The Institutional Review Board

The Institutional Review Board – The Institutional Review Board (IRB) is an administrative body mandated to protect research participants’ rights and welfare in research activities prescribed by federal regulations…

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The Institutional Review Board

Solution

The Institutional Review Board (IRB) is an administrative body mandated to protect research participants’ rights and welfare in research activities prescribed by federal regulations. The committee ensures that primary investigators do not violate the rights of research participants. Thus, IRB’s primary role is to conduct an ethical review, monitor, and evaluate any research involving humans as subjects to safeguard human rights in research activities.

The committee also monitors continuing research and is responsible for providing training on human subjects’ protection in research. Likewise, the IRB committee can also modify research studies to ensure that human subjects’ welfare, rights, and privacy are protected. Primarily, federal regulations and institutional policies give IRB the authority to ethically review, approve, disapprove, monitor, and require modifications in all research activities involving human subjects.

The National Institute of Health is one such organization that has to adhere to the IRB committee’s demands and regulations. NIH, as an agency, falls under the U.S Department of Health and Human Services. The organization is mandated to carry our medical research in the country to save and improve American lives through enhanced medical innovations.

The fact that the agency conducts medical investigations that seek to strengthen American citizens’ experience means that its activities and studies have to be monitored and approved by the IRB. NIH’s adherence to IRB standards seen in one of its requirements demanding that any individual organization who wants to get its approval to conduct research involving human beings first has to get clearance from the IRB.

Researchers requesting to conduct studies on human subjects must comply with the NIH Single IRB for Multisite Research requirement. Likewise, researchers are required to table a proposal detailing how the research intends to protect human subjects in their studies. Through these certifications, the IRB committee ensures that any investigator working with the organization adheres to set federal and institutional policies on the use of human subjects in research.

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NIH-funded research focuses on different at-risk populations, often vulnerable in medical investigations. One such group is women. The agency has enacted several policies to guide its researchers when using women as study participants. The issue of women as subjects in researches is contained in the NIH Revitalization Act of 1993 (National Institute of Health. 2020).

The act mandates the NIH to formulate policies and guidelines that ensure the inclusion and protection of women’s rights in its research. Women inclusion is included in clause “a” of the statute giving the organization’s director the powers to see that policies are enacted to allow women to participate in medical studies.

The regulation goes ahead to provide details of the different conditions in which women can be used in the research. The statute gives NIH guidelines specifying how women are to be treated while acting as research subjects. In particular, the study dictates that the “Director of NIH shall ensure that the trial is designed and carried out in a manner sufficient to provide for valid analysis of whether the variables being studied in the trial affect women or members of the minority (National Institute of Health, 2020.)”

NIH has also put policies to safeguard the minority’s rights. The rights of the minority as research subjects for NIH-funded studies are included in the same Revitalization Act of 1993. The act gives the NIH director the power to determine minority groups as seen in the statement, “The Director of NIH shall, through the guidelines established, define the terms “minority group” and put in place the necessary procedures to go ahead with the research (National Institute of Health, 2020).

Protection of both women and the minority is seen in the guidelines stating that studies with inappropriate consequences will not be allowed. The inappropriateness is evaluated by the research’s failure to promote both women and minority health or being irrelevant to the study’s purpose.

Likewise, NIH has put in place several measures to protect children as human subjects. The organization considers children vulnerable and likely to be exposed to inappropriate research due to a lack of mental capacity. Children’s vulnerability stems from the fact that they are not in a position to make informed decisions. NIH has thus put in place guidelines that detail how consent to participate in research for children.

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The parents or guardians of the children must give their consent for children to participate in research. Likewise, children should not be coerced into giving their assent to the primary investigators’ demands. On the contrary, appropriate measures relevant to the child’s educational understanding should be used to seek their permission.

Likewise, NIH demands that its researchers observe ethical conduct when dealing with individuals whose vulnerability arises from cognitive disorders. The NIH defines cognitive disorders as organic conditions that affect an individual’s emotional or cognitive functioning to the extent that they cannot make the right decisions.

NIH states that researchers should seek consent from the handlers of the cognitive impaired. Likewise, researchers must reveal their intention of including people with cognitive challenges to the study. Furthermore, the research is disapproved if it is realized that it does not bring any benefits to the participants (Nosheny, 2020).

Conclusion

IRB’s core responsibility is to protect human subjects’ welfare, rights, and privacy in research. While research drives healthcare innovation and advancement, IRB, set from federal and institutional systems, ensures that the engagement of at-risk populations such as children, women, minorities, and cognitively impaired participants are protected.

NIH, one of the most influential research organizations in the healthcare continuum, is guided by well-defined policies and guidelines that safeguard research subjects. IRB plays a critical role in healthcare research by ensuring respect for persons’ rights and welfare for all populations taking part in the research.

References

  • Amdur, R. J., & Bankert, E. A. (2010). Institutional review board: Member handbook. Jones & Bartlett Publishers.
  • National Institute of Health. 2020. NIH Policy and Guidelines on The Inclusion of Women and Minorities as Subjects in Clinical Research Accessed October 9th 2020
  • Nosheny, R. L., Camacho, M. R., Jin, C., Neuhaus, J., Truran, D., Flenniken, D., … & Hanna, L. (2020). Validation of online functional measures in cognitively impaired older adults. Alzheimer’s & Dementia.

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