HSCI705 Quiz Ethical Framework

Question 1

18 / 20 pts

List and describe the key criteria for a research proposal to be classified as exempt, expedited, or a full board review.

Your Answer:

For a research proposal to be classified as exempt, the key criterion is whether or not there is any involvement with human subjects or vulnerable populations in the proposed research. If there is any involvement, it cannot be classified as exempt (though if it ranks as nonexempt, it does not have to follow IRB requirements). However, if there is no involvement and the researcher follows appropriate human subjects research criteria, it may qualify as exempt.

For a research proposal to be classified as expedited, the key criterion is whether or not the research is intended for only educational, commercial, and marketing uses. If it is designed for education, it can be classified as expedited. However, if it is intended for commercial/marketing purposes (even if it is also used for educational purposes), it cannot be classified as expedited.

The critical criteria to classify as a full board review are whether or not a proposal has any foreign national research participants. It cannot be classified as a full board review if it does.

-2 your response is lacking detail regarding the different components involved in a full board review.

Question 2

18 / 20 pts

It has been proposed that the science community loses autonomy when scientific ethics come into conflict with social ethics. Do you agree with this statement? Why or Why not? B) Describe what this means in your own words what it could mean for the general scientific community, for your academic institution, and your own research when conflict occurs.

Your Answer:

Question: It has been proposed that the science community loses autonomy when scientific ethics come into conflict with social ethics. Do you agree with this statement? Why or Why not?

Answer: Yes, I absolutely agree with this premise of thought. Scientific autonomy becomes an issue when scientific research conflicts with societal values. For example, ethical concerns affect scientific research processes when scientists allow personal biases and political affiliations to affect ongoing research. Scientific ethics involves experimenting and analyzing data without bias, regardless of what the conclusions might suggest.

Question: Describe what this means in your own words what it could mean for the general scientific community, for your academic institution, and for your own research when conflict occurs.

Answer: Fabricating data, falsifying results, or misappropriating the ideas will give a wrong impression of the real and actual results which will misguide the public and the entire community in general thus leading to confusion or disaster for the public. For instance, if a certain immunization vaccine was falsely said to be good for children and was administered to the public would be the public will take it and die of its demerit due to false data research.

-2 you did not discuss academic institutions and your own research when conflict occurs (review question prompt).

Question 3

20 / 20 pts

What are the challenges to ethically conduct research with a vulnerable population? Identify different vulnerable populations and current guidelines to protect these populations in regards to human subjects research.

Your Answer:

Question: What are the challenges to ethically conducting research with a vulnerable population?

Challenges

The challenges to ethically conduct research with a vulnerable population include:

• Enabling participants to feel safe and comfortable in their research context.

• Incorporating social, cultural, and ethical considerations.

• Ensuring that vulnerable populations are not subjected to additional challenges such as being a target of violence from others or inadequate health care.

Enabling participants to feel safe and comfortable in their research context can be challenging for researchers who work in urban environments or with communities with limited access. Research participants may fear the consequences of being interviewed by a researcher. Researchers must find ways to engage clients in their research, whether by reassuring, disclosing trustworthiness statements, or explaining confidentiality and anonymization. Additionally, it is essential that participants feel comfortable with their identity as a member of the target group. For example, if a researcher is researching transgender people, identifying as part of the group can help them avoid facing discrimination from other members of that community. It also helps to hire an ally as a research assistant who can assist researchers in approaching others in the target group without causing additional stigma.

Incorporating social, cultural, and ethical considerations can sometimes be challenging for researchers. Research participants may be at risk of discrimination based on class, race, sexual orientation, and other identity issues. Researchers are obligated to consent to research participants involved in certain circumstances that could threaten the safety of others. For example, this type of consent would come into play for vulnerable populations whose health may be compromised by participating in research. When working with a vulnerable population, researchers must ensure the confidentiality and anonymity of all participants to protect them from harm. This is often more important than protecting the identity of researchers so that research can be conducted fairly and objectively.

They are ensuring that vulnerable populations are not subjected to additional challenges such as being a target of violence from others or inadequate health care can be a challenge because research participants and researchers alike may be working with a community that already faces high levels of discrimination. This can occur in LGBT youth, the elderly, or other groups in which people are threatened or harmed because of their membership. Researchers must identify ways to minimize harm to vulnerable people. Some options include recruiting allies and healthcare providers who are sympathetic to the target population, using small samples with minimal risk bias, or seeking government assistance in cases of high-risk populations.

Question 4

20 / 20 pts

A common set of overarching ethical principles for conducting human subjects research have been adopted international. Describe how each of these overarching principles may apply to the following research activities: A) recruitment of participants; B) informed consent; C) collection of data; D) data analysis; and E) publication or presentation of the results. Include biblical concepts that inform your responses and explain how the biblical concepts are consistent or are in conflict with the ethical application that you describe.

