In to world of healthcare, one thing has become very clear when talking about what is ethical and unethical, and that is if it is unethical it is almost always illegal. When discussing the topic of ethics you cannot leave out behavior. In most cases an individual’s behavioral patterns usually determines their level of ethical thought process. In the text is says this about behavior, “People’s behavior must match their set of values. It is not enough to believe that patient confidentiality is important if one then freely discusses a patient’s personal information with a coworker or a friend”(Fremgen, 2009). Patient Privacy is the issue at hand and one of the most important laws that we have governing healthcare profession today. According to the American Medical News Journal, patient health information was not being protected or secured to the highest level of standards in the eyes of the AMA (American Medical Association). In order to help improve that the AMA approved new policies that will provide a better blanket of security for the medical records of the individuals participating in any medical research (Aston, 1999).
The AMA wants to ensure that any entity in the United States that conducts research on human subjects are gaining proper consent for the research study, and that the consents are not being misused by others. These signed consents are permission slips for researchers to use medical information only for research purposes. The new policies focus on the confidentiality of the patient’s information that is obtained for the sake of medical research, and should not be shared for any other reason then what was originally intended. These policies also focus on accountability of many organizations and schools who conduct research to be ethical in their dealings with human subjects. Good ethics means good intent and integrity. In terms of research any typing of alterations or fraudulent acts does in display good intent. This was the case with the NIH (National Institute of Health) and NCI (National Cancer Institute) who was accused by the author of the article of not living up to their mission statement.
The mission statement of the NIH says” Science in pursuit of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend health life and reduce the burdens of illness and disability”(Lanfranchi, 2008). It also included a goal which states “to exemplify and promote the highest level of scientific integrity, public accountability, and social responsibility in the conduct of science” (Lanfranchi, 2008). These goals and mission statements from the outside look great however, it was later discover that fraudulent acts were done because of the pressure the NIH was placing on the researchers. This is a good example of unethical acts in research it start out with good intentions but ended in unethical acts will eventually turn into a legal issue.
Ethical and Legal Issues
In the article, the issues that were discussed were mainly ethical issues that could potentially turn into major legal issues. One of the issues mentioned was the fact that the IRB’s should have been more concerned with patient health information staying confidential. Though this is important, their main concern was the safety and wellbeing of research participants. The AMA developed recommendations that addressed both the informed consent issue and the confidentiality issue. Another issue was that the U.S. would only be allow a short time frame of 18mths to make stricter privacy laws and after that point federal laws would take over. Aside from the AMA’s recommendations AIVIA is a supporter of the idea that the United States should have the ability to pass stricter privacy laws (Aston,1999). According to research, the AIVIA ( All Indians Village Industries Association) is a board of 18 advisors that consist of distinguished scientist and leaders in public life founded by Mahatma Gandhi in 1934(www.mgiri.org).
The article did not discuss any managerial responsibilities in terms of the issues the AMA were trying to fix. In this case however, the AMA held their ground on the issues and stated that fairness should be across the board. They strongly urged that any time changes are being made to the research study that a new consent must be signed by the participants (Aston, 1999).
The AMA task force is concerned with the improvement of the confidentiality and to joined forces with the IRB’s to create accountability for private research (Aston, 1999). The AMA came up with eight solutions/recommendations for the issues with informed consent and confidentiality and they are as follows: The first solution is to advocate where possible, informed consent should be obtained before personally identifiable health information is used for any purpose. If informed consent is not possible then the information must be stripped for the data and the entity accountable must determine that patient consent is not needed. The second solution states that the AMA urges the government to consider adding to the Common Rule Standards and require researchers to waive/ modify patient consent for the sue of personally identifiable health information only when other protection is in place.
The third solution is to lobby for creation of a system in which research projects that fall outside the IRB process would be subject to review by local confidentiality assurance boards. The fourth solution is to make sure that teaching institutions involved in research receive personnel and resources to protect the individuals involved in the research study. The fifth solution states to continue to push for federal laws that provide a continuous layer of patient privacy protection that allows states to pass stronger measures. The sixth solution suggests to develop models of state confidentiality legislation to promote consistency The seventh solution states to continue to push to prohibit the sale and exchange of anyone’s personal identifiable health information. The eighth and final solution suggests to support voluntary of adherence to all IRB’s to the Common Rule Standards regardless of the institutions source of funding (Aston, 1999).
ed. Ch.11 Ethical and Bioethical Issues in Medicine. Lanfranchi, A., (2008). Issues in Law and Medicine. The federal Government and Academic Texts as Barriers to informed Consent. Vol. 24 (1) pp. 61-69. Retrieved from http:// www.mgiri.org/about-institute.