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The Egyptian goddess Isis was celebrated as the ideal wife and mother. The blogger known as Dr. Isis has some fancy-sounding degrees and is a physiologist at a major research university working on some terribly impressive stuff. She blogs about balancing her research career with the demands of raising small children, how to succeed as a woman in academia, and anything else she finds interesting. Also, she blogs about shoes. In fact, she blogs a lot about shoes.


...And behold, he raised the motherfucking Jameson on high as Isis bedecked her feet in glory, and the masses were sated. -- The Holy Gospel According to PhysioProf

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« Twelve Five Months of Dr. Isis... | Main | PS and the Weekly Shoe... »

Shame on CNN (The Use of Volunteers in Research)

Category: Science-y Sounding Meanderings
Posted on: December 8, 2008 12:44 PM, by Isis the Scientist

The domestic and laboratory goddess has had a lot she's wanted to write about lately. She's got about 8 unfinished posts in the queue and realizes that most of them have a fairly serious tone, little snark, and contain no shoes.   We can't have posts like that, now can we?  This is a busy time for Dr. Isis at MRU (as it is, frankly, for everyone at an MRU).  She's been laying down some incredibly hot science while also trying to make it home in time for Tuesday night swimming lessons and dinner and bed time and time with Mr. Isis and all of the other things that require her immediate attention.  Dr. Isis needed to be at work over the weekend and her solution, in order to not sacrifice family time, was to be at home until the Isis brood went down for a nap in the late afternoon and then come into work.  I really loved being able to be home with my family, but this also meant working late into the evening on Saturday and Sunday (as should be evidenced by my late night blogging exploits). 

The situation was not ideal and left me a bit sleep deprived, which I imagine is why I fell asleep in church this morning (today is a Holy Day of Obligation for us papists) with Little Isis.  Still, I realized that  moving my exploits to the late night hours are completely worth it when, as I was sleeping in church and the older lady next to be nudged me awake and frowned disapprovingly, Little Isis turned to her, scowled, and told her "Mommy is beautiful."   I realize one cannot read too much into the musings of a two year old, but it was almost as if he we were telling her, "Leave my mommy alone, you old bitty.  She's doing the best she can.  She's tired, but don't you notice what a good boy I am in church?  She's a good mommy." 

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Figure 1: Little Isis will take on any old church ladies who dare mess with his mommy.  His mommy is beautiful (and totally hot).

Ok...I'm reading far too much into this, but sometimes we look for a little bit of help wherever we can get it.  With the economy in its current state, the domestic and laboratory goddess knows that she's not the only one looking for a little bit of help (I need to stop typing for a moment to pat myself on the back for that amazing segue way.  That was hotness if I've ever seen it).  Dr. Isis's sleep deprivation is a marginal problem compared to the number of people who face losing their livelihood, the homes, and their ability to care for their families.  I try to remember this personally when I whine about being tired or how much I have to finish at work.  But, now it seems that I also have to remember this professionally.  Allow me to explain:

This morning I was working and clicked over to CNN.  I saw an article entitled Unusual -- and Legal -- Ways to Make Money.  Dr. Isis is always game for reading about the unusual (provided it does not involve farm animals or latex bodysuits), so I decided to give it a read.  Imagine my utter horror and amazement when I found that CNN, an allegedly reputable news source, was advocating that one of the ways people could make make it in the struggling economy is by becoming professional research participants.  They highlight the story of Paul Clough who made $28,000 last year participating in, essentially, Phase I clinical trials.  Last year he allegedly had his blood drawn 500 times and ingested "more than" twelve different medications.  They link to his website where he describes in a series of You Tube videos how you too, you lucky devil, can become a professional drugtaker.  I won't link to it because I find the entire idea horrid.  What I find even more horrid is CNN's statement that:

Safety concerns include side effects or drug reactions, but for many volunteers, the payout outweighs the risks.

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Figure 2: The major side effect of participating in a dozen clinical trials in a year that CNN did not make nearly clear enough is death.  I can't imagine the payout ever outweighing that risk.

