How to write a winning grant for digital research studies

A comprehensive guide to writing bulletproof grant applications for digital, virtual, or decentralized research studies 

1.   See participants as users. Involve users early and often.

a. Solicit participant input on your study design early in the form of focus groups and test users.

Focus on the who, the why, and the how; who are we targeting, why are we targeting them, and how do we plan to help them? By integrating the target audience in the planning, you will ensure maximum impact.


b. Ensure relevance to the patient population in their individual stage of healthcare journeys.

Make sure you’re asking about symptoms, disease progression, alleviating and aggravating factors, and treatments that are relevant to that lived experience.


c. Have participants offer live feedback on digital burden.

Is your app or interface design friendly enough? Are you asking too many survey questions? Are you asking the right questions? How can we make this a more impactful, effective study?


d. Be creative in personalizing incentives and compensations for participation.

Allow them to target different aspects of good health and wellbeing: CVS Extracare card, caregiver hours, massages/spas, food meal prep companies.

2. Define your tech stack and be prepared to prove it works.

a. How are digital studies more effective?

Running digital research studies is still a relatively new concept for most funding bodies and internal review boards. When using a technology, you want to be very clear about how it augments your ability to collect study data.

i. Test end-to-end functionality

Test your participant-facing digital experience by recruiting test participants to your study or running focus groups to collect feedback. Often, collecting participant feedback during testing can highlight issues in technology such as long screen loading times, unfriendly UI/UX or unclear instructions.

ii. Ease of data collection

Digital studies allow for an increased audience size due to greater reach, less clinician or participant time commitment, ease of participation without the hassle or cost of traveling for in-person visits.


b. How do digital studies monitor adverse events?

i. How do we monitor adverse events?

Adverse events or symptom exacerbations can be a part of disease progression during a study. As such, many reviewers will want to know how the physical "distance" between the PI and the participant will impact their interactions- particularly when it comes to liability and reporting of adverse events. It’s your responsibility as a researcher to show that the technology you’re using can collect data appropriately, but also takes into account risk of adverse events. Using digital methods can both increase and decrease risk based on therapeutic areas.

ii. Allows for better record keeping

Physicians are at the mercy of patient’s ability to record home blood pressures and glycemic indexes to titrate medications, timing and severity of symptoms to understand progression. By allowing this data to be saved into a server in real time, patients can pull up data or send data to physicians to allow for more accurate representations and treatments of their disease progression.

3. Don't be that study... protect user data. 

a. When entrusted with funds, protecting data privacy and security of your study participants is of the utmost importance. In order to make your grant competitive, make sure you cover the following areas:

i. Disclose financial conflicts of interest

The NIH is a great resource for this. See the NIH’s “elements of an FCOI report” for more information:

ii. Data storage details

How is data going to be managed or stored? Who will have access to it?

iii. Who owns the data?

Do participants own their data? Can they request copies or downloads of their data? Can they request that their data be deleted? 

iv. Is the technology you're using compliant?

Note any certifications such as HIPAA, SOC2 or ISO27001 for your tools.

v. Where is my data going?

Ensure that it is clear whether de-identified data is being sent or used outside of the application or if it is being shared with third parties. If so, will the data generated in the study be used to develop academic publications, presentations or reports, or used to inform other efforts, such as additional studies or marketing campaigns? Be very clear about how the study data will shared with parties outside of your immediate research group.

4. It's 2022 -- a diverse world is at your fingertips. Include it. 

a. Diversity is crucial for the future of healthcare. We must include it in our research.

Funding and regulatory bodies are increasingly interested in how digital and virtual studies can increase diversity among study participants. Digitizing research allows you to include participants in different time zones, across language barriers, in rural/urban settings, and across socioeconomic cohorts through universally accessible smartphone technology.

Document how your specific digital study aims to include a diverse cohort of participants across geographies and experiences. Digital studies can also give you the ability to incorporate rich data streams not often utilized in brick-and-mortar research settings, such as wearables and other connected device data, social determinants of health data, and even rich data collected via photos, video and audio recordings. Leverage the opportunities that digital real-world data collection afford you in your grant application.


b. Accessibility of study design impacts who can participate.

Digital studies allow for more accessible research– are you including this in your design? Are you allowing for videos as an alternative to surveys for populations for whom reading may be a barrier? Do you have language accommodations? Does your study have accessibility considerations for the vision or hearing impaired? Does your study consider overall disease burden when planning for study-related tasks and data contribution, especially for conditions that may be associated with functional impairment? Personalizing study design to include these features in the study can occur through pre-screening questionnaires.


c. Patients want researchers who understand them.

It has been well documented that participants are more likely to engage with researchers who look like them, sound like them, and come from similar cultural backgrounds. Promote the diversity and experience of your research team by including their biographies, CVs or NIH biosketches in your application. Showing how the diverse backgrounds of your research team will help you to understand and engage with participants is the key.


