NURS FPX 5005 Assessment 1 Protecting Human Research Participants ​​​​​​​Protecting Human Research Participants

NURS FPX 5005 Assessment 1 Protecting Human Research Participants

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)