Kirkegard And Bjerrekaer Dilemmas

In their article, “The Concept of Informed Consent,” Faden and Beauchamp give two varying definitions of informed consent, namely sense one and sense two. Sense one is defined as autonomous authorization, meaning that the patient or subject agrees and then gives authority to move forward with a proposal (Vaughn 191). The authors give four conditions that have to be met for informed consent to be recognized: the patient has to understand the information presented to her, there should be no manipulation or coercion, and she has to intentionally give her authorization (Vaughn 191). Faden and Beauchamp also note that the fourth condition, where the patient gives her authorization, is pivotal in this sense since it differentiates autonomous authorization

NCHICA Research Work Group Privacy and Confidentiality Focus Group. (2001). Using Protected Health Information (PHI) for Research Purposes. Retrieved from http://www.nchica.org/HIPAAResources/Samples/PHI.pdf

Patient privacy has been a major concern for patients and medical staff for many years. Patient privacy goes hand in hand with HIPPA and the privacy rule. This protects the privacy of any person of all health information (U.S. Department of Health and Human Services, 2010). Even with this a concern for many, a study conducted by Zogby Internation studies more than 2000 adults to obtain their views on patient privacy. This studied determined that individuals would rather have individual choice and control over personal health information instead of others (Patient Privacy Rights, 2010).

Respect for human dignity includes two rights; the right to self-determination and the right to full disclosure. When conducting a research study these two rights must be maintained to ensure that the participants are not coerced into participation and that they are making the choice of their own free will. Patients must be provided with all the information necessary to make an informed decision and voluntarily participate. No deception or concealed data collection can be done because it will violate the patients’ rights.

Obtaining an informed consent is a vital part of current health care. This document lists out several key pieces of information for both the patient, Provider, and the ancillary staff that also access the document during the procedure process. However, obtaining informed consent has not always been the practice norm and in research, informed consent carries different specifications.

Crawford and Schultz (2014) summarized Big Data as “a generalized, imprecise term that refers to the use of large data sets in data science and predictive analytics (p. 96). The various sources of retrieving and generating information has expanded and exposed its vulnerability, especially to health data. A single breach holds risks of sharing critical information from a multitude of patients’ records. Predictive privacy harms, which are collected information that centers on individual data behaviors, have the potential to sidestep existing antidiscrimination regulations, but also lead to privacy breaches in healthcare (Crawford & Schultz, 2014). In the U.S. Supreme Court decision in United States v. Jones there were concerns expressed about invasions of privacy that could result in direct collection of large amounts of personal information through Global Position System (GPS) monitoring. This type of governmental power is vulnerable to abuse, endangerment of privacy rights of citizens, and weaken trust in the government (Crawford & Schultz, 2014). Crawford and Schultz (2014) state that John Locke and William Blackstone defined liberty, as it pertains to an individual, as an “unabridged natural right follow his or her own will”. (p.111) In a sense, if an individual believes privacy fits the bill, then it should be respected and left alone. Big Data faces many obstacles when it comes to the topic of privacy. The question of how to correctly respond to each challenge may vary, but success can come if both just and achievable protections are present for those at risk for this type of

Failure to protect subject’s personal information, is an example of not complying the above two principles in the research industry. Researchers are in a position of dealing with a great deal of very personal information that their participants have agreed to disclose. Depending on the type of study, personal identifiers such as names, birthdates, places of residence etc. may or may not have to be collected. In situations where these data are collected, researchers may take several steps to ensure the confidentiality of their participants’

When dealing with privacy, the data protection act requires that the identity of all participants remains confidential. As well as safeguarding privacy there is an obvious practical benefit from this approach. Participants are unlikely to volunteer for procedures if they believe that their identity and behaviour will be divulged. There were clear breaches of confidentiality in the Milgram and Zimbardo studies as in both cases participants were secretly filmed. Guidelines require that participants are not identified unless they give their permission and various methods may be used to disguise their identity. For example in case studies patients may be identified only by their initials such as KF or HM.

Informed consent is the process by which a patient is fully informed about all aspects of their healthcare and has the ability to participate in choices and make an apprise decision regarding their care. It is the legal right of the patient to direct what happens to them and the ethical duty of the doctor to involve the patient in their care. My final paper analyzes informed consent and its perilous deception. I shall present three main points against informed consent by arguing the complexity of the information given to the patient, the decision-making process and lastly patient competency.

“Following ethical informed consent procedures requires nurses to advocate for participants' best interests, ensures participants' understanding of the informed consent process and the research study, and upholds the ethical principles of autonomy, beneficence, and justice” (Judkin-Cohn et al., 2014, p. 36). The two main objectives that must be met within the informed consent are to promote participant autonomy and protect the participants from potential harm (Judkin-Cohn et al., 2014). In order to meet these objects for my Capstone Project Proposal, the participants will need to provide voluntary, informed consent prior to enrolling. Respect for the participants is gained through the informed consent process involving the following: full disclosure of the nature of the research, the process, and the possibility of withdrawal from the study (Judkin-Cohn et al., 2014). The privacy of the participants must be maintained, as well. I plan to maintain privacy by locking all of my research participant data in a locked filing cabinet, within my mentor’s clinical lead office. The research will demonstrate principles of beneficence and nonmaleficence by distinguishing the possibility of direct benefit versus lack of direct benefit, but potential for improving future patient care (Judkin-Cohn et al.,

A primary protection of the rights of clinical research subjects revolves around the concept respect for persons and the provision of informed consent (Belmont Report, 1979). Legal and ethical policies and guidelines enforce that research participants give informed consent prior to voluntary enrollment in a research study (Code of Federal Regulations,1999). However, the informed consent process presents some major challenges for study participants and

In this paper, I will discuss the principles that permit disclosure of protected health information with or without the patient’s consent for each of the four categories, government agencies, legal agencies or representatives and research groups. I will also state whether I feel privacy safeguards are adequate to support those principles.

Privacy and confidentiality are basic rights in our society. Safeguarding those rights, with respect to an individual’s personal health information, is our ethical and legal obligation as health care providers. Doing so in today’s health care environment is increasingly challenging (OJIN, 2005).

“Respect for human beings involves giving due scope to peoples capacity to make their own decisions. In the research context, this normally requires that participation be the result of a choice made by the participants” (NHMR, 2007, p.3).  Freegard 2012 (p.60), states that “respecting the rights of others,” includes a responsibility for Health professionals “to let others know about their rights” and that this forms the basis of an informed consent.

The first principle is that with very few exceptions, health care information about a consumer should be disclosed for health purposes only. The information should be easy to use for those purposes, and very difficult to use otherwise. The second principle is that technical security safeguards be maintained for computerized data. Including audit trails that identify who accessed the data and the prosecution against anyone who used the records for illegal or improper purposes. The third principle is consumer access. The patient should have ability to access his or her records and know others that also have access to them. Patients should be aware of the laws, regulations, and policies that protect their information. The fourth policy is defined as accountability, which is of relation to security and consumer control. Fines and imprisonment are required to those who breach security of personal health information. The final policy is public responsibility. Legislation must be balanced between personal, private interests and national priorities of public health, research, and law enforcement. The excessive flow of information, without patient authorization, is essential to the immediate discovery and investigation in public health crisis. AHIMA's acknowledgement of these five principles are abroad outline of a sensible public policy that balances personal privacy