How to write a nursing essay on Human Subjects Protection (Solved)

How to write a nursing essay on Human Subjects Protection (Solved)

Historical Background of Human Subject’s Protection.

The current human subject protection law was developed over fifty years ago. The principles for conducting research were developed firstly as the Nuremberg Code in the trial of Nazi war criminals (Resnik, 2018). The code has three basic elements; right to withdraw without repercussions, favourable risk-benefit analysis and voluntary informed consent.  These principles later become the research regulations and subsequent ethical codes.  In 1964, a declaration was released by the World Medical Association, which built on the Nuremberg code. Later the US prompted a congressional deliberation for the protection of the rights and welfares of human subjects. Following the deliberation, a National Commission for Protection of Human Subjects of Biomedical and Behavioral Research was developed.

Historical Event

N example of a historical event of human subject abuse in research occurred in Willowbrook School for Mentally Retarded Children.  A researcher purposely infected children with hepatitis via injection root.  Later experimental vaccines were administered. However, the researcher did not explain the risks fully to the parents. The researcher violated the right of the parents to know the risks associated with the experiment before consenting to the procedure.

Steps To Take To Minimize Risks

Various steps can be taken to minimize risks to human subjects.  The risks should be minimized using procedures consistent with sound research designs and those that do not expose the participants to unnecessary risks (Resnik, 2020). Secondly, one can ensure that the risk to the participants is reasonable in relation to the benefits. Thirdly a researcher can assemble a highly-skilled research team to reduce risks associated with human errors. Finally, data should be collected from the standard of care procedures to minimize risks.

Vulnerable Populations

A vulnerable population in research refers to a group of individuals that cannot protect the self-interest of its members in the course of being test subjects. It includes those individuals with limited ability to properly obtain proper consent, such as individuals with various cultural or language barriers. Due to some reasons, these individuals may not understand the risks and benefits of the research due to the language barrier or the high illiteracy levels. Finally, it may include those individuals who are socially or economically disadvantaged; hence engaging in the research is the only way to get otherwise unavailable medical treatment.

Appropriate Ways of Recruiting Subjects

Human subjects can be recruited using various ways. Firstly advertisements and notices can be used to recruit subjects. Secondly, clinical trial websites can be utilized to recruit subjects.  A waiver consent can also be used in healthcare facilities.  Finally, individuals unknown to the researcher can be approached in public. This can include obtaining individuals from shopping malls, market areas and schools.

Obtaining Consent

Consent should be obtained properly to minimize risks to subjects. Firstly the researchers need to explain the research to the human subjects. They should provide all the pertinent information to the participants, including the risks and the benefits. In the second step, the researcher needs to assess participants’ comprehension to ensure they have understood the risks and the benefits of the research. After comprehension, the individuals can then provide written consent, requiring a declaration or their signature or both.

Elements of a Properly Executed Consent

There are various capacities of properly executed consent. Firstly participants can make a decision.  Secondly, the participants comprehend the relevant information. Finally, consent should be provided without any coercion or duress. The consent should be in written form or recorded.

Committees Responsible For Monitoring the Protection of Human Subjects

Various committees are responsible for protecting human subjects during research. One of the committees is the Institutional Review Board (Damarez, 2020). This board is mandated by the federal system to review, approve or disapprove research involving human subjects. The committee also monitors the research to ensure human subjects are protected throughout the research process.

 

References

Demarez, J. P. (2020). The Committee for the Protection of Human Subjects in biomedical research, crossroads of misunderstandings. Therapie.

Resnik, D. B. (2018). Research ethics with human subjects: Protecting people, advancing science, promoting trust (Vol. 74). Springer.

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