – How Legal and Regulatory Changes Impact Your Research” we asked each participant,

“Name your biggest challenge you are currently facing with the upcoming changes in the regulatory landscape.”

We categorized the responses, and mapped out what you consider to be the top 5 challenges of your regulatory journey….

Top 5 Challenges in the Regulatory Landscape Infographic

Challenge #5: The Valley of Informed Consent

Consent forms—and the entire consent process—are undergoing changes that could shift what was once a familiar landscape. These changes might improve participant protections or bring more red-tape mistakes. Many of you are concerned about the revised Common Rule’s effects on the trail ahead for federally funded research, and rightly so: The new regulations expand the elements of informed consent and endorse a tiered-consent approach. They also address broad consent, the rather tricky alternative consent process for the storage, maintenance, and secondary use of identifiable data or samples. Other survey respondents brought up electronic consenting (see Challenge #3), and a surprising number of you mentioned the Pennsylvania Supreme Court’s ruling in Shinal v. Toms, which requires the physician to be the one obtaining informed consent.

Challenge #4: The Switchbacks of Staff Training and Resources

It’s 9:00 a.m. on Regulatory Changes Day. Do you know where your Subject Matter Expert (SME) is? Someone needs to teach your staff about changes such as the updated National Institutes of Health (NIH) policy on Certificates of Confidentiality and FDA’s new guidance on waivers of consent.  And while training is crucial, headcount matters, too. You’re going to need enough employees to make the ascents of internal document revisions and change implementation (see Challenge #2). Many of you have investigators on your minds. One respondent’s greatest challenge is

“Helping physicians who have been conducting research for 30+ years understand the changes and the importance of some of the changes.”

Challenge #3: The Boggy Marsh of Technology

One respondent to our “biggest challenge” survey answered with a single word:


Another person commented,

“We have had subject sign the eConsent and the consent disappeared from the iPad.”

Many are fretting about eConsent—whether they should employ it, or how they can overcome the troubles they have had with it. Good Clinical Practice (GCP) updates and new FDA guidance on electronic records and signatures reflect that researchers are living and working in the Digital Age, but oftentimes individuals have made it further on the trail than their institutions. As one respondent remarked,

“Our institution is not always on the cusp of the latest and greatest [technology].”

Survey results revealed that some of your offices are far from paperless and perhaps operating similarly to how they did when the first Common Rule came out. (That was 1991, folks.)

Challenge #2: The Dense Forest of Adapting to Change

The largest Change Monster lurking in the woods is clearly the revised Common Rule. Yes, some respondents to our survey are not keen on adapting their electronic systems to GCP’s new E6(R2) requirements. But the majority is nervous about the beast that can be kept at bay for only so long. With its many teeth and arms, the revised Common Rule will require major modifications to policies, procedures, and IT infrastructures. And adapting the new requirements is only part of the battle; institutions will need to create consistent and efficient procedures and documents. With all the frantic policy-making meetings and redlining of documents, some of you worry you’ll forget about the participant. One respondent reflected,

“When I started in research 15 years ago there was a strong emphasis on patient safety and it seems that we are not talking about this as much as ensuring our procedural documentation is in place.”

Challenge #1: The Terrain Range of Understanding Change

Your heads hurt, your legs are tired, and we understand why. Hundreds of you communicated that your biggest challenge is navigating  the peaks and valleys of the changes you face on a regular basis. These are changes not only to federal regulations and guidance, but also to state and local laws. There are mountains of information. There is a lack of guidance—which is particularly frustrating for those of you trying to interpret the revised Common Rule. The language of the modified regulations and guidance tends not to be clear or concise. And there are various regulatory tracks (e.g., FDA-regulated and federally funded) and no universal requirements. Perhaps most difficult of all is the unlearning part. One respondent lamented,

“Old knowledge is hard to remove from your brain!”

Now that we’ve mapped out your challenges, we encourage you to tighten your pack straps and go forth bravely across the regulatory landscape. We can all reach our desired destinations by relying on one another, and Kinetiq is here to help lead you through those shadowy ravines. We will continue to discuss regulations and the research industry via blogs, whitepapers, and webinars. You’re welcome to lean on us for solutions to the challenges of human subjects protection and compliance in research.

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