Erin Wilhelm, MPH
Executive Director, Program for Regulatory Science & Medicine (PRSM)
Instructor, Department of Pharmacology & Physiology
Course Description: Organizations bear economic, legal, and ethical obligations to provide useful information about the risks and benefits of their product, policies, and services.” Risk Communication is a “state-of-the-art” term for communications meant to help people make informed decisions about whether and how to address the risks they encounter. The topics covered in product risk communications, however, typically should not solely be about risk, in that people must understand product-related benefits to be able to effectively evaluate product-related risks.
Communications about public health product risks and benefits focus on accuracy and comprehensiveness, thereby differing significantly from typical public relations and many public affairs communications. Regulatory Science should prepare health professionals and the public to make informed decisions about medical, food, and tobacco products. This course will introduce students to the complexities of planning, implementing, and evaluating risk communications in circumstances where all public communications are affected by varying regulatory and legal constraints.
The course will explore the perspectives of different key actors, including product developers, manufacturers, advertisers, regulators, and users – both professional and non-professional. The course will introduce critical concepts through didactic lecture (exposing students to core strategies, considerations, and the analyses required to develop and test effective risk communications) and discussion. Students will discuss real-world risk communications examples, and will identify areas where different strategies might have had different effects.
Using concepts learned from the course, students prepare a project to present describing an ideal process for planning, implementing, and evaluating a risk communication for a specific new medical product, the characteristics of which will be developed with as-needed assistance of course director(s). Students’ ability to apply the lessons, classroom discussion, and readings also will be evaluated from responses to a midterm exam, class presentation, and communication-relevant assignment.
- Identify the general purposes and goals of risk communication, the general methods of examining effectiveness, and how to determine the appropriate evaluation of effectiveness of a particular risk communication strategy.
- Explain, and provide examples to demonstrate the differences between: product-focused risk communication and crisis and emergency risk communication; and persuasive and non-persuasive risk communication.
- Describe the factors to be considered in determining how the public is likely to perceive the severity of the risks of a particular product, depending on a product’s characteristics.
- Describe the basic cognitive/psychological factors to consider in developing and evaluating risk communications, including health literacy, mental models, decision-making heuristics, processing of qualitative and quantitative information, age-related changes, and the impact of emotion.
- Compare and contrast the specific laws and regulations governing oversight of sponsored communications (advertising and labeling) about different FDA-regulated products, including animal and human drugs, medical devices, foods, and tobacco products.
- Describe how the Paperwork Reduction Act and Institutional Review Board reviews can affect the planning, implementation, and evaluation of federal government risk communications.
- Demonstrate how to apply a First Amendment analysis to a claim about, or a proposed regulation concerning, a food or medical product.
- Identify the critical actors in planning, implementing, and evaluating a risk communication strategy for a specific medical product.
- Identify and describe the impact of regulated industry, government agencies, non-government organizations, academia, and members of the public, on the development of regulations concerning product communication.
- Describe the factors likely to influence health care provider-patient discussions about the risks and benefits of potential treatment with medical products.