Exam 3: The Ethical Treatment of Research Participants

Correct Answer:

Answered by Examlex AI Copilot

The Common Rule, formally known as the Federal Policy for the Protection of Human Subjects, is a set of ethical guidelines in the United States that governs the conduct of research involving human subjects. It was originally adopted in 1991 and is based on the Belmont Report of 1979, which identified basic ethical principles and guidelines that address ethical issues arising from the conduct of research with human subjects.

The Common Rule outlines the requirements for assuring compliance by research institutions, requirements for researchers' obtaining and documenting informed consent, requirements for Institutional Review Board (IRB) membership, function, operations, review of research, and record keeping. It also establishes mandates for the protection of the privacy of research subjects and the confidentiality of their data.

The main goals of the Common Rule are to protect the rights and welfare of research participants and to ensure that such research is conducted in an ethical manner. Key provisions of the Common Rule include:

1. Informed Consent: Researchers must provide potential participants with all the information necessary to make an informed decision about their participation, including details about the research purpose, procedures, risks, benefits, and alternative treatments if applicable.

2. Institutional Review Boards (IRBs): Research involving human subjects must be reviewed and approved by an IRB, which is a committee that ensures the study is ethically sound and that the rights and welfare of participants are protected.

3. Assurances of Compliance: Institutions that engage in research involving human subjects must provide assurances that they will comply with the requirements of the Common Rule.

4. Additional Protections for Certain Populations: The Common Rule includes additional protections for vulnerable populations, such as pregnant women, prisoners, and children.

5. Requirements for Documentation: The Common Rule requires researchers to document the informed consent process and maintain records related to the research.

The Common Rule applies to all research involving human subjects that is conducted, supported, or otherwise subject to regulation by any federal department or agency that has adopted the policy. This includes research funded by the National Institutes of Health (NIH), the Department of Health and Human Services (HHS), and other federal agencies.

In 2017, the Common Rule was revised to modernize, strengthen, and make more effective the federal policy that protects the subjects of research. The revised Common Rule includes changes to the informed consent process, the criteria for IRB approval of research, and the requirements for continuing review of research, among other updates. The revisions were intended to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators.

Correct Answer:

Answered by Examlex AI Copilot

The risk of deprivation refers to the potential for individuals or groups to experience a lack of basic resources or access to services that are essential for maintaining an adequate standard of living and well-being. This can include material resources like food, clothing, and shelter, as well as non-material needs such as education, healthcare, social support, and opportunities for cultural or recreational activities.

Deprivation is important for several reasons:

1. **Human Rights**: Access to basic necessities is often considered a fundamental human right. Deprivation can lead to violations of these rights, which can have moral and legal implications.

2. **Health**: Deprivation can have severe impacts on physical and mental health. Lack of nutrition, healthcare, and living in poor conditions can lead to illness and decreased life expectancy.

3. **Social Stability**: High levels of deprivation can lead to social unrest and instability. When large segments of a population are struggling to meet their basic needs, it can result in increased crime rates, social tensions, and even conflict.

4. **Economic Impact**: Deprivation can hinder economic development. When people are deprived of education and health, they may not be able to contribute effectively to the economy. This can lead to a cycle of poverty that is difficult to break.

5. **Child Development**: Children who grow up in deprivation are at risk of long-term effects on their development and future prospects. They may perform poorly in school and have limited opportunities for upward social mobility.

6. **Equality and Fairness**: Deprivation often disproportionately affects certain groups, such as minorities, the elderly, or the disabled. Addressing deprivation is important for promoting equality and fairness within societies.

7. **Quality of Life**: Beyond the material aspects, deprivation can also mean a lack of opportunities to engage in society, pursue personal interests, and develop one's abilities, which are all important for a good quality of life.

8. **Intergenerational Effects**: Deprivation can be passed from one generation to the next, creating a cycle of poverty and limited opportunities that is difficult to break without intervention.

To mitigate the risk of deprivation, governments and organizations implement various social policies and programs aimed at poverty reduction, social welfare, and economic development. These can include social security systems, universal healthcare, education programs, housing assistance, and job training initiatives. Addressing the risk of deprivation is crucial for building more equitable, healthy, and prosperous societies.