Protecting Human Research Participants

Introduction

Human subject research is a systematic, scientific investigation that involves humans as research subjects. This type of research is used in many fields, including basic biology, psychology, sociology, political science, anthropology, nursing, and clinical medicine. Today, in the United States, the National Institute of Justice provides clear guidelines regarding ethical considerations of research. This paper provides a quick overview of the history of human’s subject protection, ethical standards in research, and strategies aiming at minimizing harm and abuse.

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History of Human Subject’s Protection

The modern system of human-subject research oversight and protections has emerged and developed over the course of the last five decades. The first instance of introducing protective legislation took place after the World War II. The ethical principles of carrying out human research were first developed in the context of the Nuremberg code to be applied at the trials of Nazi war criminal. The Nuremberg code outlined three basic elements: voluntary informed consent, favorable risk/benefit ratio, and right to withdraw without being penalized (Barber, 2018). These three principles laid the foundation for subsequent ethical codes and research regulations.

Two decades later, in 1964, the World Medical Association released the Declaration of Helsinki that drew on the principles of the Nuremberg Code. Yet, it was not enough to raise global awareness of human subject abuse. Between 1950 and 1974, the United States has seen plenty of research improprieties, which resulted in Congressional deliberations regarding human-subject research oversight (Barber, 2018).

The first legislation aimed at protecting the rights and welfare was the National Research Act of 1974 developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report issued by the same body stated three fundamental principles for conducting human-subjects research: respect for persons, beneficence, and justice. Today, human-subject research complies with the guidelines under Title 45, Part 46 of the Code of Federal Regulations.

Types of Research Activities

Today, modern science outlines the following human subject research types:

  • Unobtrusive research concerns analysis of existing statistics on humans. This type of research that the behavior of the subjects is no way affected or shaped by the investigators. Typically, they copy and collect existing data to conduct an independent analysis. Yet, doing this still qualifies as carrying out human subject research unless both of the following conditions are met:
    • Data is not a result of interaction with living humans;
    • None of the investigators have access to information that could reveal the identity of the participants.
  • Observation studies imply recording observations and analyzing obtained data, without an intervention or alteration of the treatment (exposure) that individuals receive. These studies often focus on risk factors, natural history, and disease progression variations in the absence of an intervention;
  • In an interventional study, the researcher manipulates the subject or the environment in order to impact one or more biomedical or behavioral processes. A clinical trial is defined as a research study in which one or more living humans are subject to one or more interventions (Barber, 2018).

Strategies to Minimize Potential Risks and Additional Protections

It goes without saying that it is easier to avoid risk than handle the consequences. Researchers might want to consider the following strategies to minimize potential risks and protect human subjects from harm. First, it is imperative to start off research with an accurate consent procedure during which human subjects are explained what the study entails. Ideally, the process should include more than merely handing the participants a form to sign. They deserve to gain a better understanding of what they are signing up for and, therefore, make a well-informed decision (Wolf, Carman, & Clark, 2016).

Second, researchers should be aware of ethical data collection methods such as avoiding unnecessary information that may be used for identification of subjects. Moreover, investigators need to conform with national data storage protocols (Wolf et al., 2015). Third, researchers need to possess a certain level of expertise and abstain from embarking on projects that may be too challenging to handle for them at the moment. Lastly, it makes sense to elaborate an undesirable even plan to manage risks.

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A fundamental assumption underlies modern scientific ethics: particular demographic cohorts are more likely than others to be misled, mistreated, and otherwise abused. This leads to the point that these populations might need additional protections on top of standard practices. Since 2010, the United States National Institute of Justice has been reinforcing requirements such as voluntary consent, right to safeguard integrity, and protection from physical, mental and emotional harm. Yet, as Resnik (2015) argues, unequal treatment of human subjects such as abusing cognitively and economically vulnerable individuals is likely to continue to occur.

Ethical Standards in Research

The American Psychological Association (APA) states the following five principles to be applied when conducting human-subject research:

  1. Beneficence and maleficence. Researchers must strive to benefit research subjects, and if a conflict is to occur, they must take measures to minimize harm. Given that researchers’ actions may affect the lives of others, they must safeguard their welfare and be aware of the factors that may lead to the misuse of influence.
  2. Fidelity and responsibility. Researchers must establish relationships built on trust with whom they work. They must uphold the highest standards of professional conduct and clarify roles and obligations to research participants. Researchers must also be concerned about their colleagues’ conduct and ethical outlook and moderate their behavior when necessary.
  3. Integrity. Researchers must seek to uphold accuracy, honesty, and truthfulness. They must not cheat, engage in fraud, or intentionally misrepresent information. Researchers must strive to hold their promises and avoid unjustifiable deception.
  4. Justice. Researchers must recognize that all people are entitled to justice and fair treatment. This especially concerns disadvantaged populations recruited for research.
  5. Respect for people’s rights and dignity. Researchers must rid of bias and prejudice regarding research subjects, be it on the grounds of their age, sex, social class, sexual orientation, and other characteristis. Human subjects need to be able to retain their autonomy and self-agency and be seen as an end and not a means to an end (American Psychological Association, 2016).

Conclusion

The first human subject trials date thousands of years back. Yet, research has become formalized only a few decades ago. The formalization was necessary and inevitable as first and foremost, it was the academic community’s response to many instances and allegations of abuses of human subjects. The war crimes of Nazi Germany prompted the emergence of ethical codes worldwide. Today, their principles apply to all types of human-subject research: an analysis of existing data, observational, and intervention studies. Researchers themselves should be aware of the ethical implications and adopt certain strategies to mitigate risks. Modern ethical standards stated by the American Psychological Association include beneficence and nonmaleficence, responsibility, integrity, justice, and respect for people’s dignity.

References

American Psychological Association. (2016). Ethical principles of psychologists and code of conduct. Web.

Barber, B. (2018). Research on human subjects: Problems of social control in medical experimentation. Abingdon-on-Thames, UK: Routledge.

Resnik, D. B. (2015). Unequal treatment of human research subjects. Medicine, Health Care and Philosophy, 18(1), 23-32.

Wolf, L. A., Carman, M., & Clark, P. R. (2016). Protecting behavioral health research participants in the ED setting: Issues of consent. Journal of Emergency Nursing, 42(1), 85-86.

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Wolf, L. E., Patel, M. J., Williams Tarver, B. A., Austin, J. L., Dame, L. A., & Beskow, L. M. (2015). Certificates of confidentiality: Protecting human subject research data in law and practice. The Journal of Law, Medicine & Ethics, 43(3), 594-609.

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StudyCorgi. (2021, August 6). Protecting Human Research Participants. Retrieved from https://studycorgi.com/protecting-human-research-participants/

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