Getting Started with TRANSCEND
DID YOU KNOW?
TRANSCEND Can Help Strengthen Your Application Before You Submit
Whether you are just developing an idea or polishing a final proposal, the TRANSCENDS’s Cores can help you move from concept to competitive application.
WE CAN HELP:
- Find collaborators
Need clinical, community, methodological, or content-area expertise? We can help identify potential collaborators, connect you with investigators across the network, and strengthen the team around your project. - Align your research priorities
We can help ensure your project addresses the TRANSCEND RFA, refine your research priorities, and show reviewers how your project responds to real patient, provider, and community needs. - Review your Specific Aims Page
A strong aims page can make or break an application. We can provide feedback on clarity, significance, innovation, feasibility, and alignment between aims, hypotheses, and outcomes. - Strengthen your statistics
We can help refine your research questions, identify appropriate statistical approaches, review sample size considerations, and ensure that your design matches your aims. - Build a realistic timeline
We can help you think through recruitment, data collection, analysis, milestones, deliverables, and potential roadblocks so your application presents a feasible plan. - Sharpen your NIH Biosketch
We can help you highlight the experience, training, collaborations, and contributions that make you the right person, or the right team, to carry out the work. - Budget & Administrative Readiness
We can assist with budget reviews, subaward or consultant documents. - Navigate IRB, human subjects, and regulatory documentation
We can help identify the regulatory documents required for the study, including IRB materials, human subjects sections, consent considerations, HIPAA documentation, and privacy and data protection plans. If applicable, we can also help determine whether IND/IDE guidance or additional regulatory consultation may be needed. - Legal Agreements
Core coordinators can assist researchers in determining whether any legal agreements are needed, including collaboration agreements, data use agreements, and material transfer agreements.
Not sure where to start?
Start with us. We can help you identify the next best step.
Contact: Jamie (Scholl) Bushman, TRANSCEND Navigator at Jamie.Scholl@USD.edu.
Grant Eligibility FAQs
As a prospective applicant, some questions commonly arise: What sort of research is eligible? Must I be (or have) a clinician partner? If I am a clinician, do I need a basic science or epidemiologic partner? See answers to such questions below:
What sort of research is eligible?
First, per NIH guidelines, Clinical and Translational Research Centers like TRANSCEND are intended to grow the pool of investigators capable of conducting C&T research. So, what qualifies as Clinical and what is Translational research?
The simple answer is that clinical research is research that involves individual persons and is designed to answer some questions about health, including health prevention. The short answer is:
The current NIH definition of clinical research is human subjects research that is:
- Patient-oriented research. Research conducted with human subjects (or on material of human origin, such as tissues, specimens, and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that use human tissues that cannot be linked to a living individual. This definition includes (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
- Epidemiologic and behavioral studies.
- Outcomes research and health services research.
Thus, research that is based, for example, exclusively on cell lines does not qualify as clinical research. However, research that, for example, uses human cells grafted onto animals (xenografts), probably would qualify. The key terms are “patient (or subject) oriented.”
With respect to Translational Research, a useful definition, also from NIH, is this:
Translation is the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and the public — from diagnostics and therapeutics to medical procedures and behavioral changes.
This definition can cover a large variety of studies/interventions. For example, imagine that clinicians in Specialty X find that patient compliance with medication Z is poor. An intervention designed to improve medication compliance (e.g., via reminders, incentives) would be translational research. The subjects need not be “patients”, e.g., interventions targeted at healthy individuals, such as suicide prevention, or methods to promote cancer screening, etc. are translational.
Must I be (or have) a clinician partner?
No. This is not an explicit criterion for eligibility, as it is conceivable that some research would qualify without a clinician partner (e.g., patient-oriented research that involves patient material of human origin that has already been collected). However, in practice, non-clinicians would likely need a clinician colleague to assist is some way (see Point 1 on the NIH definition of clinical research) to get access to patients.
If I am a clinician, do I need a basic science or epidemiologic partner?
Not necessarily. The basic requirement(s) is that the Principal Investigator and/or team have the skill necessary to answer the C&T question that they pose. Often a clinician may benefit from the skills of non-clinician partners, and this is one of the reasons why the TRANSCEND portal exists: to facilitate partnerships. The TRANSCEND Navigator also functions to help clinicians and non-clinicians form partnerships.
Let us know how we can help!
Questions can be directed to the TRANSCEND Navigator, Jamie (Scholl) Bushman (Jamie.Scholl@USD.edu), or the Health Research Core Coordinator, Savannah Macias-Daugherty (Savannah.M.Daugherty@UND.edu).
TRANSCEND Information Sessions
TRANSCEND 2026 Applicant Info Session
TRANSCEND 2026 RFA Info Session
Publishing for TRANSCEND: Transformative Agreements and Beyond
Tips for Using the New NIH Biosketch Common Forms
Human Subjects and Clinical Trial Information
Collaborations with the Research Design, Compliance and Data Management Core