Neuroscience research often involves risks to human subjects involved in that research. Different types of research involve different types of risk.
fMRI Risks
Many patients undergo medically unnecessary scanning in fMRI machines, purely for the sake of neuroscience research. Such scans involve substantial risks, which are discussed in my post "Poorly Designed Brain Scan Experiments Needlessly Put the Needy at Risk." One danger of fMRI scans is well-known: the risk of the very strong magnets used by such machines causing some metal object to be hurled at a high speed, causing injury or death. In 2001 a six-year-old boy was killed in the US during an fMRI scan, when the machine turned an oxygen canister into a flying projectile. There is always a risk of lingering psychological trauma when certain people are put in some noisy high-tech machine and told they must be silent and not move for a long time such as an hour. There is also the risk that the more powerful fMRI scans (and longer fMRI scans) may raise the risk of cancer in the person getting getting the scan.
The 2009 study here ("Genotoxic effects of 3 T magnetic resonance imaging in cultured human lymphocytes") cautions about the use of a high-intensity ("3T and above") fMRI, and states that "potential health risks are implied in the MRI and especially HF MRI environment due to high-static magnetic fields, fast gradient magnetic fields, and strong radiofrequency electromagnetic fields," also noting that "these results suggest that exposure to 3 T MRI induces genotoxic effects in human lymphocytes," referring to effects that may cause cancer. There are very few studies comparing cancer rates in those who have had fMRI scans and those who have not had such scans. Now neuroscientists are starting to do neuroscience experiments on humans with more powerful fMRI scanners such as 7T scanners, which have potentially higher risks. So claims by scientists that "fMRI scans are safe" are not candid about risks. It is entirely possible that every time someone has a long fMRI scan (as often done for neuroscience research) that he is increasing his lifetime risk of getting cancer. Claims that "fMRI scans are safe" are typically claims made based on short scans (such as 10 minutes) with 1.5T and 3T scanners, not claims based on hour-long scans often done in neuroscience research, and not claims based on scans with 7T scanners. Neuroscience researchers often ask subjects to engage in multiple long scans, with the total scanning time as high as 3 hours or more (see here for an example in which subjects were unnecessarily scanned for almost 3 hours).
Scientists do not track the long-term health of subjects they have subjected to long fMRI scans. Their rule is "scan them and forget them." It often happens that things that were once not thought to be carcinogenic are later shown to be carcinogenic. For example, today I read that the US surgeon general is saying alcohol uses causes 20,000 deaths a year in the US. In the high school I attended students were forced to dissect cats, and the dead cats were stored in a vat of formaldehyde, which often got on the students' skin. We now know formaldehyde is a carcinogen.
Invasive Electrode Implantation Risks
Electrodes may be implanted in the brains of epilepsy patients to help determine the best way to do surgery for epilepsy. But the same person involved in doing such surgery may be doing neuroscience research, and may try to take advantage of the opportunity offered by implanting electrodes in a patient's brain. That person may cause additional electrodes to be implanted in the patient's brain, electrodes that were not necessary for surgery evaluation. All electrode implantation comes with risks.
A paper tells us the following:
"A meta-analysis of 2542 patients implanted with subdural grids for extraoperative monitoring prior to epilepsy resection, both with and without depth electrodes, the estimated pooled prevalence of pyogenic central nervous system infection was 2.3%, of intracranial hemorrhage was 4.0%, and of transient new neurological deficits was 4.6%, with 3.5% of patients requiring additional surgical procedures to manage adverse events.23 Similar complication rates were reported from a national hospital database in addition to an estimated 11.7% rate of cerebrospinal fluid leakage, a complication that often is unreported in published case series."
The paper also tells us that implanting electrodes may cause seizures, stating this:
"The primary risk of electrical stimulation mapping is provoking a seizure. This risk may depend significantly on technique; in a review of risks in intraoperative mapping for epilepsy surgery, the risk of seizure was 1.2% with the train-of-5 technique and 9.5% with the 60-Hz technique."
Transcranial Magnetic Stimulation Risks
Transcranial Magnetic Stimulation is a noninvasive technique in which the brain is bombarded by magnetism. The technique is sometimes used in neuroscience research. A wikipedia.org article on the technique states the following:
"Although TMS is generally regarded as safe, risks are increased for therapeutic rTMS compared to single or paired diagnostic TMS. Adverse effects generally increase with higher frequency stimulation. The greatest immediate risk from TMS is fainting, though this is uncommon. Seizures have been reported, but are rare. Other adverse effects include short term discomfort, pain, brief episodes of hypomania, cognitive change, hearing loss, impaired working memory, and the induction of electrical currents in implanted devices such as cardiac pacemakers."
