AWA: Academic Writing at Auckland

Under many medical circumstances, there is no distinctive consensus about the valid authority of decision making (Faden and Beauchamp, 1986). When clinical research is to be undertaken, the U.S Food and Drug Administration (n.d.) states that potential patients need to be informed about what will be involved, how the research will work, any adverse effects they may experience, and most importantly be made aware that their agreement to participate is voluntary. An understanding of all of the information given about the research is what deems a person eligible to give what is defined as informed consent (Food and Drug Administration, n.d.). Although enrolling patients who are unable to consent into medical research may raise ethical concerns, there are situations by which this may greatly benefit the patients and existing community through advancing clinical research. This essay will examine the inclusion of non-consenting adults in medical research, including main reasons for the disagreement of including this population of people, along with some of the benefits of doing so.

  Concern was sparked in 2014 when The NZ Herald claimed that since the 1990’s, up to 4,000 patients had been enrolled into clinical trials in New Zealand while unable to give consent (Johnston, 2016). These patients were unable to consent due to physical limitations e.g. being unconscious/in a coma. The NZ Herald (Johnson, 2014) reported that a study undertaken which involved testing new antibiotics on intensive care patients followed the consent process by seeking permission from the patient’s relatives and subsequent permission from the patient themselves following recovery. Health campaigner Lynda Williams wanted further investigation into this trial, stating “We need to do something about it because it is not okay to be enrolling unconscious patients in research”. She requested that a “public information and consolidation process” take place to inform community members about the trial’s consent process, implying she believed members of the public would also find the consent process for this trial unethical. Nevertheless, this study ran under the current guidelines of the Code of Health and Disability Services Consumers' Rights Regulation, established in New Zealand in 1996 by the Health and Disability Commissioner (Health and Disability Commissioner, 1996). Although the trial using antibiotics treatment involved treating patients who were unable to give informed consent, the study correctly followed ethical guidelines, as they sought consent from the patient’s relatives before enrolling the patient in the trial, which was for the patient’s best interest in the situation. Ultimately, The Herald’s article raises concern that the public of New Zealand are potentially ill informed about the current requirements for these types of trials; therefore this is a process which should be endorsed to inform the public, and potentially reviewed considering the somewhat outdated guidelines.

  In conjunction with Lynda Williams’ negative view towards the inclusion of non-consenting patients in medical research, people who disagree with the occurrence of this process feel this way due to belief that it is an unethical practice. Emanuel, Wendler, & Grady (2000) state that “To enrol individuals in clinical research without their authorization is to treat them merely as a means to purposes and ends they may not endorse and deny them the opportunity to choose what projects they will pursue.” Patients who cannot consent themselves can be placed under this category; although having mental/physical incapability’s, these patients “nonetheless have interests and values” (Emanuel, Wendler, & Grady, 2000). However, it may be argued that a reliable way to ensure the patient’s interests/values are respected would be to appoint a proxy/someone close to the patient to make an informed decision based on their belief of what the patient would have desired. This concept is consistent with the guidelines in various documents currently available for medical research on human subjects, such as the World Declaration of Helsinki and Code of Health and Disability Services Consumers' Rights Regulation (World Medical Association, n.d.; Health and Disability Commissioner, 1996). Therefore, as long as these guidelines are met and the proxy/relative meets the wishes of what they think the patient would prefer, then the situation is most likely being handled in the best way to benefit the patient while allowing them to obtain possible benefits of the clinical trial.

  Although it has been established that it is ethically important to gain consent from an authorised person wherever applicable, it is necessary to highlight that there are circumstances where it is impractical to correctly follow this consent process for carrying out medical research on a patient who cannot consent. For example, Kämäräinen, Silfvast, Saarinen, Virta, & Virkkunen (2012) indicated that attaining consent can be difficult or even impossible in the event of a medical emergency, such as a stroke, cardiac arrest or serious trauma.  The World Medical Association Declaration of Helsinki specifies that medical research being undertaken must involve more importance for the patient than risks/afflictions (World Medical Association, n.d.). Subsequently, though the patient is unable to consent in an emergency, it may be in the patient’s best interest at the time to subject them to experimental drugs or other methods being trialled. Adams and Wegener (1999) indicated that patients requiring emergency care who are possibly at risk of serious injury or death are likely to be the population most in need of this innovative treatment, and are therefore likely to be willing to take risk for a possible benefit. In an event of emergency where time may be the difference between life and death, it may be the best possible outcome for the patient involved for medical staff to subject the person to unconsented medical methodologies.

