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.
Explain 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.
- Analyze implications of improper IRB protocols for health services organizations
- Analyze healthcare administration leader strategies for ensuring valid IRB protocols
(3-4 pages)
2: Clinical Research and Informed Consent
When entering into a clinical research study, patients are provided with several forms of information detailing the aims of the study as well as any anticipated complications or difficulties they might experience as a participant in the clinical research study. However, if patients are not aware of or do not fully understand the research materials provided, are they truly and adequately informed to enter into the clinical research study?
For this Discussion, think about the importance of informed consent necessary for patients to participate in a clinical research study. As a current or future healthcare administration leader, consider how inadequate informed consent impacts risks for litigation?
Explain and describe the implications of having patients participate in a clinical research study without adequate informed consent. Then, explain how you, as a current or future healthcare administration leader, might address patient concerns about informed consent, including what strategies you might take to reduce risks of litigation.
- Analyze stakeholder and organizational implications of patients participating in an IRB without informed consent
- Evaluate strategies healthcare administration leaders might take to reduce risk of litigation in relation to IRB participation without informed consent
(3-4 pages)
Expert Solution Preview
Introduction:
This assignment requires us to answer two questions related to healthcare administration and medical research. The first question focuses on Institutional Review Board (IRB) protocols and the issues associated with their violation. The second question deals with informed consent and how inadequate information can impact the risks of litigation. As a medical professor, it is crucial to develop an understanding of these topics to teach our students better and prepare them for real-world scenarios.
1. IRB and the Aging Physician:
The violation of IRB protocols can have significant implications for health services organizations. The scenario presented here highlights the adverse outcomes of clinical trials due to the failure of protocols. An IRB plays a crucial role in ensuring that research is conducted ethically, and all patients provide informed consent. As a healthcare administration leader, it is essential to take steps to address the issues with the IRB.
The first step should be to investigate the IRB’s functioning and identify the gaps and issues in its protocols. Then, the IRB should be restructured with new members who have expertise in their respective domains. The new members should be selected based on their understanding and knowledge of IRB protocols. Training programs can also be organized to educate them about the legal and ethical aspects associated with conducting research.
To ensure that research in health services organizations follows the IRB protocols, it is essential to develop a rigorous framework. The framework should include procedures for identifying research proposals, conducting reviews, and approving or rejecting them. It should also include processes for monitoring research projects and ensuring that researchers follow ethical guidelines. Health services organizations can appoint an independent committee to conduct periodic audits to ensure that they conform to proper IRB protocol.
2. Clinical Research and Informed Consent:
Informed consent is crucial before involving patients in clinical research studies. Without adequate informed consent, patients may not participate in the study voluntarily, and there may be significant risks associated with their participation. A lack of informed consent can also have legal implications, leading to litigation against healthcare organizations.
As healthcare administration leaders, it is essential to address patient concerns about informed consent. One strategy is to improve the quality and clarity of information provided to patients. This can be achieved by using simple language, avoiding technical jargon, and clearly outlining the risks and benefits associated with participation. Patients can be provided with opportunities to ask questions and clarify their doubts, which can help to reduce their anxiety and improve the quality of informed consent.
To reduce the risks of litigation due to inadequate informed consent, healthcare organizations can adopt several strategies. Healthcare management can develop policies and procedures that detail the processes to be followed while obtaining informed consent from patients. The policies should include the necessary steps to ensure that the information provided to patients is consistent, clear, and complete. Additionally, healthcare organizations can ensure that they have liability insurance to cover any potential litigation.
Conclusion:
In conclusion, healthcare administration leaders have a vital role to play in ensuring that IRB protocols and informed consent are followed while conducting clinical research studies. They should take all the necessary steps to address the gaps associated with IRB protocols and ensure that the organization follows them rigorously. They should also focus on improving the quality of informed consent provided to patients, which can help reduce the risks associated with participation in clinical research studies.
