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 question, 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 of 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.
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 question, 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?
- 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.
Furrow, B., Greaney, T., Johnson, S., Jost, T., & Schwartz, R. (2013). Health law: Cases, materials, and problems (7th ed.). St. Paul, MN: West Academic Publishing.
- Pages 59–126
- Pages 699–920
Shapiro, S. P. (2015). Do advance directives direct? [PDF] Journal of Health Politics, Policy and Law, 40(3), 487–530.