About iCureCeliac®: the Celiac Disease Patient-Powered Research Network
Launched in February 2016, iCureCeliac® is a patient registry composed of people with celiac disease and gluten sensitivity and their caregivers who contribute health data, knowledge and ideas to enable and accelerate research.
Data and insights contributed by iCureCeliac® participants under informed consent are available to researchers investigating topics important to people with celiac disease. Research topics can include treatments and outcomes, lifestyle and activities, quality of life, health care, biomarkers of celiac disease, and many other topics.
iCureCeliac® was created by Celiac Disease Foundation in collaboration with the Genetic Alliance. iCureCeliac® is supported by the Patient Centered Outcomes Research Initiative (PCORI) and is part of PCORnet, the National Patient-Centered Clinical Research Network, a large, highly representative, national network for conducting clinical outcomes research.
How We Can Assist With Your Research
We can assist your research efforts in a number of ways:
- Provide access to our database of information previously collected from iCureCeliac® participants
- Collect new data from iCureCeliac® participants, either through the iCureCeliac® web portal or other mechanisms, on a cross-sectional or longitudinal basis
- Help find participants for your studies or other research activities
- Conduct surveys of iCureCeliac® participants to help you understand the community’s needs and interests to enhance the impact and feasibility of your research
iCureCeliac® Cohort Descriptions
Research Resources Available Through iCureCeliac®
iCureCeliac® data: Each registered iCureCeliac® participant is asked to complete a series of core online questionnaires on the celiac.org/icureceliac portal. These are completed at enrollment to provide baseline data, and as subsequent survey questions are added. Participants have the ability to change their answers over time.
Included in the core question set are the CD-QOL, PROMIS-29, PROMIS Pediatric-25, and PROMIS-Gastrointestinal questionnaires. We can implement additional questionnaires as needed to meet the needs of your research study. These can be presented to iCureCeliac® participants as a cross-sectional survey or on a longitudinal basis. In addition, we have the ability to develop apps or integrate data from existing apps.
iCureCeliac®: If your study needs samples that can be collected by the participant directly, such as saliva, cheek cells, skin swabs, urine, or fecal samples, or which need to be collected by trained personnel, such as blood, we are happy to discuss and explore options with you.
iCureCeliac® electronic health records: In 2017, iCureCeliac participants will be invited to upload any EHRs they may have received from any of their healthcare providers. These EHRs will be available to investigators for use in research studies. We may also be able to facilitate access to EHRs from PCORnet member clinical organizations (see “PCORnet data” below).
PCORnet data: Through our status as a PCORnet Patient-Powered Research Network, iCureCeliac staff are able to propose queries of the data provided by all PCORnet members into the Common Data Model . We are also able to reach out to other PCORnet networks, many of which have data from and about people with celiac disease or focus on symptoms or comorbidities common in celiac disease, to propose research projects involving joint data or sample collection and/or analysis. Data that may be available from PCORnet member networks include EHRs from clinical care providers, patient-reported data from disease registries, and more.
Types of Research Studies That iCureCeliac® Can Support
iCureCeliac® can support many different types of studies depending on the nature and goals of your research program.
Studies using existing data: Data previously collected from iCureCeliac® participants can be readily shared with researchers. In the future, as we engage in additional research studies, any data as well as any leftover banked biosamples collected specifically for those studies will also be available to other researchers for use in their studies. Our consent processes governing the collection of data and biosamples from iCureCeliac® participants permit open sharing of these resources with any researcher without the need for additional consent.
Studies involving collection of new data/samples: If your research requires access to data and/or biosamples that have not already been collected, we will be happy to work with you to obtain these resources. We can implement new data collection mechanisms through theiCureCeliac® platform and/or arrange for collection of biosamples from participants. Data and samples can be collected either from the entire iCureCeliac® cohort or from specific subgroups, depending on your needs. For some studies, such as those involving the deployment of a new questionnaire on the celiac.org/icureceliac portal, no additional consent will be needed. If an additional consent is needed for activities not covered by our main consent, we will work with you to put this in place.
