Using Vulnerable Populations in Clinical Research
Introduction
Vulnerability is unable to protect their own interest, so they get harmed easily. The vulnerable word comes from the Latin word vulnerate means wound. The individual or group of individuals who are unable to give informed consent. In clinical research, this context is used for human subjects who are unable to protect their interest due to poverty, unemployment, immaturity, etc. So, the protection of vulnerable subjects becomes an important part. In this regard, there was a need to put an additional safeguard to protect the rights and well-being of these subjects. In 2005 UN gives a universal declaration on bioethics and rights. Article 8 explains protecting the basic principle of bioethics for humans in the development and application of medical, and scientific studies. It also contains circumstances that can be able to make individuals or families or communities vulnerable like disease, disability, other personal conditions, environmental conditions limited resources.
Different approaches to define vulnerable populations.
There are different ways to define vulnerable populations depending on which people are vulnerable and need protection.
Categorical Approach
Contextual Approach
Categorical Approach
In this approach, the population which considers vulnerable are those who share features that might make them vulnerable. For example, children, prisoners, pregnant women, and mentally disabled persons. It is very useful when all participants of the group are vulnerable to the same cause.
However, it is not a complete approach because it has certain drawbacks it doesn’t consider, persons with multiple vulnerabilities, variations in the degree of vulnerability, don’t identify an individual’s situation which causes the vulnerability.
Contextual Approach
It is another method for vulnerability in which a more distinct approach has been taken than the categorical approach. National Bioethics Advisory Commission (NBAC) defines vulnerability as “a situation in which an individual might be considered vulnerable “. So, it more advanced and focused approach to safeguarding.
NBAC determines six types of vulnerability for research participants.
Cognitive and communicative vulnerability
This includes individuals who are incapable of comprehending information and decision-making for participation. For example, children and fetuses cannot make decisions of their own and are seriously ill person.
Institutional Vulnerability
This contains individuals who might have different priorities, values, and goals in their life but they are under formal authority who are controlling them like prisoners or military personnel.
Deferential vulnerability
This contains individuals who are unable to think about their interests and priority they are under the informal authority of others like children.
Medical vulnerability
This contains individuals who have serious health diseases with no standard treatments available for them to cure. For example, terminally or incurable disease patients.
Economical vulnerability
This includes individuals who have fewer social goods and services because of disadvantages in income housing or health care services.
Social vulnerability
This contains individuals who belong to the undervalue categories in social groups. For example, ethnic, and sexual minorities.
Purpose to include vulnerable populations.
To nullify negative impact on clinical trials.
Diversity of the available subjects for a study in population.
To show a one hundred percent success rate of the drug in the subjects. To provide evidence for the medical product which is safe and effective for all and gets approved.
Broad involvement of subjects can facilitate understanding of risk and benefit factors in clinical trials.
Conclusion
We should look at vulnerability in a serious spectrum and not because of the situation of time or place one is vulnerable. Vulnerable groups of people should be avoided as much as possible to ensure keeping good value for clinical trials. Investigator and Institutional Review Boards (IRB) should take a positive approach to maintain regulations and standards and to ensure the safeguarding and welfare of vulnerable subjects.
References
Schroeder, D., and E. Gefenas. Vulnerability: Too vague and too broad? Cambridge Quarterly of Healthcare Ethics, 18, 2009, 113-121, ii) Levine, C., et al. The limitations of “vulnerability” as a protection for human research participants. American Journal of Bioethics, 4(3), 2004, 44- 49. Available at https://pdfs.semanticscholar.
World Medical Association Declaration of Helsinki: Ethical Principles for medical research involving human subjects. Journal of the American Medical Association, 310(20), 2013, 2191-2194. Available at https://pubmed.ncbi.nlm.nih.gov/24141714/
Silvers, A. Historical vulnerability and special scrutiny: Precautions against discrimination in medical research. American Journal of Bioethics, 4(3), 2004, 56-57. Available at https://pubmed.ncbi.nlm.nih.gov/16192142/
. Levine, C. Research Involving Economically Disadvantaged Participants. In E.J. Emanuel, et al. (Eds). The Oxford Textbook of Clinical Research Ethics, New York, NY: Oxford University Press, 2008, pp.431-436. Available at https://bioethicsarchive.georgetown.edu/pcsbi/sites/defaul t/files/3%20Vulnerable%20Populations%20Background%20 9.30.16.pd
Gordon B. G. (2020). Vulnerability in Research: Basic Ethical Concepts and General Approach to Review. The Ochsner journal, 20(1), 34–38. https://doi.org/10.31486/toj.19.0079
Student Name: Shrinivas Teli
Student ID: 055/032023
Qualification: MSc Biotechnology
E-mail ID: shrinivasteli@gmail.com
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