NIAID Glossary of Funding and Policy Terms and Acronyms: T-Z

For electronic grant applications, a table of contents is generated automatically.

For paper applications, go to Form Page 3 in the paper PHS 398 Grant Application.

Form listing potential populations to be enrolled for human subjects research. For paper grant applications use the Targeted/Planned Enrollment Table. For electronic applications, use the Targeted/Planned Enrollment Table form in your Grant Application Package.

See SF 424 Application Guide and Inclusion Enrollment Report Table.

For more information, go to these NIAID resources:

• Send NIAID the Inclusion Enrollment Form in NIAID Human Subjects Application and Grant Handbook
• NIAID Human Subjects Resources portal

Research funded from an NIH institute's set aside of dollars for a scientific area. Institutes solicit research using requests for applications for grants and solicitations for contracts. See the converse unsolicited research, investigator-initiated, and program announcement.

For more information, go to these NIAID resources:

• NIH Funding Opportunities Relevant to NIAID
• Targeted Research SOPs
• Application Approach: What Are Your Choices? in the NIH Grant Cycle: Application to Renewal

Conditions determined by a project officer and contracting officer during pre-solicitation for evaluating the technical merit of contract proposals responding to a solicitation.

For more information, go to NIAID's Peer Review of R&D Contract Technical Proposals SOP and the Contracts portal.

Panel of peer reviewers with scientific or technical expertise who conduct initial peer review of the scientific and technical merit of R&D contract proposals. They vote on acceptability and make other recommendations.

For more information, go to NIAID's Peer Review of R&D Contract Technical Proposals SOP and the Contracts portal.

Report prepared by a scientific review officer after initial peer review of R&D contract proposals stating scores, strengths, and weaknesses and indicating whether acceptable or unacceptable.

For more information, go to NIAID's Peer Review of R&D Contract Technical Proposals SOP and the Contracts portal.

Sharing of knowledge and facilities among federal laboratories, industry, universities, government, and others to make federally generated scientific and technological advances accessible to private industry and state and local governments.

For more information, go to NIH's Office of Technology Transfer and NIAID's Office of Technology Development.

Discontinuing a clinical investigation before its completion by a sponsor or by withdrawal of institutional review board or FDA approval.

For more information, go to 21 CFR 812.3, 21 CFR 56.113, and 21 CFR 312.44.

Government contract termination that does not hold a contractor at fault, usually done when in the government's best interest. Non-profit and educational organizations can be terminated for convenience, but not for default.

For more information, go to these resources:

• FAR 49
• NIAID's Contract Termination SOP
• NIAID's Contracts portal

Government contract termination that holds a contractor at fault for failure to make progress or comply with provisions of a contract. This action is appropriate only in cost-plus-fixed-fee and fixed-price contracts.

For more information, go to FAR 49 and NIAID's Contracts portal.

NIH legal requirements for a grant or contract, based on statute, regulation, or policy. Terms are described in a Notice of Award or contract. See NIAID's Clinical Terms of Award and select agent.

For more information, go to these NIAID resources:

• Read Your Notice of Award, Know Your Terms in the NIH Grant Cycle: Application to Renewal
• Clinical Terms of Award SOP
• Biodefense and Biosecurity portal
• Grant Award and Management portal

National Research Service Award Institutional Research Training Grant (T32) and Short-Term Institutional Research Training Grant (T35). These grants provide domestic, nonprofit, and private or public graduate-level academic institutions with funds for training predoctoral and postdoctoral candidates.

For more information, go to these NIAID resources:

• Institutional Research Training Grants in the Advice on Research Training and Career Awards tutorial
• Training and Career portal

FDA procedure for giving patients with serious or life-threatening diseases access to investigational new drugs outside a clinical trial. See investigational new drug application.

For more information, go to 21 CFR 312.34 and 21 CFR 312.36.

Contract proposal judged by a technical evaluation group to fail to satisfy minimum requirements of a solicitation without significant revisions.

For more information, go to NIAID's Contracts portal and Peer Review of R&D Contract Technical Proposals SOP.

Cost that cannot be included in a price, cost-reimbursement, or settlement under a government contract. For more information, go to FAR 31.001.

Unanticipated serious adverse effect on health or safety related to the rights, safety, or welfare of subjects associated with an investigational medical device.

For more information, go to 21 CFR 812.3 and full 21 CFR 812.

Group underrepresented in biomedical research, defined as:

• People with disabilities, i.e., who have a physical or mental impairment that substantially limits one or more major life activities.
• People from disadvantaged backgrounds.
• Racial and ethnic groups such as blacks or African Americans, Hispanics or Latinos, American Indians or Alaskan Natives, and Native Hawaiians or other Pacific Islanders.

Underrepresented status is used as eligibility for some NIH programs -- see below. See the human subjects definition of minority group.

