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 research which is enforced consistently across the government. (see CFR)

500K - Special procedures are required for clinical trial applications with direct costs greater than $500,000 in any given year.

Activity Code - Three digit identifier of a specific award type, e.g., R01 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 unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure.

Ancillary Study - 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 prepares this document with considerable assistance often provided by the Contracting Officer.

AP / RFC - 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 prepares this document with considerable assistance often provided by the Contracting Officer.

Award - Financial assistance that provides support or stimulation to accomplish a public purpose. Awards include grants and other agreements in the form of money or property in lieu of money, by the Federal Government to an eligible recipient.

BAA - Broad Agency Announcement 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. Broad agency announcements include criteria for selecting proposals and attracting qualified offerors, who develop a statement of work and performance specifications

Bar to fund - Block to an award of a grant application until problems are resolved, for example, due to insufficient protection of human subjects or research animals. For those concerns, a scientific review group puts a code 44 in the summary statement.

Belmont Report - Statement of ethical principles for human subjects research issued by the National Commission for the Protection of Human Subjects in 1978.

CFR - Code of Federal Regulations is an annually revised codification of general and permanent rules published in the Federal Register.  (see 45 CFR 46)

Clinical Trial - a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions such as drugs, treatments, devices, or new ways of using known drugs, treatments, or devices. (See Phases of Clinical Trials)

Clinical Trials Specialist - An individual who works with a Program Director on clinical research projects, managing and overseeing clinical and operational activities of the project.

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.

CMS - Centers for Medicare and Medicaid Services is a federal agency under DHHS that administers the Medicare program, partners with states to administer Medicaid, surveys and certifies health care facilities and regulates all laboratory testing.

COI - Conflict of Interest

Co-I or Co-PI - Co-investigators are individuals with whom the Principle Investigator (PI) conducts research. Under the new Multiple Investigator program, each investigator will be considered a PI with one PI designated as the “Contact PI” for communication with the awarding Institute.

Contract - A procurement which is used to acquire property or services for the Federal government's direct benefit or use.  (see proposal)

Contract Specialist - An 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 - The only person vested with the legal authority to bind the Government in contracts. This individual has the authority to solicit, negotiate, select, award, and terminate on behalf of the Government.

Cooperative Agreement - A grant award that provides for substantial involvement between the Federal agency and the recipient in carrying out the activities of the award.

COB - Contracts Operations Branch (now the Office of Acquisitions) is responsible for planning, organizing, directing, and accomplishing research and development contracting, station support contracting, and simplified acquisitions for the National Heart, Lung, and Blood Institute (NHLBI) and for other Institutes and Centers through service center agreements at the National Institutes of Health (NIH). COB is responsible for implementing federal, departmental and NIH procurement policies and procedures in its acquisition activities.

Council - See NHLBAC.

Cost Sharing or Matching - The portion of project or program costs not borne by the Federal Government.

CRF - Case Report Forms are documents used to collect data in studies.  They are developed individually for each study and may also be called data collection forms.

CRISP - Computer Retrieval of Information on Scientific Programs is a searchable database of federally funded biomedical research projects conducted at universities, hospitals, and other research institutions.

CSR - Center for Scientific Review is the portal for NIH grant applications and their review for scientific merit.  It organizes the peer review groups that evaluate the majority (70%) of the research grant applications sent to NIH.

DCC- Data Coordinating Centers provide support for large studies and focus on central training in research methods, statistical leadership, data collection and management including tracking systems, study communications and logistics, and assisting with materials development.related for new research projects.

DEA - Division of Extramural Affairs advises the Director on research contract, grant, and training program policies and represents the Institute on overall NIH extramural and collaborative program policy committees and more.

DHHS - Department of Health and Human Services is 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)

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.

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.

DSMB - Data and Safety Monitoring Board is 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).

F & A - Facilities and Administrative Costs are costs associated with general operation of an institution.  HHS supports full reimbursement for facilities and administrative costs for most grant programs which may include operations and maintenance, general administration and departmental expenses and libraries.  Also commonly known as indirect costs.

FDA - Food and Drug Administration 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.

FIC - Fogarty International Center 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 mission through international partnerships.

FSR - Financial Status Reports show the status of funds for a grant or cooperative agreement. Mandatory for continued funding, FSRs are due to NHLBI’s Grants Operations Branch from a grantee within 90 days of the end of a budget period.

