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Clinical Research and Informed Consent
Clinical Research and Informed Consent When entering into a clinical research study, patients are provided with several forms of information detailing the aims of the study as well as any anticipated complications or difficulties they might experience as a participant in the clinical research study. However, if patients are not aware of or do not fully understand the research materials provided, are they truly and adequately informed to enter into the clinical research study?
For this Discussion, think about the importance of informed consent necessary for patients to participate in a clinical research study. As a current or future healthcare administration leader, consider how inadequate informed consent impacts risks for litigation?
Describe the implications of having patients participate in a clinical research study without adequate informed consent. Then, explain how you, as a current or future healthcare administration leader, might address patient concerns about informed consent, including what strategies you might take to reduce risks of litigation.Clinical Research and Informed Consent
Discussion
Continue the Discussion to 2 of your colleagues and identify one strength and weakness with your colleagues’ selected strategy for addressing the issue as presented in the scenario. Be specific and provide examples.
Each Colleagues 250 words or more (Colleague 1 250 words, Colleague 2 250 words, Total 500 words)
Colleague 1
Informed consent is the process through which potential study participants are informed of the study, and its participants are informed of the study and its participation requirements. It usually takes the form of an official written document developed by the researcher that informs study participants of the purpose and scope of the study. However, informed consent forms’ specific wording and format may vary widely across institutions (DePoy, 2011).
An important element of informed consent includes a description of the procedures you ask the person to participate and your assurance that participation is voluntary. It needs to be clear if there are any known risks and what these risks are and what measures should be taken if they occur (Mitchell, 2010).
Complications stemming from patient-provider interactions remain a key source of ethical violations and complaints. Informed consent is a major issue with a direct bearing on the provider-patient relationship. The origin of informed consent continues to have a direct outgrowth of advances in professional ethics, legal precedent, and continuous moral development. Through informed consent, patients have been able to take responsibility and explore options for their well-being (Welfel, 2012).
A code of ethics and informed consent are vital parts of health care. Quality health care involves keeping a patient informed. A code of ethics reduces risks for an organization, and so does informed consent. When patients know what they are getting into, they are less likely to sue or feel angered because they knew what they were chosen before they selected treatment or participated in a study.
Reference:
DePoy, E. & Gitlin, L.N. (2011). Introduction to Research: Understanding and Applying Multiple strategies (4th ed.). Elsevier St. Louis, Missouri
Mitchell, M.L., & Jolley, JM. (2010). Research Design (7th ed.). Wadsworth Cengage Learning
Welfel, E.R. (2012). Ethics in counseling and psychotherapy. Belmont, CA: Wadsworth Clinical Research and Informed Consent
Colleague 2
Informed consent is an ethical and legal requirement for participation in a clinical research study. Without informed consent, the research group does not have adequate permission to include the individual in the study. Research without full informed consent is considered negligent. If any harm comes to the individual, the medical professional could be found guilty of medical malpractice (Auchmuty, 2019). Informed consent is also crucial to the trust between the medical professional/research staff and the participant. It is a part of successful patient-physician communication, which fosters trust and openness. Without fulfilling the basic legal and ethical needs for informed consent and comprehension, this communication and trust will likely be broken (American Medical Association, n.d.)
Outside of the obvious ethical concerns, obtaining true informed consent is essential to avoiding litigation and protecting the legitimacy of the research. To address any issues about previous lack of consent, it is imperative that those participating are to be fully informed and taken through the entire process of informed consent and ensure they have full comprehension of the goals of the research and their participation. They should then be told that their participating going forward is entirely optional, and they are free to leave/discontinue the research study (Nusbaum et al., 2017).
References
American Medical Association. (n.d.). Informed Consent. https://www.ama-assn.org/delivering-care/ethics/informed-consent
Auhmuty, M. (2019). Informed Consent and Medical Malpractice. https://www.dolmanlaw.com/informed-consent-medical-malpractice/
Nusbaum, L., Douglas, B., Damus, K., Paasche-Orlow, M., & Estrella-Luna, N. (2017). Communicating risks and benefits in informed consent for research: a qualitative study. Global Qualitative Nursing Research, January 2017. https://doi.org/10.1177/2333393617732017 Clinical Research and Informed Consent