For Institute program-specific acronyms, go to NIAID Profile and Fact Book.
Written report from a sponsor notifying FDA and investigators of serious and unexpected adverse events or adverse device effects with an investigational new drug or investigational medical device.
Go to these resources:
See Small Business Innovation Research.
See NIAID Advanced Technology Small Business Innovation Research and NIAID Advanced Technology Small Business Technology Transfer.
See Small Business Innovation Research Fast-Track.
Internal NIAID database that archives descriptors for initiatives, concept clearance, and tracking for initiative development for fiscal years 2000 through 2010. Replaced by the Research Initiative Management System (RIMS)
Go to these NIAID resources:
See research misconduct.
Overlap of support that occurs when substantially similar research is proposed in more than one concurrent PHS grant application.
Formerly used term. See scientific review officer.
Chartered committee performing initial peer review in either the NIH Center for Scientific Review or an institute. SRGs are managed by a scientific review officer.
Institutes review grant applications with their own review requirements. See study section, integrated review group, and peer reviewer.
See Scientific Review Program for a list of application types reviewed by NIAID.
Federal scientist who organizes and manages the initial peer review of grant applications assigned to a scientific review group.
Scientific review officers act as intermediaries between principal investigators and reviewers and prepare summary statements for applications that are reviewed. Also see not discussed.
NIAID organization in the Division of Extramural Activities that oversees initial peer review of grant applications and contract proposals with Institute-specific requirements:
Go to NIAID's Grants and Peer Review portals. For contact information, go to SRP Contacts.
Also see Center for Scientific Review (CSR).
See technical evaluation group.
Human subjects term indicating an initial peer review group's determination whether gender and minority representation conform to NIH guidelines and pertain to the science.
A determination of unacceptable bars funding an application or proposal until NIH staff and the principal investigator resolve the issue. Criteria are different for clinical trials and other clinical research.
Scientific parameters of a funded research project. Grantees cannot change the scope of a project without NIAID approval because that would significantly alter the project the peer reviewers and Council recommended for funding.
See prior approval for grants
Go to NIAID's What Constitutes a Change in Scope? in the Strategy for NIH Funding.
Grant application a study section judges to be competitive, generally in the upper half of those assigned to it. The application receives an overall impact score and summary statement and may be funded by an Institute or center. Also see not discussed.
Review generally conducted by an institute's advisory Council that results in funding recommendations to the NIAID or other NIH institute director.
Second-level review looks at program priorities and balance and a lack of barriers to funding such as unresolved human subjects issues. It does not reassess the science. See expedited second-level review and initial peer review.
Assignment of a grant application by the Center for Scientific Review to an institute or center (IC) as a backup for funding should the primary IC decide not to fund it. Either a program officer or applicant can request secondary assignment.
See primary assignment, dual assignment, and receipt, referral, and assignment of applications.
Go to these NIAID resources in the Strategy for NIH Funding:
Peer reviewer who serves as a backup for a primary peer reviewer. Both read a grant application thoroughly before an initial peer review meeting to lend their expertise to the group discussion. The secondary peer reviewer may also write a critique.
Also see reader and scientific review officer.
Secure system peer reviewers use to receive electronic reimbursement for expenses and honoraria that result from participating in initial peer review meetings. SPRS is in the Commons.
Go to NIAID's Reimbursement for Peer Reviewers SOP.
Biological agent or toxin that has the potential to pose a severe threat to public health and safety, animal or plant health, or animal or plant product.
CDC in HHS and Animal and Plant Health Inspection Service (APHIS) in USDA administer the National Select Agents Registry.
U.S. investigators who possess, use, or transfer a select agent must register with and get approval from CDC or APHIS depending on the agent.
As outlined in NIAID's standard operating procedure, both domestic and foreign institutions using select agents are subject to NIAID's select agent terms and conditions of award. NIAID also has special procedures for international awards.
Also see dual use research, highly pathogenic infectious agent, NIAID category A, B, and C priority pathogen, overlap select agent, restricted experiment, and USA Patriot Act.
For R01 applications at the margin of the payline, the funding of a small number of grant applications that are programmatically important or from investigators who are new, as recommended by NIAID's advisory Council.
Investigators cannot apply for selective pay funding; rather, they are nominated by NIAID program officers. Also called select pay.
Go to these NIAID resources: Selective Pay SOP
See Research and Related Senior/Key Person Profile.
Information that could have a serious adverse effect on a person or an organization's operations or assets if lost, stolen, or tampered with.
Examples include the following:
See special emphasis panel.
Adverse event that results in death, life-threatening experience, hospitalization or prolongation of hospitalization, significant disability, or a birth defect.
Investigators must file serious adverse event reports with a sponsor and institutional review board, which reports them to FDA. IND sponsors must notify FDA and NIAID within 24 hours. If applicable, investigators must also file an FDA Adverse Event Report.
