But if I asked the same question in an academic setting, like the university, it would fall under the legal jurisdiction of the Animal Welfare Act. If I wanted to write an academic paper on which dog biscuit was most effective for training, I would still need to get IACUC approval. The main difference between doing research at home and at the university is that the university is considered a “research facility” that receives money from the federal government. As part of the deal for receiving federal funds, the university must abide by all federal rules and regulations. One big part is compliance with the Animal Welfare Act. (The other is compliance with human research regulations like the ones established in The Belmont Report.)
Although I was accustomed to navigating the maze of human research rules, I had had no experience with the animal rules. Surprisingly, the rules of animal research were a lot more complicated. Unlike humans, animals have no choice in whether they want to participate in research. So while a human can theoretically judge the risks and benefits and make an informed decision, animals cannot. As a result, the rules around animal research acknowledge that their lives will be awful and limit as much as is practical the pain and suffering they must endure.
None of this seemed terribly relevant to the Dog Project. After all, the dogs were going to be people’s pets. They weren’t going to be housed at the university. The plan was for the owners to train their dogs at home and, when they were ready, bring them in for an MRI scan. Andrew and I figured this should be pretty simple. We wrote a document describing our plan for the experiment. This document spelled out the research protocol. It contained everything from how we would select the subjects, to how we would train them, to how we would protect their hearing during the scans. It even included a consent form (for the owner, not the dog).
We sent the protocol document to the IACUC and waited for a response.
Two weeks later, I received a phone call from a university lawyer.
“We have a jurisdiction problem with your protocol.”
Trying not to get upset, I asked him to explain the problem.
“For starters,” he continued, “you included a consent form.”
“Yes,” I replied. “We thought it was reasonable to get consent from the dog’s owner.”
“The IACUC doesn’t do consent forms,” he said. “This sounds like human research.”
“But the humans aren’t the subjects,” I said. “The dogs are.”
“Well, we don’t know what to do with a consent form,” he said. “You need to send it to the IRB.” The Institutional Review Board, or IRB, was the committee that reviewed human research protocols.
“They’re not going to want to review it because it’s not human research.”
“There are other problems,” the lawyer continued, ignoring me. He then ticked off a laundry list of issues. Once on campus, how would we transport dogs to the MRI? How would we prevent the dogs from escaping? What would happen if they bit someone? The hospital risk management lawyers would have to sign off on this too. I would need to check with the Occupational Safety and Health Office to see if there were OSHA issues to resolve. I would also need to check with the biosafety officer to see if she had concerns about the spread of biological pathogens.
I couldn’t believe what I was hearing. Suddenly, the little feist that slept in our bed and licked my face every morning represented a threat to the safety and welfare of the entire university.
“Have you considered purpose-bred dogs?” the lawyer asked, referring to dogs, usually beagles, bred and sold exclusively for research. There was no way I would support that ugly practice, and I said so.
“That would mitigate some of the liability concerns because Emory would own the dogs,” the lawyer continued.
“We need to find a way to do this project with community-owned dogs,” I said. “I’m confident that people will volunteer their dogs just to have a chance to participate in this research.” Then I had an idea. “Do you have a dog?”
“Yes.”
“Then surely you’ve wondered what your dog is thinking,” I said. “Would you volunteer him?”
“Well, I don’t think he would be a good subject,” the lawyer replied. “But I see your point.” He paused and then continued. “Maybe the IRB would act as a consultant to help us with your consent form.”
A glimmer of hope.
“But because of the liabilities, you’re still going to need all the offices to approve your protocol.”
This was not going to be easy. I had interacted with some of these offices before, and I knew that nobody would want to be the guy who approved the crazy dog experiment. What if something went wrong? But there was no turning back. If I had to, I would do this off campus, on my own time. I would find some private MRI facility willing to take dogs.
One way or another, the Dog Project was going to happen, even if I had to fight every lawyer in Atlanta.
Many of the people who work in the divisions of the university concerned with regulatory compliance adopt a cover-your-ass attitude. This typically manifests as a preoccupation with the letter of the law. Unfortunately, there is an endless array of federal regulations, and they are not always consistent with one another, so knowing which rules take precedence in a given situation is a bit of an art. In my experience, many of the people in the compliance divisions were primarily concerned with minimizing the chance of any violation or anything that might bring negative publicity if something went wrong, without much regard to the potential benefits of taking that risk.
I called Sarah Putney, the director of the IRB. Sarah had always helped me work through ethical issues in our human work. She had an incredible knowledge of the rules, she loved research, and, perhaps most important, she was a dog person.
I explained what we wanted to do and Sarah immediately seemed to understand.
Getting right to the heart of the matter, she asked, “Who is the subject of the research?”
“The dog.”
“Then this isn’t something the IRB would review,” she replied. “We only review human research.”
“But we have a consent form,” I explained.
“Why?”
I explained that since we were asking people to volunteer their pets for research, it seemed appropriate to explain what we were doing and what the risks were.
All research entails risk. In human research, the spectrum ranges from minimal risk to high. Minimal risk means that the probability and magnitude of harm in the research aren’t greater than what is ordinarily encountered in daily life or during the performance of a routine physical or psychological exam. Anything more than that is considered moderate or high risk. But that is a judgment made by the IRB.
Our human fMRI work is considered minimal risk because we study normal, healthy people, and we don’t give them any drugs. MRI doesn’t use radiation, so it’s considered very safe in and of itself. The main risks to humans are anxiety, because of the tightly enclosed space, and hearing loss from the noise. To limit the risk of a claustrophobic panic attack, subjects are given a button they can press if they want to be removed from the scanner. To protect their hearing, they wear earplugs and earmuffs.
The risks for dogs would be the same, in theory. Dogs have more sensitive hearing, so there might be a greater risk for hearing damage. To minimize that risk, the dogs would need to be trained to wear earmuffs, but I felt that their owners should be aware of all the things that might go wrong, however unlikely. In my opinion, the worst that could happen would be a dog escaping, getting lost or injured in the process.