Study Design Recommendations
STEP 1: Determine Your Representation Goals
When designing a study, be sure that the research addresses the needs of the impacted communities. Representation goals should aim to ensure that diverse groups are included and that any barriers to participation are identified and mitigated. Some key recommendations:
Resource
The University of Washington’s Human Subjects Division (HSD) offers further study design guidance to help you set enrollment goals that are not only feasible but also ensure representation from applicable demographic groups.
STEP 3: Consider Decentralizing
The use of decentralized elements in the design of clinical studies offers the potential to improve accessibility, flexibility and participant engagement in clinical trials. Key points from FDA guidance include:
- Trial location flexibility: consider conducting trial activities outside traditional clinical trial sites. Alternatives include participants’ homes, mobile research units, community centers, or local healthcare facilities.
- Telehealth for remote visits: Use telehealth visits when in-person interaction isn’t needed. Be sure the protocol is clear about when such visits are appropriate.
- Using local health care providers: Use local health care providers for in-person visit tasks (be sure the tasks are within their scope of practice).
- Digital health technologies for remote data collection: Explore the use of digital health to streamline remote data collection and enhance participant accessibility.
Resource
FDA Draft Guidance on Decentralization
Inclusive Recruitment Strategies
STEP 4: Reduce Participant Burden
Addressing logistical and financial barriers can reduce the burden on participants in clinical studies, which will increase recruitment and retention. Key recommendations from the FDA include:
Study Implementation—Barrier Mitigation Strategies
STEP 6: Implement eConsent
The use of electronic consent (eConsent) lets patients review and provide consent remotely, improving accessibility, especially for those with limited ability to attend in-person visits. Please note that each institution has unique requirements for implementing eConsent. All methods require prior approval by the applicable IRB overseeing the study. Below are the key institutional guidelines for using eConsent in research:
University of Washington
DocuSign: offered for use with non-FDA-regulated and minimal-risk research only
Resource Link: UW eConsent Guidance
Fred Hutchinson Cancer Center
Florence: Fred Hutch generally mandates the use of Florence for electronic consent. However, for minimal risk studies, other eConsent methods may be considered on a case-by-case basis.
Policy Document: Fred Hutch eConsent Policy
Seattle Children’s
DocuSign & REDCap: both are permissible with non-FDA-regulated research after applying through the SCRI IT department.
Policy Document: Seattle Children’s eConsent Information
Language Access
Language access is a necessary step to increase reach to populations with varying levels of English comprehension.
STEP 7: Improve Readability of Materials
Making sure that your participant materials (informed consent forms, surveys, educational handouts, etc.) are easily understandable will aid participant comprehension and informed decision-making. When designing these materials, it’s important write the content at around a 6th-grade reading level.
STEP 8: Translate Materials
Below are the guidelines for accessing translation services across different institutions to ensure materials are accessible to non-English speaking participants.
University of Washington
UW Medicine can assist with providing document translation or connect departments and personnel with contracted translation vendors. UW Language Access & Cultural Advocacy offers recommendations for vendors and other support materials to facilitate translations for study-related documents.
Fred Hutchinson Cancer Center
Fred Hutch provides translation services through its ITIS group, part of the Collaborative Data Services (CDS) team. The Fred Hutch Translation Services team can translate materials into Spanish and coordinate translation requests for additional languages with existing vendors.
Funding for translations through Fred Hutch can be requested through Bridge Funding.
Seattle Children’s
The Research Integration Hub allows requests for translations of materials through Research Language office. Apply for the service through the SCRI Translation Request Form.
Rural Participation
Conducting research in the communities where patients typically receive care is essential to ensuring that participant cohorts are representative of the broader patient population.
STEP 9: Tap Into Clinical Research Networks
Clinical Research Networks like the ITHS Northwest Participant and Clinical Interactions (NW PCI) Network connect medical centers, healthcare systems, and universities to support clinical trials and other research in both rural and urban settings. The NW PCI Network is a collaboration of regional clinical and translational research centers across the Washington, Wyoming, Alaska, Montana, and Idaho region. Engage with the NW PCI Network or other networks in your region to help expand access to clinical trials in rural areas and better serve diverse patient populations.
Community Engagement
The following resources will help you in connecting with communities as you design, conduct and disseminate your research.