Go to FDA's Adverse Event Reporting System.
Monies budgeted for a defined purpose in a fiscal year. NIAID's set-asides include selective pay and R56-Bridge awards. For congressional set-asides, see earmark.
Go to these NIAID resources:
Instructions for completing an electronic Grant Application Package. Each funding opportunity announcement has its own application package and uses one of several standard application guides.
Go to NIH's SF 424 (R&R) Application and Electronic Submission Information and these NIAID resources:
Cover page for an electronic Grant Application Package together with the PHS 398 Cover Page Supplement. See funding opportunity announcement. SF 424 also signifies these forms:
See model organism sharing.
Predoctoral trainee supported for a two to three-month training experience, usually in the summer.
See principal investigator signature assurance.
1. One of the standard NIH initial peer review criteria used to assess the extent to which a research project addresses an important problem or a critical barrier to progress in its field.
Significance does not evaluate the significance of the field or the ability of the investigators to conduct the research. Also see Approach, Innovation, and overall impact score.
2. Section of the Research Strategy in a grant application that describes the significance of the research.
See other significant contributor.
Human subjects term indicating a difference of clinical or public health importance based on substantial scientific data. This definition differs from the commonly used one, which refers to statistical significance.
Investment, income, property, or equity as defined in 42 CFR 50.603. See financial conflict of interest.
Term used in the Commons to denote person with authority to legally bind an institution for grant matters.
In the Commons, signing officials can register an institution, create and modify institutional profile and user accounts, and view all the institution's grants, including status and award data.
See Scientific Initiative Management System.
Business independently owned and operated and not dominant in its field that meets a size standard.
Organization that assists and protects the interests of small businesses and helps families and businesses recover from national disasters.
Go to the Small Business Administration.
Grant under the Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) program.
For-profit business located in the U.S., independently owned and operated, not dominant in its field of operation, and qualified as a small business using criteria in 13 CFR part 121.
Go to 13 CFR part 121 and FAR 19.102.
Government-wide program that promotes R&D with the potential for commercialization at small business concerns.
See NIAID Advanced Technology SBIR, SBIR Fast Track, Small Business Technology Transfer, and Bayh-Dole Act.
See NIAID Advanced Technology Small Business Innovation Research (NIAID-AT-SBIR).
See NIAID Advanced Technology Small Business Technology Transfer (NIAID-AT-STTR).
Type of contract that fosters technological innovation by small businesses. Eligibility is limited to for-profit businesses that qualify as a small business concern.
SBIR award that allows concurrent submission and peer review of phase I and phase II grant applications to reduce a potential funding gap between the phases.
Government-wide program that promotes R&D with the potential for commercialization at small business concerns. It differs from Small Business Innovation Research in requiring a formal collaborative relationship with a university or other non-profit research institution.
See Small Business Innovation Research and Bayh-Dole Act.
Business that is at least 51 percent owned (including publicly owned) by socially and economically disadvantaged U.S. citizens who control its daily business. Companies are certified by the Small Business Administration under Section 8(a) of the Small Business Act.
Go to the Small Business Act.
NIH grant that supports new research projects that can be carried out in a short period of time with limited resources. R03s are not intended for new investigators. They are awarded for up to two years and are not renewable.
Go to NIH's Small Grant Program (R03).
Formerly used term. See Research Performance Progress Report (RPPR).
Term used by the U.S. Small Business Administration for people who have been subjected to racial or ethnic prejudice or cultural bias, including blacks or African Americans, Hispanics or Latinos, American Indians or Alaskan Natives, and Native Hawaiians or other Pacific Islanders, and Subcontinent Asian Americans.
Contracting process to acquire supplies or services after soliciting and negotiating with only one source. Go FAR 6.303.
Formal document that elicits proposals for acquisition or financial assistance awards. Includes requests for proposals (RFP) and broad agency announcements (BAA).
Go to NIAID's Contracts portal.
See targeted research.
All cells in an organism except germline cells.
Transfer of a nucleus from a somatic cell to an unfertilized egg that has had its nucleus removed. See cloning.
Process for selecting a contractor after initial peer review.
Go to NIAID's Contracts portal and the Negotiation, Source Selection, and Award SOP.
Committee that reviews final proposal revisions from offerors in the competitive range, resulting in an award recommendation to NIAID.
Notices in FedBizOpps.gov that survey the market to determine if there are potential contractors that can satisfy government requirements.
See statement of work.
Single project assurance.
Ad hoc initial peer review group with expertise to review a set of research grant applications or contract proposals. NIH's Center for Scientific Review uses SEPs for continuous submission, fellowship, and small business applications and in other special situations.
See scientific review group, integrated review group, and study section.
Go to NIAID's Peer Review at NIAID questions and answers.
Section of an NIH grant application's Research Plan describing the objectives of a research project.
