The Silent Treatment on Regulatory Road

Featured Article

 The Silent Treatment on Regulatory Road

It’s always been a rough ride, and—maybe—it’s worse than ever, or just too tricky to talk about

I still remember the chirps erupting when I opened the door to the cricket room at Cornell University in the late 1980s. That room housed plastic garbage cans filled with mounds of crumpled paper towels—all of it crawling with crickets. These were not just any crickets, but Australian field crickets (Teleogryllus oceanicus), and they could only be used for research in the United States with a permit from the U.S. Department of Agriculture (USDA). Dealing with regulations—then and probably even more so today—makes up part of life for many scientists, and it’s not the easiest part of doing research.

For most people, getting a permit from a government agency to study crickets might seem like overregulation. But keep in mind that this cricket really does come from Australia, and Oceania in general. It also lives in Hawaii, but not as a native species. Instead, people—maybe as long ago as the year 1500—took these crickets to that island. If the USDA didn’t control research use of this insect, it could cause trouble.

According to the USDA’s Forest Service: “Hundreds of species of non-native (aka alien or exotic) invasive forest insects, diseases, plants, and other organisms are established in the United States. Some of these species have become invasive, spreading rapidly and causing significant economic and ecological impacts to the nation’s forest and urban trees.”

When it comes to dealing with research regulations, the U.S. Food and Drug Administration (FDA) probably comes to mind for most people, scientists or not. It makes sense, because when I search online for FDA research regulations, my browser returns 18.5 million hits. By comparison, a search of USDA research regulations turned up 11.3 million hits. So, with all that information out there, scientists must have a lot to say about it, right?

Dozens of dead ends

I start this journey with the usual expectation that I’ll find plenty of sources. I usually come up with more information than I need and more people than I can reasonably fit into any story. Surely, I think, the same will be true when I go in search of people to tell me about their experiences in aligning research with federal regulations, such as those from the USDA or the FDA.

The journey begins with scientists who work on compounds that might turn into medications. Even if these scientists never take a compound beyond preclinical testing—and they almost certainly won’t, at least not without a funding partner, which is probably a pharmaceutical company—they still must pay attention to government guidelines, such as the Code of Federal Regulation Title 21 Part 58, which describes “good laboratory practices for nonclinical laboratory studies.”

So, I send a few requests for interviews to scientists who work in this area. Nothing. That’s not all that unusual. So, I send some follow-up requests, as well as expanding my circle of possible scientists to interview. Again, nothing, or maybe worse than nothing. After several notes to someone I’ve worked with for years at a world-renowned center of clinical research, I’m told that despite “multiple requests, my colleagues got only polite declines.”

Now, that is unusual.

After that, I take a different approach by contacting university offices that help researchers comply with guidelines and regulations. Most of them—all but one, in fact—don’t even respond. The one that does respond says that the people in the office are not researchers, and that they do not belong to a lab or work on a specific research project. Yeah, I know that. I’m just looking for some tips, some ideas to help researchers stick with guidelines, the very thing that this office claims to do. Luckily, that office does wish me the best of luck with my article. It looks like I’m going to need it.

Reluctant to rock the boat?

When it comes to current funding for federal organizations and people who depend on them, Charles Dickens might write: “It was the worst of times, it was the worst of times … .” The Trump administration’s proposed budget cuts the FDA by millions of dollars, and some say it goes much deeper if you really explore the ramifications. So, maybe no one wants to rock the boat and say anything bad about how to work within these regulations.

In all fairness, funding concerns for science aren’t new. For example, the U.S. National Institutes of Health saw its budget stop increasing in 2003. Plus, the FDA did offer to help me unravel the pathways that researchers must negotiate. In the end, though, a spokesperson there asked for increasingly specific questions and just sent me a few links to the FDA website.

So, what’s the deal? Maybe the regulations are so specific that only very precise pointers matter. Or the rock tumbler-like experience for people working at government agencies these days makes them hesitant to say anything that they don’t have to. And for scientists, maybe it’s like ordinary people avoiding any discussion of the IRS, because no one wants to wake a sleeping giant who might try to stomp on you.

Learning from failure

Some readers, no doubt, will point out that I didn’t contact everyone. Someone will probably even respond to this and say, I would have talked to you. I’m not suggesting that absolutely no one would talk, but I am saying that far fewer people would talk about this than maybe any article that I’ve written in more than a quarter of a century.

We live in a world largely interested in positive results, and negative ones get ignored. So, before you write to me to say how this is just negative results, think about it for a second. That’s not how science used to work. In the 1940s, Alan Hodgkin and Andrew Huxley—who later shared the Nobel Prize in Physiology and Medicine in 1963 with Sir John Eccles for work on the ionic mechanisms involved in signaling in nervous-system cells—wrote about what worked and what didn’t in their research.

When I think back to my doctoral work, exploring the aerodynamic abilities of those crickets filling the garbage cans, the negative results—the things that didn’t work—taught me more about scientific research than my successes.

Sometimes, less really can be more, and nothing often tells you something. Maybe that’s what happened here. In the end, I’ve circled back to where I started. All I hear … crickets.

Mike May is a freelance writer and editor living in Texas. He can be reached at [email protected].

Related Products