Thinking Out Loud: I Was a Human Guinea Pig

Perhaps guinea pig is too strong a choice; I was a volunteer in a research study – I am afraid I learned more than the researchers. I bring this up because there has been a great deal of ink spilled in the last few months decrying the lack of diversity in those individuals participating in research and the subsequent roundup of the usual suspects – implicit bias on the part of some researchers, lack of diversity in recruitment, and concerns among the target populations that they are being used Tuskegee-like. 

The usual suspects are part of the problem, but there is nothing like participating in research to offer another point of view. The study I participated in involved old, overweight men with prostate issues (am I being redundant?) placed on a plant-based diet to reduce their weight vs. continuing their regular diet. In both arms of this randomized study, participants met weekly with a nutritionist, and those in the plant-based arm were given a choice of meals to be delivered to them for the first six weeks of the six-month study. The study is incomplete, so I have no data to share, but I will share my experience.

Why participate?

Being recruited into the study is the first but not the last hurdle. I participated for two reasons. Most salient was that I really liked my doctor, who was the principal investigator, and he personally asked me to participate. Like many patients, even if we are lapsed physicians ourselves, I would like to please the guy or gal dispensing my medical care. The second reason was that the study featured food frequency questionnaires, a means of information gathering that I have written about. I thought some real-world experience with that survey might better inform my writing. 

On other occasions, I have been asked to participate in a research study by a study coordinator or nurse, which I have uniformly turned down. This brings me to the first point that those researchers wringing their hands over a lack of diverse participants fail to recognize. I agreed to the study because of my personal relationship with the individual asking. Like much of medicine, recruitment for studies is a one-on-one personal enterprise, like all big ticket sales. Online recruitment, e.g., the Amazon Mechanical Turk, is suitable for a blood draw or an hour of compensated pay. However, if you want me to change my diet or other behavior, asking yourself is a necessary first step. 

Informed Consent

Having now evidenced interest, I was given the gist of the study verbally and handed several pages of detailed information explaining the study, testing, risks, and benefits. In this instance, the testing required blood and stool samples and imaging tests without radiation. There were no particular risks, and the baseline benefit was some free nutritional counseling, and you might get lucky and lose some weight. These are standard consents drawn up by the research group, legal counsel, and any oversight committee (Institutional Review Boards), and as a result, they are often word-dense and lengthy. 

I was offered the opportunity to ask questions, and having none, I signed my portion of the consent form. The principal investigator's signature would be obtained later since most of the consent was obtained from a specifically trained study coordinator, in this case, an RN.

The Rubber Meets the Road

All having gone well, I was randomized, which did not hurt but did disappoint. I had hoped for the plant-based arm but was assigned to the control. My only hope for weight loss was left to follow the personalized nutritional advice I might receive. I was then scheduled for my initial blood work and imaging. Scheduling was the easy part. The logistics turned out to be problematic. 

I live 2 hours from the sites where the blood and imaging were to be done. While that is a great distance, it is not uncommon for study participants to travel to a central site (reference lab) for study testing – it is a way to bring consistency to the test results. In my case, every time I had to travel on-site for testing, it would take up 6-8 hours of my day and cost me $60. Admittedly, these are times and costs that most participants do not incur; however, they are for many significant hurdles. For a participant in one of the boroughs, we may speak about a few dollars for the subway and maybe 3 hours of their day, but those are real financial and temporal costs. Here is the second significant hurdle for diversity in participation. I am “retired” and can afford the time, and with grumbling the cost, but not everyone is so situated. 

If you want diverse participation, which frequently means pulling from a diverse geography, reduce the cost, and big hint, that doesn’t mean paying for my train or their subway. Do the laboratory work where participants live and have the health system bring the blood to the reference lab. If the same machine and imaging are available where the participants live, get the images there and have those digits sent electronically to the specified radiologist to read. 

Food Frequency Questionnaire (FFQ)

The FFQ is a standard tool in nutritional studies and asks you to remember or record the foods you eat for a 24-hour interval. In my instance, I recorded everything I ate and drank for three days out of a week. I would say at this point that FFQs based on memory are so quantitatively challenged that studies using them as tools can be almost immediately dismissed. I was asked to write down when, what, and where I ate – and what included estimated or known amounts. Eating an entire bag of potato chips makes for an easy, although guilt-ridden, entry – the brand and quantity are right on the package.

On the other hand, having dinner at a restaurant poses challenges: how big exactly is that Caesar salad or that fish fillet? To hone my estimates, I spent 30 or 40 minutes reviewing the FFQ with a nutritionist who brought along plastic food models and measuring cups to help me visually identify the correct quantity. For recorded FFQs, the nutritional tally will be better but not best, making the borders of uncertainty more constrained. For those nutritional studies using recorded FFQs, their reported findings are more like an out-of-date map rather than a GPS locator. 

Speaking as a participant I am more likely to be recruited when the ask is personal and the participation convenient. A trusted relationship cuts through the usual skepticism and inertia, making people more likely to step forward. But it’s not enough to get a signature; logistical hurdles like transportation and time commitments must also be addressed. If studies are to be truly diverse, they must meet people where they are, figuratively and literally. This is far more likely to ensure that everyone, regardless of geography or socioeconomic status, can contribute to the advancement of science.