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Clinical ResearchResearch with human subjects that is:  1) 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 utilize human tissues that cannot be linked to a living individual. It includes: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies. 2) Epidemiological and behavioral studies. 3) Outcomes research and health services research Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition.
      
        
  
            A
  
          AREAAcademic Research Enhancement Award
  

        B
  
          Basic ResearchSystematic study directed toward greater knowledge or understanding of the fundamental aspects of phenomena and of observable facts without specific applications towards processes or products in mind. (CFR 272.3)
          BRAINThe Brain Research through Advancing Innovative Neurotechnologies Initiative aims to accelerate the development and application of innovate technologies to produce a new, dynamic picture of the brain.
          BRDPISee Biomedical Research and Development Price Index
  

        C
  
          Clinical ResearchResearch with human subjects that is:  1) 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 utilize human tissues that cannot be linked to a living individual. It includes: (a) mechanisms of human disease, (b), therapeutic interventions, (c) clinical trials, or (d) development of new technologies. 2) Epidemiological and behavioral studies. 3) Outcomes research and health services research Studies falling under 45 CFR 46.101(b) (4) (Exemption 4) are not considered clinical research by this definition.
          Clinical TrialA 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.
          Competing ApplicationsCompeting applications are applications for a new, renewal, or resubmission research project grants(RPG), including R01s, R21s, and related mechanisms, that require competitive peer review
          CRADASee Cooperative Research and Development Agreement
  

        D
  
          Data and Safety Monitoring Board (DSMB)A formal, independent board of experts including investigators and biostatisticians that advise study investigators regarding the safety progression of a study. In general, NIH requires the establishment of DSMBs for multi-site clinical trials involving interventions that entail potential risk to the participants and for all Phase III clinical trials. As necessary, a DSMB may be appropriate for Phase I and Phase II or other clinical trials if the studies are blinded (masked), employ high-risk interventions, or involve vulnerable populations.
  

        E
  
          Early Established Investigator (EEI)A Program Director / Principal Investigator (PD/PI) who is within 10 years of receiving their first substantial, independent competing NIH R01 equivalent research award as an Early Stage Investigator (ESI).
          Early Stage Investigator (ESI)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. A list of NIH grants that a PD/PI can hold and still be considered an ESI can be found at https://grants.nih.gov/policy/early-investigators/list-smaller-grants.htm.
          Early Stage Investigator ESIAn 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.
          Extramural AwardsFunds provided by the NIH to researchers and organizations outside the NIH.
          Extramural ResearchResearch supported by NIH through a grant, contract, or cooperative agreement.
  

        H
  
          Human SubjectA 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
  
          IDeAInstitutional Development Awards (IDeA) enhance biomedical and behavioral research in specific geographic areas.
          Impact ScoreThe impact score is the rating which is assigned to an individual application by an SRG, and designates the reviewers' assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of established review criteria. The impact score is one mechanism by which the SRG makes a recommendation to the funding component concerning the application's scientific and technical merit. Impact scores may be numeric (10 ‚Äì 90) or alphabetical (ND, for example).
          Independent Clinical TrialAn independent clinical trial is one for which the researcher proposing the study has primary or lead responsibility for conducting and executing the trial. NIH policy permits individual career development awardees and individuals appointed to institutional career development awards to be involved in a range of clinical trial activities, including leading independent clinical trials. For NRSA trainees or fellows, however, NIH policy precludes leading an independent clinical trial as part of their training experience. Instead, NRSA trainees and fellows interested in clinical trials may gain clinical trial research experience by working on a trial led by their mentor or another investigator.
          Informed ConsentPerson's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects research or undergo a medical procedure. In giving informed consent, people may not waive legal rights or release or appear to release an investigator or sponsor from liability for negligence. Go to 21 CFR 50.20 and 50.25
          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 CCCSR Center for Scientific Review RGCIT Center for Information Technology CITFIC John E. Fogarty International Center TWNCATS National Center for Advancing Translational Sciences (NCATS) TRNCCIH National Center for Complementary and Integrative Health ATNCI National Cancer Institute CANCRR National Center for Research Resources (dissolved 12/2011) RRNEI National Eye Institute EYNHGRI National Human Genome Research Institute HGNHLBI National Heart, Lung, and Blood Institute HLNIA National Institute on Aging AGNIAAA National Institute on Alcohol Abuse and Alcoholism AANIAID National Institute of Allergy and Infectious Diseases AINIAMS National Institute of Arthritis and Musculoskeletal and Skin Diseases ARNIBIB National Institute of Biomedical Imaging and Bioengineering EBNICHD *Eunice Kennedy Shriver*National Institute of Child Health and Human Development HDNIDA National Institute on Drug Abuse DANIDCD National Institute on Deafness and Other Communication Disorders DCNIDCR National Institute of Dental and Craniofacial Research DENIDDK National Institute of Diabetes and Digestive and Kidney Diseases DKNIEHS National Institute of Environmental Health Sciences ESNIGMS National Institute of General Medical Sciences GMNIMH National Institute of Mental Health MHNIMHD National Institute on Minority Health and Health Disparities MDNINDS National Institute of Neurological Disorders and Stroke NSNINR National Institute of Nursing Research NRNLM National Library of Medicine LMOD Office of the Director OD
          Institutional Review BoardAn administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the organization with which it is affiliated.
          Intramural ResearchResearch conducted by, or in support of, employees of the NIH.
          Investigational New Drug ApplicationUnder regulation 21 CFR 312, application filed by a drug sponsor with FDA on Form FDA 1571 to conduct clinical trials, including detailed descriptions of all phases, protocols, IRB members, and investigators.
          Investigator-Initiated ResearchResearch funded as a result of an investigator, on his or her own, submitting a research application.
  

