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Glossary
45 CFR 46 - Part A of this code is also known as the "Common Rule". It describes the rules and regulations relating to human subjects  Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. research which is enforced consistently across the government. (see CFR).
500K - Special procedures are required for clinical trial applications with direct costs Direct Costs
costs in a grant or contract identified with a project or program which may include salaries, travel, supplies, patient care costs, consultant services and others.
greater than $500,000 in any given year.
Activity Code - three digit identifier of a specific award type, e.g., R01 R01
grant mechanism used by NIH to provide support for health-related research which can be investigator-initiated or in response to a program announcement or request for application. is a research project grant. Major series of activity codes are: F -- fellowships, K -- career development awards, N -- research contracts, P -- program project and research center grants, R -- research project grants, S -- research-related programs, T -- training grants, U -- cooperative agreements, and Y -- interagency agreements.
Adverse Event - Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An adverse event (also referred to as an adverse experience) can also be any unfavorable and unintended sign (e.g., an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. An adverse event can arise from any use of a drug (e.g., off label use, use in combination with another drug) and from any route of administration, formulation or dose, including overdose.
Adverse Reaction - an undesirable effect, reasonably associated with use of a drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. This definition does not include all adverse events observed during use of a drug, only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence to the adverse event.
Acquisition Plan / Request for Contract - is a detailed plan that includes a complete statement of work, required deliverable items, criteria for evaluating proposals, an independent Government cost estimate and a milestone schedule through award. The Project Officer Project Officer
the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ). prepares this document with considerable assistance often provided by the Contracting Officer.
Applicant Institution - Institution applying for a grant. Informally, applicant may refer to a principal investigator writing a grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. application, though the institution is the official applicant.
Ancillary Study - additional study independent of the parent grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. or contract.
Assent - child's agreement to participate in research, which is not just a failure to object.
Award - provision of funds by NIH, based on an approved application and budget or progress report, to an organizational entity or an individual to carry out a project or activity.
Awardee - an institution receiving a grant, cooperative agreement, or contract.
Bar to fund - block to an award of a grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. application until problems are resolved, for example, due to insufficient protection of human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. or research animals.
Belmont Report - statement of ethical principles for human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. research issued by the National Commission for the Protection of Human Subjects in 1978.
Biospecimen - a full range of human specimen types including: sub-cellular components such as DNA or RNA, cells or tissues from any part of the body, organs, gametes, embryos and fetal tissues, bodily products (teeth, hair, sweat, urine, feces), blood and blood fractions, saliva and buccal cells.
Board of External Experts (BEE) - the NHLBI National Heart, Lung, Blood Institute (NHLBI)a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage. advisory group that helps to prioritize ideas and initiatives and makes recommendations about emerging challenges and opportunities.
Broad Agency Announcement (BAA) - is a general solicitation that identifies areas of scientific interest or aims to advance science. It differs from an RFP, which specifies a service or product the government wishes to acquire.
Case Report Forms (CRF) - documents used to collect data in studies. They are developed individually for each study and may also be called data collection forms.
Certificates of Confidentiality (CoC) - issued by NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. to protect identifiable research information from forced disclosure. Federal funding is not a prerequisite for receiving a certificate.
Center for Scientific Review (CSR) - the portal for NIH grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. applications and their review for scientific merit. It organizes the peer review groups that evaluate the majority (70%) of the research grantapplications sent to NIH. CSR Homepage
Centers for Medicare and Medicaid Services (CMS) - a federal agency under DHHS Department of Health and Human Services (DHHS)the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. (also known as HHS) Department of Health and Human Services Homepage that administers the Medicare program, partners with states to administer Medicaid, surveys and certifies health care facilities and regulates all laboratory testing. CMS Homepage
Clinical Research - patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects.
Clinical site - a facility at which clinical research is conducted.
Clinical Trial - A clinical trial is a controlled experiment, conducted in human beings, that is designed to evaluate and/or compare the effects of specific regimens or strategies on one or more pre-specified health outcomes in a defined population over a defined period of time. (Clinical Trials: Phase I Phase I Clinical Trial
testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects). , Phase II Phase II Clinical Trial
study in a larger group of people (several hundred) to determine efficacy and further evaluate safety. , Phase III Phase III
study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use. , Phase III(as defined by NIH) Phase III(as defined by NIH)
is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials. , Phase IV Phase IV Clinical Trial
studies done after an intervention has been marketed to monitor its effectiveness in the general population and to collect information about any adverse effects associated with widespread use. )
Clinical Trials Specialist (CTS) - individual who works as part of the program staff on clinical research projects, managing and overseeing clinical and operational activities of the project.
