Protection of Human Subjects in Research

Protection of Human Subjects in Research

Student’s Name

Institution of Affiliation

The Purpose of Institutional Review Board (IRB)

The Institutional Review Board (IRB) is the administrative body charged with the responsibility of protecting the rights and the welfare of human subjects in research conducted under the auspice of the institution that is affiliated to the research (Grady, 2015). The IRB was established for the sole purpose of safeguarding the welfare, rights, and privacy of human subjects in research (Kaiser Online, 2020).  As a result, the IRB is mandated to review, before its initiation, all research activities that involve human subjects,  regardless of whether the research is funded or not.  

Vulnerable Population

It is essential to note that in most studies, the vulnerable population is often overlooked. The vulnerable population refers to the economically disadvantaged, racial, and ethnic minorities. They include children and women from low-income families, the elderly, prisoners, the homeless, the individuals with HIV, as well as those with chronic health conditions like severe mental illness (Patrick, Flegel, & Stanbrook, 2018). Social factors can exacerbate the health and healthcare matters of the vulnerable population.  They face higher risk factors, worse accessibility to care, and more significant morbidity and mortality rates in comparison to the overall population.

Protection of Human Subjects

The protection of human subjects in any research is crucial. Prior to conducting the research, the researcher can protect the human subjects by conducting an assessment of risk and identify the measures to be taken to protect the human subjects from such risks. During the study, the human subjects can be protected by monitoring the safety of participants to ensure that the risks are minimized through reporting of unanticipated issues or adverse experiences (Resnik, 2018). After the study, human subjects can be protected by establishing a data and safety monitoring plan. In this plan, the researcher must determine the specific data that needs to be monitored and define the procedures for analysis and interpretation of the data. Besides, during monitoring, the researcher must plan for the review and report any adverse events and unanticipated events to IRB.

Securing both Organizational and IRB Approval

Securing both organizational approval and IRB approval for any study requires a proper preparation. Preparation is the key to any successful result whenever there is a need to submit a research proposal for internal or external approval and funding. The plan for securing approval includes the following:

• Selection of a suitable research project
• Reading and evaluating the scientific literature for the study
• Formulating a research plan

After selecting a suitable research project, it is essential to embark on performing a literature review and recruiting collaborators. Afterward, the researcher questions are formulated, and the research hypothesis developed.  The research hypothesis is explained in the proposal and be included at the end of the introduction section of the proposal. The next step is getting ethical approval and producing the first draft of the correct length with figures. In the research plan, the methods to be used are outlined and described in detail (Moule, Aveyar, & Goodman, 2016).. Besides, all the rules, such as section headings, maximum word length in each heading, the maximum number of figures or tables, the maximum number of references, the kind of experiments, and the equipment or staffing permitted in the study are also detailed in the proposal. Most importantly, the research proposal plan is simple and uses simple language. The proposal outlook is as follows:

Outline of Research Proposal	Comments
Title of proposal	Brief and not too technical
Names of researchers	Stipulating principal investigators
The aims and objectives	Concise and SMART
Summary of proposal	Both simple and technical summaries
Introduction	Background to the project
Hypotheses	Scientific basis of the project
Plan of Investigation	Detailed research plan with time frames
Analysis of Data	Incorporating statistical methods
Expected Results	incase hypotheses are proven
Expected benefits	To the patients and service users
Finances requirement	Including staff and equipment
Justification for finances	For assuring the value for money
References	From key scientific literature
Curriculum vitae of investigators	Incorporating publications and grants held
Approvals	Evidence of ethical approval and licenses
Support Letters	From collaborators and employers

References

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

Kaiser Online. (2020). Institutional Review Board. Retrieved 14 February 2020, from https://www.kpwashingtonresearch.org/get-involved/institutional-review-board

Moule, P., Aveyard, H., & Goodman, M. (2016). Nursing research: An introduction. Sage.

Patrick, K., Flegel, K., & Stanbrook, M. B. (2018). Vulnerable populations: an area CMAJ will continue to champion.

Resnik, D. B. (2018). The ethics of research with human subjects: Protecting people, advancing science, promoting trust (Vol. 74). Springer.

ALSO READ: IRB APPLICATION PROCESS