For more information, go to NIH's Research and Training Opportunities and these NIAID resources:

• Predoctoral Grants Support Minority and Disabled Students in the Advice on Research Training and Career Awards tutorial
• Special Populations questions and answers
• Research Supplements to Promote Diversity in Health-Related Research
• Research Supplements and Training and Career portals

Improper pressure or coercion to shape a person's presence of mind and actions, depriving that person's freedom of choice. Human subjects protections prevent investigators from using such measures to enroll people in research. See informed consent.

For more information, go to 45 CFR 46.116 general requirements for informed consent and 21 CFR 50.20.

Adverse event not described in labels, brochures, published medical literature, protocols, or consent documents.

For more information, go to NIH Adverse Event Reports and NIAID Human Subjects Resources portal.

Expenses agreed to but not paid for by the end of a budget period.

In the financial status report for a final budget period, unliquidated obligations must be zero.

Funds not used by the completion of a grant's project period. Grantees must report unobligated balances over 25 percent of total costs to their grants management specialist.

Grants awarded under expanded authorities may carry over unobligated funds from one budget period to another within an approved project period without prior approval, as stated in the Notice of Award.

For more information, go to NIAID's Using Leftover Funds in the Grants Policy and Management Training for Foreign Investigators.

Describes a grant application that does not receive a full initial peer review or overall impact/priority score because it was either streamlined or not recommended for further consideration.

These applications receive the primary and secondary reviewers' critiques as a summary statement. Occasionally, an unscored application is funded by a special action of an NIH institute's advisory council. See recommended.

For more information, go to these NIAID resources:

• Part 11b. Not Funded, Reapply in the NIH Grant Cycle: Application to Renewal
• Peer Review portal

Written proposal to obtain a contract with the government that offerors submit on their own initiative rather than respond to a request for proposals or other government solicitation.

For more information, go to FAR 15.602 and the official definition in FAR 2.101.

Research funded after an investigator submits a research grant application on a topic of his or her choice, including applications responding to program announcements. See investigator-initiated research and parent program announcement; see the converse, targeted research.

For more information, go to NIH's Parent Announcements and these NIAID resources:

• Application Approach: What Are Your Choices? in the NIH Grant Cycle: Application to Renewal
• How does NIH define investigator-initiated applications? question and answer
• NIH Funding Opportunities Relevant to NIAID
• Grant Application portal

Public law to deter and punish terrorism inside and outside the U.S. and provide investigatory and other tools. These include restricting access to select agents, described in SEC. 175b. Possession by Restricted Persons. See dual use research.

For more information, go to these resources:

• USA Patriot Act of 2001
• USA Patriot Improvement and Reauthorization Act of 2005
• NIAID's Biodefense and Biosecurity portal

Federal government agency with programs for food, agriculture, natural resources, and related topics. USDA implements the Animal Welfare Act and regulates the study of pathogens and toxins for livestock and plants.

CDC in HHS and Animal and Plant Health Inspection Service (APHIS) in USDA administer the National Select Agents Registry.

For select agent-related information, see select agent. For more information, go to USDA.

Human subjects term indicating an unbiased assessment that generally yields a correct estimate of the difference in outcomes between two groups of subjects. Used for small and large clinical studies, a valid analysis does not need high statistical power for detecting an effect. Also see analysis.

Main requirements for ensuring a valid analysis are as follows:

• Allocation of study participants of both genders and from different racial and ethnic groups to intervention and control groups by an unbiased process, such as randomization.
• Unbiased evaluation of an outcome.
• Use of unbiased statistical analyses and methods of inference to estimate and compare intervention effects among different groups.

For electronic grant applications, automated check of an application against the SF 424 Application Guide and funding opportunity announcement that can result in errors or warnings.

For more information, go to these resources:

• NIAID's About Validations in the NIH Grant Cycle: Application to Renewal
• NIH's SF 424 (R&R) Application Guides

For electronic grant applications, two-day period an applicant can use to check an application image to make sure it meets expectations.

Unless a signing official rejects an application, it automatically becomes final -- moves to the Center for Scientific Review -- at midnight EST two business days after passing validation.

For more information, go to these NIAID resources in the NIH Grant Cycle: Application to Renewal:

• If Your Application Passes Commons Validation
• If You Want to Correct After Passing Commons Validation

For electronic grant applications, result of Grants.gov or eRA Commons validation that may require the applicant's attention although it does not stop an application from becoming final, i.e., moving to the Center for Scientific Review. Also see error.

For more information, go to these NIAID resources:

• About Validations in the NIH Grant Cycle: Application to Renewal
• Corrected or Late Electronic Applications questions and answers

Exception to an NIAID grant policy that NIAID approves when highly beneficial to either the Institute or a project's scientific goals or fiscal stewardship. See deviation.

For more information, go to this NAID resource: Deviations and Waivers to Grant Policies SOP.

Human subjects term indicating a person having origins in any of the original peoples of Europe, the Middle East, or North Africa.

See Targeted/Planned Enrollment Table and Inclusion Enrollment Report Table.

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