Closed Session - A monitoring board session which involves discussion of grouped safety data and, if appropriate, efficacy data which are presented by the study statistician(s). Grouped data should be presented by coded treatment arm.
Closeout - process by which the awarding agency determines that all applicable administrative actions and all required work of the award have been completed by the grantee.
Code of Federal Regulations (CFR) - Code of Federal Regulations is an annually revised codification of general and permanent rules (see 45 CFR 46)
Coded Private Information - Identifiable private information, such as a person's name or social security number, that is replaced with a code, e.g., number, letter, or symbol.
Conflict of Interest (COI) - financial, career, or other interest, includes interests of family members that could be advanced by participation in a NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. advisory Council, IRB, study section, or other advisory body.
Co-investigators (Co-I or Co-PI) - individuals with whom the Principal Investigator (PI) conducts research. Under the new Multiple Investigator program, each investigator will be considered a PI Principal Investigator (PI)
a qualified person designated by an applicant institution to direct a research project or program, oversee scientific and technical aspects of a grant and the day-to-day management of the research. with one PIdesignated as the "Contact PI" for communication with the awarding Institute.
Confidential Information - information one party discloses with restrictions to another party that is not generally known to the public and concerns scientific knowledge, processes, inventions, techniques, products, data, plans, software or similar information.
Conflict of Interest (COI) - A real, potential, perceived or apparent conflict of interest that arises when an individual's commitments and obligations to a board, committee or other advisory body are likely to be compromised by a person's other interests or commitments, particularly economic, especially if those interests or commitments are not disclosed. Such commitments or obligations may constitute a real, potential, or perceived conflict of interest from the viewpoint of some external observer, or some combination of these three categories.
Consent form - a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. research. Also known as Informed Consent.
Contract - award instrument establishing a binding legal agreement between NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. and an award recipient for products or services. The Office of Acquisition Office of Acquisition (OA)OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH Office of Acquisition Management and Policy) Management and Policy (OAMP) web site provides additional information
Contract Specialist - individual who performs many of the duties required by the contracting officer but is not authorized to sign contract documents or provide authorizations.
Contracting Officer - government employee authorized to execute contractual agreements and to obligate funds on behalf of the Government. Also known as Project Officer.
Contracting Project Officers - government employee responsible for monitoring the technical aspects of a project such as progress, resolving problems and assisting the contracting officer in the administration of the contract.
Contracting Officer's Technical Representative (COTR) - government employee responsible for monitoring the technical aspects of a project such as progress, resolving problems and assisting the contract ing officer in the administration of the contract. Also known as Project Officer.
Cooperative Agreement (U series) - a support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, scientific or program staff will assist, guide, coordinate, or participate in project activities.
Contracts Operations Branch (COB) - currently called the Office of Acquisition, is responsible for planning, organizing, directing, and accomplishing research and development contracting.
Cost Sharing or Matching - the portion of project or program costs not borne by the Federal Government.
Council - also known as NHLBAC, this group considers applications and advises the Institute on research grants, training grants and cooperative agreements to recommend funding for applications that show promise of making valuable contributions.
Data Coordinating Center (DCC) - provides support for large studies and focuses on central training in research methods, statistical leadership, data collection and management. Also known as Coordinating Center or Biostatistical Center.
Data and Safety Monitoring Board (DSMB) - an independent committee that reviews clinical trial progress and safety, and advises the appointing body whether to continue, modify, or terminate a trial. This is sometimes called a Data Monitoring Committee (DMC).
Data and Safety Monitoring Plan (DSMP) - designed by the investigator and approved by Program Staff to ensure safety of human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. and integrity of data.
Department of Health and Human Services (DHHS) - the United States government's principal agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves. (also known as HHS) Department of Health and Human Services Homepage
Direct Costs - costs in a grant or contract identified with a project or program which may include salaries, travel, supplies, patient care costs, consultant services and others.
Disallowed Costs - Charges to an award that the awarding agency determines to be unallowable, in accordance with Federal cost principles or other terms and conditions contained in the award.
