Week 6: Assignment – Human Subjects Protection Assignment Prompt This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants. Evidence-based research involving human subjects requires that researchers be cognizant of and adhere to the important tenets necessary to protect subjects from abuse, harm, injury, and/or other undesirable outcomes resulting from the research process. Based on this fact, write a minimum of 2 pages (Title page and Reference not included in page count) of an APA formatted paper answering the following questions with a minimum of 3 “short” sentences for each question: PROTECTING HUMAN RESEARCH PARTICIPANTS PROTECTING HUMAN RESEARCH PARTICIPANTS a. Historical background of human subjects prote

PROTECTING HUMAN RESEARCH PARTICIPANTS

Investigators involved in clinical research should protect the welfare of human subjects. To accomplish this, they should adhere to the provisions of Good Clinical Practice and Clinical Trials (UCI.edu, n.d.). Also, they should ensure that their research protocols are approved by relevant committees such as the Institutional Review Board (UCI.edu, n.d.). This paper discusses various aspects of research involving human participants.

Historical Background of Human Subjects Protection

The research’s principles of protecting human subjects have developed over the past few decades. To begin with, the Nuremberg Code was formulated in 1948 (UNLV.edu, n.d.). It advocates for obtaining voluntary informed consent from participants involved in research (UNLV.edu, n.d.). Secondly, in 1962, the Kefauver Amendments were established. These amendments direct all manufacturers to prove the efficacy and safety of a drug before it is marketed or used in human subjects (UNLV.edu, n.d.). Thirdly, in 1964, the Declaration of Helsinki was formulated (UNLV.edu, n.d.). According to this declaration, human research should be guided by findings from animal studies and other laboratory tests (UNLV.edu, n.d.). Also, an independent committee should review and approve research protocols before they are implemented. Furthermore, voluntary informed consent must be sought from the participant (UNLV.edu, n.d.). In addition, the researchers should be competent and qualified in the medical or scientific field. Lastly, the benefits of the research should outweigh the risks (UNLV.edu, n.d.). Fourthly, in 1974, the Belmont Report was drafted. The report advocates for ethical principles to protect human subjects in research. Examples of these principles include respect for persons, justice, and beneficence (UNLV.edu, n.d.).

Historical Incident of Human Subject Abuse

Cases of abuse of the rights of humans involved in research are well documented. The first case involves German physicians and authorities. These physicians and authorities subjected prisoners to medical experiments without obtaining their voluntary informed consent (UNLV.edu, n.d.). The experiments resulted in mortalities and lifetime impairments of the subjects. This case breaches the provisions of informed consent and beneficence. The second case is the Tuskegee Syphilis Study. This study targeted low-income participants from the African American community (UNLV.edu, n.d.). 399 out of the 600 participants were suffering from syphilis (UNLV.edu, n.d.). The researchers did not inform participants of their diagnoses. Also, they intentionally withheld medication from the participants. As such, many participants succumbed to the disease. This case breaches the provisions of informed consent, beneficence, and justice.

Minimizing Risks on Human Subjects

Various approaches can be used to reduce risks to human subjects. Firstly, informed consent should be obtained from human participants (UCSF.edu, 2023). Informed consent should be voluntary and based on the provision and comprehension of pertinent facts about the research (UCSF.edu, 2023). Secondly, the benefits accrued from the research should outweigh the potential risks. This can be accomplished via an independent review of research protocols (UCSF.edu, 2023).

Furthermore, the confidentiality of participants should be upheld using strategies such as assigning codes to participants, using passcodes, and data encryption. Also, the researchers involved in the study should be qualified, competent, and adhere to good clinical practice guidelines (UCSF.edu, 2023). Thirdly, nondiscriminatory approaches should be embraced when dealing with human participants. The inclusion criteria of participants should avoid individuals with diminished autonomy. In addition, the potential merits and risks should be distributed equally among the participants.

Vulnerable Populations

Vulnerable populations should be protected because they have diminished autonomy. Examples of vulnerable populations include children, prisoners, people with terminal illnesses, and mentally handicapped individuals (Gordon, 2020). This population is vulnerable because their decisions are likely to be made by other parties. Children are considered a vulnerable population because they are unlikely to comprehend the purpose of a study and the potential risks and benefits of participating in research (Gordon, 2020). Similarly, mentally disabled people are unlikely to comprehend the purpose and potential risks and benefits of participating in research (Gordon, 2020). People with terminal illnesses have diminished autonomy because they are likely to be desperate for survival. Lastly, the decisions of prisoners are likely to be made by prison staf