Introduction
Nowadays, many people are involved in research because of different purposes and tasks. Some researchers take responsibility for the development of the work, the establishment of the goals, the identification of available methods, and evaluation of each decision made, and each step is taken. Some people may be defined as vulnerable populations in human research. An investigator takes responsibility for protecting all participants, referencing all sources, and promoting safety and rights recognition among research subjects. Researchers have to know how to obtain informed consent in regards to the already approved and identified regulatory and ethical requirements (Higgins, n.d.). In this paper, I will pay attention to the importance of protecting vulnerable populations, the ways of how these populations can be categorized, and the guarantees that can be given to avoid possible violations.
Vulnerable Populations: Definitions and Principles
Regarding my observations, I can say that human subjects who may be defined as vulnerable populations are usually developed in such fields as healthcare, nursing, and psychology. It is not enough for a researcher to identify disparities, determine risk factors, and develop appropriate conditions for research. Researchers have to be prepared to work with vulnerable populations, define who these people are, and what their roles are. Shivayogi (2013) admits that several definitions can be given to the term “vulnerable population”, including disadvantaged minorities who may need additional health, social, or economic care, protection, or recognition. I think that a vulnerable population is a term that requires additional attention and explanations, appropriate agreements and evaluations, new strategies, and special methods of work. In some cases, vulnerable populations are the people who are not able to protect their rights, their interests, or their well-being. These people are exposed to various types of harm that includes social, economic, legal, psychological, or even physical challenge (Henry, 2012).
Research ethics is based on several main principles that underline the importance to respect people, promote beneficence, and promote justice. No harm should be done to vulnerable populations or other human subjects in research. The vulnerability may have different characteristics, and the task of a researcher to understand what kind of work should be done and what impact can be observed in regards to the chosen subjects. People should not be afraid of their participation in research but have to consider the benefits that can observe.
Vulnerability Categories
I think that not all researchers can identify if their participants can be called vulnerable. There is a need for a guide for researchers to be followed when human subjects are chosen. For example, vulnerable populations can be a pregnant woman, who should take much responsibility and avoid any discomfort, a human fetus, a child who requires the permission of their parents to participate in research, prisoners, who cannot make independent decisions, students or employees, who become a part of a certain facility, and other disadvantaged individuals. The peculiar feature of vulnerability is the possibility for every person to be a part of this type of population. Veterans can also be defined as vulnerable populations in research due to such factors as the necessity to obey orders and make sacrifices and the inability to access the necessary portion of health care and cope with emotions and memories. This type of vulnerability is complicated because of the impossibility to control such people, predict the outcomes of communication with them, and develop effective solutions. Almost the same complications and challenges may occur during the work with mentally disabled people.
On the one hand, to avoid possible complications with vulnerable populations, researchers may replace human subjects with literary sources or inanimate subjects. In such a situation, researchers can use already offered ideas and materials and develop their evaluations and thoughts. On the other hand, people may investigate the peculiar features and details of research with human subjects and learn how to plan ethically responsible research (Sieber & Tolich, 2013). However, the protection of vulnerable populations should not gain the form of a simple avoidance. Vulnerability is a condition that has to be accepted and treated properly (DePoy & Gitlin, 2013). In my opinion, vulnerability presupposes the condition when human subjects cannot be autonomous agents. Besides, the voluntariness of such participants may be compromised. There are two types of situations when human subjects in research can become vulnerable. First, there is a decisional type of impairment when participants cannot make decisions regarding their interests and values. Second, there is situational vulnerability when participants are coerced to make some decisions, participate in research, answer questions, and make themselves available to observations or investigations. To avoid complications and ambiguity, researchers have to follow certain ethical norms and standards, like those defined in the Belmont Report.
Belmont Report and Its Role in Treating Vulnerable Populations
In 1978, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research created the Belmont Report in terms of which the concept of vulnerability was defined and discussed (UNESCO, 2013). According to this document, all researchers have to demonstrate their respect for persons who may suffer from limited autonomy in a certain situation. There is also a necessity to control inappropriate and excessive rewards that can be offered to participants to motivate them and support their participation in the study.
The Belmont Report is the document where the main ethical principles are gathered to choose the correct direction in the investigations with human subjects. It is a declaration of human rights and responsibilities that have to be identified in human experimentation (Quinn, 2015). It is hard to predict what types of ethical problems and concerns may occur during research with vulnerable populations. Anyway, the conduct of a researcher has to be ethically approved in regards to the existing codes and norms (Creswell, 2014). The Belmont Report is a guide for both, researchers, who want to identify their boundaries and possible limitations, and participants, who have to learn their rights and obligations.
