Investigator-Initiated Clinical Sequencing Research (R01) | Apply Online

Frequently Asked Questions (FAQs)

What is the Investigator-Initiated Clinical Sequencing Research (R01) opportunity (PAR 16-209)?

It is a discretionary NIH funding opportunity that uses the R01 research project grant mechanism to support investigator-initiated clinical sequencing research. The program is administered under HHS through NIH (listed as HHS-NIH11) and specifically through the National Human Genome Research Institute (NHGRI).

What is the main goal of this funding opportunity?

The core goal is to expand NHGRI's investigator-initiated research portfolio in genomic medicine by supporting clinical sequencing studies that generate practical, evidence-based knowledge about how genome sequencing can be used effectively in real-world health care.

Is this program focused on developing new sequencing technology?

No. The emphasis is not simply on sequencing technology development. The focus is on research that helps move clinical genome sequencing from a promising capability to routine, well-supported clinical practice.

What type of research is especially encouraged?

Implementation-oriented research is a central emphasis. This includes studies that examine whether and how clinical genome sequencing changes patient care and how sequencing can be integrated and scaled in clinical settings.

What kinds of patient-care impacts can projects evaluate?

Projects may evaluate impacts on disease diagnosis (such as diagnostic yield, time to diagnosis, and diagnostic accuracy compared with standard approaches) and how sequencing results influence treatment decisions (such as medication selection, surveillance strategies, referrals, preventive interventions, or other clinical actions).

Can projects focus on how genome sequencing affects diagnosis?

Yes. The opportunity specifically highlights diagnostic-focused evaluation, including improvements in diagnostic yield, faster time to diagnosis, and higher diagnostic accuracy versus standard approaches.

Can projects focus on how genome sequencing affects treatment decisions?

Yes. Studies may examine how sequencing results influence clinical decision-making, including changes in medication choices, surveillance plans, referrals, preventive steps, and other care actions.

What implementation barriers does the announcement highlight?

The opportunity highlights research aimed at understanding and overcoming barriers such as workflow integration challenges, provider readiness and training needs, test ordering and reporting practices, health system capacity, reimbursement and cost-related hurdles, patient understanding and consent processes, and institutional policies affecting when and how sequencing is used.

Does the opportunity support research on integrating sequencing into clinical workflows?

Yes. Workflow integration challenges are specifically named as a potential barrier, and implementation-oriented research addressing these kinds of issues is emphasized.

Does the opportunity support research related to provider readiness or training?

Yes. Provider readiness and training needs are explicitly mentioned as barriers that can slow or complicate implementation in clinical settings.

Does the opportunity support research related to reimbursement and costs?

Yes. Reimbursement and cost-related hurdles are listed as barriers that may be studied as part of research intended to improve implementation of clinical genome sequencing.

Does the opportunity address patient understanding and consent?

Yes. Patient understanding and consent processes are included among the implementation barriers the announcement calls out as relevant research topics.

Does the program include work on variant identification and interpretation?

Yes. Another major theme is improving the identification and interpretation of genomic variants to support broad clinical dissemination, including methods and tools to strengthen variant detection, classification, interpretation consistency, and clinical reporting.

What does it mean to improve variant interpretation "for broad clinical dissemination"?

In this context, it refers to research that makes genomic results more reliable, clinically meaningful, and usable by clinicians and health systems, including approaches that facilitate sharing or dissemination of interpretive knowledge into clinical environments.

Are projects expected to connect sequencing outputs to real clinical decisions and systems?

Yes. The overall direction points toward studies that connect sequencing outputs to clinical decisions, system processes, and scalable practices, rather than work that remains limited to laboratory proof-of-concept.

What is the award mechanism for this opportunity?

The award mechanism is an NIH R01 research project grant, which typically supports investigator-initiated, hypothesis-driven or well-justified research programs with substantial scope.

Which agency and institute administer this opportunity?

The opportunity is administered under HHS through NIH (agency listed as HHS-NIH11) and through the National Human Genome Research Institute (NHGRI).

What is the activity category listed for this opportunity?

The activity category is listed as Health.

Are CFDA numbers associated with this opportunity?

Yes. The listing references CFDA number 93.172 (and also shows "93."), indicating alignment with NIH funding classifications used for federal reporting.

When was this opportunity posted, and what are the closing dates shown?

The opportunity was posted and created on April 19, 2016. The listing shows an original closing date and a current closing date of November 15, 2016.

Is there an award ceiling listed or an expected number of awards?

No. The provided listing does not specify an award ceiling or the expected number of awards. This typically means applicants would need to consult the full announcement text and NIH budget guidance for budget expectations and related considerations.

Who is eligible to apply?

Eligibility is broad and includes many types of domestic organizations and governments, including various government entities, higher education institutions, tribal entities, nonprofits, and for-profit organizations (with certain distinctions noted in the listing).

Are state, county, city, or township governments eligible?

Yes. State, county, city, and township governments are explicitly listed as eligible applicants.

Are special district governments eligible?

Yes. Special district governments are listed as eligible applicants.

Are independent school districts eligible?

Yes. Independent school districts are listed as eligible applicants.

Are public housing authorities or Indian housing authorities eligible?

Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.

Are colleges and universities eligible?

Yes. Higher education institutions are eligible, including public/state-controlled institutions and private institutions.

Are tribal governments and tribal organizations eligible?

Yes. The listing includes federally recognized Native American tribal governments and also non-federally recognized tribal organizations as eligible applicants.

Are nonprofit organizations eligible?

Yes. Nonprofit organizations with and without 501(c)(3) status (outside of higher education) are listed as eligible.

Are for-profit organizations eligible?

Yes. For-profit organizations are listed as eligible, excluding small businesses. Small businesses are also listed separately as eligible.

What does the "Others" eligibility category mean?

The listing notes an "Others" category with a reference to additional eligibility information in the full text, suggesting there may be further clarifications or conditions not captured in the summary fields provided here.

What kinds of teams or disciplines are a good fit for this opportunity?

Based on the description, the opportunity is designed for research teams working at the intersection of genomics and clinical care who want to answer implementation-relevant questions about when genome sequencing helps, how it changes care, what prevents smooth adoption, and what improvements are needed for interpretation and reporting to support consistent clinical use.

What is the unifying theme across the projects this opportunity wants to support?

The unifying thread is generating evidence and approaches that help health systems and clinicians deploy genome sequencing in ways that are accurate, interpretable, scalable, and beneficial for patient diagnosis and treatment.