Human Subjects Protection Risks
Human subjects in research have contributed significantly towards the advancement of social and medical sciences. However, during the process of research, some risks are likely to occur; hence, it is vital to consider ethical and legal aspects to minimize such possibilities. Therefore, Institutional Review Boards (IRBs) should ensure that the expected benefits to the subjects are greater than the anticipated risks (NBAC, 2006). In this case, OHRP (2016) defines such dangers as the probability of occurrence of an injury or harm, which can be economic, social, physical, or psychological, during the process of research. Although human subjects play an essential role in research, various protection risks may arise during measurement as part of the study design, which can adversely affect their well-being.
Social and Economic Risk
Many research studies involve sensitive data. If such information is accessed by a third party, it might harm the subjects and violate research confidentiality. In some cases, privacy invasions could lead to embarrassments among a subject’s social group, lead to termination of employment, or initiate litigation. In addition, some behavioral studies might reveal personal information about the subjects, which could lead to stigmatization and labeling. Therefore, in such scenarios, confidentiality must be maintained. Hence, to minimize such risk, it is vital to mention any expected costs to the research respondents at the beginning of the study.
Physical risks may arise when a subject is exposed to discomfort, pain, or even injury, which may be caused by invasive medical processes or exposure to some drugs. Some of these effects could be permanent, although the majority of them are temporary. Most research methods used in medical research lead to minor discomforts, such as venipuncture pain and temporary dizziness. However, the differences arise in the type of medical research applied. For instance, research that measures the effects of diagnostic or therapeutic procedures carried out in the process of caring for the ill may not have a major impact beyond the medically indicated risks. On the other hand, studies that evaluate new procedures or drugs might be risky and can lead to disabling effects (Walsch & Kay, 2019). Therefore, researchers should gather information by applying standards of care processes to avoid hurting the subjects, especially in risky procedures.
Participating in research can lead to confusion, hallucination, stress, self-esteem issues, guilt, and even depression. According to Walsch and Kay (2019), these effects could be recurrent, transitory, or even permanent, but the majority of psychological risks tend to be transitory and minimal. In some cases, guilt and stress may transpire after a subject reflects on personal issues and sensitive topics, such as sexual preferences, drug use, and violence among others (Walsch & Kay, 2019). On the other hand, stress might occur when researchers tend to change the subjects’ surrounding, including creating emergencies or assaults to see how outsiders react. In essence, such risks may occur whenever the researcher includes deception, especially in behavioral research.
Research ethics state that every person in a human subject study must have access to privacy rights. Privacy invasion may arise when observation is done secretly without the consent of the subject. In some instances, whenever the researcher needs to access private information, such as hospital records or employment registry, the access could be allowed if the researcher keeps the information confidential (Fouka & Mantzorou, 2011). Therefore, the researcher must consider privacy concerns and only proceed with the study when consent is given, or if confidentiality is assured.