Go to NIAID's Explain Your Aims in the Strategy for NIH Funding.
Person or organization that initiates but does not conduct a clinical study, usually a drug or device manufacturer or the research institution that developed a drug.
Sponsors distribute investigational new drugs or investigational medical devices to principal investigators and ensure compliance with regulations, for example, obtaining FDA approval to conduct a clinical trial and reporting results to FDA.
Go to FDA and 21 CFR 812.3.
Negotiated contract usually between an academic institution and a private corporation giving the institution financial support in return for an option for the company to license patentable items stemming from the research.
Go to NIAID's Office of Technology Development.
Clinical investigator acting also as a sponsor, i.e., who both initiates and conducts a clinical investigation. Go to 21 CFR 812.3.
See Secure Payee Reimbursement System.
See scientific review officer.
See scientific review group.
See Scientific Review Program.
Special study section.
See grant start date.
Detailed description of work written in a proposal to be performed under a contract. Go to NIAID's Contracts portal.
Cell that can divide indefinitely in cell culture and produce specialized cells. Usually derived from an early embryonic stem cell or embryonic germ cell, but certain types can be derived from adult cells. For policy term, see human embryonic stem cell.
See multipotent, oligopotent, pluripotent, totipotent, and unipotent stem cells.
Go NIH Stem Cell Information and the NIAID Human Subjects Resources portal.
See American Recovery and Reinvestment Act (ARRA).
Student financial support for living expenses on National Research Service Award (NRSA) training grants and fellowships. Grantees may supplement stipends from non-federal funds only. Also see compensation.
Practice through which grant applications judged unanimously by peer reviewers as unlikely to be funded are not discussed and do not receive an overall impact score.
These are roughly in the bottom half of applications being reviewed, though the percentage varies by study section and grant type. NIH sends the investigator the primary and secondary reviewers' initial scores and critiques as feedback.
Formerly called triage. Also see recommended, not discussed, and summary statement.
See Small Business Technology Transfer.
Component of an integrated review group of the NIH Center for Scientific Review that conducts initial peer review in a designated scientific area.
Composed of scientific experts, study sections are managed by CSR scientific review officers. Also called scientific review group. See initial peer review and dual peer review.
Collaborative arrangement between a grantee institution and one or more participating profit or nonprofit institutions in support of a research project. Also known as consortium agreement.
Contract between a prime contractor and a subcontractor to furnish supplies or services. Go to NIAID's Providing Consent to Subcontract SOP.
Healthy person or patient who participates in a clinical investigation of an investigational drug or investigational medical device or who is a control.
Invention defined by the Bayh-Dole Act as emanating from government funding conceived of or first reduced to practice under an award.
Go to 37 CFR 401.2 and full 37 CFR 401.
For electronic grant applications, date Grants.gov must receive the application, same as receipt date.
For paper applications, date by which an applicant must mail an application to (not date received by) the Center for Scientific Review, which differs from the receipt date.
Submission date also differs from closing date.
Human subjects term indicating a group further defined by geographic origins, national origins, or cultural differences. Subpopulation data can be defined and reported by self-reporting or other means.
Mixed racial or ethnic descent also applies to subpopulations, and such combinations may have biomedical or cultural implications for the science.
Roughly the number of grant applications funded by an NIH institute divided by the number of applications referred to it that were peer reviewed. Applications resubmitted during the fiscal year are counted only once.
For data, go to Research Project Success Rates for NIAID on NIH's RePORT Web site.
Official document showing the outcome of initial peer review, including overall impact score (and percentile for an R01), codes if there are areas of concern (e.g., a human subjects concern), and a recommended budget.
Summary statements also have a short synopsis prepared by a scientific review officer based on the discussion.
Noncompeting—money NIAID adds to an existing grant, including research supplements and administrative supplements.
Competing—now called revision; adds funds to a grant to expand its scope or meet needs of a research protocol following a competing application.
Go to NIAID's Supplements to Grants questions and answers.
See administrative supplement.
See research supplement to promote diversity in health-related research.
See research supplement.
Monies added to a budget appropriations bill. Supplemental funds bolster an existing appropriation deemed insufficient by Congress or pay for activities not covered by an appropriation.
Action taken to disqualify a contractor temporarily from government contracting and subcontracting. Go FAR 9.407 and NIAID's Contracts portal.
Temporary withdrawal of a grantee's authority to use grant funds, pending either corrective action by a grantee or a decision by NIH to terminate the award.
Database that institutions must register with before they may receive a grant or contract from NIH.
SAM consolidates award information from registrations of potential grantee or contractor institutions, federal procurement systems, and the Catalog of Federal Domestic Assistance (CFDA), and it replaces the Central Contract Registration (CCR) system.
Go to System for Award Management (SAM).
Last Updated May 07, 2013
Last Reviewed April 30, 2012