Doctor in hospital room with patient and the family members
HealthAugust 17, 2020

Participation in research: Laying the framework for patients and their families

A crucial part of the United States’ response to the Covid-19 pandemic is the emergence of new research efforts designed to identify and produce vaccines for mass distribution to the general public. Key to this goal is the scientific process, by which clinicians and clinician-researchers take steps to increase medical knowledge and provide benefit to the public.

The Archives of Neuropsychiatry journal defines scientific research as a neutral, systemic, planned, and multistep process using previously discovered facts to advance medical knowledge. With Covid-19 research, as with all research, the process generally falls into two categories: observational and experimental.

According to news networks like CNN, thousands of Americans want to be exposed to Covid-19 to aid in national research efforts. Many people believe their participation in studies will help speed up the development of a vaccine. Such human-challenge studies may help reduce the time needed for vaccine development, but it’s important to keep in mind that there are also dangers. More specifically, there is no proven treatment options for Covid-19, and participation in a vaccine study may result in infection, or worse.

Developing specific frameworks for patient involvement in research is crucial for fostering democracy, equality, and research quality in the entire process. However, to date such frameworks concerning patients with potentially life-threatening illnesses is limited.

A Norwegian framework for research participation

As noted by the authors of a study in Advances in Nursing Science, any research project involving vulnerable patient populations inherently carries ethical challenges and considerations regarding user involvement. However, it is still essential to include these patients in research efforts to solve modern clinical issues. In many cases, family members or other caregivers are also included in the research process.

In Norway, a group of clinician-researchers have worked to develop new strategies for managing the involvement of patients and their caregivers. The lessons from the Dying With Dignity project, which focused on patients diagnosed with terminal cancer, can also be applied to those willing to participate in Covid-19 research.

The main objective of the project was to develop a formal research collaboration between clinician-researchers and patients and caregivers involved in any studies. The process consists of clearly defining the study’s goal, encouraging patient participation in the development of interview guides and informative letters, and using their expertise to help review data analysis and article drafts.

Patients and caregivers may be considered experts within the subject matter under investigation, including those diagnosed with Covid-19. As such, their contributions to research efforts are of great value scientifically.

In Norway, patient representatives and caregiver representatives were present on the projects’ advisory board. The project proceeded with regularly scheduled phone calls and planning sessions to help the completion of various study processes.

The authors postulate that this co-research process encourages collaboration between study participants and clinician-researchers. They also describe the importance of viewing the entire process as a collaborating together with patients, rather than involving patients and caregivers in the process. However, this process requires empowerment on the part of patients and caregivers, including emotional support when warranted.

The authors note that it’s important to shield study participants from potential burdens, especially since they may struggle unpredictably from day-to-day. This problem may be solved by using additional patient and caregiver representatives to help create a structure by which research responsibilities are shared by a larger group of people.

Defining and developing frameworks for research study participants may help strengthen the research process through collaboration and support. While each organization must find solutions that work best for them, it is still crucial to develop this foundation to promote the scientific method.

Lippincott Solutions note: for the latest coverage on Covid-19 by the Lippincott Nursing team, please visit

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