Protecting Human Research Participants Reflection Essay Assignment

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Protecting human research participants is of utmost importance. Even though your change project will not be implemented in the field and you will not be engaging with human subjects in this context, it is still critical that all healthcare professionals have a solid foundation in patient rights and protections within the realm of research. It is essential that all healthcare professionals, whether or not they are currently involved in research studies, remain aware of regulatory policies and updates such as the Federal Policy for the Protection of Human Subjects, or Common Rule, that will take effect January 2019 Protecting Human Research Participants Reflection Essay Assignment.

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*Please see attached file for Protecting Human Research Participants*

*Discuss at least two of the following in your paper:

A)Describe the circumstances that influenced the need for a policy to protect human research subjects. Give examples of specific ways human research subjects can be harmed by researchers.

B)Identify three vulnerable populations and the special restrictions associated with human research among these groups. Evaluate the requirements and restrictions. Do you think they are adequate? Why or why not?

C)The Belmont Report summarizes the ethical principles and guidelines for research involving human subjects. Three core principles are identified: respect for persons, beneficence, and justice. Even though these principles are considered equal, prioritize them in order of importance to you. Explain your decisions.

D)Although you are not implementing a change project at this time, and you may not be directly involved in research as part of your professional responsibilities, explain the reasons why it is important for you to know about these rights and protections.

Your reflective paper should be two pages and written in current APA Style. Refer to the rubric for more information.

Please use the attached rubric. Also please use the attached file on Protecting human research participants as one of the references.

NIH Protecting Human Research Participants Reflection

The National Institutes of Health (NIH) has issued guidelines to ensure the ethical treatment of human subjects in research. Two key guidelines include protecting vulnerable populations with special restrictions and adhering to the ethical principles outlined in the Belmont Report (National Institutes of Health, 2013)Protecting Human Research Participants Reflection Essay Assignment. These guidelines are crucial for upholding the dignity and autonomy of human participants and ensuring that research is conducted in a responsible and ethical manner.

Question B

In research, it is necessary that the researcher identifies vulnerable populations. In the context of this report, the three vulnerable populations in human research that are considered are minors, pregnant women, and prisoners. According to Shi and Stevens (2021), each group has unique ethical and legal considerations that must be addressed to protect their rights and welfare. Minors are children under 18 years of age and are considered vulnerable due to their inability to provide informed consent. If possible, research involving minors must obtain consent from their parent or legal guardian and the child’s assent. De Chesnay and Anderson (2019) advised that research involving minors must be minimal risk, meaning the risks should not exceed those encountered in daily life.

The second population is pregnant women. This group is vulnerable because the research intervention could affect the fetus. According to Shi and Stevens (2021), pregnant women are only allowed to participate in research if it directly benefits their health or the health of their fetus. For example, NIH guidelines support the participation of pregnant women in a study to test a new drug that can help prevent preterm labor (National Institutes of Health, 2013)Protecting Human Research Participants Reflection Essay Assignment. The researcher would be right to invite pregnant women who are at high risk for preterm labor in the study. In addition, researchers must take measures to ensure the safety of the fetus and adhere to ethical principles of autonomy, non-maleficence, and justice. Prisoners are the third vulnerable population, which is justified by their limited autonomy and the inability to consent to research participation freely. This population can only participate in research if it offers potential benefits to their health or the health of other prisoners and the risks are minimized.

The requirements and restrictions for research involving vulnerable populations aim to protect their rights, safety, and welfare. However, these requirements sometimes hinder the progress of medical research, making it difficult to obtain data from these groups. This notwithstanding, the restrictions and regulations safeguard against exploitation and harm of the highlighted vulnerable populations, and they are necessary to ensure ethical and responsible research.

Question C

The three core principles of the Belmont Report are respect for persons, beneficence, and justice. Brothers et al. (2019) have explained that respect for persons refers to recognizing individuals’ inherent value and autonomy, which involves obtaining informed consent, protecting privacy, and ensuring confidentiality. Using an example, in a study on a new medication’s effects on memory, the researcher would need to obtain an informed consent from participants, to duly protect their privacy and confidentiality, and respect their autonomy by giving them the freedom to choose to participate or not (National Institutes of Health, 2013)Protecting Human Research Participants Reflection Essay Assignment. Brothers et al. (2019) further explained that beneficence requires research to maximize benefits and minimize risks to participants. Justice entails that the distribution of the benefits and burdens of research should be fair and equitable. While all three principles are essential, beneficence should be prioritized as the most important principle in research involving human subjects. The rationale for this is that the primary purpose of research is to benefit society and improve human welfare. Drawing from this, researchers have a moral obligation to maximize the potential benefits of research while minimizing its risks and must also prioritize the well-being of participants and ensure that the research design, implementation, and dissemination of findings are ethically responsible.