The technique of Transcranial Magnetic Stimulation is a fairly new one, and no one has done has long-term studies on the topic of whether such TMS increases a person's risk of brain cancer, Alzheimer's disease or dementia. If you accept the typical assumptions of neuroscientists about memory, you should tend to suspect that such stimulation might increase a person's risk of dementia. Zapping computers with magnetism is known to incur a severe risk of data loss.
Transcranial Direct Current Stimulation Risks
Transcranial Direct Current Stimulation (tDCS) is a noninvasive technique in which the brain is bombarded by electricity. A scientific paper tells us this:
" Nevertheless, several papers have reported that, in tDCS, some adverse events persist even after stimulation. The persistent events consist of skin lesions similar to burns, which can arise even in healthy subjects, and mania or hypomania in patients with depression. Recently, one paper reported a pediatric patient presenting with seizure after tDCS, although the causal relationship between stimulation and seizure is not clear."
The technique of Transcranial Direct Current Stimulation is a fairly new one, and no one has done long-term studies on the topic of whether such tDCS increases a person's risk of brain cancer, Alzheimer's disease or dementia. If you accept the typical assumptions of neuroscientists about memory, you should tend to suspect that such stimulation might increase a person's risk of dementia. Zapping computers with electricity is known to incur a severe risk of data loss.
The Charade and Farce of "Informed Consent"
Neuroscientists claim that the human subjects used for neuroscience research have given what they call "informed consent." However, there are very strong reasons for believing that a large fraction or most of the subjects in neuroscience experiments do not understand the risks they are taking. Below are some of the reasons:
(1) Unclear "informed consent" documents. A person participating in a neuroscience research study will be asked to sign a document called an Informed Consent document. Such documents are typically long, filled with jargon, and hard for the layman to understand.
(2) "Informed consent" documents failing to candily discuss all the risks. A person participating in a neuroscience research study will typically be asked to sign a document that is not candid about all the risks involved, a document that fails to adequately inform the person about all the risks involved. The document may give the person false ideas about the risks involved. Some technique such as fMRI scanning may be described as "safe," which gives the impression that there is no risk; but as I discuss above, there are actually very substantial risks involved in fMRI scanning, particularly when it occurs for longer periods, with repeated scans, and higher-intensity scans such as 3T scans and 7T scans. So-called "informed consent" documents are full of "spin" designed to reassure the subject about the safety of the procedures he will be exposed to. Such "spin" often fails to adequately inform the subject of the risks he is taking.
(3) "Informed consent" documents are frequently presented under situations in which the reader is discouraged from taking his time to read the document. Anyone who has gone to a hospital emergency room or a very busy hospital may have experienced a situation under which "informed consent" documents are rather a charade or farce, because of a high degree of time pressure to sign the long documents as quickly as possible. Lengthy fine-print forms are given to someone, with the clear impression given that he is expected to sign them very rapidly, rather than taking minutes to study and properly understand them. For example, a doctor may come to a hospital room and give three pages of fine-print forms for a patient to sign, while impatiently waiting for an immediate signature. I don't know how often such dynamics occur in neuroscience research studies, but I would imagine that the same "hurry up and sign" dynamics frequently occurs.
(4) No one ever verifies that the person reading the "informed consent" document is capable of reading and understanding a document of that type. So-called "informed consent" documents are typically written in college-level language. But studies indicate that roughly half of the US population cannot read well-enough to understand documents written in such language. A very sizable fraction of Americans have a native-language other than English, and a very large fraction of people whose native language is English never learned to read well-enough to understand language written like "informed consent" documents. It would be an easy task to verify that a subject can read and understand an "informed consent" document. You could ask them to read aloud a crucial part of the document, and then to summarize that part in his own words. Scientists never do that.
(5) Rarely does anyone ever verify that a subject spent adequate time reading an "informed consent" document. So-called "informed consent" documents are typically given to people, with some pressure for them to rapidly sign. Almost never does anyone verify that the person spent adequate time studying the document, a very easy thing to do.