I'm not naive.  I appreciate that there have probably been people who have participated in a study I have conducted purely for the $60 and all-you-can-drink juice and not for the pursuit of medical knowledge or my charming personality.  Still, I try to be diligent and assure that individuals are truly informed about the risks of what they are doing and that, to the best of my knowledge, they are not participating in any other protocols in combination with mine.  It's not good for them and, equally importantly, it's not good for science.  Those of us that are clinical investigators need to be aware of the factors that motivate an individual to participate in research and of the fact that, because of the current economic climate, it is increasingly possible to coerce participation with monetary payments.  The FDA notes in its guide for human volunteers:

Subjects are sometimes paid for their participation in research, especially in the early phases of investigational drug, biologic or device development. Payment to research subjects for participation in studies is considered a a recruitment incentive. Financial incentives are most often used when health benefits to subjects are remote or nonexistent. Volunteers may be offered compensation in certain trials for their time, and for discomfort that may be experienced during the trial. The amount of compensation is determined by the amount of time you will be required to dedicate to the trial, and to the level of discomfort that might be associated with medical or surgical procedures related directly to the study. Payment information, including the amount and schedule of payment(s), as well as any possible costs to volunteers who participate in a study, are discussed with potential participants during the informed consent process, and documented in the informed consent form.

Thus, some of the biggest payouts come from some of the most dangerous studies.  Still, the onus is upon us to make sure that we are offering these payments responsibly.  I've written before on numerous occasions about the need to safeguard human research participants, but we also need to safeguard the quality of our data.  Human participants involved in a number of concurrent protocols are not reflective of the general population and their data is likely confounded by their overzealous participation.  And frankly, I have found that people who participate in research purely to make a buck tend to be less motivated to adhere to the study requirements compared to individuals who have some level of interest in the science and its outcome.  At Dr. Isis's former MRU our clinical research center had a great system that kept track of individuals participating in in research.  When someone enrolled in a study, they went into the database and we were alerted if they they were participating (or had participated within the last 30 days) another protocol.  We were not necessarily alerted as to the nature of their participation in the other protocol, and it was often hard to turn someone away knowing you only needed 1 or 2 more volunteers, but it at least let us put the kibosh on their participation so that we didn't confound our data or that of the other investigator to whom they were already committed.

Such is the nature of human research.  Human research participants as a population (not individuals) are unreliable, can potentially confound the hell out of a study with a small sample size, and are motivated by all sorts of crazy things. Still, we have a responsibility to protect them and the quality of our data; I fear the current economic crisis may make this a more difficult task than before.

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Figure 3: It is the responsibility of the investigator to ensure that we are not capitalizing on the desperation of others. 

I know things have been more science than domestic lately.  Hang in there, gentle readers, and on Friday you'll get a how-to post on tamale making. 


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Comments

1

I wonder if Dr. Isis would be posting this if she were a behavioral psychologist.
I mean, I don't see any huge downside to participating in multiple studies if they mostly consist of holding a cup of coffee and then choosing prizes.

Clinical research like the mad-crazy kind Dr. Isis blogged, on the other hand... Yeah, I'd seriously worry about anyone who signed up for 12 of those a year.

Random side note- this reminds me of Chez Geek.

Posted by: Becca | December 8, 2008 6:03 PM

2

Wow, Becca! You're awfully scrappy on the ole blogz today.

The answer is, yes. I would feel exactly the same way if I did behavioral research and think those people need to be just as careful of confounding effects and aware of the potential impact of their studies on an individual. The studies I do result in apparent mechanical and biochemical alterations to my participants. However, behavioral researchers impact their participants too, albeit in a much less tangible way. I think the idea that behavioral research is in anyway benign is total bullshit.

I offer you this as an example.

Posted by: Isis the Scientist | December 8, 2008 6:18 PM

3

I would argue that the average Phase I drug trial still bears more risk than studies that, for example, ask one to report on which picture they find more appealing or bartering for objects after some treatment. Experiments like the Stanford prison and Milford experiments can't be conducted today. I understand that there are psychological risks associated with behavioural studies, but variables are much more easily controlled than in clinical trials, where the objective is to rule out adverse reactions, not so much to measure a response under controlled conditions. But I would suppose that the relative earnings a subject might earn would also be scaled to the risk, no?

