Most patients consider the issue of informed consent as a broken promise in healthcare provisions. Informed consent covers all pieces of information the physician should allow the patient to know, alternatives, and pros and cons of such options, and then the physician should go with the patient’s option. This means that alternatives must exist to enable the patient to select his or her choice. The patient also has a right to refuse all the options where necessary.
This article focuses on a recent issue that arose from an informed consent involving 23andMe Company. 23andMe Company deals with consumers in gene testing. In May 2012, the company announced that it was waiting for an impending award of its first patent (Rush, 2012 p.1). The company conducted a study on Parkinson’s disease with information from several clients. Data from its customers led to the patent. The patent on the gene sequence would be useful in predicting the risk of the disease and its course of spread.
According to the company, the patent shall bring practicality and not academic publications by impacting lives through prevention, treatment, and cure for the disease.
Informed consent and health care delivery debate
One client responded to the announcement by questioning the terms of service in the informed consent form. The customer wanted to know whether it was right for the company to patent their genes. She also wanted to understand the language that covered the use of such data. According to the customer, she could not find such terms in the form.
However, these terms were in the form. The Independent Review Board (IRB) approved this form. It had all the risks and benefits of taking part in the research. The document reads, “If 23andMe develops intellectual property and/or commercializes products or services, directly or indirectly, based on the results of this study, you will not receive any compensation” (Rush, 2012 p.1).
The problem with the Informed Consent
This case shows that the issue of informed consent has never been clear enough for research participants. Participants have to read words in small prints carefully to understand the contents of the form. Therefore, the protections of research participants remain a thorny issue and difficult to uphold.
The problem has become profound in the era in which data collections have increased rapidly. Researchers are collecting more data about human subjects than in the past. Several studies now involve collections of data about human genes. In addition, scientists can manipulate such data in many ways.
Whether health care in the United States is a right or a privilege
Currently, health care delivery in the US remains a privilege and not a right. Proponents of affordable healthcare believe that it should be a social right (White, 2012). Given the raging debate about whether health care is a right or a privilege, the plight of research subjects may remain obscure. This is because the IRBs have failed to protect human subjects from subsequent activities of researchers.
The proper role of the government
We may argue that IRBs of various institutions have failed to ensure maximum adherence to ethical standards in research involving human subjects. Thus, the government must formulate laws to protect the rights of individuals involved in research. Rush notes that many “US states, including California, are considering laws that shall curtail the way researchers, law enforcement officials and private companies can use a person’s DNA” (Rush, 2012 p.1).
However, researcher coordinators who write such consent forms “cannot predict how researchers may use personal DNA in the future” (Rush, 2012 p.1). At the same time, they “cannot guarantee that the data shall remain safe in the future” (Rush, 2012 p.1).
Critics argue that research subjects should control how researchers or institutions can use their data. Thus, the law should give them this control. According to researchers, such laws can only lead to bureaucracy without meaningful gains to research subjects. As a result, both researchers and participants shall face challenges dealing with several procedures and opinions, which shall only lead to confusion and deter subjects from participating in studies.
Impacts of informed consent on health care delivery
From historic cases, research subjects who have detected that researchers have abused their rights by withholding information about the study and its future purposes usually fail to participate in subsequent studies. At the same time, they also develop a distrust for medical facilities, especially public institutions (Pelias, 2006 p.67).
Such cases highlight a rift that exists among researchers, research subjects, and the public over informed consent and what information they need to know before participating in a study.
The rise in genome analysis has created many concerns regarding consent. Currently, researchers can analyze stored tissues and identify donors. In addition, they may analyze how the donor may be prone to certain diseases. The case of the Havasupai tribe of Arizona can explain how researchers can use such samples for other purposes. The tribe provided blood samples to Arizona State University in Phoenix for studying high rates of diabetes in the tribe. However, the University also used “the samples in mental illness research and population genetics studies that called into question the tribe’s beliefs about its origins” (Rush, 2012 p.1).
Researchers and institutions have attempted to “protect such samples by legal and technological ways, but they also have their weaknesses” (Rush, 2012 p.1). For instance, studies have demonstrated that geneticists can still use these tissues for identification even if they have minimum features of references to real donors. This can lead scientists to identify people using a public database with background information available from past studies or other sources.
To avoid the identification of research subjects, institutions must find ways of separating genetic information and demographic data. Such approaches must make it difficult for anyone to use such data for the identification of patients. This is the case at Vanderbilt University Medical Center of Nashville in its BioVU databank.
The center has a different approach to consent. The center gives research subjects opportunities not to keep their DNA at the databank. This is the opt-out model.
Full disclosure remains the solution to issues concerning informed consent. However, study results may present challenges to physicians. For instance, the result may indicate other causes of genetic susceptibility to ailments, which are different from the original purpose of the study. However, there are no provisions on what physicians can do with such information.
The legal position allows physicians to inform the patient reasonably. However, what is reasonable in this case remains a challenge to physicians. Thus, in case of a legal contest, the physician must prove what is reasonable by using an expert’s opinion. In this case, another expert must clarify what is reasonable a physician should inform the patient (Erlen, 2010 p. 276).
The patient’s data and informed consent have become sources of challenges to researchers. With the development in technology and genome analysis, the issue of informed consent has presented new challenges. Therefore, policymakers must review informed consent forms with particular attention to emerging challenges, the use of personal DNA, and future protection of such information.
In addition, current consents only allow researchers to use data for specific investigations. Therefore, it is imperative for new policies or consent forms to allow researchers to use such information to tackle other research issues or questions emerging from studies. Researchers want informed consent to be broad and allow them to use data freely.
Erlen, J. (2010). Informed Consent: Revisiting the Issues. Orthopaedic Nursing, 29(4), 276–280.
Pelias, M. K. (2006). Human Subjects, Third Parties, and Informed Consent: A Brief Historical Perspective of Developments in the United States. Community Genet, 9(2), 73-77.
Rush, B. (2012). Informed consent: A broken contract. Web.
White, J. (2012). Health care is a social right, not a privilege for the rich. Web.