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In order to understand how an Institutional Review Board functions and the type of knowledge one needs to participate in a research study involving human participants, you will use the link to the Office of Research Integrity, RCR Resource Development Program’s  “Teaching the Responsible Conduct of Research in Humans” website at Office of Research Integrity. The tutorial will help you identify research activities that involve human participants and help you understand how to protect the rights and welfare of all human participants involved in research.

As the new Director of Health Information Management for Cook County Regional Hospital, one of your duties is to serve as a resource for the Institutional Review Board (IRB). You have reviewed their policies and procedures and have familiarized yourself with the IRB’s functions and are concerned when you do not find any mention of “vulnerable subjects.”


Prepare a report with recommendations you will make about addressing vulnerable subjects, and how you will defend your position for a meeting with the IRB, 

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As the Director of Health Information Management for Cook County Regional Hospital, it is important to ensure that the Institutional Review Board (IRB) recognizes and addresses the rights and welfare of vulnerable subjects involved in research. In this report, recommendations will be provided on how to address and protect vulnerable subjects, along with a defense of these recommendations.

Recommendations for addressing vulnerable subjects:

1. Definition and identification of vulnerable subjects:
The IRB should establish a clear definition of vulnerable subjects, which includes individuals who may have diminished autonomy or decision-making capacity, increased susceptibility to coercion, or are at a higher risk of experiencing harm. This definition should align with recognized ethical guidelines and regulations, such as those provided by the Office for Human Research Protections (OHRP) or the World Medical Association’s Declaration of Helsinki. It is crucial for the IRB to identify and categorize vulnerable subjects appropriately to ensure their specific needs are addressed.

2. Enhanced informed consent process:
The informed consent process should be adapted to meet the needs of vulnerable subjects. Additional measures should be taken to ensure that they fully understand the research, risks, benefits, and alternatives. This may involve the use of simplified language, visual aids, or the involvement of trusted individuals, such as family members or advocates. Moreover, the IRB should require researchers to provide documentation detailing the steps taken to ensure the informed consent process is appropriately tailored for vulnerable subjects.

3. Special protections and monitoring:
The IRB should establish specific protections and monitoring mechanisms for vulnerable subjects. These may include increased oversight, stricter inclusion and exclusion criteria, limitations on the types of interventions or procedures used, or additional safeguards to minimize potential harm. The IRB should also require researchers to provide regular reports on the welfare, safety, and progress of vulnerable subjects throughout the study.

4. Education and training:
To ensure a comprehensive understanding of working with vulnerable subjects, the IRB should develop and implement educational programs and training sessions for researchers, investigators, and IRB members. These programs should cover the ethical considerations, legal requirements, and best practices for research involving vulnerable subjects. Additionally, the IRB should consider requiring investigators to demonstrate their knowledge of working with vulnerable subjects before granting approval for research projects.

Defense of recommendations:

1. Ethical obligation:
The inclusion of vulnerable subjects in research raises significant ethical concerns. As a healthcare institution committed to patient welfare, it is imperative for the IRB to actively address the rights and well-being of vulnerable subjects. Failing to do so would disregard the principles of beneficence, respect for persons, and justice, which are fundamental to ethical research.

2. Legal and regulatory requirements:
Various regulations and guidelines, such as the Common Rule and the Belmont Report, emphasize the importance of protecting vulnerable populations in research. Adhering to these legal and regulatory requirements is not only an ethical obligation but also essential for maintaining compliance with federal regulations and ensuring the institution’s reputation.

3. Mitigating potential harm:
Vulnerable subjects are often more susceptible to potential harm due to their unique circumstances. By implementing the recommended measures, the IRB can actively mitigate risks and ensure the protection of these individuals throughout the research process. This approach promotes both the well-being of vulnerable subjects and the overall integrity and validity of the research outcomes.


Addressing the inclusion and protection of vulnerable subjects is crucial for maintaining ethical standards and promoting the welfare of human participants in research. The recommendations provided above, including defining vulnerable subjects, adapting the informed consent process, establishing special protections, and implementing education/training programs, will ensure that the IRB fulfills its role in safeguarding the rights and well-being of vulnerable subjects. By adopting these recommendations, Cook County Regional Hospital can demonstrate its commitment to responsible and ethical research practices.

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