Background and Literature Precisionmedicine is an emerging approach to disease treatment and prevention that takesinto account individual’s variability in genes, environment, and lifestyle1. According to the NationalResearch Council, collection and analysis of such data could lead to a moreaccurate disease taxonomy, which could then be used to tailor medicaltreatments to each patient’s individual characteristics2.Precision medicine hasreceived increasing attention since United States President Barack Obamaannounced the Precision Medicine Initiative in January 20153.The promises of precisionmedicine include: discovering new biomarkers predictive of individual risk offuture disease for many common diseases, understanding individual variation inresponse to therapies, and studying populations that reflect the diversity ofthe US population 4. Precision medicine givesclinicians tools to better understand the complex biological and environmentalmechanisms underlying a patient’s health, disease, or condition, and to betterpredict which treatments will be most effective5.
Precision medicine requires assembly of acohort that broadly reflects the diversity of the US: those that areunderrepresented, in all states of health and disease, from all areas of theUS, and in all life stages4. Historically, most medicaltreatments have been designed for the average patient—too often not reflectingthe likely diversity and patient mix in the real-world setting. Clinical trialsoften lack adequate inclusion of diverse groups relevant to the therapy 6,7. As a result of thisone-size-fits-all approach, treatments may be characterized for safety andefficacy for certain patients but not for others. Furthermore, lack ofinclusion of ethnic minority and socially disadvantaged population subgroups ingenomic research and development has the troubling potential to further alreadyexisting health disparities.
Patients who have attained a higher level ofeducation, are treated at academic medical centers, have more comprehensivehealth insurance or greater personal wealth, or possess a broader socialnetwork may be able to avail them- selves of genetic experimental treatmentsunder right-to-try laws, while less educated, less well-connected, or poorerpatients may not 8. Severalbarriers exist in involving minority groups in clinical research and geneticbiobanking. In terms of research benefit itself, several studies found barriersto participation centered around perception of low therapeutic benefit or beingineffective, viewing the intervention or treatment as distasteful, fear ofbeing a “guinea pig”, and belief that researchers are more interested inresearch than patient well-being9,10.
Notable risks in participation involved fearof genetic discrimination. Further concerns revolved around confidentiality andmisuse of information, rights to give feedback or to withdraw from the project,storage and protection of genetic information, and access by third parties(e.g. insurers, police)11. Additionally, it appearsimperative that an oversight body defines and arbitrates for the public good inrelation to all aspects of biobanking 12. Historical injustices,including the Tuskegee Syphilis Study and the Havasupai Indian Tribe Case havealso been cited to negatively affect trust between minority communities andresearchers7,13–15.
Notably, however, aliterature review of published health research studies found very smalldifferences in the willingness of minorities, most of whom were African-Americans and Hispanics in the US, to participate in health research comparedto non-Hispanic whites. These findings, based on the research enrollmentdecisions of over 70,000 individuals, the vast majority from the US, suggestthat racial and ethnic minorities in the US are as willing as non-Hispanicwhites to participate in health research. Hence, efforts to increase minorityparticipation in health research should focus on ensuring access to healthresearch for all groups, rather than changing minority attitudes 16. Altruism, or the desire for personal andcollective health benefits is a common motivation for participation in research15,17,11. Participants also identifiedtrust in the research organization as particularly important in recruitingminority research participants 17–20.
There are anumber of key elements to building strong relationships between communities andresearchers. Involvement of ethnic communities earlier in research, such asduring the agenda-setting phase, and requesting input to identify areas ofconcern in the local area can better promote feelings of inclusion in theresearch process8,21. Information sessions about research, alone,are not helpful. Consultation from the community increases the likelihood thatcommunity members will feel empowered rather than exploited, being partnersrather than simply subjects. Furthermore, such involvement helps studyinvestigators by providing a community sounding board and sets up ground workfor broader longitudinal communication activities22. The method of “deliberativedemocracy” has been cited as a useful tool to facilitate public engagement andbuild trust. “Deliberative democracy”focuses on purposeful provision of information to participants with an emphasison dialogue leading to evolution of opinions by participants as they integratenew information and others’ perspectives23.
In the use of deliberative democracy for community development of abiobank in Tanzania, nearly all participants felt heard and respected, andexpressed confidence in the overall decisions made by the group24. Other recommendations include providingeducation on the risks and benefits associated with precision medicine andsetting realistic expectations about research outcomes as to engender trust 8. Additionally, since genetic research andbiobank projects can extend for long periods of time, regular ongoingcommunication to enrollees is necessary to maintain awareness and trust,especially relating to protocol changes reflecting evolving science 10. Finally, it is important to note that allcommunication and outreach efforts should consider the values and personalinterests of that specific community, and so engagement efforts should becarefully tailored 12,11.
Successful real-life approaches exist for solicitingcommunity input, dissemination of information, and general community outreach.Popular approaches to community engagement include focus groups withdeliberative democracy, consensus development panels (which liaises between thecommunity and researchers to review studies and provide policyrecommendations), community group surveys on project implementation, mailsurveys, and telephone interviews 22. For information dissemination, approachesinclude: newsletters, community talks and media coverage (TV or Radio), andworksite/direct mail 10.
Effective methods andsettings for outreach include primary care provider referrals to trials, community clinics and providers asliaisons to research, health fairs, cultural events, community meetings, faith-based gatherings10,17,21,25. SPHERE (Stanford Precision Health forEthnic and Racial Equity) is a Stanford precision health collaborative that haspartnered with local communities in order to develop innovative precisionhealth research and clinical practices that will improve health and healthinequity. As one component of community engagement, SPHERE aims to providecommunity education on the concept and promise of “precision medicine” bycreating a publicly accessible community guide that integrates existingliterature with community members’ input. Furthermore, dissemination plans willbe created and piloted based on recommendations of our community partners. Througheffective public education on the promise of precision health and throughmeaningful community partnerships, this community guide may help build capacitywithin communities and enhance the inclusiveness of precision medicine.
ResultsSummary of focus groups, town hall meetings, and keyinformant interviews Focus Group: · Provide information on general promise ofprecision health, and how it might address health disparities · Use simple terms · Define terms of health disparities· Discuss how precision health relates to screening,prevention, treatment, related to genetics/ancestry, environment/society· How is it different from current medicine? · Provide more details about precision medicinefor those with increased knowledge · Major concerns about: security, confidentiality,cost, discrimination, trust, historical injustices, discrimination frominsurance or employers, concerns about hackers · Discuss transparency and accountability inresearch Town Hall Meeting: -Pending Key InformantInterviews (themes): · Explaining Precision health o Define: genetics vs precision health, etc.o Benefits of precision health as it applies tospecific community o Use community specific exampleso Simple terms-low literacy levels o Create “connection” imagery, more info-graphics o Communicate that this is medical care that is the “right fit for you”· Researcho Examples of researchers that look like them o Address cultural/spiritual aspects of donating personalsamples o Explain how to participate in research, whatthat looks like, how community members “fit in”, process of follow-ups andreferrals o Address personal protections o Provide translated clinical trials · Outreach/Trust:o Use community members to establish trusto Create for low literacy…but also for providerso Culturally appropriate o Share focus group data o List other resources Outcomes Conclusion and Future Directions