Division of Extramural Research Activities (DERA) - advises the Director, NHLBI National Heart, Lung, Blood Institute (NHLBI)a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage. on contract, grant, and training program policies and represents the Institute on overall NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. extramural and collaborative program policy committees.
Executive Secretary - The person assigned to a DSMB, OSMB or PRC, who is responsible for writing and transmitting minutes and recommendations to the NHLBI National Heart, Lung, Blood Institute (NHLBI)a NIH Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage. leadership and to the study team.
Executive Session - A monitoring board session which involves discussion of general trial conduct, and all outcome results, including toxicities and adverse events. DSMB Data and Safety Monitoring Board (DSMB)
an independent committee that reviews clinical trial progress and safety, and advises the appointing body whether to continue, modify, or terminate a trial. This is sometimes called a Data Monitoring Committee (DMC). members also make decisions, and formulate recommendations regarding the study.
Exempt Research - research conducted in educational settings or where information is obtained where human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. cannot be identified. 45 CFR 46.101(b) provides a complete list of such research.
Extramural Research - Research supported by NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. through a grant, contract, or cooperative agreement.
Facilities and Administrative (F & A) - Costs that are incurred by a grantee for common or joint objectives and cannot be identified specifically with a particular project or program. These costs are also known as "indirect costs".
Federal Wide Assurance (FWA) - assurance of compliance accepted and approved by OHRP for institutions engaged in human subjects research conducted or supported by HHS. Under an FWA, an institution commits to HHS Health and Human Services(HHS)a federal government department to which NIH belongs whose mission is to protect the health of Americans and provide essential human services. Also referred to as Department of Health and Human Services (DHHS). HHS Homepage. that it will comply with the requirements set forth in 45 CFR part 46.
Financial Status Report (FSR) - shows the status of funds for a grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. or cooperative agreement. Mandatory for continued funding, FSRs are due to the Grants Management Officer from a grantee within 90 days of the end of a budget period.
Fiscal Year (FY) - for the federal government: October 1 to September 30.
Fogarty International Center (FIC) - is the international component of the NIH. It addresses global health challenges through innovative and collaborative research and training programs and supports and advances the NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. mission through international partnerships. Fogarty International Center Homepage
Food and Drug Administration (FDA) - is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Food and Drug Administration Homepage
Food and Drug Administration Act Amendment (FDAAA) - signed into law in 2007, the Food and Drug Administration Amendments Act (FDAAA), reauthorizes some existing parts of the law (e.g., User Fees) and adds many new provisions to the Federal Food, Drug, and Cosmetic including Clinical Trial Clinical Trial
A clinical trial is a controlled experiment, conducted in human beings, that is designed to evaluate and/or compare the effects of specific regimens or strategies on one or more pre-specified health outcomes in a defined population over a defined period of time. (Clinical Trials: Phase I , Phase II , Phase III , Phase III(as defined by NIH) , Phase IV ) Databases.
Grant - financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities.
Grant Application - An application for financial assistance from a Public Health Service agency to fund biomedical or behavioral research, using the paper PHS 398 or electronic SF 424 forms and instructions.
Grant Application Type - indicates whether a grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. is new, continuing, transferred from another IC and is noted as the first digit on an application identification number. See the Clinical Research Guide for more information.
Grants Management Officer (GMO) - NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. official responsible for the business management aspects of grants and cooperative agreements, including review, negotiation, award, and administration, and for the interpretation of grants administration policies and provisions.
Grants Management Specialists (GMS) - staff members who are the focal point for all business and policy activities associated with the negotiation, award and administration of a grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. or cooperative agreement, and who interpret and apply grants policies.
Grants.gov - electronic system that allows organizations to find and apply for grants offered by all Federal grant-making agencies. Grants.gov Homepage.
Grantee - the organization or individual awarded a grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. or cooperative agreement by NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. that is responsible and accountable for the use of the funds provided and for the performance of the grant-supported project or activities.
Health and Human Services(HHS) - a federal government department to which NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. belongs whose mission is to protect the health of Americans and provide essential human services. Also referred to as Department of Health and Human Services (DHHS). HHS Homepage.
Health Insurance Portability and Accountability Act (HIPAA) - a Law to improve portability of health insurance coverage, promote medical savings accounts, improve access to long-term care services and coverage, and simplify administration of health insurance. Implications for research can be found at: Clinical Research Clinical Research
patient-oriented research (human subjects, tissues, specimens, and cognitive phenomena), including epidemiologic and behavioral studies, outcomes research, and health services research in which a researcher directly interacts with human subjects. and the HIPAA Privacy Rule.
