Posted: August 15th, 2023

Protecting Human Subjects in Research: The Role of Institutional Review Boards (IRBs)

Week 6 Discussion. The Institutional Review Board (IRB) exists to ensure the ethical treatment and rights of human participants in research studies. Its goal is to safeguard human subjects’ rights, welfare, and well-being, balancing the pursuit of knowledge with the dignity and autonomy of individuals involved in the research.
Components to Determine if IRB Submission is Needed:
1. Human Participants: If your research involves human subjects in any capacity, be it through interviews, surveys, or direct interventions, IRB oversight is generally necessary.
2. Data Privacy: If personally identifiable information is collected where participants can be identified directly or through identifiers linked to them, an IRB review becomes necessary.
3. Physical Procedures: Involvement in procedures like medical examinations, sample collection, or drug administration typically requires IRB oversight.
4. Psychological Stress or Harm: Studies that might introduce emotional, psychological, or social stress to participants often need IRB approval.
5. Vulnerable Populations: Projects involving children, prisoners, pregnant women, or other vulnerable groups usually undergo stricter scrutiny and demand IRB review.
6. Risk and Benefits Assessment: Any research that poses more than minimal risk to participants—i.e., beyond the risks of daily life—will typically need a review.
Example from Literature Review:
In the article by Cima et al. (2011) titled “Use of Lean and Six Sigma Methodology to improve operating room efficiency,” the researchers conducted direct observations in the operating room. They interacted with the healthcare staff to assess and improve efficiency.
Reason for IRB Approval:
1. Human Participants: The study involved human subjects as they directly observed the activities and procedures conducted by the operating room staff. This observation could have influenced the behavior of the staff, introducing a form of intervention.
2. Data Privacy: Observations made in the operating room could have collected information that could lead back to specific patients or healthcare providers if not correctly made anonymously.
3. Physical and Psychological Stress: Any change or observation in a high-stress environment, like an operating room, can introduce potential risks or alter routines, leading to psychological or emotional stress for the staff involved.
Given the above factors, IRB approval was essential to ensure the ethical conduct of the study, protect the privacy of the staff and patients, and ensure the validity of the data collected.
References:
• Cima, R. R., et al. (2011). Use of Lean and Six Sigma methodology to improve operating room efficiency. Journal of the American College of Surgeons, 213(1), 83-92.

Because of the unethical treatment of human subjects in the past such as unethical Nazi research and the Tuskeegee Airmen, much has been done to ensure the protection of subjects involved in research (Barrow, et al, 2022). There are multiple aspects to look at when determining if a study should go before a review board. Things to consider are: data obtained that is identifiable or private, is the data obtained as part of a classroom exercise or to be used outside of the class, the data is derived from living individuals, and will the data contribute to the body of knowledge publicly.
One article that I used was Cernelic-Bizjak et al, (2022) who was studying the effect of the Pandemic and Nursing Education outcomes. This study was a primary study who surveyed the data from thousands of nursing students across multiple schools in an effort to obtain data. IRB approval was submitted due to the inclusion of a large quantity of individuals that was not limited to a single classroom or program. Information that was sought after was not publicly available and was to be obtained by interacting with thousands of subjects. Also, the data derived from the study was to be used for the benefit outside of a single organization and for the greater knowledge.

Barrow JM, Brannan GD, Khandhar PB (2022). Research ethics. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing. Available from: https://www.ncbi.nlm.nih.gov/books/NBK459281/
Links to an external site.
Cernelic-Bizjak, M & Dolenc, P. (2022) Relationship between nursing students’ attitudes toward nursing profession and online learning satisfaction during COVID-19 lockown. Plos One. https://doi.org/10.1371/journal.pone.0277198
Links to an external site.
Reply

Protecting Human Subjects in Research: The Role of Institutional Review Boards (IRBs)

In the realm of research, ethical considerations hold paramount importance, especially when human participants are involved. The Institutional Review Board (IRB) stands as a vigilant guardian, ensuring the rights, welfare, and dignity of individuals engaged in research endeavors. The primary goal is to harmonize the quest for knowledge with the respect for the autonomy and well-being of research subjects (Jones & Childers, 2019).

Determining the Need for IRB Submission

Human Participants: Involvement of human subjects in research activities, whether through surveys, interviews, or direct interventions, invariably necessitates IRB oversight (Jones & Childers, 2019).

Data Privacy: The collection of personally identifiable information that could lead to the direct identification of participants mandates an IRB review to safeguard their privacy (Perry & Coe, 2020).

Physical Procedures: Any research incorporating physical procedures such as medical examinations or sample collection calls for IRB scrutiny (Jones & Childers, 2019).

Psychological Stress or Harm: Studies introducing psychological, emotional, or social stress to participants are subject to IRB approval to ensure their well-being (Perry & Coe, 2020).

Vulnerable Populations: Research involving vulnerable groups such as children, prisoners, or pregnant women warrants enhanced scrutiny and mandatory IRB review (Jones & Childers, 2019).

Risk and Benefits Assessment: Projects carrying risks beyond the norms of daily life mandate IRB assessment to uphold participant safety (Perry & Coe, 2020).

Real-World Example: Cima et al.’s Operating Room Efficiency Study

For instance, consider the study conducted by Cima et al. (2011) titled “Use of Lean and Six Sigma Methodology to improve operating room efficiency.” The researchers performed direct observations within the operating room, engaging with healthcare staff to enhance efficiency (Cima et al., 2011).

Reasons for IRB Approval:

Human Participants: The study involved direct observation of operating room activities, introducing an element of intervention and influence on staff behavior (Cima et al., 2011).

Data Privacy: The observations held the potential to gather information linking back to specific patients and healthcare providers if not anonymized appropriately (Cima et al., 2011).

Physical and Psychological Stress: The alteration of routines in a high-stress environment like an operating room could induce psychological and emotional stress among the staff (Cima et al., 2011).

This instance exemplifies the necessity of IRB approval to uphold ethical standards, ensure participant privacy, and maintain data integrity (Cima et al., 2011).

In Modern Context: Pandemic and Nursing Education Outcomes

Consider the study by Cernelic-Bizjak and Dolenc (2022) exploring the relationship between nursing students’ attitudes and online learning satisfaction during the COVID-19 lockdown. The study encompassed a substantial number of nursing students from various schools, warranting IRB submission due to the involvement of a significant participant pool and the non-public nature of the data (Cernelic-Bizjak & Dolenc, 2022).

Conclusion

In conclusion, the IRB serves as a crucial guardian of ethical research involving human participants. Its oversight ensures the protection of subjects, their privacy, and the integrity of the research process. By scrutinizing various aspects like participant involvement, data privacy, and potential risks, the IRB plays a pivotal role in maintaining the balance between the pursuit of knowledge and the well-being of those involved.

References:

Cernelic-Bizjak, M., & Dolenc, P. (2022). Relationship between nursing students’ attitudes toward nursing profession and online learning satisfaction during COVID-19 lockdown. Plos One. https://doi.org/10.1371/journal.pone.0277198

Cima, R. R., et al. (2011). Use of Lean and Six Sigma methodology to improve operating room efficiency. Journal of the American College of Surgeons, 213(1), 83-92.

Jones, T. A., & Childers, L. M. (2019). Determining the need for institutional review board submission for research activities at a single institution. Journal of Oncology Practice, 15(6), e509-e514.

Perry, L. A., & Coe, T. R. (2020). A guide to understanding institutional review board (IRB) for graduate nursing students. Nurse Educator, 45(1), 34-38.

Order | Check Discount