FWA - Federal Wide Assurance is the only type of 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 that it will comply with the requirements set forth in 45 CFR part 46.

FY - Fiscal Year for the federal government: October 1 to September 30

GCP - Good Clinical Practice is a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials.

GMS - Grants Management Specialists are staff members who are the focal point for all business and policy activities associated with the negotiation, award and administration of a grant or cooperative agreement, and who interpret and apply grants policies.

GOB - Grants Operations Branch provide business management support to the program divisions for review, award, pre-award and post-award administration of research and training grants and awards.

Grant - An award of financial assistance, the principal purpose of which is to transfer a thing of value from a Federal agency to a recipient to carry out a public purpose of support or stimulation.

Grants.gov - Grants.gov allows organizations to electronically find and apply for grants offered by all Federal grant-making agencies.

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 is new, continuing, transferred from another IC and is noted as the first digit on an application identification number.

HHS - Health and Human Services (Department of) also referred to as DHHS is a federal government department to which NIH belongs whose mission is to protect the health of Americans and provide essential human services.

HIPAA - Health Insurance Portability and Accountability Act is a Law from 1996 that amends the Internal Revenue Code 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.  See also: Clinical Research and the HIPAA Privacy Rule.

Human Subject - A healthy person or patient with whom an investigator directly interacts or intervenes or obtains identifiable, private information..

IBC - Institutional biosafety committee set up by a research institution under NIH Guidelines for Research Involving Recombinant DNA Molecules to review recombinant DNA research and ensure its legal use. IBCs may also review other biohazardous research, including biodefense select agents.

IC - Institutes or Centers at NIH is a term used by NIH to denote major NIH organizations: institutes, such as NHLBI and centers, such as the Fogarty International Center.  Go to the NIH ICs web site.

IC - Informed Consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants.

ICD - Informed Consent Document describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are also explained.

IDE - Investigational Device Exemption that is similar to an IND, allows an unapproved medical device to be used for investigational purposes. FDA

IND - Investigational New Drug application is filed by a drug sponsor with FDA on Form FDA 1571 to conduct clinical trials, including detailed descriptions of all trial phases, protocols, IRB members, and investigators. Once clinical evaluation is completed, a new drug application must be submitted to FDA to obtain approval to market the drug.

Indirect Costs - Also known as F & A (Facilities and Administrative). Costs that are associated with general operation of an institution are fully reimbursed by HHS for most grant programs which may include operations and maintenance, general administration and departmental expenses and libraries.

Initiative - Request for applications, request for proposals, or program announcements stating the interest of an IC in receiving applications or proposals because of a programmatic need or scientific opportunity.

Interaction - Includes communication or interpersonal contact between investigator and subject.

Intervention - Includes both 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.

IRB - Institutional Review Board means any board, committee, or other group formally designated by an institution to review, to approve the initiation of, and to conduct periodic review of, biomedical research involving human subjects. The primary purpose of such review is to assure the protection of the rights and welfare of the human subjects.

IRG - Integrated Review Group is a cluster of study sections responsible for the review of grant 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.

JIT - (Just-in-time) Grant application timeframe that requires applicants to send some information to NIH only if an award is likely.  Items may include certification of IRB approval, Federal Wide Assurance and letter stating key personnel have been trained in protecting human subjects.

NHLBI - National Heart, Lung, Blood Institute provides leadership for a national program in diseases of the heart, blood vessels, lung, and blood; blood resources; and sleep disorders. Since October 1997, the NHLBI has also had administrative responsibility for the NIH Woman's Health Initiative.

NHLBAC - National Heart, Lung, and Blood Advisory Council (commonly called Council) 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 to human knowledge.

NIH - National Institutes of Health is a federal government agency composed of diverse Institutes and Centers that conduct and support biomedical and behavioral research.

NIH Commons - Web site where NIH grantees, staff, and the public access and share administrative information about research awards; includes both restricted and public sites.

NIH-Defined Phase III Clinical Trial - A broadly based prospective clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a placebo or control 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.

NOGA - Notice of Grant Award (also NGA) is the award document which indicates the dates of and funds authorized for expenditure during a single budget period. Recommended funding amounts for future years will also be reflected in the document.