Studies involving PCORnet data: We can facilitate celiac disease-related studies requiring access to data contained within the PCORnet Common Data Model or collaboration with other PCORnet member networks.
Collaborative studies with other studies and cohorts: We welcome collaborations with studies using other research networks or cohorts, other data collection platforms, and/or other research resources that already exist or are in development. If iCureCeliac® can enhance the statistical power of your study, provide access to new patient populations, supply valuable patient input to your efforts, and/or provide other types of support, we would be delighted to talk with you.
Other Types of Research Support
In addition to developing an iCureCeliac® research study with you, we can support your research efforts in other ways:
- Subject recruitment: If you are recruiting subjects for an existing study, we are able to notify the entire iCureCeliac® participant community or identified participants. We are also able to provide notice to the Celiac Disease Foundation constituency through email, website posting and social media.
- Community feedback: In addition to soliciting input from our community on individual research studies, we can also survey our iCureCeliac® participants and Celiac Disease Foundation constituency for other purposes. For instance, we have surveyed our community on behalf of the FDA regarding their concerns about the FDA gluten-free labeling rule, gluten in medication, and the need for therapeutic treatment alternatives to a gluten-free diet.
- Volunteer recruitment: If you have a research-related activity that would benefit from direct involvement from people with celiac disease or non-celiac wheat sensitivity we can help identify willing and interested individuals to participate. For example, we can provide PCOR-trained patient advocates to serve on advisory panels for research studies or programs.
Submitting a Research Proposal
How to Submit a Research Proposal
CDF works closely with investigators and the iCureCeliac participant community to assure that approved studies will benefit people with celiac disease and non-celiac wheat sensitivity. To submit a research proposal for consideration:
- Review the iCureCeliac® Data Access Data Access Guidelines and Data Access Agreement.
- Contact CDF at firstname.lastname@example.org to set up a call to discuss your research concept.
- Submit your proposal using theiCureCeliac® Research Proposal Form to email@example.com.
- The CDF Research Committee will review your proposal and provide feedback to you.
- Submit your final proposal, incorporating any feedback.
- CDF provides you with a data set, or direct access to the de-identified data as determined by the Research Committee.
iCureCeliac® Research Study Review Criteria
The CDF Research Committee using the following criteria in approving research proposals:
- Research focuses on issues and concerns that are known or believed to be considered important by people with celiac disease or non-celiac wheat sensitivity.
- Research has been developed with input from people with celiac disease or non-celiac wheat sensitivity.
- Research is scientifically rigorous.
- New data is feasible to collect where not already in iCureCeliac®.
- Research has the potential to definitively answer an important question.
Open Access and Data-Sharing
CDF has a policy of providing its research resources on an open-access basis, meaning that we will work with any investigator, at any institution, anywhere in the world who is conducting valid research that is in alignment with our mission and policies.
We also have a policy supporting data sharing among investigators. Researchers who use iCureCeliac® resources in their studies are obligated to share the data and/or findings generated using these resources with CDF for further use, including sharing with the broader scientific community.
We welcome researchers in the US and worldwide to learn more about conducting research with iCureCeliac® and to contact us to explore research studies and collaborations.
CDF Research Committee
The CDF Research Committee is comprised of clinicians, researchers and patient advocates, expert in and committed to patient-centered outcomes research. The Research Committee oversees and provides advice for iCureCeliac® research-related activities, including:
- Informing researchers about iCureCeliac® and encouraging them to develop studies using iCureCeliac® resources.
- Facilitating engagement between researchers and iiCureCeliac® members.
- Informing network members about the research process and soliciting their input on iCureCeliac® research activities including individual studies.
- Facilitating the development of new research studies based on topics of importance to the iCureCeliac®community.
- Publishing and disseminating results from iCureCeliac® supported studies.
- Providing review and approval of all research studies to be conducted through iCureCeliac®.