Protection of Human Subjects During Evidence-Based Research

Question 1 

            The history of human subjects protection in evidence-based research can be dated as early as 1931, when Reich Circular was drafted (Lynch, 2014). The circular was adopted following an incident in Germany whereby infants were given a tuberculosis vaccine without their parent’s consent. The booklet provided ethical guidelines that were to be followed during human experimentation. During world war II, several doctors in Germany were found guilty of conducting criminal experiments o concentration camp prisoners. Following the incident, Dr. Alexander drafted a memorandum and presented it to United States Counsel for War Crimes. The Memorandum outlines several points that characterized ethical medical research, and it was adopted as Nuremberg Code. The Nuremberg Code gave birth to World Medical Association. White (2020) observed that the Declaration of Helsinki was published in 1964 to protect children’s rights and other vulnerable populations who are unable to give consent. 

Question 2 

            In 1964, a study was conducted on African Americans to determine the effects of Syphilis if left untreated in the negro male (White, 2020). The study lured 399 syphilis-positive participants and 201 negative participants with free medical screening, free food, and burial insurance. The research provident no treatment to the patients as it focused on the syphilis natural history. The research must be deemed unethical because it perverted the participant’s right to consent.  

Question 3 

            The safety of the subjects is critical, and therefore, all the necessary procedures must be established to minimize risks to the human subjects. First, in research involving human subjects, I will use functions supported by sound research design, which reduce unnecessary risks. Moreover, I will refrain from studies that pose more risks than human participants’ benefits (Zoborowska et al., 2019). My research will start by seeking informed consent from the participants, and the study should not cause long-term- term suffering to the participants. My research would monitor and protect the data collected to ensure that the participants’ safety and confidentiality are upheld. 

Question 4 

            Over the years, children and prisoners became vulnerable populations of infamous scientific researches. Children are unable to give informed consent because they lack knowledge, while prisoners have their freedom infringed. White (2020) observed that in 1721 Lady Montagu and Price of Wales conducted variolation of prisoners and abandoned children by inserting smallpox scabs under their skin. Later on, in Germany, between December 1929 and April 1930, Albert Calmette Conducted tuberculosis vaccination to 251 infants, leading to several infants’ death and suffering. Further, in 1946, German doctors were found guilty of conducting dangerous experiments on prisoners in concentration camps (Breault, 2020).  

Question 5 

            The recruitment process for research starts by defining the target group. The second step is explained by ways of informing the targeted population of the intended study and invitation to participate. The invitations can be posted on hospitals’ websites or notice boards; it will also be appropriate to engage friends and colleagues for referrals. During the recruitment process, the privacy of the participants will be a key to ensure confidentiality. Additionally, research objectives and coverage will be fully disclosed (Breault, 2006). Moreover, the recruitment process should eliminate pressure; the participants must be given ample time to analyze the study and decide whether to participate. I will explain the benefits, and the intended research risks will be explicit to the participant.  

Question 6 

            The process of obtaining informed consent starts by exposing the participant of the study to the study environment. According to Lynch (2014), the research coordinator must assess the participants’ capacity to give legally effective consent. The participants who are incapacitated to make an informed decision can only be involved in the study through their legally authorized representatives’ support. After that, the informed consent elements are presented and explained to the prospective participant with an emphasis on the risks of the research, and the research coordinator should ice out the therapeutic misconception from the participant if any. A delayed consent procedure is a necessary process whereby the participant is given ample time to discuss the participation in the study with friends, family, and other confidants before signing the consent. After the participant has understood and internalized their involvement, they will sign the support that will be documented. Ongoing consent will be conducted whereby the participants will be informed of any new findings that may affect their participation.  

Question 7 

            Various components characterize informed consent. Breault (2006) outline below essential elements of informed consent: 

Inclusion of a statement that defines the extent of the research, objectives, procedures, and the duration of the subject’s participation and degree of involvement. 

An explanation of all anticipated risks to the topic. 

Must explicitly state all the expected benefits to the subject. 

A statement explaining how it will uphold the participants’ confidentiality. 

A candid explanation of whether there will be compensation or some form of treatment involving risks above the minimum threshold. 

A description of preferable subject’s contacts in case of research-related injuries or declarations. 

A statement that the matter is willingly and voluntarily participating and that they may withdraw from the participation at any time without any form of penalty or punishment. 

Question 8 

            Institutional review boards (IRBs) in American history were established to become a backbone in the protection of human research participants. IRBs provide an independent review of proposals involving human research. According to Grady (2015), IRBs review all the research conducted in America and those born outside the United States but funded by the American government. To ensure that the investigation is ethically viable, IRBs determine that risks involving subjects are minimal and a strategy to obtain informed consent. 

References 

Breault, J. L. (2006). Protecting human research subjects: The past defines the future.  Ochsner Journal ,  6 (1), 15-20. 

Grady, C. (2015). Institutional review boards: purpose and challenges.  Chest ,  148 (5), 1148-1155. 

Lynch, H. F. (2014). Protecting human research subjects as human research workers.  Human Subjects Research Regulation , 327-340.  https://doi.org/10.7551/mitpress/9780262027465.003.0027 

White, M. G. (2020). Why human subjects research protection is important.  Ochsner Journal ,  20 (1), 16-33. 

Zaborowska, M., Shah, F. A., Trobos, M., & Palmquist, A. (2019). Retrieval, sample processing, and analyses of bone-anchored implants. In  Bone Repair Biomaterials  (pp. 447-466). Woodhead Publishing.