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Research can be defined as “a systematic investigation,” designed to provide new knowledge (Gottesman and Sandler, 2004). Systematic investigation could entail many different procedures like observation and interviewing. A human subject in research implies an individual from whom a researcher obtains information through a given data collection method be it interviews, use of questionnaire or review of private records of the individual (Grant & Sugarman, 2004).
Private information in this case is that information, which an individual considers personal and cannot be revealed to the public. For the information to be treated as private information in research, then the information must be personally identifiable such that the information is associated with someone precisely (Grant & Sugarman, 2004). Children are defined by human subjects’ research regulation as persons who have not attained the legal age for consent to treatment or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted (Williams, 2005).
In the US, the definitive age of adulthood varies from state to state. This therefore means that, there is no blanket rule of legal age for adulthood (Williams, 2005). Nonetheless, majority of the states has eighteen years as the legal age of adulthood. The specific methods and treatments used in the research take also into account the definition of children (Williams, 2005). For instance, in some areas individuals may legally assent to certain medical action even when they are sixteen years old. In such an instance, such persons will be regarded as adults if they will be involved in a research activity that involves such treatments.
However, a person must be considered a child if a proposed research activity includes an issue for which the person has not attained the legal age of consent. It is also worth noting that an assent is viewed as the child’s confirmatory accord to take part in research. Children are taken as vulnerable populations since they have limited objective, logical, and legal abilities (Williams, 2005).
Current policies on human subjects’ research
The Department of Health and Human Services (HHS) was the first organization to create formal policies for protection of human subjects (Williams, 2005). The Common Rule (45 CFR 46 Subpart A), which was informed by the Belmont Report of 1979 and which became law in 1981 gives guidelines for the protection of human subjects in research (Beauchamp, 2008). Included in the Belmont Report are the important aspects of ethical research with human individuals, which include the three ethical principles; beneficence, justice and respect for persons (Grant & Sugarman, 2004). All these principles are contained even in international protocols such as the Declaration of Helsinki which indicates that physicians in medical research have a duty to not only protect life, health and privacy but also the dignity of human subjects (Jastone, 2006).
The Common Rule is a set of policies by which research conducted on human beings and funded by federal agencies (Kalat, 2008). The common rule has three main elements namely; the informed consent of research subjects, a review of proposed research by Institutional Review Board, and institutional assurance of compliance with regulations. All these are meant to protect the research subjects. To date, 18 federal agencies and departments in their regulations use the Common Rule (Kalat, 2008).
In the view of informed consent, the Common Rule provides that before one is admitted into a study, the investigator must acquire assent from a living individual or their representative who is authorized by law. Among other requirements, the Common Rule also expects that the information be given to the subject at the level of 8th grade and in a language that is understandable to the subject (Kalat, 2008).
The Common Rule provides that the etiquette for human subject research be permitted by the IRB before embarking on the research (Beauchamp, 2008). Although the Common Rule does not dictate that the IRB be accredited, it requires that such a board should meet the prescribed membership and review conditions. Such conditions relate to membership composition in light of gender, cultural background, numbers, heterogeneity in terms of professional backgrounds and qualification as well as presence of a member who is external to the institution (Jastone, 2006). Despite the fact that the Common Rule does not provide specification for procedures to be followed by an IRB in reviewing its protocol, it provides that there should exist written protocols.
Assurance of compliance
An assurance is a written document that contains promises of institutional compliance to regulations. Before receiving funds provided by the federal, then there should exist an assurance of compliance with the Common Rule by the institution. In order to satisfy the requirements by the Common Rule, an assurance must indicate that the research has been reviewed, approved, and will continuously be reviewed by an IRB (45 CFR 46.103(a)) (Jastone, 2006).
However, the Common Rule only applies to those researches that are funded by the federal agencies that are signatory to the Common Rule. This implies that anyone or any institution that is not funded by these federal agencies is not compelled to follow the Common Rule (Kalat, 2008). Thus, even when private companies choose to follow the Common Rule, they are not subject to the enforcement by federal agency mechanisms in the event that they are not compliant with the regulation.
The Food and Drug Administration regulation
This is the federal agency that is responsible for the review of the wellbeing and effectiveness of new biomedical goods prior to being sold out in the US. As Williams (2005) indicates, there exist major similarities between the Common Rule and the FDA’s regulations for protection of human subjects (21 CFR 50, 56). The similarities occur since like the common rule, the FDA’s regulation requires informed consent, IRB review and assurance of IRB review (Jastone, 2006). The major difference between the two is that irrespective of the funding source, FDA’s regulations for the protection of human subjects attach when the research is used to support an application to FDA for marketing. The common rule provides also that for children subjects, 45 CFR 46 Subpart D indicates that an IRB may waive the requirement of the consent of the parent where need be in order to protect the subjects (Jastone, 2006).
Another regulation is Privacy Rule, which regulates handling of protected health information (PHI) by certain health related entities (Beauchamp, 2008). In the event that a research will involve handling PHI by an institution, the provisions of the Privacy Rule apply, regardless of the source of funding or the provisions of FDA (Jastone, 2006). The provisions of the Private Policy differ from the common rule in that while the private policy requires only patient’s authorization for release of their PHI, the later requires informed consent before participating in the research (Kalat, 2008). Authorization has elements such as use of plain language, the authorization must give a description of information and intended use, must have the identity of the requesting individual, indicate start and end dates of the research, show the expiry date of the authorization and indicate individual’s right to cancel the authorization.
Personal opinion and Conclusion
The principles of beneficence, privacy, and justice are highly embodied in policies on research ethics (Kalat, 2008). In the light of children as human research subjects, it has clearly emerged that the existing policy options have the potential to protect children’s right as human subjects of research while at the same time ensuring adherence to the above principles. The Common Rule 45 CHR 46 Subpart D particularly emphasizes protection of vulnerable populations of which children are included (Gottesman and Sandler, 2004). The inclusion of the aspect of consent and authorization in both the Common Rule and the Privacy Rule respectively helps in the protection of children’s privacy and beneficence.
Nonetheless, the Common rule and other regulations have not been adopted in unison by all federal agencies and this makes protection of children as human subject of research a great challenge. Similarly, the fact that some researches that are not federally funded may be conducted without the regulation of federal agencies pose a threat to the use of children as human research subjects. In addition, lack of harmony and simultaneous application of the Common Rule, Privacy Rule and/or the FDA regulations have brought about confusions to those involved in human subjects research (Grant and Sugarman, 2004).
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Beauchamp, T. (2008). Contemporary issues in bioethics. (7th Ed.). Belmont, CA: Wadsworth Publishing. Web.
Gottesman, M., & Sandler, A. (2004). Guidelines for the Conduct of Research Involving Human Subjects at the National Institutes of Health. US Department of Human and Health Services, National Institute of Health. Web.
Grant, R., & Sugarman, J. (2004). Ethics in Human Subjects Research: Do Incentives Matter? Journal of Medicine and Philosophy, 29(6): 717-738. Web.
Jastone, O. (2006). Federal protection for human research subjects: an analysis of the common rule and its interactions with FDA regulations and the HIPAA privacy rule. New York: Nova Publishers. Web.
Kalat, J. (2008). Biological Psychology. Farmington: Cengage. Web.