The next in the order of priority is respect for persons. Respect for persons acknowledges the autonomy and dignity of individuals. Participants should have the right to informed consent, privacy, and confidentiality. Researchers must emphasize that these participants are fully informed about the study, the potential risks, and the benefits of participation. In addition, they should also be allowed the freedom to withdraw their consent at any time. Lastly, the principle of justice should be applied to certify that the benefits and burdens of research are distributed fairly and equitably among all members of society (Shi & Stevens, 2021)Protecting Human Research Participants Reflection Essay Assignment. Further, justice requires researchers to avoid exploiting vulnerable populations and to ensure that the research benefits all members of society.

Recap

In conclusion, the NIH guidelines on protecting vulnerable populations and adhering to the ethical principles some of which are outlined in the Belmont Report are critical for safeguarding the well-being and rights of human participants in research. It is the responsibility of researchers and institutions to adhere to these guidelines to ensure that research is conducted in an ethical and responsible manner.

References

Brothers, K. B., Rivera, S. M., Cadigan, R. J., Sharp, R. R., & Goldenberg, A. J. (2019). A Belmont reboot: Building a normative foundation for human research in the 21st century. Journal of Law, Medicine & Ethics, 47(1), 165-172. https://doi.org/10.1177/1073110519840497

De Chesnay, M., & Anderson, B. (2019). Caring for the vulnerable. Jones & Bartlett Learning.

National Institutes of Health. (2013). protecting Human research participants. NIH Office of extramural research.

Shi, L., & Stevens, G. D. (2021). Vulnerable populations in the United States. John Wiley & Sons.

NIH Protecting Human Research Participants Reflection

Question B

In research, it is necessary that the vulnerable populations are identified by the researcher. In the context of this report, the three vulnerable populations in human research that are considered are minors, pregnant women, and prisoners. According to Shi and Stevens (2021)Protecting Human Research Participants Reflection Essay Assignment, each of this group has unique ethical and legal considerations that must be addressed to protect their rights and welfare. Minors are children under 18 years of age and are considered a vulnerable population due to their inability to provide informed consent. Research involving minors must obtain consent from their parent or legal guardian and the assent of the child, if possible. De Chesnay and Anderson (2019) advised that research involving minors must be minimal risk, meaning the risks should not exceed those encountered in daily life.

The second population are pregnant women. This group are vulnerable because the fetus could be affected by the research intervention. According to Shi and Stevens (2021), pregnant women are only allowed to participate in research if it directly benefits their health or the health of their fetus. In addition, researchers must take measures to ensure the safety of the fetus and adhere to ethical principles of autonomy, non-maleficence, and justice. Prisoners are the third vulnerable population and this is justified by the fact that they have limited autonomy and inability to freely consent to research participation. Prisoners can only participate in research if it offers potential benefits to their health or the health of other prisoners, and the risks are minimized.

The requirements and restrictions for research involving vulnerable populations aim to protect their rights, safety, and welfare. However, these requirements sometimes hinder the progress of medical research, making it difficult to obtain data from these groups. This notwithstanding, the restrictions and regulations serve to safeguard against exploitation and harm of vulnerable populations, and they are necessary to ensure ethical and responsible research Protecting Human Research Participants Reflection Essay Assignment.

Question C

The three core principles of the Belmont Report are respect for persons, beneficence, and justice. Brothers et al. (2019) have explained that respect for persons refers to the recognition of the inherent value and autonomy of individuals, which involves obtaining informed consent, protecting privacy, and ensuring confidentiality. Beneficence, Brothers et al. (2019) have further explained, requires that research should aim to maximize benefits and minimize risks to participants. Justice entails that the distribution of the benefits and burdens of research should be fair and equitable. While all three principles are essential, beneficence should be prioritized as the most important principle in research involving human subjects. The rationale for this is that the primary purpose of research is to benefit society and improve human welfare. Drawing from this, researchers have a moral obligation to maximize the potential benefits of research while minimizing its risks and must also prioritize the well-being of participants and ensure that the research design, implementation, and dissemination of findings are ethically responsible.

The next in the order of priority is respect for persons. Respect for persons acknowledges the autonomy and dignity of individuals. Participants should have the right to informed consent, privacy, and confidentiality and researchers are required to place emphasis in ensuring these participants are fully informed about the study, the potential risks, and benefits of participation. In addition, the participants should also be allowed the freedom to withdraw their consent at any time. Lastly, the principle of justice should be applied to certify that the benefits and burdens of research are distributed fairly and equitably among all members of society (Shi & Stevens, 2021)Protecting Human Research Participants Reflection Essay Assignment. Further, justice requires researchers to avoid exploiting vulnerable populations and to ensure that the research benefits all members of society.

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References

De Chesnay, M., & Anderson, B. (2019). Caring for the vulnerable. Jones & Bartlett Learning.

Shi, L., & Stevens, G. D. (2021). Vulnerable populations in the United States. John Wiley & Sons Protecting Human Research Participants Reflection Essay Assignment