(6) Rarely does anyone ever verify that a subject properly understood the risks explained in an "informed consent" document. It would be very easy to verify that someone properly understood the risks explained in an "informed consent" document. You could simply give the person a one-page multiple-choice test, asking him about the contents of the document. Anyone failing to answer all of the answers correctly would be assumed to not understand the risks involved. Such tests are virtually never done.
At the link here, we have a University of Michigan template for an "informed consent" document for a research study. It is ten pages of fine print, written at a reading level that most or a large fraction of Americans will not be able to understand well. The documents mentions an unusually long fMRI scan time of 1 to 3 hours, much longer than the average MRI scan (between 15 and 30 minutes). No mention is made of how strong the fMRI scanner will be (whether it will be 1.5 T, 3T or 7T). The document fails to make any mention of the very real possibility of an increased cancer risk or dementia risk caused by the long scanning, which is small but real and significant in that long a scan. We have a document that will fail to cause most of its readers to understand the risk in the experimentation involved. The document has a profoundly misleading clause claiming "it is anticipated that at least 10,000 subjects will participate," tending to create a reassuring impression of very high numbers of people participating. The truth is that the vast majority of neuroscience experiments involve fewer than 20 human subjects, and a brain-scanning study of more than 50 people almost never occurs.
For all of these reasons and others, the "informed consent" procedures of neuroscience experiments are a charade and a farce. We should assume that the majority of subjects in neuroscience experiments do not understand the risks they are taking. The very idea of a mere "informed consent" is a profoundly defective one. A more stringent standard would have to be followed in order for good morality to be practiced in neuroscience experiments on humans. You might call such a standard the standard of "risk-cognizant consent."
The idea of risk-cognizant consent would be to verify that a subject understood all of the risks involved in an experiment, not merely that he had been informed of such risks in a way that might well have failed to cause a good understanding of the risks. Here is how such a protocol of risk-cognizant consent might work.
(1) Consent documents would be carefully written according to a "plain English" standard.
(2) All risks would be candidly discussed, including known risks, and unknown risks that it might be reasonable to suspect the subject was incurring.
(3) Before any subject was asked to sign such a document, his or her reading skills would be verified (for example, he might be asked to read the first paragraph aloud).
(4) Anyone lacking very good reading skills would be offered the consent document in an audio form, or would have the consent document read to him.
(5) All persons signing such a document would then be given a ten-question multiple-choice test trying to determine how well they understood the information in the consent document.
(6) Any persons failing such a test would be encouraged not to participate in the study, although they might be offered a second chance to read or listen to the consent document, and then retake the test, with a second failure assuring exclusion as a participant.
Following such a protocol would make it likely that the great majority of subjects in neuroscience research understood well the risks they were taking by participating in such research.
Much of today's neuroscience research is morally questionable. The research techniques followed are typically bad, with a very high occurrence of Questionable Research Practices such as way-too-small study group sizes, a lack of a detailed blinding protocol, a lack of pre-registration, and "make it up as go along" analytics following a "keep torturing the data until it confesses" approach. Very often the most dubious and arbitrary computer programming post-processing is occurring, in which scientists senselessly contort the data in any way they please in order to twist the data into some desired form so that a discovery or "statistical significance" can be claimed. There is no benefit to society from such junk research, which causes much suffering and death to animals.
The people who benefit from such neuroscientist busy work are neuroscientists, who get to add to their count of published papers. Serious risks are incurred in such experiments by the human subjects, who are often paid only "chump change" payments such as $20 an hour for the risks they endure. The people lured by such tiny payments are typically some of society's neediest, people in need of every little payment they can earn. Most of the subjects do not understand the risks they are taking, because of the problems like those discussed above. Most neuroscience research these days is of low quality, for reasons such as too-small study group sizes, lack of pre-registration, lack of control groups, and lack of a good blinding protocol. What we have here is mainly activity that is for the benefit of the few (neuroscience professors and their colleagues) at the expense of the many (tax payers who fund the junk research, readers who are misled by misleading claims flowing from the bad research, and research subjects undergoing substantial health risks).
I advise all participants in neuroscience research to keep a permanent record of any document they signed, to collect the names of all participating scientists and the name or identifier of the research study, and to keep a careful record of any health complaints such participants have at any time in the future, whether physical or psychological. Such information may be useful in filing a law suit or claim trying to collect payment for damages inflicted.