Health Science Administrators (HSA) - a staff member who oversees a scientific program and the progress of grants in a portfolio. Also known as a program officer or Project Officer Project Officer
the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ). , this individual works closely with grants management specialists to administer and resolve issues with grants.
Human Subject - Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA.
Human Subjects Research - a systematic investigation that includes human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. or human tissue from identifiable donors.
IMPAC II - an internal NIH database with confidential information on grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. applications and awards. IMPAC stands for Information for Management, Planning, Analysis, and Coordination. Go to the IMPAC II Web site.
Indirect Costs - also known as F & A (Facilities and Administrative), these are costs associated with the general operation of an institution and are fully reimbursed for most grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. programs which may include maintenance, departmental expenses and libraries.
Individually Identifiable - Describes private information regarding the identity of human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. that an investigator may ascertain directly or through a coding system. Go to definitions in 45 CFR 46.102(f) and full 45 CFR 46. If identity is knowable, the study is considered to be human subjectsresearch.
Informed Consent - a person's voluntary agreement, based upon adequate knowledge and understanding, to participate in human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. research.
Initiative - request for applications, request for proposals, or program announcements stating the interest of an Institute/Center (IC) in receiving applications or proposals because of a programmatic need or scientific opportunity.
Institutional Review Board (IRB) - a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC).
Integrated Review Group (IRG) - a cluster of study sections responsible for the review of grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. applications in scientifically related areas. Applications generally are assigned first to an IRG, and then to a specific study section within that IRG for evaluation of scientific merit.
Interaction - any communication or other interpersonal contact between an investigator and a human subject. For more information, go to definitions in 45 CFR 46.102 and full 45 CFR 46.
International Committee of Medical Journal Editors (ICMJE) - Initially known as the "Vancouver Group," this group first met in 1978 to establish formatting guidelines (known as the Uniform Requirements for Manuscripts) for manuscripts submitted to their journals. As it began to respond to issues beyond the scope of manuscript preparation, the group expanded and became more formalized and is now known as the International Committee of Medical Journal Editors (ICMJE).
Intervention - physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Intramural Research - Research conducted by, or in support of, employees of the NIH.
Investigational Device Exemption (IDE) - similar to an IND, this allows an unapproved medical device to be used for investigational purposes.
Investigational New Drug (IND) - an application, filed by a drug sponsor with FDA Food and Drug Administration (FDA)is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Food and Drug Administration Homepage ( Form FDA1571) to conduct clinical trials. It includes detailed descriptions of all trial phases, protocols, IRB Institutional Review Board (IRB)
a board or committee designated by an institution to ensure the protection of rights and welfare of human research subjects and reporting to the Office for Human Research Protection (OHRP). IRBs make ongoing independent determinations to approve, require modifications in, or disapprove research protocols based on whether human subjects are adequately protected. Also known as Research Ethics Boards (REB) or Ethics Committee (EC). members, and investigators
Investigator - Person involved in human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. research, excluding one who provides only coded private information or specimens, e.g., through a tissue repository, unless also a consultant or collaborator. Investigators who do not have access to identifiers are exempt from human subjectsrequirements.
Just-in-time (JIT) - timeframe for applicants to send required information if an award is likely. Items may include certification of IRB approval, Federal Wide Assurance (FWA) and human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. protection certifications of key personnel.
Life-threatening (Adverse Event) - an adverse event or suspected adverse reaction is considered "life-threatening" if, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk or death. It does not include an adverse or suspected adverse reaction that, had it occurred in a more severe form, might have caused death.
Minimal Risk - the probability and magnitude of harm or discomfort anticipated in the research is not greater than that ordinarily encountered by the research population in daily life or during the performance of routine physical or psychological examinations or tests.
National Heart, Lung, Blood Institute (NHLBI) - a NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. Institute that provides leadership for a national program in diseases of the heart, lung, and blood as well as blood resources, sleep disorders and the Woman's Health Initiative. NHLBI Homepage.
National Heart, Lung, and Blood Advisory Council (NHLBAC) - an independent group commonly called Council Council
also known as NHLBAC, this group considers applications and advises the Institute on research grants, training grants and cooperative agreements to recommend funding for applications that show promise of making valuable contributions. that considers applications and advises the institute and recommends funding for applications that show promise of making valuable contributions. NHLBAC Homepage.