5. Clearly establish your recruitment approach

a. Define the recruitment approach.

In addition to defining the inclusion and exclusion criteria, you may also choose to include some of the recruitment materials you will use: e.g. social media ads, community-based outreach etc. to demonstrate the populations that will be targeted and the messaging around your study.



b. Demonstrate an understanding of recruitment and enrollment timelines.

The most successful grant applications have a realistic approach to recruitment timelines. Studies need to be long enough to have measurable data, but not so long that participants burn out. Be realistic.


c. Explore innovative partnerships to drive study enrollment.

Partner with established organizations that work with the target patient population in order to aid recruitment, build communities with shared diagnoses, and encourage adherence. Today, organizations like ACIRAH, Acclinate, or even your local community patient networks specifically focus on enrolling and educating underrepresented minorities in clinical trials - leverage their networks or simply ask them for expert advice.


6. Align study aims and data

a. Be thoughtful with data points.

With data privacy and participant burden being ever increasing concerns in healthcare and research, do not over-collect. Your proposal should clearly define what every data stream will be used for (graphics and images of your data flows may help here). Have clear objectives, rationales, and end points for your study.


b. Zoom out to include context.

As healthcare begins to focus on social determinants of health as key factors in disease progression, research must contextualize its participants. What data points are crucial for understanding the impact of a condition not just on physiology, but on meaningful aspects of health? If researching coronary artery disease, for instance, it is useful for the researcher to also understand BMI, dietary habits, exercise patterns, family history, social history, and other active comorbid conditions for a given participant. Ensure that the measures collected provide a comprehensive picture of the participant.


c. Combine complimentary data streams.

Tie in passively contributed data streams for physical activity, sleep and key vital signs to support data from patient-reported outcome measures and other clinical outcome assessments.


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7. Explain participant compensation

a. Clearly document your approach to incentives and compensation.

Ensure that your study has appropriate and compliant compensation with a clear timeline, for both researchers and participants.


b. Digital studies enable seamless study compensation.

Digital studies allow for personalization of compensation and incentives, as well as automated compensation distribution. Whether study compensation is a direct deposit, a gift card, or includes other types of payouts, digitally-enabled workstreams reduce the workload of disbursement for researchers and the time spent waiting for participants.


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8. Paint an accurate picture of your study for reviewers.

a. Make it tangible.

Use a tool available to prototype your study on multiple devices and operating systems. Digital studies are more tangible when there are visuals that display their methodology, aims, and vision. Export study screens as a representative walkthrough of a user’s experience in the study. Include GIFs or videos of user flows through the study enrollment and scheduling process. Check out this example of a rich participant flow:



b. How are you using technology to engage participants?

Make sure to highlight technology and UX design elements that are specific to boosting participant retention, engagement, task adherence, etc.

c. Provide a schedule of assessment.

This will allow reviewers to visualize how and when data in your study will be collected, and allow them to assess your proposal for key aspects like participant burden, experimental design and how data collection supports your overall study aims aims. Here is a sample Schedule of Assessment to guide your study design.

d. Give a realistic timeline for important milestones in the study.

Will it be rolling participation or strict timelines for cohorts? How will you monitor success in this study? What are the milestones at which you offer incentives, elicit feedback from participants or share insights from their data contributions?

9.  Support and empower participants in their research journey.

a.  Support and empower participants in their research journey.

How will participants and researchers interact and address issues or questions that may arise during the study? A chat functionality in the technology? Via email/phone? Will there be built in communication points in the study timeline, such as telehealth check-ins or a technology feedback session? If so, will they have resources to aid with referrals for needed clinical care or other health-related questions?

b. What tools does your participant need?

Is your participant able to use the technology effectively? How are you onboarding your participants - are you using videos, photos or quizzes? How can assessment tools in the study also be used by participants to draw meaningful insights into their own health?

c. Bidirectional data usage.

Show a plan for sharing data / results with participants after the study for their own health empowerment. Many researchers today provide participants the opportunity to download all their study data, so it can be shared with a provider or other researchers. Even small touches, like offering participants real-time visibility into the data submitted and their consequent study adherence can provide them with a valuable touchstone regarding their participation. At the very least, make sure you show reviewers a plan to communicate with participants at the end of the study to express your gratitude for their participation (emails or postcards can go a long way), and how you plan to disseminate published study results.


10.  Provide a succinct, transparent budget and timeline. 

a. Define it. 

Clearly define your study budget, timeline, and itemized costs. You can use this free template to guide your budgeting.

b. Explain it.

Include the requested overhead budget and justification for its cost and utility.

c. Cut it. 

Where you can, prioritize cost-effectiveness.


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