Brilliant Answer

Discussion 1: IRB and the Aging Physician

There have been a series of adverse outcomes in clinical trials being conducted at your hospital. The Medical Director who has headed the Institutional Review Board (IRB) has been doing so for the past 20 years. After further investigation, legal counsel has informed you that the protocols have not been followed, and in many instances, patients have not been provided adequate informed consent. You have also heard rumors that the Medical Director, now aged 71, has noticeably slowed in recent years and at times seems forgetful.

For this Discussion, reflect on the scenario presented. Then, consider how you as a current or future healthcare administration leader might address the issues with IRB in the scenario. Think about what steps might be needed to make an IRB valid and to ensure that research conforms to IRB protocol.

What steps you, as a current or future healthcare administration leader, might take to address the issues with IRB as presented in the scenario. Explain what steps are needed to make an IRB valid and how you would ensure that research in a health services organization conforms to proper IRB protocol. Be specific and provide examples.

Discussion

Continue the Discussion to 2 of your colleagues below and suggest an alternative step not mentioned by your colleagues to address the issues with IRB as presented in the scenario.

Each Colleagues 250 words or more (Colleague 1 250, Colleague 2 250, Total 500 words)

Colleague 1

IRB and the Aging Physician

Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects (U.S. Food & Drug Administration, 2019). The first step is to ensure that the IRB is valid. The steps to do so are determine if the project requires IRB approval, complete the mandatory online certification for researchers, complete the IRB research project application, prepare the informed consent document, submit proposal form, adjust as necessitude by IRB review until approved, report changes and annually renew authorization, and submit close out form (Bellevue College, n.d).

In this scenario the first step would be to address the impairment of the Medical Director. At work, impaired physicians make every attempt to conceal their symptoms, making it challenging for others to detect a problem. If their workplace provides access to drugs, they may work long hours to stay close to the source of their addiction. Behaviors that might signify a problem would include unpredictable behavior to the staff or patients, often late to or absent from the office or rounds, lack of availability when on call, and careless medical decisions (Johnson, 2009). So, a focus would be to get the Medical Director on why he may be slowing down in his work.

Another step would be to talk to leadership and investigate providing the necessary tools to fix what happened with the protocols. Risk Management would be able to assist with this matter as well. This department would focus on proactively performing risk assessments for the matter. They can identify risks before and after they occur. Leadership should conduct failure mode effects analyses, which score a process or product based on potential failures, the probability of these failures occurring, their likely frequency and the ability to detect them (Becker’s Healthcare, 2013) The resulting risk score enables managers to proactively establish practices that will reduce or eliminate these risks for failure. This way it would have caught the issue that occurred sooner than later.

References

Becker’s Healthcare. (1 April 2013). 4 Best Practices for Hospital Risk Management. Retrieved

https://www.beckershospitalreview.com/quality/4-best-practices-for-hospital-risk-management.html

Bellevue College. (n.d). Institutional Review Board. Retrieved from

https://www.bellevuecollege.edu/irb/review/

Johnson B. A. (2009). Dealing with the impaired physician. American family physician, 80(9),

1007.

U.S. Food & Drug Administration. (18 April 2019). Institutional Review Boards Frequently

Asked Questions. Retrieved from https://www.fda.gov/regulatory-information/search-fda-

guidance-documents/institutional-review-boards-frequently-asked-questions

Colleague 2

The healthcare organization’s IRB is a committee comprised of experts for purpose of ensuring patients are treated safety and fairly during a clinical trial or research study. As an administrator working with a hospital that is receiving funding or oversight for research, it is essential to ensure that all studies follow the IRB standards, and that all protocols are being followed.  

The administration has taken the first step by investigating the negative outcomes. With the information provided by legal, it is apparent that reeducation is required for any staff member participating in clinical trials or research involving human subjects. If an education program has not been established at the healthcare organization, the education department will need to develop a training program that encompasses the courses provided by the Institute for Healthcare Improvement. During this time, the IRB would need to be educated on what is required for clinical trials prior to approval. Federal regulations that set criteria for the approval of research by IRBs require that the risks to research subjects be minimized and that patients receive informed consent (Steinbrook, 2003). According to the legal counsel, this was not occurring at the organization. The data and outcomes from the investigation should be presented to the IRB with a discussion on how to remedy the situation. Additional volunteers or appointments to the committee would be recommended. Risk management and the legal team would need to be involved due to the noncompliance to protocols in the areas of patient education and consent. Noncompliance to protocols increases the risk of liability and medical malpractice (Icenogle, 2003).

Rumors regarding the physician are extremely concerning. With the increased focus on medical errors coupled with the aging population of the physician workforce, there is a growing concern in the area of cognitive deficiencies in physicians (Del Bene & Brandt, 2020). Because of this growing concern, the healthcare organization has neuropsychological testing completed annually. If the physician has not had the testing completed, this would need to be scheduled after speaking with the physician and advising him of the rumors. Establishing open communication without making any accusations in regards to the physician’s memory would need to be accomplished. If the neuropsych testing determines that the physician would need additional services provided to perform his job, additional services would be discussed at that time.

 

References

Del Bene, V. A., & Brandt, J. (2020). Identifying neuropsychologically impaired physicians. The Clinical Neuropsychologist, 34(2), 318-331.

Icenogle D. L. (2003). IRBs, conflict and liability: will we see IRBs in court? Or is it when?. Clinical medicine & research, 1(1), 63–68. https://doi.org/10.3121/cmr.1.1.63

Steinbrook, R. (2003). Trial design and patient safety-the debate continues. New England Journal of Medicine, 349(7), 629-701.