February 1, 2024
None
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
The purpose of this Notice is to alert the community that NIH plans to publish a Research Opportunity (RO) to support a rapid transition of the online, web-based secure participant registry, DS-Connect®: The Down Syndrome Registry, from an NICHD contracted system that will no longer be supported by the contractor as of February 28, 2024, to a new, secure, sustainable platform. The RO will be a targeted solicitation to institutions closely connected to the scientific aims and goals of DS-Connect, who are familiar with the structure and governance of the platform, who are closely connected to the community of people with Down syndrome, and who can provide the necessary coordination with the INCLUDE Data Coordinating Center for data sharing and other partners for study coordination and recruitment. The targeted solicitation will be by invitation only and will include programs currently in place that have the necessary infrastructure to host a secure online database with personally identifiable information (PII) from participants. Applications will be accepted through early March 2024 for FY'24 funding with the goal of making an award no later than early May 2024.
An award under this funding opportunity will be issued as an Other Transaction Agreement (OT2), which is not a grant, contract, or cooperative agreement. Other Transaction awards will involve active NIH program management.
Research Initiative Details
In September 2011, the NIH created the Down Syndrome Consortium to foster communication and idea-sharing among the NIH, individuals with Down syndrome and their families, national organizations interested in Down syndrome, and pediatric and other groups. Under the auspices of the Down Syndrome Consortium, NICHD supported development of a family-focused, web-based registry for individuals with Down syndrome, DS-Connect®.
DS-Connect facilitates contact and information sharing among families, individuals with Down syndrome, researchers, and parent groups. Down Syndrome Consortium members are involved in outreach efforts to the Down syndrome community to encourage families to sign up for DS-Connect. It is composed of a demographic survey as well as an Initial Health Survey that collects baseline information about the health status of the person with Down syndrome, with additional specialty surveys based on their age, sex, and specific medical issues. Participants can compare their survey answers to the aggregate, de-identified responses of other DS-Connect participants, as well as access resources such as health care provider lists, Down syndrome-specific growth charts, a medication tracker, and information about NIH-funded Down syndrome clinical trials. The participant registry is available in Spanish as well. In 2014, a Professional Portal was incorporated into the registry to allow investigators and others with an interest in Down syndrome research to set up an account and request access to participants to invite them to join in specific clinical studies. The registry must facilitate outreach from approved researchers to eligible registry participants without revealing participants’ private information.
This RO will rapidly transition the online, secure participant registry, DS-Connect®: The Down Syndrome Registry, from a NICHD contracted system that will no longer be supported by the contractor as of February 28, 2024, to a new, sustainable platform. Applicants are required to have: a strong working knowledge of the DS-Connect® Registry; a ready-to-implement system capable of handling participants’ personally identifiable information (PII) at an appropriate level of security, an existing registry infrastructure; the ability to receive existing data from the government and transition it to an operable data infrastructure that meets requirements for usability; and the ability to work with NIH/NICHD staff to develop, implement, enhance, and maintain the online registry, including related responsive-template design all of which are Section 508 compliant in accordance with HHS regulations (https://www.hhs.gov/web/section-508/).
The applicant will also need to provide support for human subjects research in compliance with the Federal Policy for the Protection of Human Subjects (Common Rule), including protection of participant-provided data that includes PII and IRB oversight.
Funding Information
Estimated Total Funding: TBD
Expected Number of Awards: 1
Estimated Award Ceiling: $6 million
Anticipated Eligible Organizations
Higher Education Institutions
- Public/State Controlled Institutions of Higher Education
- Private Institutions of Higher Education
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
- Hispanic-serving Institutions
- Historically Black Colleges and Universities (HBCUs)
- Tribally Controlled Colleges and Universities (TCCUs)
- Alaska Native and Native Hawaiian Serving Institutions
- Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Applications are not being solicited at this time.
Sujata Bardhan, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-0471
Email: sujata.bardhan@nih.gov
and Human Services (HHS)
