Importance of Informed Consent
Informed consent means that the client voluntarily agrees to participate in a particular trial or research study. Depending on the subject’s consent, it may include several sub-paragraphs. Personalized consent means that the consent is tailored to a specific person and is given to that person based on the type of trial. According to the consent document, the person must be fully aware of all the consequences, have all of the materials needed to understand the study, and be able to withdraw from the study at any time.
Ethical Considerations
To adhere to all ethical standards, it is critical not to cross the line in pursuit of legal rights. For example, a person may be offered a risky experimental treatment with severe side effects or a risk of death, but the patient is offered this treatment because there are no other options (Nathe & Krakow, 2019). Although the patient may consent to such a trial, the consent document cannot state that the patient agrees that the medical staff is not to blame for the patient’s death. The consent must be worded in such a way that the patient is aware of the potential for death and thus agrees to be informed of the potential for death or side effects. In this way, the patient does not get the impression that the medical staff is trying to protect them from legal claims, which fosters trust.
Legal Considerations
However, the legal aspect of consent should not be overlooked, as it is intended primarily to avoid future legal complications. Depending on the research, this could be permission to collect genetic material, store it in a database, or, for example, inform researchers about one’s condition, which could affect the course of the research (De Sutter et al., 2021). Legally, the consent document should protect both the researcher and the research subject, forming a mutually beneficial contract. If the research involves risks, the consent should reflect this and make it clear to all contract parties that consent can be withdrawn for any reason.
Requirements for Research Consent
Personalized consent involves both ethical and legal standards, but it can also be formed with the person being studied if they so desire. This consent cannot be copied because it is unique to each situation and individual. This contributes to the development of consent that is both ethically and legally beneficial to all.
Still, any consent must be formed without demeaning the person’s dignity (Dankar et al., 2020). The consent must not contain any terms that are derogatory to the person. This includes both inappropriate and medical terms that may unintentionally offend someone. Even if it is consent for an unusual experiment, all words must adhere to both legal and ethical guidelines.
However, not all aspects of a study may be specified to obtain patient consent. Furthermore, the researcher may keep anything unrelated to the research from the researched person, in accordance with the researcher’s non-disclosure ethics. In the pursuit of research results, doctors have withheld information about a patient’s condition, withheld treatment, or withheld referrals for treatment.
This created widespread skepticism toward all kinds of human experimentation. There is now the Declaration of Helsinki, which clearly defines the permissions granted to researchers conducting research with human subjects (Dankar et al., 2020). Personalized consent, like any other, must adhere to this declaration.
Along with potentially permissible consents for the researcher, consent should not include any that are not permissible or at least controversial. To obtain full patient consent for better results, one completely unacceptable consent may be required in addition to permissible consents. This is easy to detect, and such a condition is usually quite noticeable. The person may suspect fraud and possible manipulation right away, especially if all the points have been discussed and agreed upon previously (Dankar et al., 2020). Consent should be uniform in its demand from the client and should not include anything out of the ordinary.
One of the few crucial aspects of consent is awareness. To obtain consent, one may not be fully informed, stating that it is too complicated for someone unfamiliar with it. However, a person may be interested in the issue, particularly if it has a direct impact on the human body.
The client can be given the necessary materials separately so that they can familiarize themselves with them at home (Dankar et al., 2020). These materials should be accessible not only to medical and legal personnel but also to the general public (Dankar et al., 2020). It is also possible to create the material in video or audio format. As a result, the patient will agree that they are familiar with the material and understand the research and thus will have no further questions.
A personalized informed consent document assumes compliance with all current ethical standards, including those outlined in the Declaration of Helsinki and the Universal Declaration of Human Rights. This document should establish a trusting relationship. The consent itself should be informed, voluntary, and fully comprehended. Consent should not be abused, contain negative contexts or terms, or be manipulative or coerced. A person may leave the study at any time.
References
Dankar, F. K., Gergely, M., Malin, B., Badji, R., Dankar, S. K., & Shuaib, K. (2020). Dynamic-informed consent: A potential solution for ethical dilemmas in population sequencing initiatives. Computational and Structural Biotechnology Journal, 18, 913–921.
De Sutter, E., Borry, P., Geerts, D., & Huys, I. (2021). Personalized and long-term electronic informed consent in clinical research: stakeholder views. BMC Medical Ethics, 22(1).
Nathe, J. M., & Krakow, E. F. (2019). The challenges of informed consent in high-stakes, randomized oncology trials: A systematic review. MDM Policy & Practice, 4(1).