Presentation
MDD22 - Special Considerations for Human Factors Work Involving Vulnerable Populations
DescriptionUnderstanding a product's intended users and designing the product to accommodate those users’ attributes is a critical tenet of product design and development. In addition, FDA guidance and international standards put forth that it is necessary that human factors research is conducted with representative intended users as participants to understand and evaluate whether the medical device or drug-delivery devices are safe and effective for the intended users. Sometimes the intended users of a product are considered a “vulnerable population.” Vulnerable populations include children, pregnant women, and people who have cognitive impairments, among others.
This poster will describe how to identify a vulnerable population and how to safely and appropriately incorporate vulnerable populations in design and research if they are the intended users. If a product is intended to be used by a vulnerable population, considerations should be made throughout the design process and we have two authors from industry who will discuss approaches they have taken. In addition, before potential participants are approached to participate, consider the role of an IRB in planning the study and defining ethical recruitment practices. We have an author who will describe the IRB process and the necessity of involving an IRB before conducting research.
Finally, there are research considerations when working with vulnerable populations, and some thoughts related to conducting studies will be provided. For example, when designing a study involving users with cognitive impairments, additional time should be planned for the consenting process itself, to ensure that the participant clearly understands the research. Researchers should also be open to the idea that some vulnerable populations might be better represented in the context of a natural dyad.
This poster will describe how to identify a vulnerable population and how to safely and appropriately incorporate vulnerable populations in design and research if they are the intended users. If a product is intended to be used by a vulnerable population, considerations should be made throughout the design process and we have two authors from industry who will discuss approaches they have taken. In addition, before potential participants are approached to participate, consider the role of an IRB in planning the study and defining ethical recruitment practices. We have an author who will describe the IRB process and the necessity of involving an IRB before conducting research.
Finally, there are research considerations when working with vulnerable populations, and some thoughts related to conducting studies will be provided. For example, when designing a study involving users with cognitive impairments, additional time should be planned for the consenting process itself, to ensure that the participant clearly understands the research. Researchers should also be open to the idea that some vulnerable populations might be better represented in the context of a natural dyad.
Event Type
Poster Presentation
TimeMonday, March 254:45pm - 6:15pm CDT
LocationSalon C
Digital Health
Simulation and Education
Hospital Environments
Medical and Drug Delivery Devices
Patient Safety Research and Initiatives