Week 6: Assignment Human Subjects Protection

Week 6: Assignment Human Subjects Protection

Week 6: Assignment Human Subjects Protection

Human Subjects Protection

This short essay conducts an investigation into the history of human subjects protection. It also highlights an example where the rights of participants were violated, steps to minimize risk to human subjects, vulnerable populations, and appropriate ways to recruit human subjects, the ethical principle of informed consent and the committees responsible for monitoring the protection of human subjects in the United States.

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Historical Background of Human Subjects Protection?

The present framework of human-subject research protections and oversight has evolved over the past five decades. In the United States (US), the history of protecting human subjects in the field of research can be traced to the formal enactment of the National Research Act of 1974, which paved the way for the establishment of the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research (the Commission) (Shamoo & Resnik, 2022). Equally, the subsequent issuance of the Belmont Report by the Commission marked a milestone development in articulating the key basic principles to be followed when performing human-subjects research and they include: beneficence, respect for persons and justice (National Cancer Institute, 2020). Moreover, changes to national and international policies and regulations have over the years played a fundamental role in creating a system of oversight and protections requiring the ethical engagement of researchers, research sponsors, federal agencies, healthcare providers, scientists, consumer groups, patients and other individuals in the research process (Spellecy & Busse, 2021).

Find and discuss at least one historical incident of human subjects abuse in research and what human right was violated.

Within the realm of human rights law, there are various known examples that involved intentional violation of the rights of research participants. Constantin (2018) indicated that the controversial US Syphilis Experiment conducted in Guatemala between 1946 and 1953 can be considered a historical incident involving the blatant violation of human rights of the study participants. Precisely, whilst this research involved research investigators from the U.S. and Guatemala, and had received immense support from public institutions including Guatemalan government ministries, it involved conducting non-consensual medical experiments on vulnerable persons in Guatemala under the pretext of pursuing scientific advancements. Individuals from marginalized populations in the country were subjected to non-consensual experiments that included deliberate exposure to sexually-transmitted infections including gonorrhea, syphilis, chancroid and others, which had detrimental and long-term implications on their health and wellbeing (Reverby, 2016). Involving more than 1,500 study subjects, the non-consensual experiments violated fundamental bio-ethical principles of respect for autonomy (informed consent), justice (fair, dignity and humane treatment), beneficence (maximizing benefit) and non-maleficence (minimizing harm and injury). Some of the basic rights violated in the Guatemala syphilis study included the right to health (including the right to be free from interference and the right to control one’s body and health), the right to treatment, and freedom from unwarranted experimentation (Rodriguez & García, 2013).

What steps will you take to minimize risks to human subjects?

The first step is to uphold the key provisions of the existing legislative and institutional measures aimed at governing research activities involving individuals as study participants. The National Cancer Institute (2020) indicated that strict compliance with the regulations and standards set in the National Research Act of 1974, the Nuremberg Code, the Helsinki Declaration, and The International Ethical Guidelines for Biomedical Research involving Human Subjects, the Oviedo Declaration and other instruments may help to strengthen the protection of the basic rights, liberties and freedoms of research respondents. Other steps to minimize or eliminate risks to human subjects taking a proactive approach focused on  applying the appropriate procedures, information-sharing to reduce participant confusion, identifying and responding to the risks a research initiative might pose to study participants, incorporating adequate safeguards, and obtaining authorization from relevant agencies and/or institutions (O’Sullivan et al., 2018).

What populations are considered vulnerable populations and why?

Some of the vulnerable populations more likely to experience risks in human subject research include pregnant women, neonates and fetuses; minors (children); prisoners; students; sex workers; and scientifically-disadvantaged persons (people with disabilities, incapacitated persons) (Shamoo & Resnik, 2022). Whilst the vulnerability of pregnant women is exacerbated by their intricate medical condition, prisoners may be blatantly exposed to coerced, involuntary participation. Moreover, children are considered a vulnerable population due to their young age, health status, and the capacity to comprehend the details and outcomes of the research. The vulnerability of significantly-disadvantaged persons is reinforced by the dire economic, social, mental and/or educational circumstances that might undermine their overall capacity to rationally and effectively engage in complex research programs involving humans as study participants (Spellecy & Busse, 2021).

What are appropriate ways to recruit subjects?

Developing and using recruitment plans and materials that are approved by the Institutional Review Board (IRB) can form the starting point for upholding ethical considerations when dealing with research subjects. The recruitment approaches adopted must take into consideration privacy concerns and informed consent (Manti & Licari, 2018). Equally, participation in human-subject research must be voluntary, and free from undue influence. The provision of adequate background information and data regarding the study to the targeted participants may also help to obtain informed consent and to diffuse any fears that might surround the intentions and outcomes of the particular research study (Constantin, 2018).  

How would you properly obtain consent?

