The Human-Subject System of Protection in Bioethics

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Table of Contents

Historical Background of Human Subject Protection
Historical Incident of Human Subject Abuse and Human Rights Violated
Steps Taken to Minimize Risks on Human Subject
References

Historical Background of Human Subject Protection

The human-subject system of protection currently being used has undergone serious development in the last six decades. The rules followed today while conducting human research were developed as the Nuremberg code used in the trial of the Nazi war criminals (Resnik, 2018). The three basic constituents of the code were consent that was informed, favorable risk and risk analysis, and the right to pull out from the research. The principles became the foundation and cornerstone for the research regulations and ethical codes that followed the Nuremberg code (Malgieri & Niklas, 2020)

After the Second World War, the world superpowers focused most of their attention on finding cures for some deadly diseases, and human subjects were needed for the success of the research. Between 1950 and 1973, countless research misconducts were reported in the United States, prompting congressional contemplation about human-subject research management. The National Research Act of the year 1974 was Congress’s first legislation move to safeguard the rights of those participating in their research (Artal & Rubenfeld, 2017). The legislation created a national commission that protected participants in Biomedical and behavioral research. The commission issued a report stating three fundamental principles in conducting human subject research. The three principles were respect for the persons participating in the human subject research, justice, and benefaction for those involved (Resnik, 2018).

Historical Incident of Human Subject Abuse and Human Rights Violated

The public health service, in collaboration with Tuskegee’s institute, began researching syphilis in 1932 in the hopes of justifying treatment for black men. A total of 600 people were interested in the study, all of whom were black; 399 had contracted syphilis, and 201 did not have the disease. (Dickert et al., 2017) The 600 men involved in the Tuskegee study were not given the benefit of the human subject’s informed consent as the researchers carrying out the research informed the subjects that they were testing for bad blood, a word they used to describe various diseases. The project was initially scheduled for six months, but it went on for forty years.

The Tuskegee study violated the bioethical code of respect and denied the participating human subjects the right to complete information to make sovereign decisions. The participants faced racial injustices as the researchers were only using human subjects from the African American community. The human subjects that were tricked into participating in the study were denied the right to receive good healthcare (Dickert et al., 2017). The participants’ treatment was withheld after it was identified as the best choice of treatment.

Steps Taken to Minimize Risks on Human Subject

Consent

Participants are the best judges as to what is the acceptable amount of risk. Providing the participants with consent that is accurate and communicates effectively about what the study entails helps them decide on what is best for them (Lentz et al., 2016). The participants must read and understand the consent form before signing.

Data Collection and Storage

Losing confidentiality always proves to be a risk to those participating. Therefore, the data collection and storage methods ought to be the practices recommended and compliant with the data storage protocols (Malgieri & Niklas, 2020). Research that collects its information anonymously means that the data about participants cannot be leaked, which is considered a minimal risk. The data must be appropriately stored and destroyed after analysis to protect the participants’ confidentiality (Artal & Rubenfeld 2017).

The Population Considered Vulnerable

Refugees and IDPs, children, and pregnant women are a vulnerable population. The International Rescue Committee has a policy that does not tolerate anyone’s abuse in the vulnerable population. Children are not to continue participating in research if the team notices they are experiencing guilt, fear, or obligation (Blades et al., 2018). Refugees may be in trouble if any breach of confidentiality occurs. Pregnant women, and those that are still nursing children, may encounter increased mental and physical risks from taking part in the research (Goodwin, 2016).

Appropriate Ways of Recruiting Human Subjects

All research recruitment methods must be described following the International Rescue Committee protocol. The recruitment process materials have to be approved by the IRC (Kadam et al., 2016). Ways of recruiting people for human subjects include notices, advertisements, and the mainstream media. Furthermore, the UCIMC Clinical Trials Website can be utilized to post information related to the research study. The researcher should consider approaching the patients, students, and even employees in person (Lada, 2017).

Proper Ways of Obtaining Consent from Human Subjects

Any research that needs human subjects must be pre-emptively accepted by the participants after thoroughly briefing them on the whole exercise. Competent participants able to understand and comprehend the information related to the research topic can give proper consent (Goodwin, 2016). Giving the subject enough information about the study, giving them enough time to weigh all of their choices, and answering their questions accurately and honestly are all part of the informed consent process (Resnik, 2018).

Components of a Properly Written Consent

The study definition, threats, and any discomforts, benefits of the research to the subject and others, alternative procedures or therapies, confidentiality, human subject compensation, and any medical check-up or accident care, communications, and voluntary involvement are all included in a well-executed consent. All research-related information must be given so that participants can determine whether or not to be part of the study (Goodwin, 2016).

Committees Responsible for Monitoring Human Subjects Protection

Institutional Review Boards (IRBs) provides protection to human subject participating in research through the advanced and periodic reviews of the ethical acceptability of proposals presented by the researchers (Lada, 2017). IRBs play a significant role in the protection of human subjects from possible exploitation and harm.

References

Artal, R., & Rubenfeld, S. (2017). Ethical issues in research.Best Practice & Research Clinical Obstetrics & Gynaecology, 43, 107-114. Web.

Blades, C. A., Stritzke, W. G., Page, A. C., & Brown, J. D. (2018). The benefits and risks of asking research participants about suicide: A meta-analysis of the impact of exposure to suicide-related content. Clinical Psychology Review, 64, 1-12.

Dickert, N. W., Eyal, N., Goldkind, S. F., Grady, C., Joffe, S., Lo, B., Miller, F. G., Pentz, R. D., Silbergleit, R., Weinfurt, K. P., Wendler, D., & Kim, S. Y. (2017). Reframing consent for clinical research: A function-based approach.The American Journal of Bioethics, 17(12), 3-11. Web.

Goodwin, M. (2016). Vulnerable subjects: why does informed consent matter?.The Journal of Law, Medicine & Ethics, 44(3), 371-380. Web.

Kadam, R. A., Borde, S. U., Madas, S. A., Salvi, S. S., & Limaye, S. S. (2016). Challenges in recruitment and retention of clinical trial subjects.Perspectives in Clinical Research, 7(3), 137. Web.

Lada, F. (2017). Guidance for the management and administrative operations of Research Ethics Committees (REC). In Research ethics in the Arab Region (pp. 325-342). Springer.

Lentz, J., Kennett, M., Perlmutter, J., & Forrest, A. (2016). Paving the way to a more effective informed consent process: Recommendations from the Clinical Trials Transformation Initiative.Contemporary Clinical Trials, 49, 65-69. Web.

Malgieri, G., & Niklas, J. (2020). Vulnerable data subjects.Computer Law & Security Review, 37, 105415. Web.

Resnik, D. B. (2018). The ethics of research with human subjects: Protecting people, advancing science, promoting trust. Springer.

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