National Institutes of Health (NIH) - the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage.
NIH Commons - a virtual meeting place for exchanging research grants administration information, used by NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. extramural grantee organizations, grantees, and the public. Also known as "Electronic Research Administration (ERA) Commons" Web site.
NIH-defined phase III clinical trial - is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials.
New investigator - Scientist who has never successfully competed as a principal investigator on many types of NIH grants, including an R01. Investigators who are appointed as PI for an existing grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. still qualify as new. For more information, go to these resources: NIH's New and Early Stage Investigator Policies.
Notice of Award (NOA) - a legally binding document, notifying the grantee and others that an award has been made, including all terms and conditions of the award and outlining the obligation of Federal funds. Previously known as Notice of Grant Award(NGA).
Observational and Safety Monitoring Boards (OSMB) - independent monitoring group whose principal role is to regularly monitor regularly data from large or complex observational studies and to review and assess the performance of its operations. Whether an OSMB is needed is determined on a case-by-case basis by NHLBI.
Offeror - a contracting term denoting an applicant responding to a request for proposals.
Office for Human Research Protections (OHRP) - HHS Health and Human Services(HHS)a federal government department to which NIH belongs whose mission is to protect the health of Americans and provide essential human services. Also referred to as Department of Health and Human Services (DHHS). HHS Homepage. office overseeing human subject protection for HHS-supported research. OHRP protects the rights, welfare, and well-being of subjects involved in research conducted or supported by HHSand helps ensure that such research is carried out in accordance with the regulations described in 45 CFR 46. OHRP Homepage.
Office of Acquisition (OA) - OA is part of the NHLBIs Division of Extramural Research Activities. OA provides support during the planning, negotiation, award and administration of research contracts. (Not be confused with the NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. Office of Acquisition Management and Policy)
Office of Extramural Research (OER) - a NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. office that supports extramural research by providing policy and guidance to the NIHICs that award grants and assisting investigators through the process of attaining grants funding and helping them understand and navigate through federal policies and procedures. OER Homepage
Office of Grants Management (OGM) - provides business management support to the program divisions for review, award, pre-award and post-award administration of research and training grants and awards. OGM is part of the NHLBI's Division of Extramural Research Activities.
Office of Management and Budget (OMB) - oversees the preparation of the federal budget, evaluates the effectiveness of agency programs, policies, and procedures, assesses competing funding demands among agencies, and sets funding priorities. OMB Homepage
Open Session - A monitoring board session which involves discussion of issues relating to the general conduct and progress of the study, including adverse events and toxicity issues, accrual, demographic characteristics of enrollees, disease status of enrollees (if relevant), comparability of groups with respect to baseline factors, protocol compliance, site performance, quality control, and timeliness and completeness of follow-up. Any data provided must be presented without grouping by treatment assignment or otherwise by preserving the masking of all subjects. Outcome results must not be discussed during this session.
Payline - a term used to describe the funding selection process for most competing grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. applications at the NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. based entirely on the result of peer review. The payline separates the applications that will be paid in rank order from those that may be selected based on programmatic relevance, as exceptions, or not paid at all.
Peer Review - system for evaluating research grant applications and contract proposals using non- NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. reviewers who are professional peers of an investigator or offeror.
Percentile - represents the relative position or rank of each priority score (along 100.0 percentile band) among the scores assigned by a particular study section.
Performance Based Contracting (PBC) - emphasizes objective, measurable performance requirements and quality standards in developing statements of work, selecting contractors, determining contract types, and incentives, and in performing contractadministration.
Phase I Clinical Trial - testing in a small group of people (e.g. 20-80) to determine efficacy and evaluate safety (e.g., determine a safe dosage range and identify side effects).
Phase II Clinical Trial - study in a larger group of people (several hundred) to determine efficacy and further evaluate safety.
Phase III - study to determine efficacy in large groups of people (from several hundred to several thousand) by comparing the intervention to other standard or experimental interventions, to monitor adverse effects, and to collect information to allow safe use.
Phase III(as defined by NIH) - is a broad-based, prospective study, including community and other population-based trials, usually involving several hundred or more people, to compare an experimental intervention with a standard or control or compare existing treatments. It often aims to provide evidence for changing policy or standard of care. It includes pharmacologic, non-pharmacologic, and behavioral interventions for disease prevention, prophylaxis, diagnosis, or therapy and includes community and other population-based intervention trials.