Your Answer:

Overarching ethical principles

Recruitment of participants involves explaining how to participate in the study and what is expected of them. Recruitment of participants may also include explaining that participation can help participants since they may receive payment while, at the same time, they will be contributing to medical research (Birnbaum, 2020). The overarching ethical principles that apply to the recruitment of participants include benevolence and fairness. Biblical concepts of beneficence and fairness have the premeditated intention to do good for others, avoid harm, and consider the needs of the individual (Ezekiel 18). Respect for persons includes respecting the dignity and worth of people. Justice means treating people equally without causing harm, who are mistreated also experience this kind of harm. Each principle that applies to the recruitment of participants will inform how to conduct ethical research with them.

Informed consent is a process whereby each person consents or agrees to be treated for a particular condition in a way that considers their interests. It is also a process where participants are told what will happen to them, what benefit they can get from the study, who they should contact if they have questions or want to withdraw from the study, and how their confidentiality will be protected. The overarching ethical principles of informed consent include respect for persons and justice. Respect for persons includes respecting the dignity and worth of people. Justice means treating people equally without causing harm. Each of these principles informs how to conduct ethical research with participants so that they understand what is expected of them and they give their voluntary consent.

Collection of data is one of the research activities that may be conducted in order to get the results needed by researchers. Collection of data is a process where investigators collect data related to human subjects and record it in a way that can be analyzed. The overarching ethical principles that apply to the collection of data include confidentiality in order to protect the privacy of participants as well as keep them trustworthy since they will never know what happens with their data.

Data analysis is a scientific practice that involves selecting, organizing, cleaning, and interpreting data. The overarching principles may apply to data analysis in a variety of contexts, including individual research, large-scale surveys, or data archives. The principles apply by their nature to the scientific analysis of all data, regardless of their form or purpose (Tight, 2020). The overarching principles can be applied to the analysis of large and small samples, clinical and non-clinical data, observational and experimental data, and prospective and retrospective studies.

Presentation of the results is the essence of reporting research results (clinical or basic science). The manner of presentation of the results may be judged by a number of criteria: accuracy, completeness, consistency with the data presented in the report, methodological rigor, and appropriateness for the audience. The overarching ethical principles applied include the principle of beneficence. Beneficence requires that data be reported in a true and fair manner without exaggeration or censoring results. This principle of beneficence may be violated if the research or the results are made part of a pseudoscientific or fraudulent enterprise.

References:

Birnbaum, M. H. (2020). Human research and data collection. Annu. Rev. Psychol, 55, 803-32.

Blaxter, L., Hughes, C., & Tight, M. (2020). How to research. McGraw-Hill Education (UK).

Question 5

20 / 20 pts

Describe the unique contributions of the Declaration of Helsinki, the Belmont Report, and the Nuremburg code. Provide specific examples for each in detail.

Your Answer:

The unique contributions of the Declaration of Helsinki include:

1. To ensure that the supervisory boards are represented on the committees of supervisors, thereby representing the rights of physicians fully. The only counter to this is if a state insists that its own laws apply, in which event the full legal responsibility for Health Care rests with the state.

2. To set limits to medical experimentation on human subjects without their consent, and force it upon them if they refuse.

3. To guarantee that no patient’s information may be obtained legally or otherwise without consent by them unless required by law.

The unique contributions of the Belmont Report include:

1. To guarantee that the consent of patients may be obtained, in order to conceal unethical practices.

2. To make it a public offense to refuse to authorize research on a patient’s files, even if they have made such authorization impossible by death.

3. To allow the state to force treatment on reluctant patients without their consent, even if they themselves object; and also to allow its doctors not to inform them of this fact, without punishment by law.

4. To lay down many restrictions (but not enough) on experimental medicine and its abuses.

The unique contributions of the Nuremberg code include:

1. To make it a crime to conduct, support, or promote experiments on human subjects without informed consent.

2. To make it a crime not to report all experiments on human subjects.

3. To make it a crime to force anyone against their will, or regardless of their consent, to participate in medical experimentation endeavors.

For example:

The Declaration of Helsinki set a standard for medical ethics, promoted the concept of medicine as a science and not just an art, and protect patients from experimentation (Goodyear,2017). The Belmont Report protected patients from experimentation. While the Nuremberg Code protected patients from unethical treatment.

In conclusion, each of these documents has made unique contributions to protect the rights of patients throughout their whole course of treatment and care. As it is unethical to conduct experiments on humans without consent whether or not they are terminal, the Declaration of Helsinki protects the rights of those who are potentially terminal but would not want to be experimented on.

Quiz Score: 96 out of 100