Glossary

2 A B C D E F G H I K M N O P R S T U X

Personally Identifiable Information

Information that can be used to distinguish or trace an individual's identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual. Some information that is considered to be PII is available in public sources such as telephone books, public Web sites, and university listings. This type of information is considered to be Public PII and includes, for example, first and last name, address, work telephone number, email address, home telephone number, and general educational credentials. The definition of PII is not anchored to any single category of information or technology. Rather, it requires a case-by-case assessment of the specific risk that an individual can be identified. Non-PII can become PII whenever additional information is made publicly available, in any medium and from any source, that, when combined with other available information, could be used to identify an individual.

C

Clinical Trial

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

See Common Rule definition of research at 45 CFR 46.102(d)

See Common Rule definition of human subject at 45 CFR 46.102(f)

The term "prospectively assigned" refers to a pre-defined process (e.g., randomization) specified in an approved protocol that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of the clinical trial.

An intervention is defined as a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related processes and/or endpoints. Examples include, but are not limited, to: drugs/small molecules/compounds, biologics, devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, face-to-face); strategies to change health-related behavior (e.g., diet, cognitive therapy, exercise, development of new habits); and, treatment, prevention, and diagnostic strategies.

A health-related biomedical or behavioral outcome is defined as the pre-specified effect of an intervention on the study subjects. Examples include positive or negative changes to physiological or biological parameters (e.g., improvement of lung capacity, gene expression); psychological or neurodevelopmental parameters (e.g., mood management intervention for smokers; reading comprehension and/or information retention); disease processes; health-related behavior; and, well-being or quality of life

Biomedical clinical trials of an experimental drug, treatment, device, or behavioral intervention may proceed through four phases:

Phase I. Tests a new biomedical intervention in a small group of people (e.g. 20-80) for the first time to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).

Phase II. Study the biomedical or behavioral intervention in a larger group of people (several hundred) to determine efficacy and further evaluate safety.

Phase III. Study to determine efficacy of the biomedical or behavioral intervention in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions as well as to monitor adverse effects, and to collect information that will allow the interventions to be used safely.

Phase IV. Studies conducted after the intervention has been marketed. These studies are designed to monitor the effectiveness of the approved intervention in the general population and to collect information about any adverse effects associated with widespread use.

E

Early Stage Investigator ESI

An Early Stage Investigator is a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award.  See our list of NIH grants that a PD/PI can hold and still be considered an ESI. For more information, please click here.

F

FOIA

See Freedom of Information Act

Freedom of Information Act (FOIA)

Requires dissemination, upon request, of Government documents while ensuring protection of proprietary and other privacy act information. Go to FOIA.

G

Government Printing Office (GPO)

Produces and distributes Federal Government information products.

Grant Number

Sample Grant Number 1 R01 AI 183723 -01 A1 S1

H

Human Subject

A living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or obtains identifiable private information. Regulations governing the use of human subjects in research extend to use of human organs, tissues, and body fluids from identifiable individuals as human subjects and to graphic, written, or recorded information derived from such individuals. (See Public Policy Requirements and Objectives-Human Subjects Protections).

I

Institute or Center (IC)

The NIH organizational component responsible for a particular grant program or set of activities. The terms "NIH IC" or "awarding IC" are used throughout this document to designate a point of contact for advice and interpretation of grant requirements and to establish the focal point for requesting necessary prior approvals or changes in the terms and conditions of award.

Acronym Full Name Organizational Code
CC Clinical Center CC
CSR Center for Scientific Review RG
CIT Center for Information Technology CIT
FIC John E. Fogarty International Center TW
NCATS National Center for Advancing Translational Sciences (NCATS) TR
NCCIH National Center for Complementary and Integrative Health AT
NCI National Cancer Institute CA
NCRR National Center for Research Resources (dissolved 12/2011) RR
NEI National Eye Institute EY
NHGRI National Human Genome Research Institute HG
NHLBI National Heart, Lung, and Blood Institute HL
NIA National Institute on Aging AG
NIAAA National Institute on Alcohol Abuse and Alcoholism AA
NIAID National Institute of Allergy and Infectious Diseases AI
NIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases AR
NIBIB National Institute of Biomedical Imaging and Bioengineering EB
NICHD Eunice Kennedy Shriver National Institute of Child Health and Human Development HD
NIDA National Institute on Drug Abuse DA
NIDCD National Institute on Deafness and Other Communication Disorders DC
NIDCR National Institute of Dental and Craniofacial Research DE
NIDDK National Institute of Diabetes and Digestive and Kidney Diseases DK
NIEHS National Institute of Environmental Health Sciences ES
NIGMS National Institute of General Medical Sciences GM
NIMH National Institute of Mental Health MH
NIMHD National Institute on Minority Health and Health Disparities MD
NINDS National Institute of Neurological Disorders and Stroke NS
NINR National Institute of Nursing Research NR
NLM National Library of Medicine LM
OD Office of the Director OD

O

ORIS

Office of Research Information Systems - Provides IT systems, data and reporting support for grants processing for NIH and other agencies (HHS Operating Divisions and the Veterans' Administration).

P

Personally Identifiable Information

Information that can be used to distinguish or trace an individual's identity, either alone or when combined with other personal or identifying information that is linked or linkable to a specific individual. Some information that is considered to be PII is available in public sources such as telephone books, public Web sites, and university listings. This type of information is considered to be Public PII and includes, for example, first and last name, address, work telephone number, email address, home telephone number, and general educational credentials. The definition of PII is not anchored to any single category of information or technology. Rather, it requires a case-by-case assessment of the specific risk that an individual can be identified. Non-PII can become PII whenever additional information is made publicly available, in any medium and from any source, that, when combined with other available information, could be used to identify an individual.

PROMIS

Patient-Reported Outcomes Measurement Information Systems

Protected Personally Identifiable Information

PII - An individual's first name or first initial and last name in combination with any one or more of types of information, including, but not limited to, social security number, etc.

S

Scored Review Criteria

For research grant applications, and most other types of applications, reviewers judge the overall impact to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, taking into account five criteria, among other pertinent factors: Significance, Investigator(s), Innovation, Approach, and Environment. These scored review criteria may not be applicable for some types of applications. When these criteria are not applicable, the FOA will include the specific review criteria. Reviewers will consider each of the five criteria in the determination of scientific and technical merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have a major scientific impact. See Peer Review Process/Scoring for additional information.

Significant Differences

For purposes of NIH policy, a "significant difference" is a difference that is of clinical or public health importance, based on substantial scientific data. This definition differs from the commonly used "statistically significant difference," which refers to the event that, for a given set of data, the statistical test for a difference between the effects in two groups achieves statistical significance. Statistical significance depends upon the amount of information in the data set. With a very large amount of information, one could find a statistically significant, but clinically small difference that is of very little clinical importance. Conversely, with less information one could find a large difference of potential importance that is not statistically significant.