participantburden

Participant burden refers to the demands placed on individuals who participate in research. It encompasses not only physical risks but also time commitments, travel, procedural requirements, emotional strain, privacy concerns, and other costs associated with participation. Burden is a key consideration in study design, ethics review, and the interpretation of study results, as it can affect recruitment, retention, and generalizability.

Components of burden include time spent on visits or assessments, the duration of procedures (such as biopsies or lab tests), the frequency of follow-ups, travel requirements, and waiting periods. Data collection demands, such as frequent surveys, diaries, or sensor wear, can intensify burden. Privacy and data handling concerns, as well as the potential disruption to work, family life, or daily routines, also contribute. Economic burdens, including lost wages or child care costs, may be incurred by participating.

In ethical review, participant burden is weighed alongside potential benefits and risks. Researchers employ strategies to minimize burden, such as simplifying procedures, reducing visit frequency, using remote or decentralized data collection, aligning visits with routine care, and providing clear, accessible consent. Transparent communication about what participation involves is essential to respect autonomy.

Burden reporting varies across studies; some publications quantify burden through time estimates or participant-reported measures. Acknowledging burden helps interpret participation rates, adherence, and data quality. Burden can be unevenly distributed across populations, and attention to equity is an important aspect of trial design and ethics oversight.