Participant recruitment is deemed as a key step of the informed consent process. Anderson and Corneli (2018) mentioned that providing timely and adequate information regarding the purposes and projected outcomes of the research to the eligible participants is integral to obtaining a valid consent. It is also important for the investigators to document the consent appropriately and to offer copies of the consent documents to the eligible participants as the basis for ensuring credibility, professionalism and verifiability. Moreover, engagement in honest and open communication between the research investigator and the research subject (or a formally designated surrogate) may also assist to encourage or motivate the participants to enter the research without pressure or undue influence (Spellecy & Busse, 2021). Similarly, a comprehensive understanding of the vulnerability of the targeted participants may also prove instrumental in determining the ethical considerations and moral dilemmas that must be fully addressed as the basis for obtaining a subject’s voluntary permission prior to his/her inclusion in the human subject study.

What are the elements of a properly executed consent?

Shamoo and Resnik (2022) insisted that the documentation of informed consent is done by means of a clearly written, signed, dated and archived informed consent document. Some of the key elements of a properly executed and valid consent include: (1) a un-coerced (voluntary) choice, (2) determined by comprehension of potential benefits and risks, and (3) conducted by a competent individual (or his/her legally-authorized representative). Considered to be the bedrock for the ethical conduct of human-subject research, ensuring the three elements are met can go ahead to ensure all the key issues, risks and uncertainties surrounding the study are identified and resolved, and to promote autonomy, unbiased presentation of the study, and to ensure only eligible and consenting participants are allowed to become participants in a particular study (Spellecy & Busse, 2021).

What committees are responsible for monitoring the protection of human subjects?

In the United States, various committees and institutional review boards are mandated with safeguarding the rights of human subjects and they include the Office of Human Research Protections (OHRP), and Committees for the Protection of Human Subjects (CPHS) established at the various research institutions, universities, medical facilities, and other relevant organizations (Constantin, 2018).

Conclusion

Dealing with human subjects in research is an intricate process that must be informed by ethical principles and other instruments aimed at protecting the rights of study subjects. Strong emphasis must be placed on minimizing risks and amplifying benefits associated with human-subject research. In nursing, the centrality of informed consent must be upheld in order to ensure only eligible participants are voluntarily included, and to avoid harms and other unwanted outcomes on vulnerable populations. 

References

Anderson, E.E. & Corneli, A. (2018).How do I obtain informed consent? 100 Questions (and Answers) About Research Ethics, 81-82. https://doi.org/10.4135/9781506348681.n42

Constantin, A. (2018).Human Subject Research. Health Human Rights, 20(2), 137-148. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6293356/

Manti, S., & Licari, A. (2018). How to obtain informed consent for research. Breathe, 14(2), 145-152. https://doi.org/10.1183/20734735.001918

National Cancer Institute, (2020).Human subject research. Definitions. https://doi.org/10.32388/skaquz

O’Sullivan, E., Rassel, G., Berner, G., & Taliaferro, J. (2018).Protection of human research subjects and other ethical issues. Research Methods for Public Administrators, 268-289. https://doi.org/10.4324/9781315563534-13

Reverby, S. M. (2016). Restorative justice and restorative history for the sexually transmitted disease inoculation experiments in Guatemala. American Journal of Public Health, 106(7), 1163-1164. https://doi.org/10.2105/ajph.2016.303205

Rodriguez, M. A., & García, R. (2013). First, do no harm: The US sexually transmitted disease experiments in Guatemala. American Journal of Public Health, 103(12), 2122-2126. https://doi.org/10.2105/ajph.2013.301520

Shamoo, A. E., & Resnik, D. B. (2022). The protection of human subjects in research. Responsible Conduct of Research, 229-270. https://doi.org/10.1093/oso/9780197547090.003.0011

Spellecy, R., & Busse, K. (2021). The history of human subjects research and rationale for Institutional Review Board oversight. Nutrition in Clinical Practice, 36(3), 560-567. https://doi.org/10.1002/ncp.10623

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Assignment Prompt

This course is designed to prepare investigators involved in the design and/or conduct of research involving human subjects to understand their obligations to protect the rights and welfare of subjects in research. The course material presents basic concepts, principles, and issues related to the protection of research participants.

Evidence-based research involving human subjects requires that researchers be cognizant of and adhere to the important tenets necessary to protect subjects from abuse, harm, injury, and/or other undesirable outcomes resulting from the research process. Based on this fact, write a minimum of 4 pages (Title page and Reference not included in page count) of an APA formatted paper answering the following questions with a minimum of 4 “short” sentences for each question:

—Historical background of human subjects protection? (10 points)
—Find and discuss at least one historical incident of human subjects abuse in research and what human right was violated. (10 points)
—What steps will you take to minimize risks to human subjects? (10 points)
—What populations are considered vulnerable populations and why? (10 points)
—What are appropriate ways to recruit subjects? (10 points)
—How would you properly obtain consent? (10 points)
—What are the elements of a properly executed consent? (10 points)
—-What committees are responsible for monitoring the protection of human subjects? (10 points)
Scoring Scheme

NOTE: This is a written APA formatted assignment and “NOT” a YES or NO answer assignment. You are expected to answer each question with at least 4 short sentences, points will be deducted for using a single sentence. Title and Reference pages are required. 5-6 High-level scholarly peer-reviewed references in APA from within the last 5 years

Expectations

—-Introduction and Conclusion Required for all APA paper
Length: a minimum of 4 pages, title page and references not included in page count
Citations: a minimum of 3-4

Students should read the instructions and ensure to follow all required for this paper.