Voluntary and informed clinical research participation is an ethical requirement. Clear communication respects autonomy and empowers decisions that are in line with personal values.  All communication with potential, enrolled and past participants should be clearly designed to support understanding and informed decision-making.

Clinical research stakeholders should be sensitive to the vulnerability of potential, enrolled, and past participants, and open to learning from the participant community as research partners. Participants, their caregivers, and their community should all be included in the process of developing and reviewing clinical research information.  Stakeholders should engage with the intended audience(s) to learn from them, co-develop communications with them, and solicit feedback before, during and after the clinical research study, from study design to the reporting of research results.  This engagement increases the likelihood that the way information is communicated meets the population’s needs and is understandable and actionable.

All clinical research communication should be sensitive to cultural differences in order to better support autonomy and informed decision making. In the context of developing research communications, culture should be considered broadly, and go beyond country of origin to include race, ethnicity, sex, gender identity, sexual orientation, physical ability, disability, geography, and so on.  Considering what culture means to different groups, and engaging in training on cultural humility and methods like teach-back, can lead to communication that is more likely to meet the information needs of the intended audience, especially given the power imbalance that is inherent within the context of medicine, research, and illness.

Written, printed, and electronic media clinical research communications, including any standard templates and boilerplates, should incorporate the concepts of plain language, numeracy, readability, reader-friendly document design, and visual aids like infographics to augment the recipient’s ability to understand.

Health literacy evaluation methods increase the likelihood that the audience will be able to understand and act on the clinical research information presented to them. These methods include some combination of testing for readability, piloting study materials and research processes, and performing usability testing with members of the potential participant community.

All stakeholders should develop a plan that allows for multiple conversations with participants and gives them the time needed to process the information provided and ask questions. To this end, using scripts that clearly explain common terminology and key takeaways can help to ensure that the communicators share consistent information with each participant.  Researchers and their study teams should also use interactive methods like teach-back to confirm understanding at all points of the clinical trial life cycle that involve sharing and collecting information, not just when obtaining informed consent.

Organizational policies and funding mechanisms, announcements and conditions should support health literacy processes being integrated into all aspects of clinical research, including study design and development. Corporate, non-profit, and academic sponsors and funders should specify that health literacy concepts be incorporated into all participant-facing communications, including recruitment materials, consents, research summaries, and templates.  Institutional review boards and ethics boards should promote the inclusion of health literacy best practice in all participant-facing materials they review.

A true commitment to developing clear research information and engaging in meaningful study-related conversations is reflected in the adoption of health literacy practices throughout an organization’s clinical research infrastructure. In many cases, integrating health literacy is a matter of enhancing processes that are already in place.  All clinical research stakeholders and their organizations should optimize their workflows to include developing, testing, modifying, and confirming understanding of research communications and be open to continuously improving their processes