Several evidence-informed consent practices (ECPs) have been shown to improve informed consent in clinical trials but are not routinely used. These include optimizing consent formatting, using plain language, using validated instruments to assess understanding, and involving legally authorized representatives when appropriate. We hypothesized that participants receiving an implementation science toolkit and a social media push would have increased adoption of ECPs and other outcomes.

We conducted a 1-year trial with clinical research professionals in the USA (n = 1284) who have trials open to older adults or focus on Alzheimer’s disease. We randomized participants to receive information on ECPs via receiving a toolkit with a social media push (intervention) or receiving an online learning module (active control). Participants completed a baseline survey and a follow-up survey after 1 year. A subset of participants was interviewed (n = 43).

Participants who engaged more with the toolkit were more likely to have tried to implement an ECP during the trial than participants less engaged with the toolkit or the active control group. However, there were no significant differences in the adoption of ECPs, intention to adopt, or positive attitudes. Participants reported the toolkit and social media push were satisfactory, and participating increased their awareness of ECPs. However, they reported lacking the time needed to engage with the toolkit more fully.

Using an implementation science approach to increase the use of ECPs was only modestly successful. Data suggest that having institutional review boards recommend or require ECPs may be an effective way to increase their use.

Participants and research professionals often overestimate how well participants understand and appreciate consent information for clinical trials, and experts often vary in their determinations of participant’s capacity to consent to research. Past research has developed and validated instruments designed to assess participant understanding and appreciation, but the frequency with which they are utilized is unknown.

We administered a survey to clinical researchers working with older adults or those at risk of cognitive impairment (N = 1284), supplemented by qualitative interviews (N = 60).

We found that using a validated assessment of consent is relatively uncommon, being used by only 44% of researchers who had an opportunity. Factors that predicted adoption of validated assessments included not seeing the study sponsor as a barrier, positive attitudes toward assessments, and being confident that they had the resources needed to implement an assessment. The perceived barriers to adopting validated assessments of consent included lack of awareness, lack of knowledge, being unsure of how to administer such an assessment, and the burden associated with implementing this practice.

Increasing the use of validated assessments of consent will require educating researchers on the practice and emphasizing very practical assessments, and may require Institutional Review Boards (IRBs) or study sponsors to champion the use of assessments.

This paper reports on a novel measure, attitudes toward genomics and precision medicine (AGPM), which evaluates attitudes toward activities such as genetic testing, collecting information on lifestyle, and genome editing – activities necessary to achieve the goals of precision medicine.

The AGPM will be useful for researchers who want to explore attitudes toward genomics and precision medicine. The association of concerns about precision medicine activities with demographic variables such as religion and politics, as well as higher levels of education, suggests that further education on genomic and precision activities alone is unlikely to shift AGPM scores significantly.

We wrote items to represent psychological and health benefits of precision medicine activities, and concerns about privacy, social justice, harm to embryos, and interfering with nature. We validated the measure through factor analysis of its structure, and testing associations with trust in the health information system and demographic variables such as age, sex, education, and religion.

The AGPM had excellent alpha reliability (.92) and demonstrated good convergent validity with existing measures. Variables most strongly associated with higher levels of concern with precision medicine activities included: regular religious practice, republican political leanings, and higher levels of education.