The Belmont Report can be used as a tool to protect the rights of vulnerable populations in research. There are three main principles with the help of which researchers should establish their relations with human subjects. Respect for persons, beneficence, and justice represent the judgments with the help of which the guidance of research is possible. The identification of these principles causes numerous discussions and debates because not all people can come to the same conclusions and follow the norms. Bracken-Roche, Bell, Macdonald, and Racine (2017) admit that people who cannot provide informed consent may be disclosed to harm and disrespect because they are not able to protect their interests. At the same time, researchers do not deviate from one of the main ethical principles, beneficence, under which vulnerable populations are invited and supported. Such contradictions and the inability to create one definite system of work challenge researchers and create certain doubts that bother participants. Each category of vulnerable populations may be protected with the help of the Belmont Report or other precautions that can cause no harm to participants, researchers, and lead to the achievement of positive research results.
In this paper, I would like to focus on such vulnerable populations as prisoners, veterans, employees, students, and children and investigate these research peculiarities regarding past mistakes, the cases of neglect of human rights and ethical norms, and the ways which were used to correct those mistakes, promote participants’ protection, and ensure the development of investigations.
Vulnerable Populations: Historical Violations
The Belmont Report was created as an opportunity to provide human subjects in research with guarantees of respect, justice, and beneficence. It means that in the past, there were cases when participants could experience unpleasant and unethical conditions, could not protect their rights, and did not know how to avoid complications, humiliation, or other challenges. I was able to find several historical cases when the concern of protection of vulnerable populations was violated or simply not followed.
For example, in the middle of the 1900s, Stanley Milgram conducted an experiment where obedience to authorities was evaluated. It was a famous Milgram experiment in the field of psychology when it was decided to investigate the level of conflict that could be developed between obedience to authority and personal conscience (Picardi & Masick, 2013). It was a shocking situation when the psychologist used male Germans as the main human subjects to explain the behaviors of the Nazi people during World War II. They had to follow the orders of an experimenter and cause harm to another person (in the experiment, it was a confederate who played the role). The results were impressive: the majority of the participants continued to kill an innocent person just to complete the task established by an authority. Though all participants were against the orders and demonstrated their negative emotions, inconvenience, and unwillingness to participate, they had no other choice but to participate. The emotional well-being of some participants was put under a question. It was necessary to determine the possible level of harm. Another ethical challenge that influenced the participants was deception because the participants who performed the role of a teacher did not know that they did not do any harm. Finally, there was no right to withdraw the experiment. That violation was the cruelest issue in research.
The Tuskegee Syphilis Study was a clinical experiment that lasted approximately 20 years as a result of which many people died, including a representative of racial minorities, children, and pregnant women. Children were the vulnerable populations against whom rights and beneficence were violated. Children could not protect their rights because of a lack of knowledge and poor explanations, and adult participants could not understand the true nature of the experiment at all.
Prisoners as Vulnerable Population
Prisoners are people who have been confined in a special facility. These people can be defined as vulnerable populations in research due to their incarceration constraints and the inability to demonstrate personal attitudes, make voluntary decisions, and demonstrate informed consent. There is minimal risk that can be appropriate in investigations with human subjects, including psychological or physical harm. To protect the rights and well-being of such participants, I would use several rules and standards. For example, it is necessary to make sure that any possible risks that may be involved in research may be commensurate with risks that any other non-prison volunteer can accept. I also find it obligatory to make sure that all information about research, its conditions, and outcomes are given in a clear language, and a prisoner comprehends each word. Finally, the protection of prisoners as vulnerable populations in research can be promoted through cooperation with a specially trained person who knows how to communicate with prisoners and recognize their rights and demands.
Violations against Employees and Students
Employees and students are frequently chosen as the main participants. Researchers have to identify any precautions to protect the rights and welfare of this vulnerable group. It is necessary to ensure that all participants have access to informed consent and explanations of all circumstances that can predetermine their participation in the study. Such attention to the details has to decrease coercion and promote a positive influence. As a researcher, I think that it is easy and effective to choose students and employees as the main participants due to their multifunctional abilities, ease of motivation, and effective results.
The vulnerability of such participants may be explained by the presence of some superior with whom it is necessary to agree on participation. Students’ participation has to be approved by a college or a university. Besides, students have to be informed about the information that can be available to all people and identify what facts have to be confidential. Almost the same situation can be observed with employees. A researcher has to get permission to elaborate personal information about a participant, as well as some facts about an organization. To protect the rights of such vulnerable populations, a researcher has to cooperate with a facility and a person separately to avoid coercion, promote voluntary and equal participation. Each participant has to be informed about the alternatives available and the possibilities to withdraw a project at any time without getting approval from another authority. Besides, I think that some compensation details and interventions have to be discussed to provide participants with enough guarantees.