Posted by: SJC | December 8, 2008 10:17 PM

4

Then again, Isis, using people from your own lab as research subjects is also frowned upon in some quarters.

Regardless people running phase 1 studies do not want professional lab rats. Too much risk of an interaction with another phase 1 drug.

Posted by: nm | December 8, 2008 11:42 PM

5
Then again, Isis, using people from your own lab as research subjects is also frowned upon in some quarters.

Regardless people running phase 1 studies do not want professional lab rats. Too much risk of an interaction with another phase 1 drug.

You're very right, nm. The issue arises when the investigator either a) has a vested interest in the outcome in the trial and could thus bias the data or might not be able to really give consent or b) is a trainee who might feel that they have no choice but to say "yes" to participation. This is a very nuanced issue.

But, no one said that working with human subjects was cake.

mmmmmm....cake.

Posted by: Isis the Scientist | December 9, 2008 9:37 AM

6

First - Little Isis is freakin' awesome. Way to go for giving props to mom! You must be doing A LOT of things rights to be able to get this kind of appreciation from a 2-year-old.

Second - I was also horrified by the CNN article. Though, as an underpaid grad student I admit to participating in clinical trials (in part) for the money. I do have a real interest in the science though too and that is part of my motivation. But honestly, I would be much less likely to participate in some of them were I not compensated financially simply because of the time involved. Had I nothing else to do with my time, I would be happy to donate my time to being a research "subject". However, that is not the reality I live in.

What I do think is sort of weird is that for one trial I have been involved in from Phase I, they were very explicit at each visit that I should not be participating in any other trials concurrently and they asked me to confirm this at each visit. Furthermore, they wanted assurance that I had not participated in any other trials in the previous 6 months to avoid any confounding effects from other procedures. Good plan! But now I am in their database and they keep asking me to participate in other trials that THEY are running...within 6 months of finishing a previous study of theirs. Hypocrisy? Or are "subjects" just that hard to come by?

Posted by: ambivlalent academic | December 9, 2008 10:45 AM

7

ok, you're making me feel really bad. Being a poor grad student as I am, I admit to having sold myself to research studies for cash. On the other hand, they are not clinical trials for drugs, ever. They're usually studies involving caffeine and MRIs, or alcohol and driving simulators. And being a grad student, I am usually very interested in the outcome. I have a great hope someday that there will be a really pretty picture of my brain on the cover of a journal or something.

Posted by: scicurious | December 9, 2008 11:03 AM

8

Isis. Being a research subject when you are also a PI in your own right is a little different. You have the power structure balanced in the right way.

There does seem to be a strong physiological tradition of self-experimentation- just don't go all JS Haldane on us.

Posted by: nm | December 9, 2008 4:55 PM

9

Dr. Isis- scrappy on the ole blogz is how I roll.
We undoubtably agree that the Stanford prison experiment constitutes a totally creepy and hazardous psychological study. But it's only as relevant as bringing up Tuskegee (or Nazi science) in the context of medical research.
"Worst case scenarios" may be good for reminding us why we need to always consider the ethical implications of our actions, but, by definition, they are not an accurate picture of the risk (of course, you could follow the Cheney doctrine that accuracy is irrelevant because no matter how small the likelihood, a sufficiently horrible possibility merits pretty lousy actions on a preemptive basis).

So if somebody wants to propose a "cake testing" study, I refuse to believe it will inherantly be bad for me to participate 12 a year. Possibly 12 a day could be a problem. Possibly.

Also, that story is amazing. It never occurred to me my hair might be worth that much! To think, I've been *giving* it away.... I'm tempted to sell it, but will probably not do so unless my mother cannot afford to visit my father and I have someone around who'll catch the literary reference and gasp that it was "my one true beauty!"

Posted by: becca | December 9, 2008 10:17 PM

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