Phase IV Clinical Trial - studies done after an intervention has been marketed to monitor its effectiveness in the general population and to collect information about any adverse effects associated with widespread use.
Principal Investigator (PI) - a qualified person designated by an applicant institution to direct a research project or program, oversee scientific and technical aspects of a grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. and the day-to-day management of the research.
Preproposal Conference - A meeting with offerors to improve their understanding of the contract proposal Proposal
a written offer by an individual or non-federal organization to enter into a contract, consisting of a technical and a business proposal which includes a description of the project and its costs, and the methods, personnel, and facilities to carry it out. requirements and judge whether or how they can satisfy them especially for large and/or complex R&D programs.
Priority Score - a numerical rating that reflects the scientific merit of the proposed research relative to the "state of the science." Average of individual ratings of scientific merit given by reviewers of an initial peer review scientific review group.
Private Information - Information for which a person can expect that observations or recording are not taking place, and the information will not be made public. Information must be individually identifiable to constitute human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. research.
Program Announcements (PA) - NIH announcements requesting grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. applications in stated scientific areas where money is generally not set aside to pay for the grants.
Program Official (PO) - staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer Project Officer
the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ). if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Director.
Project Costs - all allowable costs, as set forth in the applicable Federal cost principles ( see 45 CFR 74.27), incurred by a recipient and the value of the contributions made by third parties in accomplishing the objectives of the award during the project period.
Project Officer - the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR Contracting Officer's Technical Representative (COTR)
government employee responsible for monitoring the technical aspects of a project such as progress, resolving problems and assisting the contract ing officer in the administration of the contract. Also known as Project Officer. ).
Project Scientist - As it relates to a particular study, a staff member who regularly attends and interacts with the study steering committee, is considered an investigator, and will be an author on the final paper.
Program Director - staff member who oversees a scientific program and the progress of grants and contracts in a portfolio. This title is most frequently used to refer to the scientific or technical representative for grants, but the generic "program official" term also may refer to a Project Officer Project Officer
the NIH staff member designated as a Contracting Officer's Technical Representative (COTR) to coordinate the substantive aspects of an acquisition from its development through to contract award and administration. Also known as Contracting Officer's Technical Representative ( COTR ). if the funding mechanism is a contract. Also known as Health Scientist Administrators or Program Official.
Proposal - a written offer by an individual or non-federal organization to enter into a contract, consisting of a technical and a business proposal which includes a description of the project and its costs, and the methods, personnel, and facilities to carry it out.
Protests - written objections by an interested party to contract solicitations, cancellation of solicitations, awards or proposed awards of a contractor termination or cancellation of awards.
Protocol Review Committee (PRC) - an independent group which reviews multi-center protocols and makes recommendations to the Institute regarding the scientific review and possible modifications to protocols.
R01 - grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. mechanism used by NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. to provide support for health-related research which can be investigator-initiated or in response to a program announcement or request for application.
Randomized Controlled Trial (RCT) - a type of scientific experiment to test interventions or technologies involving the random allocation of subjects to different interventions to ensure that confounding factors are evenly distributed between treatment groups.
Recombinant DNA Advisory Committee (RAC) - experts whose responsibility it is to review human gene transfer research, receiving NIH National Institutes of Health (NIH)the United State's medical research agency, a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research. NIH Homepage. funding for recombinant DNA research. Protocols are discussed at quarterly public meetings. RAC Homepage
Requests for Applications (RFA) - initiatives sponsored by one or more NIH institutes or centers that stimulate research by requesting grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. applications in a well-defined scientific area.
Request for Contract (RFC) - a detailed plan that includes a complete statement of work, required deliverable items, criteria for evaluating proposals, an independent Government cost estimate and a milestone schedule through award.
Requests for Proposals (RFP) - initiatives sponsored by an NIH institute for a contract to meet a specific need, such as the development of an animal model or circulatory assist devices or a specific multicenter clinical trial.
Research Project Grants (RPG) - grants awarded to an institution to address a single research topic even if it involves multiple sites. R series are single research project grants; P series are multi-project grants or U series are cooperative agreements.
Review Branch - part of the NHLBI Division of Extramural Research Activities. The Review Branch oversees initial peer review of grant applications and contract proposals with Institute-specific requirements.
