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 research subjects. The course material presents basic concepts, principles, and issues related to the protection of research participants. Protecting Human Subjects in Research- Principles and Obligations for Researchers Protecting Human Subjects in Research- Principles and Obligations for Researchers 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: Historical background of human

Protecting Human Subjects in Research- Principles and Obligations for Researchers

Historical background of human subject protection

The basic regulations governing human subjects’ protection in research were introduced in 1974.During that year, Congress passed the first legislation aimed at protecting the welfare and right of human subjects. The regulation was known as the National Research Act that led to the formulation of the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research that provided the Belmont Report (Rice, 2008). The report provided three major principles for conducting research using human subjects, which were justice, beneficence and respect for persons.

Historical incidents of human subject abuse in research and what human rights were violated

One of the major historical incidents where human subjects were abused in research was the US syphilis study conducted in Guatemalan. In the research, people from the marginalized populations in Guatemala were subjected to experiments without their consent, including intentional exposure to gonorrhea, syphilis, and chancroid, resulting in permanent damage. The research experiments targeted sex workers, prisoners, patients in psychiatric hospitals run by the state, soldiers and children in orphanages (Caplan, 2007). The sex workers were required to have intercourse with the other group of people who did not have mobility and were kept in one place to facilitate observation throughout the experiment. The experiments violated the human right to be free from torture and degrading treatment.

Steps taken to minimize risks to human subjects

The main steps that should be taken to minimize putting human subjects at risk are obtaining informed consent from them, protecting their confidentiality and anonymity, avoiding deceptive practices when formulating the research and providing the participants with the right to withdraw from the research at any time. It is additionally important to provide a safe environment for the experiment. Participants should additionally not be confined in one place without their consent.

Populations considered vulnerable populations and why

Vulnerable populations include racial and ethnic minorities, ill people dependent on healthcare providers, children and economically disadvantaged people. These people are considered vulnerable because they have difficulty providing informed consent and voluntarily participating in a study due to limited decision-making capacity and situational circumstances. They are also considered vulnerable because they are easily exploited by people who have higher authority.

Appropriate ways to recruit subjects

One of the appropriate ways to recruit subjects is contacting the targeted research participants to inform them about the study and get their consent to voluntarily participate by signing a consent. The second way is using the UCIMC Clinical Trials website or a website similar to it to post information on the research study. The third way is providing the targeted research participants with an introduction letter describing the research, its purpose, and the procedures to be used.

Properly obtaining consent

Obtaining consent in the right way includes various steps. One of the steps that I would follow is giving adequate information about the research to targeted research participants in a language they understand. The second step is providing adequate opportunity for the targeted participant to consider all options before agreeing to participate in the study. The third step is responding to the questions asked by the targeted participant without withholding any information, including information on any harm the participant could face. The fourth step is obtaining voluntary agreement from the targeted participant and maintaining an exchange of information between the targeted participant and researcher, and requiring the documentation that the participant gave consent.

The elements of a properly executed consent

A properly executed consent includes disclosure of information, the voluntary nature of the decision, and the competency of the patient to make a decision (Valapour et al., 2010). Adhering to these elements requires a detailed and full explanation of the study and its possible risks. The risks need to be clearly outlined without holding any information.

Committees responsible for monitoring the protection of human subjects

The main committee responsible for overseeing the protection of human subjects is the Institution Review Board. It guarantees that appropriate steps are taken to protect the welfare and rights of the huma