Human genomics and population research has a lot it needs to get done and get right in order to recruit and engage participants across its study duration. In a recent conversation with Howard McLeod, a leading precision health expert, we explored this topic.
Our discussion led me to come away with a few important conclusions. Some of these included: researchers need ongoing effort to engage potentially eligible populations with consistent messaging across a variety of formats, they need stakeholders who understand the population they’re engaging, and simplifying consent and other processes leads to better engagement.
Ongoing effort has to be made to build human cohorts, regardless of size.
Dr. McLeod’s work on the HerediGene®: Population Study seeks to sequence the genes of over 500,000 participants in an effort to better predict and prevent serious diseases.
No doubt that large research programs that aim to recruit thousands – or hundreds of thousands – of research participants have a large job ahead. But many research programs struggle with much smaller cohorts. Dr. McLeod emphasized that ongoing effort must be made in order to attract the appropriate populations to a study. Especially with broad inclusion criteria, the individual and personal benefits may not be clear to the individuals you approach.
He told me, “[there had to be] a lot of effort to socialize the idea that one could participate in this study. It’s not just people who have cancer, or just people who have heart disease or some other reason why they might care. Many of the people that we have involved are, are fine, they’re well, they’re there for annual physical. And so the idea that they could participate and that genomics is has some value, that the concerns around genomics are covered as much as they can be is important from a legal standpoint, from an ethics and moral standpoint. All that effort had to start well before the accrual of participants onto the protocol and the obtaining of blood samples.”
In genomics research, effort has to be made to communicate that genomics has some value to the health of those it studies. In the case of HerediGene, effort to message the aims and relevance to the local population started well before the accrual of participants onto the protocol and the obtaining of blood samples. This upfront communication of value to potential participants holds importance. Regardless of whether a study’s potential cohort is large or small in number.
Familiarity is an important part of choosing to participate.
For HerediGene, messaging to the communities inside of the catchment area has taken place over time to build familiarity with potential participants. Dr. McLeod emphasized creating familiarity with the public as a way of convincing those eligible to enroll. He emphasized the idea that seeing messaging around a study multiple times – can make someone comfortable with finding out more.
The HerediGene study worked across multiple channels to build rapport in the community. This included advertising, public relations, interviews, digital media, billboards, and more.
Not every research program has vast resources to spend on advertising. However, when you lack financial resources, you can lean on those in the community you’re seeking to consent. They can advise you on how to reach the population you’re studying.
Any research program that seeks to build a human cohort should take a participant-focused approach.
Dr. McLeod underscored the reality that successfully engaging your target research population means you have to put yourself in a potential participant’s shoes. He reflected that many in academia adhere to a university’s protocol or process. Rather than meeting participants where they are.
He described how the HerediGene team created a participant-centric engagement process. The research team sometimes chose to hire people who knew how to communicate with the population – but little about genomics. They needed people who knew what they were doing in terms of engagement with the public. And the HerediGene team then trained them on the details of the study.
There are ways to simplify a complex consent document or process for participants to more easily understand.
In any research program, designing materials requires the balance of the IRB’s expectations, the nuances of the science and the protocol, and resources available to translate those things into informed consent materials.
But for most laypeople, the elements that are written in the informed consent are hard to understand. And that places a high burden on participants.
Like many recent studies, the HerediGene study takes a modern approach. It utilizes video in the eConsent process to efficiently convey what the study is about.
Using video in eConsent can lower the barrier of understanding for potential participants. The complex information in the consent material is distilled into a shorter format. Animations can illustrate concepts that can otherwise be very complex to explain verbally.
Meeting participants where they are means you can’t rely on a single method to consent patients and collect data.
Dr. McLeod described how HerediGene has recruited and consented patients through multiple channels:
- When they’ve visited a health center or clinic where there was staff available to help them complete the consent
- Digital advertising, where they could eConsent at home
- Approaching patients post-biospecimen collection, for their consent to use the discard or leftover.
According to McLeod, the last approach has been the most successful and is also an approach other research programs have successfully adopted, such as the Mount Sinai Million Discoveries Project.
Vibrent, in its work with our collaborators, has seen that the most success occurs when research programs leverage multi-modal approaches for consent and data collection.
Every step – all the way to returning results – needs to consider the participant’s experience.
Dr. McLeod revealed that the HerediGene study has had a much higher rate of results that require genetic counseling than expected.
This is an important thing to consider if you’re collecting genetic data. In our research collaborations, we often suggest these things to consider:
- Allowing participants to consent to not just participation, but receiving results, in case they don’t want to know
- Creating educational content (in the way of video or other materials) in partnership with the genetic counselors that you can use broadly for all participants to learn
- Planning to use digital technologies, like online scheduling with genetic counseling or study staff, to reduce patient and researcher burden
- Listening to the patient community and respond to genetic counselor feedback to create additional educational content to reduce the burden on staff – and promote these materials to participants regularly
Population research teams would be well advised to engage with professionals in community outreach.
Too often population research, especially academic population research, chooses to do everything themselves – without working with professionals. Dr. McLeod emphasized that doing things this way really does limit the success of research programs. Particularly as it comes to participant engagement.
The Vibrent team collaborates with research programs across the nation. We provide the technology platform and a team of research experts to improve your engagement with your community.
Interested in learning more and exploring how we could collaborate? Request a pilot.