        M
  
          MSTPMedical Scientist Training Program - MTSP supports the integrated medical (or equivalent professional clinical) degree and graduate research training required for the investigation of human diseases
  

        N
  
          NCRRNIH National Center for Research Resources (dissolved 12/2011)
          New InvestigatorA PD/PI who has not previously competed successfully as a PD/PI for a substantial independent research award is considered a New Investigator.
          NHGRINIH National Human Genome Research Institute
          NIDCRNIH National Institute of Dental and Craniofacial Research
          NIH Guide for Grants and ContractsThe official publication for NIH's medical and behavioral research grants policies, guidelines and funding opportunities.
          NIH-Defined Phase III Clinical TrialAn NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled intervention or comparing two or more existing treatments. Often the aim of such investigation is to provide evidence leading to a scientific basis for consideration of a change in health policy or standard of care. The definition includes pharmacologic, non-pharmacologic, and behavioral interventions given for disease prevention, prophylaxis, diagnosis, or therapy. Community trials and other population-based intervention trials are also included.
          NINRNIH National Institute of Nursing Research
          NOSINotices posted in the NIH Guide for Grants and Contracts that succinctly highlight a specific topic of interest, for example a specific area of research or program. These notices direct applicants to one or more active funding opportunity announcements (often parent announcements) for submission of applications for the initiative described. Many program announcements will be issued as Notices of Special Interest going forward.
          NRFCAn application may be designated Not Recommended for Further Consideration (NRFC) by the Scientific Review Group if it lacks significant and substantial merit; presents serious ethical problems in the protection of human subjects from research risks; or presents serious ethical problems in the use of vertebrate animals, biohazards, and/or select agents. Applications designated as NRFC do not proceed to the second level of peer review (National Advisory Council/Board) because they cannot be funded.
          NRSANational Research Service Award - Ruth L. Kirschstein National Research Service Award (NRSA)
  

        O
  
          Office of Research Integrity(ORI) - HHS office promoting integrity in biomedical and behavioral research supported by the Public Health Service by monitoring institutional investigations of scientific misconduct and facilitating the responsible conduct of research.
          OHRPOffice for Human Research Protections - HHS office overseeing human subject protection for HHS-supported research.
          ORISOffice 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
  
          Parent AnnouncementNIH-wide FOA enabling applicants to electronically submit investigator-initiated grant application for a specific activity code, e.g., Research Project Grant (Parent R01). Learn more about types of funding opportunity announcements.
          Peer Review CriteriaThe reviewers judge the overall impact for the project to exert a sustained, powerful influence on the research field(s) based on five criteria: Significance, Investigator(s), Innovation, Approach, and Environment.
          Planned Enrollment ReportThe Planned Enrollment Report is used when you are planning to conduct a study that meets the NIH definition for clinical research. It provides a breakdown of the planned sample by sex/gender, race, and ethnicity.
          Program AnnouncementA PA is a formal statement about a new or ongoing extramural activity or program. It may serve as a reminder of continuing interest in a research area, describe modification in an activity or program, and/or invite applications for grant support. Most applications in response to PAs may be submitted to a standing submission date and are reviewed with all other applications received at that time using standard peer review processes. NIH may also make funds available through PARs (PAs with special receipt, referral, and/or review considerations) and PASs (PAs with set-aside funds).

PAs may be used for any support mechanism other than construction awards. Unless otherwise specified in the PA, new applications (and associated renewal and revision applications) submitted in response to PAs are treated as investigator-initiated. PAs also are used to annually solicit applications for the SBIR and STTR programs. Those applications must be received by the dates specified in the PA.

Program Announcements (PA) are published in the NIH Guide for Grants and Contracts. Go to Program Announcements. Learn more about types of funding opportunity announcements.
          Public Access PolicyThe NIH policy designed to ensure that the public has access to the published results of NIH-funded research.
  

        R
  
          REAPResearch Enhancement Award Programs
          RePORTResearch Portfolio Online Reporting Tools
          Research & DevelopmentAll research activities, both basic and applied, and all development activities that are performed by HHS award recipients. The term research also includes activities involving the training of individuals in research techniques where such activities utilize the same facilities as other research and development activities and where such activities are not included in the instruction function. "Research" is defined as a systematic study directed toward fuller scientific knowledge or understanding of the subject studied. "Development" is the systematic use of knowledge and understanding gained from research directed toward the production of useful materials, devices, systems, or methods, including design and development of prototypes and processes.
          Research and Development ContractA funding mechanism by which the NIH procures specific services.
          Research CentersCenter grants are awarded to institutions on behalf of program directors and groups of collaborating investigators. They support long-term, multi-disciplinary programs of research and development.
          Research GrantsMajor extramural research grants awarded to institutions, hospitals, and other research organizations, including small businesses, to support circumscribed research led by investigators, create developmental opportunities, and to provide research related resources under programs such as Research Careers, Research Centers, Research Projects, SBIR/STTRs, and Other Research.
          Research MisconductFabrication, falsification, or plagiarism in proposing, performing, or reporting research, or in reporting research results. Fabrication is making up data or results and recording or reporting them. Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that research is not accurately represented in the research record. Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit. Research misconduct does not include honest error or honest differences of opinion.
      
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