Miami CTSI

UM’s Consent to Contact Initiative Increases Recruitment for All of Us Research Program


The All of Us Research Program from the National Institutes of Health (NIH) is a long-term observational study focused on enrolling 1 million participants in the U.S. and collecting data to accelerate research. The NIH has selected a network of health provider organizations to help recruit participants for this Precision Medicine Initiative. The UM Miller School of Medicine is the lead site of the Southeast Enrollment Center (SEEC) - a consortium for the All of Us Research Program that is focused on enrolling a diverse group of study participants across Florida and Georgia.  In addition to UM, members of the SEEC include the University of Florida College of Medicine, Emory University and Morehouse School of Medicine.

The All of Us Research Program collects data such as health records, blood and urine samples, survey results and other information from participants. It will eventually conduct whole genome sequencing studies. The goal of the program is to build large databases that can be used to inform future studies and to improve health outcomes on a national level.

UM’s Consent to Contact Approval Expands Recruitment

The recent approval to utilize UM’s Consent to Contact for the All of Us Research Program expanded recruitment in underrepresented communities. The Miami CTSI helps oversee UM’s Consent to Contact initiative, which is a valuable resource for researchers who are looking to recruit study participants.

Olveen Carrasquillo, M.D., M.P.H., professor of medicine and public health sciences at the Miller School of Medicine, and co-director of the CTSI’s Community and Stakeholder Engagement Program, has been working on recruitment for the All of Us Research Program. “We’ve been using Consent to Contact in one of our clinics. We call patients who consented to be contacted and ask them to come in an hour before their appointment, so we can enroll them in the study if they’re interested,” says Carrasquillo. “Consent to Contact allows us to focus on patients who haven’t been approached before about participating in the All of Us Research Program.”

Preliminary Recruitment Results

As of the end of May 2019, they reached out to 790 people through UM’s Consent to Contact initiative, and about half responded. Of those who responded, 40 percent enrolled in the All of Us Research Program. Overall, the Southeast Enrollment Center’s cohort has recruited 10,000 participants, and half were recruited through UM. “Recruiting 5,000 research participants in one year is a major accomplishment and one that has never been done at UM before,” says Carrasquillo. About 70 percent of the participants enrolled through the SEEC are underrepresented minorities in biomedical research, particularly of Hispanic/Latino and Caribbean ancestry, and 20 percent are low-income.

“Sometimes, people assume that it’s more difficult to recruit from underrepresented communities because they may be scared to participate. We have found that when you approach people the right way, in a culturally competent way, and you’re very respectful of their time, most people actually want to be part of research. They’re excited to participate in a study,” says Carrasquillo.

Future Goals

The NIH has started to share limited data, such as demographics, through the All of Us Research Hub and is “working on creating scientifically and ethically robust mechanisms to make all participant data arising from the All of Us widely available for studies that may help speed up medical breakthroughs,” says Rosario Isasi, JD, MPH, a co-investigator and co-chair of the All of Us Resource Access Board.

The Miller School of Medicine plans to continue to use Consent to Contact and expand recruitment at the Neurology and Urology clinics - amongst others - to recruit more participants. In addition, the All of Us team has been approved to recruit direct volunteers outside of the health system and plan to engage the local community to increase participation.

To learn more about the All of Us Research Program or to enroll through the UM Miller School of Medicine, visit their website.

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