By Michael Gorback, M.D., board-certified in Anesthesiology and Pain Medicine. He taught for 8 years at Duke University and is the author of 32 scientific articles and textbook chapters, and one medical book. Dr. Gorback currently practices pain management at the Center for Pain Relief in Houston, TX, and claims that nobody has ever suffered due to lack of knowledge of his opinion.
In 1939, researchers at the University of Iowa conducted research on a cohort of 22 orphans to see if they could influence whether or not children stuttered. Researchers gave half of the children positive speech therapy that praised their fluency of speech, and gave the other half negative speech therapy, belittling them for any speech imperfections and telling them they were stutterers. Some of the normal speaking children undergoing negative speech therapy suffered psychological effects and a few ended up with permanent speech problems.
This has been nicknamed “the Monster Study.”
In 2012, hundreds of thousands of Facebook users were subjected to human psychological experimentation without their consent. Facebook manipulated the amount of positive or negative content in comments on users’ news feeds to see how they would react. The purpose of the study was to see if emotions could be propagated without face-to-face interaction.
Users were unaware of the emotional manipulation to which they were subjected. Facebook has defended its action by pointing out a small snippet in their Terms of Service Agreement that referred to “research.” Most users probably understood this to mean passive research such as data mining. If anyone actually read it.
The WMA Declaration of Helsinki, “Ethical Principles for Medical Research Involving Human Subjects“ defines the parameters for human research. Vague generalized references to “research,” such as those in the Facebook TOS, are completely inadequate for informed consent. And it is universally accepted that the Declaration applies to both physical and mental human experimentation (see The American Psychological Association’s (APA) Ethical Principles of Psychologists and Code of Conduct).
The infliction of emotional discord on a human being for research purposes without informed consent is a violation of the Declaration, as is the lack of ethics committee oversight. This is S.O.P. for human research. It’s very strict. The paper should never have been accepted for publication in a scientific journal.
Note the following items from the Declaration:
Researchers’ duty to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information….
7. Medical research is subject to ethical standards that promote and ensure respect for all human subjects and protect their health and rights.
9. It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects. The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.
Guidance and Approval by the research ethics committee before the study begins.
23. The research protocol must be submitted for consideration, comment, guidance and approval to the concerned research ethics committee before the study begins. This committee must be transparent in its functioning, must be independent of the researcher, the sponsor and any other undue influence and must be duly qualified. It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.
The committee must have the right to monitor ongoing studies. The researcher must provide monitoring information to the committee, especially information about any serious adverse events. No amendment to the protocol may be made without consideration and approval by the committee. After the end of the study, the researchers must submit a final report to the committee containing a summary of the study’s findings and conclusions.
Subject “must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest…. and “must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time…”
26. In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study. The potential subject must be informed of the right to refuse to participate in the study or to withdraw consent to participate at any time without reprisal. Special attention should be given to the specific information needs of individual potential subjects as well as to the methods used to deliver the information.
Must seek subject’s freely-given informed consent, either “in writing” or “formally documented and witnessed.”
After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing. If the consent cannot be expressed in writing, the non-written consent must be formally documented and witnessed.
All medical research subjects should be given the option of being informed about the general outcome and results of the study.
35. Every research study involving human subjects must be registered in a publicly accessible database before recruitment of the first subject.
From my point of view as a physician, FB’s psychological experimentation on hundreds of thousands of users is a gross human-rights violation and the responsible parties should be prosecuted to the fullest extent of the law for illicit human experimentation.
But that might not happen. Legally, the case is murky because FB did the actual experiment while the Cornell researchers just analyzed the data. When the Cornell researchers asked the Cornell Institutional Review Board (IRB) to review it, the IRB washed its hands of it; since the Cornell researchers hadn’t performed the actual experiment, the IRB had no role to play.
The question then is whether a private entity is subject to the same ethical standards regarding human research. That this should even be doubted for a second is repellant to me, although I don’t see anyone going after Blackwater for its actions in Iraq either. By Michael Gorback, M.D., Center for Pain Relief.
Also by Michael Gorback, M.D.: Confused and outraged by the prices, often unknown upfront, that you and your insurance company pay for medical services? You’re not the only one. Enter the bizarre world of “Place of Service” pricing. Read….Doctor: The Sheer Insanity of What You Pay For Medical Services
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