Scientific Review Administrator (SRA) - presides over a scientific review group, and coordinates and reports the initial peer review of each grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. application assigned to it. They are intermediaries between applicants and reviewers, and prepare summary statements for all applications reviewed.
Scientific Review Group (SRG) - the first level of a two-stage peer review system. these panels of subject matter experts are established according to scientific discipline or medical specialty to review and rate applications for scientific and technical merit, appropriate level of support and duration of award. Also known as a Study Section.
Serious Adverse Event (SAE) - - An adverse event or suspected adverse reaction is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse reaction, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above.
Site Visit - process by which an external evaluation team visits an institution, to evaluate its policies and procedures for clinical research, during the study to assess for quality or problems.
Standard Form 424 (SF424) - a form used for electronic grant Grant
financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. A grant is used whenever the NIH Institute or Center anticipates no substantial programmatic involvement with the recipient during performance of the financially assisted activities. application submissions, gradually replacing the PHS 398.
Standard Operating Procedures (SOP) - detailed, written instructions to achieve uniformity of the performance of a specific function. SOPs are necessary to achieve maximum safety and efficiency in clinical research.
Statement of Work (SOW) - a detailed description of work written in a proposal Proposal
a written offer by an individual or non-federal organization to enter into a contract, consisting of a technical and a business proposal which includes a description of the project and its costs, and the methods, personnel, and facilities to carry it out. to be performed under a contract.
Steering Committee (SC) - a group, in a Network or multi-center study, composed of the principal investigators, sponsor representatives, the study statistician(s), and others who oversee the design, execution, analysis, and dissemination of results of a study.
Study section - the first level of a two-stage peer review system, these panels of subject matter experts are established according to scientific discipline or medical specialty to review and rate applications for scientific and technical merit, appropriate level of support and duration of award. Also known as Scientific Review Group (SRG)
Subcontract - a contract between a primary award recipient and a subcontractor to furnish supplies or services, a secondary contractundertaking some or all of the obligations of a primary or previous contract.
Summary Statement - official document with a short synopsis of peer reviewer critiques scores, codes indicating various concerns (e.g., human subjects Human Subject
Legally defined term for living persons about whom an investigator obtains specimens or data through direct interaction or intervention or through identifiable, private information. Regulations include but are not limited to human organs, tissues, body fluids, and recorded information. Term is defined differently by FDA. research), and a recommended budget.
Suspected (Adverse Event) - any adverse event for which there is a reasonable possibility that the drug caused the adverse event. For the purposes of IND Investigational New Drug (IND)an application, filed by a drug sponsor with FDA ( Form FDA 1571) to conduct clinical trials. It includes detailed descriptions of all trial phases, protocols, IRB members, and investigators safety reporting, ‘reasonable possibility’ means there is evidence to suggest a causal relationship between the drug and the adverse event. As suspected adverse reaction implies a lesser degree of certainty about causality than adverse reaction, which means any adverse event caused by a drug.
Termination - The cancellation of awarding agency sponsorship, in whole or in part, under an agreement at any time prior to the date of completion.
Third Party In-Kind Contributions - the value of non-cash contributions provided by non-Federal third parties. They may be in the form of real property, equipment, supplies and the value of goods and services directly benefiting and specifically identifiable to a project or program.
Unanticipated Problem - any incident, experience, or outcome that meets all of the following criteria: 1) unexpected 2) related or possibly related to participation in the research; and 3) suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized. OHRP Office for Human Research Protections (OHRP)HHS office overseeing human subject protection for HHS-supported research. OHRP protects the rights, welfare, and well-being of subjects involved in research conducted or supported by HHS and helps ensure that such research is carried out in accordance with the regulations described in 45 CFR 46. OHRP Homepage. provides detailed information in What are unanticipated problems?
Unexpected (Adverse Event) - An adverse event or suspected adverse reaction is considered "unexpected" if it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; or, of an investigator brochure is not required or available, is not consistent with the risk information described in the general investigational plan or elsewhere in the current application. "Unexpected" as used in this definition, also refers to adverse events or suspected adverse reactions that are mentioned in the investigator brochure as occurring with a class of drugs or as anticipated from the pharmacological properties of the drug, but are not specifically mentioned as occurring with the particular drug under investigation.
Unobligated Balance - the portion of funds authorized by an awarding agency that has not been obligated by the recipient.
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