Protecting Human Research Participants

Human research has long been recognized as essential for advances in human health and welfare (University of Alaska Fairbanks, n.d.).  Human research subject protection is crucial to ensure the safety of those participating in studies and experiments (the University of Alaska Fairbanks, n.d.).  Guidelines are in place to protect study participants from unethical treatment or abuse (University of Alaska Fairbanks, n.d.).  Abuse of human research subjects must be avoided at all costs if we are to continue conducting necessary studies with integrity.  Human research has the potential to do tremendous good, but only when done responsibly and ethically.

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

History and Importance of human subject protection

Over the past century, the current approach to protecting human subjects has changed in response to dubious moral conduct in research (White, 2020).  A lengthy tradition of using what is now understood as vulnerable groups as study subjects may be traced back to the early use of children and inmates (White, 2020).  Those who took part in the studies seldom gave their informed permission, did not understand the purpose of the studies they were in, and often were not given any information about the study (White, 2020). 

Two examples of where human participants were taken advantage of while being the subject of research are the Tuskegee Experiment and the criminal experiments conducted in German concentration camps during World War II (White, 2020).  The Tuskegee experiment enlisted 399 syphilis patients and 201 uninfected controls from the African American population surrounding Tuskegee, AL, to investigate the efficacy of a drug (White, 2020).  The men were provided free checkups, food, and funeral coverage for their participation in the study, but they were not allowed to grant informed consent (White, 2020).  No intervention was given as the study’s goal was to determine how the condition progresses in unmanaged cases (White, 2020).  The research was supposed to last only six months, but it has already been going on for four decades (White, 2020). Penicillin was shown to be a viable treatment for syphilis with few adverse reactions by 1945 (White, 2020).  After the effectiveness of penicillin was demonstrated, the US Public Health Service created treatment clinics, but the data from the Tuskegee trials were deemed too essential to discard; thus, the research was extended without treatment being given to the subjects (White, 2020).  German concentration camps during World War II are another instance of damage occurring to research subjects (White, 2020).  The so-called physicians of the concentration camps subjected captives to unethical medical procedures that caused impairment, disease, and death (White, 2020).

Types of research activities that require the involvement of human subjects

The Health and Human Services Policy for Protection of Human Research Subjects in 45 CFR Part 46 describes a human subject as a live person whom a researcher investigates by gathering personal data and biological samples for utilization, examination, and evaluation (National Institute of Dental and Craniofacial Research, 2022).  A human subject is also someone whose private information or biospecimens a researcher utilizes, examines, and evaluates (National Institute of Dental and Craniofacial Research, 2022).  According to the National Institute of Health, there are two types of human subject research: observational and interventional (National Institute of Dental and Craniofacial Research, 2022).  In an observational study, the researcher monitors subjects and collects data without designating participants to a particular treatment or therapy (National Institute of Dental and Craniofacial Research, 2022).  These studies concentrate on observing potential causes of disease, the manifestation of illness, and changes in disease development (National Institute of Dental and Craniofacial Research, 2022).  In an interventional study, one or more biological or cognitive systems are changed by altering the participant or the participant’s surroundings (National Institute of Dental and Craniofacial Research, 2022).

Strategies to minimize potential risks to research participants

Since the early days of research, human subjects have often been exposed to risks with little understanding of the potential consequences (White, 2020).  In many cases, these subjects were not given a choice in whether to participate and were not adequately informed of the risks they were taking (White, 2020).  As a result, numerous instances of research experiments have resulted in harm to the participants (White, 2020).  In response to this, strategies have been implemented to minimize the risks to research participants. 

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

The Nuremberg trials were a turning point in history, setting limits for research that would be conducted on humans.  This trial occurred after World War II in reaction to the criminal experiments in the German concentration camps (White, 2020).  The result of these proceedings was the establishment of The Nuremberg Code (White, 2020).  This code stipulated ten principles to which physicians must adhere while conducting experiments on human subjects, but it was insufficient for dealing with complex situations (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1978).  A more comprehensive range of moral guidelines will help establish, analyze, and understand specific regulations (White, 2020).

The Belmont Report was released in 1979 by the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research (CITI Program, n.d.)  The three guiding concepts of this report are respect for persons, beneficence, and justice (CITI Program, n.d.).  The Belmont report is one of the most influential studies on ethics and medical research because it safeguards human participants in clinical trials and other scientific investigations (White, 2020).  According to respect for persons, everyone has the right to autonomy, and those who lack competence must be protected (White, 2020).  Two requirements govern the concept of beneficence: do no harm, optimize potential benefits, and limit possible harms (White, 2020).  The justice principle covers the issue of who should reap the rewards and shoulder the research obligations (White, 2020).  The Belmont Report’s last section discusses three crucial aspects of human subject research: informed consent, risk assessment, and subject selection  (White, 2020).  •The informed consent procedure includes providing prospective research participants with information, assisting them in comprehending it, and encouraging their voluntary choice to join the study (CITI Program, n.d.).  Performing research where risks to participants are appropriately compared to expected benefits is the aim of risk assessment (CITI Program, n.d.).  The element of subject selection requires that the advantages and drawbacks of research are shared fairly (CITI Program, n.d.).  This means that no one or group is put in jeopardy of harm while others reap the rewards (CITI Program, n.d.)

