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.

Because what we were proposing did not meet the definition of human research, no federal law required us to have a consent form. But, as I explained to Sarah, it seemed like the right thing to do. We were about to make a decision that elevated the rights of dogs to the same level as those of our human subjects.

Ever since I started running a research laboratory, I have operated under a simple ethical principle: Do not do any experiments that you wouldn’t be willing to do on yourself or a loved one. This is not a universally shared philosophy. Many scientists do experiments that they would never volunteer for themselves. There is no rule that says you have to. Everyone has their own opinion of the risks and benefits of volunteering for research. The principle of “respect for persons” allows everyone to make their own informed decision to participate in an experiment, including the person running the experiment. But what message would it send if I were unwilling to be a subject in my own experiments? I have had about fifty MRIs over the years. I have no qualms about crawling into one. I would put my kids in an MRI. And my dogs.

After explaining my logic to Sarah, we agreed that the rules governing research on children provided the best model for what we wanted to do. If adults want to participate in research, they simply need to understand the risks and benefits and make an informed decision. Children are different. Not only do they not have the legal standing to make their own decisions, but the rules also recognize that they don’t have the necessary knowledge or experience to understand the risks and benefits.

Research on children is given special scrutiny. If the research is considered minimal risk, then the approval process is pretty much the same as for adults. The main difference is that the parent gives permission and signs the consent form. However, the child must still indicate a willingness to participate, which is called assent. If the research is more than minimal risk, several different factors are weighed, including the relative risk and likely benefit to the child.