Ethical Review, Consent Forms

Hillary Szydlowski

Review of Informed Consent Form

There is a research project being conducted at Purdue University named Neural Representation of Speech Sounds in Normal Hearing and Hearing Impaired Individuals. This study is examining the differences in frequency following responses (sustained neural activity in the brain stem) between normal and hearing impaired individuals. A consent form for this research has been obtained and will be examined for its adherence to the standards of ethical informed consent.

The question of what constitutes informed consent is not one to be taken lightly. It has its roots in World War II, in some of the worst atrocities ever committed by men in the name of science. The issue was addressed globally by the Nuremburg Code, so named for the Nuremburg Trials which were held against the Nazi scientists who used human subjects during the Holocaust. The very first point in the Code states clearly, “The voluntary consent of the human subject is absolutely essential,” and goes on to clarify that this consent should be given, “without the intervention of any element of force, fraud, deceit, duress, over-reaching or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved, as to enable him to make and understanding and enlightened decision.”

This global agreement clearly outlines the scope of the term informed, requiring that the subject be made aware of the length, drive and type of experiment and the way it will be administered. The subject should be made aware of any inconveniences or hazards that may come about as a result of his participation as well. The Nuremberg Code was adopted by the United States and expanded upon by the Department of Health & Human Services in the Belmont report which further regulates the type, method and drive of any testing that is to be performed upon human subjects.

This is not the only possible interpretation of informed consent. As Elliot (2006) points out, scientists have an obligation to the public both to perform their work, as they are funded by the people, and to disseminate that work, as it is to be conducted for the benefit of society. However this responsibility to create and disseminate information moves the idea of informed consent into an entirely different sort of moral situation. He interprets informed consent as the public’s ability to participate in to social and political processes that are derivative of the knowledge they consume.

This view moves the focus of consent from the initiation of the experiment (where it also rightfully belongs) to the final result, the research paper or article. In essence Elliot (2006) draws the notion of consent all the way through the research process, demanding that humanity be the focus of every aspect of the experiment (as supported by the Belmont Report’s mandate of beneficence). When reviewing an informed consent form, an eye to how the researcher intends to disseminate the results, and how they will impact society is essential. A balance must be found between protecting the individual’s privacy and well being and providing the greatest benefit to mankind. Given that the guidelines of consent were born in reaction to the violation of the individual, it seems necessary that science err in favor of the test subject- but not all agree.

Varelius (2009) highlights the intricacies of the balance between serving humanity and allowing the individual a say in the social and political direction of research by discussing mass projects of study and pointing out the power that the mandate of informed consent gives the individual in such situations. Varelius (2009) proposes that the weight of an individual’s veto power of consent is tied to that individual’s physical, financial and psychological stake in the project. While his belief is explicit to the realm of society and not to the microcosm of the individual experiment, it could be a dangerous leap to make, as it presents consent as an action which is restrictive on the rights of others, and thus makes the individual’s will a matter of public domain.

This seems like a small distinction, but it is extremely relevant in the case of any sort of medical research. The most explicit way this can be illustrated is by the study of experiments involving placebos- which, it should be noted, the Neural Representation of Speech Sounds in Normal Hearing and Hearing Impaired Individuals does not use. Still, since the research is medical in nature and will add to the bank of scientific knowledge, a pointed examination of the relevance of the individual’s will as public domain is worthwhile.  

On a historical note, the Belmont Report is enforced by a University’s Review Board and is specific to the United States. When moving into the commercial field, and abroad, these rules are not as stringently followed. Zaborowski & Gorski (2004) examine the role of consent in Poland, which is much more implied than explicit. They use the lens of placebos to illustrate the lack of recourse that a patient has should negative outcomes derive from a physician’s treatment. The power is held more firmly by the administrator as to the amount of information that is distributed, mandating that the degree of possible risk be conferred and that the information should be formulated in a manner which is intelligible to the patient. These interpretations clearly allow for gaps in the dissemination of information which allow for placebo treatments- treatments by which a patient believes they are getting medical help, but in actuality they are not. This is a violation of informed consent, but one for which there is no easy fix, due to the wording of the laws and the placement of will for decision making more firmly in the role of the medical technician. This shift in power is present, nominally, to provide the greatest benefit for the patient.

The pro-societal benefit point of view reaches its limits in the realm of emergency medicine for obvious reasons. Emergency care procedures and treatments can only be administered in situations of the utmost immediacy and the ability of the recipient to receive and comprehend the information necessary to make an informed decision is so difficult that it actually damages the level of emergency care available. So many treatments remain untested or insufficiently tested that could potentially benefit or even revolutionize the field due to blocks created by informed consent. Gefenas (2007) points out that US Law as of 2001 allows for treatment to begin prior to consent in an emergency medical situation.