Ethical Standards Applied in Research

Before releasing the Belmont Report, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research produced Institutional Review Boards report (White, 2020).  An Institutional Review Board is a body explicitly authorized to review and oversee biomedical research involving human beings in compliance with federal and institutional standards (White, 2020).  An Institutional Review Board can demand changes be made for research acceptance or rejection (US Food and Drug Administration, 2019).  This group review safeguards human research participants’ rights and well-being (US Food and Drug Administration, 2019).  Furthermore, the Institutional Review Board verifies that the participant selection method is unbiased and that informed consent is secured (US Food and Drug Administration, 2019).

Protections Needed for Federally Identified Vulnerable Populations

The federal regulations for protecting human research subjects issued by the Department of Health and Human Services include protections that help vulnerable populations (US Department of Health & Human Services, 2020).  The first portion, subpart A of 45 CFR 46 of the Department of Health and Human Service’s federal guidelines for protecting human research participants, is commonly referred to as the Common Rule (US Department of Health & Human Services, 2020).  The Common Rule mandates that researchers get institutional review board permission and informed consent from subjects enrolled in human research (US Department of Health & Human Services, 2020).  Groups of people who are regarded as vulnerable are protected by three additional subparts (US Department of Health & Human Services, 2020).  Subpart B contains regulations safeguarding pregnant women, human fetuses, and neonates (CITI Program, n.d.).  Since there is a possibility of unidentified dangers to pregnant women, human fetuses, and newborns in research, it is necessary to provide additional protective measures (Williams, 2005).  Subpart C contains regulations that protect prisoners.  Inmates are a particularly susceptible demographic because of their limited freedom and limited opportunities, making it difficult for them to provide informed consent.  (Williams, 2005).  Subpart D contains regulations that safeguard children (CITI Program, n.d.).  Children are a vulnerable group because of their underdeveloped physical and intellectual capacities (Waisel, 2013)

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

Conclusion

The importance of human research cannot be overstated.  By protecting the rights and welfare of human subjects, we allow for critical medical advances to be made while ensuring that participants in studies are treated fairly and with respect.  We owe a great deal to those who have participated in human research, and it is our responsibility to continue to protect their well-being.

References

CITI Program.  (n.d.).  https://about.citiprogram.org/en/homepage/

National Institute of Dental and Craniofacial Research.  (2022, June).  Human subjects research overview.  https://www.nidcr.nih.gov/research/human-subjects-research

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.  (1978).  The Belmont report: Ethical principles and guidelines for the commission for the protection of human subjects of biomedical and behavioral research.  http://www.videocast.nih.gov/pdf/ohrp_belmont_report.pdf

US Department of Health & Human Services.  (2020, January 28).  Principal regulations.  Office for Human Research Protections. Retrieved November 28, 2022, from https://www.hhs.gov/ohrp/education-and-outreach/about-research-participation/protecting-research-volunteers/principal-regulations/index.html

US Food and Drug Administration.  (2019, September 11).  Institutional review boards (ribs) and protection of human subjects.  Center for drug evaluation and research.  Retrieved November 27, 2022, from https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/institutional-review-boards-irbs-and-protection-human-subjects-clinical-trials

University of Alaska Fairbanks.  (n.d.).  Human subjects in research.  Office of research integrity.  Retrieved November 28, 2022, from https://uaf.edu/ori/responsible-conduct/human-research-subjects/index.php

Waisel, D. B. (2013). Vulnerable populations in healthcare.  Current Opinion in Anaesthesiology, 26(2), 186–192.  https://doi.org/10.1097/aco.0b013e32835e8c17

White, M. G. (2020).  Why human subjects research protection is important. Ochsner Journal, 20(1), 16–33. https://doi.org/10.31486/toj.20.5012

Williams, E. D. (2005).  Federal protection for human research subjects: an analysis of the Common Rule and Its interactions with FDA regulations and the HIPAA privacy rule.  https://doi.org/https://heinonline.org/HOL/Welcome?message=Please%20log%20in&url=%2FHOL%2FPage%3Fhandle%3Dhein.crs%2Fcrsuntaaeyd0001%26collection%3Dcongrec%26id%3D1%26startid%3D1%26endid%3D79