Essay on Protecting Human Research Participants

History and importance of human subject protection

I found out that human research subject protection has developed over the last 50 years. It first came into being as Nuremberg Code to try Nazi war criminals. I found out that after world war two, doctors conducted scientific and medical experiments on the concentration of camp prisoners, which was termed as a criminal activity. The doctors underwent trial, and 16 of them were found guilty, but they argued that there was no law on any legal or illegal experiment. These formed the basis of human research protection. Their argument was objected to, and the Nuremberg code developed. It included; Voluntary informed consent, the right to withdraw from the research and good risk/benefit analysis, do a study based on animal studies, avoid physical or mental suffering and injury to subjects, and proper protection of subjects were the elements of the code(Experiments, 1996). I found the Tuskegee study very unethical. It was a study of STDS’ in Guatemala that was conducted by cutler and associates who infected more than 5000 people with bacteria that causes sexually transmitted diseases intentionally who were never treated; these came into light 65 years after its conduction, making the US president make an apology (heller j p, 2017). I also came across a study carried on Ellan Roche where the pulmonary function was manipulated by inhalation of hexamethonium, which was withdrawn from the FDA in 1972. After the manipulation, she died within a month; this was an unethical study (Springs, n.d 2019.) The National Research Act (1974) created the national commission for protection of Human Subjects of biomedical and behavioral research, which brought about the Belmont Report. The Belmont report brought about the following principles; beneficence, justice, and respect for persons(Kim Czubaruk, 2019). The code for federal entails human subject research protections. It has enabled the advancement of human subject protection. Human subject protection is essential in protecting individuals from malicious acts which end up causing harm in the process of doing research Through this protection, there has been a reduced incidence of human injury through research where there are rules to be followed before researching humans.

Describe the types of research activities that require the involvement of human subjects

Research on humans’ subjects is a very sensitive issue. Therefore, it is a regulation that all studies and activities involving human beings as study subjects must be approved by the office of research administration. Human subject research is a study conducted that affects humans as study subjects. As a result, below is the discussion of the various studies that involve humans as their study participants.

Surveys and questionnaires; A questionnaire is a research collection instrument containing prompts or a set of structured questions administered to respondents to collect information. For instance, a customer satisfaction questionnaire can be used to determine customers’ level of satisfaction with the provision of goods and services at a hospital.

Analysis of existing information and specimens; these studies require approval by the IRB. They may entail the analysis of patients’ data, samples, biospecimens, or corpses.

Human genetic research; this type of research comprises studies on pedigree, cloning, transfer of genetic material and gene frequency research.

Epidemiological studies; These studies may be carried out among human studies to determine health outcomes, impact of diseases, and overview of interventions, delivery of health services, and cost-effectiveness in a given population.

Studies on evaluation of social and behavior; for instance, these studies may involve investigating a single individual or group to determine the social constraints, mental processes, and behavior.

Clinical investigations; Studies were conducted to provide evidence-based practice on treatment and prevention of diseases, understand physiology, drug trials, and evaluate the safety of medical products.

Pilot studies; a pretest study involving human participants is research conducted on a small population to test the feasibility of the primary analysis.

Describe strategies to minimize potential risks to research participants.

• Before researching study participants, the researcher needs to provide all essential information regarding the study’s rationale, benefits, risks, and experiment design (Most Vulnerable Known Members of the Group., n.d.).
• Besides, the researcher should obtain an informed consent from the subjects in his target population. The study participants should be freely engaging in the study without influence by the research. Also, they should have a legal capacity to give consent before participating in the study. However, the researcher should provide essential information about the survey.
• The study should be carried out to protect against unnecessary human injuries such as mental and physical injury.
• The study should be conducted within a sufficient limit that safeguards participants.
• At any point of the research, the researcher can terminate the experiment if he believes that the progression of the study may cause serious injury, harm, disability, or death to subjects.
• The study subjects are free to opt out of the experiment at any time if they feel the continuation of the study is impossible due to physical and mental problems.
• The extent of the risks to be taken in the experiment should not surpass that gauged out on the study’s outcome.
• No experiment can be conducted where anticipated death or injury is unavoidable unless the researchers are subjects.
• Stipulate procedures in research to guarantee participants’ confidentiality.
• Lastly, all experiments to be conducted on human subjects have to undergo various stages before experimenting on human subjects (n.a, 2020. It should be based on factual information on the natural history of disease and animal experimentation findings

 Analyze additional protections needed for federally identified vulnerable populations.

Children ; children are individuals who have not reached the legal age to consent to participate in research involving treatment or procedures in a given jurisdiction for which the study will be conducted. Minors can be included in clinical investigations that involve minimal risks, generating benefits to minors, or are anticipated to provide generalizable new knowledge about a condition(Subjects et al., n.d.). However, for children to be subjects, their parents have to provide permission, and children must assent. Also, the children’s age, maturity, and psychological state have to be taken into consideration.

Pregnant women, fetuses, and neonates; the research associated risks that may involve a woman during the expectancy period. Women are a vulnerable population because they have fetuses, and studies on them may cause harm to the developing fetus. As a result, women need to be protected. Research among pregnant women may be conducted if animal studies showed minimal risks if the research accrues direct benefit to pregnant women or fetuses, and no inducements or monitory coercions,

Additional protection for prisoners; a researcher intending to research prisoners has to obtain permission from IRB. Also, the researcher must provide the rationale for picking prisoners as study participants. Other written approval requirements required include a written approval to enroll a prisoner and entry permission to make frequent visits to a correctional facility.

Additional protection for significantly disadvantaged groups; Some people or particular groups that may require extra protection include individuals with mental, social, and economic challenges(Most Vulnerable Known Members of the Group., n.d.). These particular groups require their special interests to be met and welfare before enrolling them in research.

The ethics in doing research are:

• Respect for persons where individuals should be treated as autonomous agents and those with diminished autonomy offered protection.
• Beneficence where no harm should be done while conducting research and maximize on benefits of doing the research
• Justice in that research conducted should benefit the individuals on whom it is performed.
• Informed consent where participants have to be given information on the research and voluntarily agree to participate.
• Confidentiality and data protection where subject information obtained should not be shared with anybody else.
• Integrity in that before conducting research, it should meet the set integrity standards.

References.

Experiments, P. M. (1996). The Nuremberg Code ( 1947 ). 313(7070).

Heller j p. (2017). Guatemala syphilis experiment – Study flaws and ethical considerations _ Britannica_rJXsDO. Washington: USA.

Kim Czubaruk. (2019). The Belmont Report_ What is it and how does it relate to today’s clinical trials_ _ Cancer Support Community_bHHKxu (p. 16). p. 16. NewYork: USA.

Springs, j savulescu. m. (n.d.). 9-hexamethonium-study_jtRkQx.pdf. Maryland: Hopkins university. Most vulnerable known members of the group. (n.d.). 1–4.

White, G. (2020). Why Human Subjects Research Protection is Important. The University of Queensland. New Orleans. LA. retrieved from file:///C:/Users/admin/Downloads/TOJ-20-5012_16White.pdf

Subjects, H., Program, P., & One, M. (n.d.). Additional Safeguards for Children ( < 18 ) in Clinical Investigations ( OHRP ) Additional Safeguards for Children ( < 18 ) in Clinical Investigations ( OHRP ). 1–2.