Gefenas (2007) points out the sections of the Declaration of Helsinki (which are also borne out in the Belmont Report) providing special protections for those incapable of giving consent- specifically that the research only be administered if it is believed to be of direct benefit to the individual. This removes the moral weight of any benefit to mankind and places the sole benefit on the wellbeing of the individual. It does not, however, replace informed consent as it cannot. The individual in question is incapable of giving consent (and is generally of a protected class, although this is not he case in emergency medical situations).

In EM situations, cost benefit enters the equation and CIOMS and the Council of Europe have allowed for EM research to move forward without consent provided a minimal risk rule is followed. As previously mention, the cost benefit is analyzed with an eye solely towards the patient’s benefit, but without the patient’s consent. Such a concession is in direct violation of the stricture of informed consent with regards to experimental research, and other roads could be taken. When registering for a driver’s license a person is asked if they wish to donate organs in the event of a fatality- a simple resolution to an issue of consent in situations where it is impossible to procure. Such forward looking methods could easily be applied to experimental emergency procedures as well.

There is no evidence in any of these views that, in the case of experimental procedure, an individual’s right to consent (or dissent) should ever be revoked. There is a good deal of evidence that the individual’s right to informed consent should be protected during all aspects of a study and can even be expanded upon to affect the imperative of the study itself, impacting the directive to inform the public in the most comprehensible manner possible for informed consent in the social and political arenas.

With regards to the Neural Representation of Speech Sounds in Normal Hearing and Hearing Impaired Individuals the mandate of informing the individual of the purpose of the study, and of directing that drive to the further education of the public seem to be lacking. In Purpose of Research, the scientist says only, “You are being asked to volunteer for a study aimed at evaluating how speech sounds are processed in the brain of normal hearing, and individuals with hearing loss.” No further scientific knowledge, nor direction is supplied. The individual is supplied with the minimum information required to understand the procedure, which may protect them from overanalyzing the process, but presents them with less of an opportunity to truly understand their role in the project.

The informed consent form indicated the Specific Procedures to be Used- that electrodes will be employed to monitor frequency following responses, but no additional information is presented with regards to what a frequency following response is. The procedure itself is outlined clearly and consideration is taken for the safety of the subject. Assurance is given that at no point will the experiment pose an issue to the patient’s hearing, whether or not they are currently hearing impaired. This safeguards the patient’s psychological wellbeing during the course of the experiment but presenting specific parameters as to the stimulus that will be enacted upon their person. It is also mentioned the exact stimulus which is to be enacted- speech sounds in the presence of quiet and in the presence of background noise.

The form is honest that the study will not present any individual benefit outside of monetary compensation, and a potential psychological benefit that participation in scientific research, and presumably the betterment of mankind, brings.

The form clearly lays out the potential risks inherent in the individual participating in a scientific experiment- specifically the risk of a breach in confidentiality. It specifies only the measures taken to protect electronic information. It guarantees that client data will be kept behind a firewall and will only be accessed by the National Institute of Health, Office for Human Research Protections and Purdue’s research oversight committees. It does acknowledge that should the information be subpoenaed, or a case arise in which the records are required by law to be surrendered that they will be released to law enforcement.

The form mentions several times that the individual is not required to take part in the study and that they may cease participation at any time with no negative consequences. The specifics of how this will affect compensation are laid out in two different sections in the paper.

The study is not one that poses a risk to the individual and as a result many of the ethical issues regarding informed consent that have been discussed may seem moot point. That is not the case. The purpose of examining the exact boundaries and extreme points of issues such as informed consent are to allow for an understanding of the ideal handling of such an important issue even in low risk situations.

While all points of information have been covered in the attached form, additional information should be given to the participants so that they may more fully understand the process, the study and its impact. Doing this will simultaneously prompt the researchers to conduct, summarize and distribute their experiment and experimental findings with an eye to their duty of facilitating informed consent not only in the scientific community, but also in the social and political realms of the average person.

The inception of ethical standards for obtaining informed consent took place under extraordinary circumstances. This may cause simple, everyday, or non threatening procedures to disregard their significance, and the responsibility of the scientist to the people. The imperative to acknowledge informed consent through all aspects of scientific research is on that will both serve and protect humanity, and is the best possible interpretation of the laws and regulations currently in place. Informed consent does not end with the signature on a consent form.