The validity of informed consent
Informed consent is often perceived as a solution to all the possible problems that may occur during research. While it is supposed to protect patients’ rights and ensure a positive outcome of research, it does not always live up to the expectations. In reality, informed consent in practice is not as effective as it is in theory. As experience shows, healthcare professionals tend to overestimate the value of the written documentation. Even if a patient has signed a form, it does not mean they have understood all research details.
Due to a complicated legal language, the documentation is extremely difficult to understand, especially for non-native English-speaking patients. Some studies have concluded that many research participants do not fully understand complex study information. Namely, patients with illness might not comprehend the difference between randomized study and individualized clinical care (Grady, 2015). Such findings question the validity of informed consent, which is a serious ethical problem.
Seedhouse’s ethical grid
Working with vulnerable populations is a delicate process, and the researchers must be extra careful not to cause a person any harm. In addition to getting a patient’s informed consent, healthcare professionals should remain ethical in all their actions. To ensure that research is conducted within the ethical boundaries and that the rights of subjects are not compromised, healthcare professionals can use Seedhouse’s ethical grid.
This framework for ethical analysis during the research includes different aspects of ethical dilemmas also called “layers”: the ones relating to the core health foundations, to practitioners’ professional duties, to the healthcare intervention outcomes, and external considerations (Jaye, p. 33). The grid enables researchers to check whether their actions during the study correspond to the most important ethical principles. All the layers combined create a comprehensive picture of each particular case and serve as a reference point for researchers in their patient-related actions. Overall this framework can be very useful as it protects a patient’s rights in several interconnected ethical dimensions.
Electronic health records system
Patient’s consent and confidentiality are critical for every medical study, but healthcare professionals should realize that their responsibility goes beyond research settings. It is much easier to get a patient’s informed consent than to ensure their confidentiality, which is one of the biggest challenges in today’s medical environment. There are many governmental and organizational ways of ensuring the patient’s right to confidentiality, but unfortunately, they are more effective in theory than in practice.
The most vivid example of this problem is the use of an electronic health records system (EHRs). Despite the convenience of the system, it has some significant drawbacks. Namely, once the patient’s data is entered into the system, and even though the records may never be relevant for a patient again, they remain in EHRs forever (Wallace, 2015). Also, a patient’s data might be disclosed due to lack of encryption or other technical problems. However, the biggest concern that arises in regards to EHRs is that most confidentiality breaches are the results of the healthcare professionals’ actions rather than computer issues (Wallace, 2015). In addition to advocating for patient’s safety, it is also our ultimate responsibility to ensure that the patient’s sensitive information is secure.
Grady, C. (2015). Enduring and emerging challenges of informed consent. New England Journal of Medicine, 372(9), 855-862.
Jayes, M. (2019). Improving practice in supported decision-making and mental capacity assessment. Logopedia E Comunicazione, 15(1), 27-35.
Wallace, I. (2015). Is patient confidentiality compromised with the electronic health record? CIN: Computers, Informatics, Nursing, 33(2), 58-62.