Protection of Veterans
As I have already mentioned, veterans are unique participants in research due to their history and the impossibility to predict the outcomes of their services from physical and psychological points of view. First, veterans may have a history, including obeying orders, accepting sacrifices, and even causing deaths to other people. Emotional issues may change the way of participation in research. Therefore, I believe that researchers have to be able to combine respect and recognition of all achievements made by such a vulnerable population as veterans in a special way. On the one hand, some veterans may not like the way of how other people treat them and underline the importance of their history, their contributions, and their experiences that not all ordinary people can understand. On the other hand, some veterans expect that people appreciate the contributions made during their services. A researcher has to pay much attention to the personal and professional qualities of veterans when a decision to invite such participants is made.
I find some preparations to work with veterans an integral part of the research. Raising awareness is a crucial step to be taken. Veterans may have such issues as homelessness, unemployment, or some health problems. Researchers have to understand the importance of such issues and do everything possible to protect veterans from the impact of these problems. Still, this kind of help should not be intrusive. Veterans have to demonstrate their desire to cooperate and be a part of the study offered.
Insurance to Vulnerable Populations in Research
In this paper, the task is to clarify what kind of work should be done to provide vulnerable populations with guarantees that their rights are respected, their well-being is protected, and their participation is appreciated (DePoy & Gitlin, 2013). In my opinion, modern research is based on several ethical issues to create appropriate conditions for all participants, including vulnerable populations. When I start working with such a population, I have to be ready to take several steps that help me develop trustful relations, understand participants’ needs, and clarify my responsibilities. The first step is usually connected with the permission from facility participants are taken from. If I work with veterans, I have to address the Department of Veterans Affairs. If students or employees are my potential participants, I should consult the HR department of the facility and get permission. If prisoners have to be a part of the study, special organizations, legal rules, and social norms have to be considered along with prisoners’ advocates or prosecutors. As soon as a request is submitted and a positive answer is obtained, I should think about the methods to cooperate with participants, identify the level of vulnerability of the chosen population, and start gathering information. If I choose children as the participants of my study, my task is to obtain parental permission and follow the established norms.
Special protection means are important for vulnerable persons. They observe their guarantees and comprehend their importance in society. It is not complicated to establish the rules and follow them. Still, researchers have to understand that the work with vulnerable populations may be unpredictable and unwanted results can be achieved.
Conclusion
In general, the protection of the vulnerable population in research is a serious issue for consideration. There are many rules and many norms that have to be identified and followed. Veterans, children, students, and employees are the participants whose vulnerability has to be investigated in the research. I think that every researcher has to remember the level of responsibility in regards to the population chosen. Some people cannot make independent decisions because of the presence of authorities in their lives. Some people do not achieve the age under which free and voluntary participation can be promoted. Some participants are challenged by certain responsibilities in front of other people. Such situations prove that vulnerable populations in research may vary, and I, like any other researcher, have to recognize the needs of such participants, develop appropriate research conditions, and introduce the results that can introduce positive results to a researcher, all participants, and their authorities.
References
Bracken-Roche, D., Bell, E., Macdonald, M.E., & Racine, E. (2017). The concept of vulnerability in research ethics: An in-depth analysis of policies and guidelines.Health Research Policy and Systems, 15(1), 8. Web.
Creswell, J.W. (2014). Research design: Qualitative, quantitative, and mixed methods approaches. Thousand Oaks, CA: SAGE.
DePoy, E., & Gitlin, L.N. (2013). Introduction to research: Understanding and applying multiple strategies. St. Louis, MO: Elsevier Health Sciences.
Henry, D. (2012). Human subjects research with vulnerable populations. Web.
Higgins, Y. (n.d.). Protecting vulnerable populations during research: Guidelines for safeguarding the health and welfare of children. Web.
Picardi, C.A., & Masick, K.D. (2013). Research methods: Designing and conducting research with a real-world focus. Thousand Oaks, CA: SAGE.
Quinn, C.R. (2015). General considerations for research with vulnerable populations: Ten lessons for success.Health & Justice, 3(1), 1. Web.
Shivayogi, P. (2013). Vulnerable population and methods for their safeguard. Perspectives in Clinical Research, 4(1), 53-57.
Sieber, J.E., & Tolich, M.B. (2013). Planning ethically responsible research. Thousand Oaks, CA: SAGE.
UNESCO. (2013). The principle of respect for human vulnerability and personal integrity: Report of the International bioethics committee of UNESCO (IBC). London, UK: UNESCO.