  Procedures/treatments used in medical emergency situations require research and trialling as much as any other medical practices do. Adams and Wegener (1999) specified that researching into medical therapies for use in emergency circumstances requires the inclusion of vulnerable patients, in this case those who cannot give informed consent. The research in this area would be greatly limited if the requirements for consent in emergencies were very strict, and would result in many less medical advances in this area due to the prevention of research (Adams & Wegener, 1999). They also mentioned a paradox; this population of people who are most likely to benefit from this therapy are the ones who are unable to consent to being treated by it. This is a valid point when considering whether to include emergency patients in research methods without consent, as this population of patients would be receiving treatment via these techniques if they were to be proven successful via trials/research. Kämäräinen, Silfvast, Saarinen, Virta, & Virkkunen (2012) mentioned that the consent requirements may be hindering clinical research and medical emergency advances. The consent process, while trying to protect patients, is potentially inhibiting medical progression in the area these patients require treatment from (2012). Overall, the allowance of non-consenting patients in emergency medical trials is likely to be a long term benefit for people subjected to emergency care, and to maximise the advances in this area of medical research.

  In conclusion, this essay has discussed the views surrounding the controversial topic of the inclusion of non-consenting adults in medical research. The main reason for disagreeing with the inclusion of this population is due to ethical reasons; as the patient’s interests/values/opinions may not be met through this process. However, by allowing their consent to be granted through a proxy/relative, this is the best way to attempt to meet the patient’s needs in the situation while still allowing them to reap potential benefits from medical trials. Under circumstances where there is surplus time, consent from a person with authority should be obtained to be as ethical as possible. However, emergency situations should not require the same process for consent in order to use techniques that are being researched. This is due to limited time restraints which may otherwise be putting the patient’s health/life at risk by attempting to obtain consent from a proxy. In addition to this, it should be acknowledged that research into emergency treatment needs to be carried out on emergency patients in order to gain important evidence on the effects of the treatment. Overall, if advances can be made in the area of emergency research, then non-consenting patients are required to make this happen. In turn, their involuntary participation will benefit populations on a global scale for the future of medical emergencies.

Reference List

Adams, J. G., & Wegener, J. (1999). Acting without asking: an ethical analysis of the Food and Drug Administration waiver of informed consent for emergency research. Annals of emergency medicine, 33(2), 218-223.

Emanuel, E. J., Wendler, D., & Grady, C. (2000). What makes clinical research ethical? Jama, 283(20), 2701-2711.

Faden, R. R., & Beauchamp, T. L. (1986). A history and theory of informed consent. Oxford University Press.

Health and Disability Commissioner (1996). The Code (full). Retrieved from http://www.hdc.org.nz/the-act--code/the-code-of-rights/the-code-(full)

Johnston, M. (2014, May 14). Drugs tested on critically ill, coma patients. The NZ Herald. Retrieved from http://www.nzherald.co.nz/nz/news/article.cfm?c_id=1&objectid=11254381

Johnston, M. (2016, May 16). In-coma drug trials: plea for review. The NZ Herald. Retrieved from http://www.nzherald.co.nz/

Kämäräinen, A., Silfvast, T., Saarinen, S., Virta, J., & Virkkunen, I. (2012). Conduct of emergency research in patients unable to give consent—Experiences and perceptions of patients, their consent providing next of kin, and treating physicians following a prehospital resuscitation trial. Resuscitation, 83(1), 81-85.

U.S Food and Drug Administration. (n.d.) Informed consent for clinical trials. Retrieved from http://www.fda.gov/ForPatients/ClinicalTrials/InformedConsent/ucm20041763.htm

World Medical Association. (n.d.) WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Retrieved from http://www.wma.net/en/30publications/10policies/b3/