Offeror - Contracting term denoting an applicant responding to a request for proposals.

OER - Office of Extramural Research serves as the focal point for policies and guidelines for extramural research grants administration.

OHRP - Office for Human Research Protections provides leadership on human research subject protection and implements a program of compliance and oversight for DHHS regulations for the protection of human subjects.

OMB - Office of Management and Budget oversees and coordinates the Administration's procurement, financial management, information, and regulatory policies.

OSMB - Observational and Safety Monitoring Boards' principal role is to monitor regularly the data from the observational study and to review and assess the performance of its operations.

PA - Program Announcements are NIH announcements requesting grant applications in stated scientific areas where money is generally not set aside to pay for the grants.

Payline - A term used to describe the funding selection process for most competing grant applications at the NIH. If one visualizes a list of grant applications sorted in rank order by percentile or priority score (often called a “paylist”), one can imagine a line drawn under the last application on that list, which will be funded based entirely on the result of peer review. That virtual line is the “payline.” 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.

PBC - Performance Based Contracting emphasizes objective, measurable performance requirements and quality standards in developing statements of work, selecting contractors, determining contract types, and incentives, and in performing contract administration. In short, PBC focuses on "what, when, where, how many and how well" services are provided instead of "how" services are provided.

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.

Phase I - clinical trials are the first studies in humans of a new biomedical or behavioral intervention to evaluate safety (e.g. determine a safe dosage range, and identify side effects).

Phase II - clinical trials study the biomedical or behavioral intervention in a larger group of people to determine efficacy and to further evaluate its safety.

Phase III - studies investigate the efficacy of the biomedical or behavioral intervention in large groups of human subjects (often several hundred to several thousand) to compare the intervention to placebo, standard or  experimental interventions as well as to monitor adverse effects, and to collect information that will allow the intervention to be used safely.

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

PHS - The United States Public Health Service (U.S) is an umbrella organization in the U.S. federal government consisting of eight HHS health agencies, the Office of Public Health and Science, and the Commissioned Corps, a uniformed service of more than 6,000 health professionals.

PI - Principal Investigator is a qualified person designated by an applicant institution to direct a research project or program supported by NIH and will oversee scientific and technical aspects of a grant and the day-to-day management of the research.

PD - Program Directors (or Health Scientist Administrators) are staff members who oversee a scientific program and the progress of grants and contracts in his or her portfolio. Program officers work closely with grants management specialists,  contracting officers and contract specialists to administer and resolve issues with grants and contracts.

PRC - Protocol Review Committee reviews multi-center protocols and makes recommendations to the Institute regarding the scientific review and possible modifications to the protocols.

Preproposal Conference - A meeting with offerors to improve their understanding of the contract proposal requirements and judge whether or how they can satisfy them especially for large and/or complex R&D programs.  All offerors must have access to the information disseminated at a preproposal conference which will be posted at the RFP internet site and by RFP amendment.

Priority score - A numerical rating that reflects the scientific merit of the proposed research relative to the "state of the science."

Private information - Information that is individually identifiable and also includes data about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public for example, a medical record (see HIPAA).

Program Director - also known as Program Officers or Officials are staff members who oversee a scientific program and the progress of grants in his or her portfolio. They work closely with grants management specialists to administer and resolve issues with grants.

Project Costs - All allowable costs, as set forth in the applicable Federal cost principles (see Sec. 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.

Proposal - A written offer by an individual or non-federal organization to enter into a contract, usually in response to a request for proposals. It consists of a technical and a business proposal, including a description of the project and its costs, and the methods, personnel, and facilities to carry it out.

RAC – Recombinant DNA Advisory Committee is comprised of experts in a wide range of scientific and medical disciplines, ethicists and members of patient and other lay communities. Its major responsibility is to review human gene transfer research on behalf of the NIH. Human gene transfer trials conducted at, or sponsored by, institutions receiving NIH funding for recombinant DNA research are registered with OBA and reviewed by the RAC. Protocols that raise novel or particularly important scientific, safety or ethical considerations are discussed by the RAC at one of its quarterly public meetings.

RCT - Randomized Controlled Trial

RFA - Requests for Applications are initiatives sponsored by one or more NIH institutes or centers that stimulate research by requesting grant applications in a well-defined scientific area.

RFC - Request for Contract. Formal document a contracting officer uses to begin preparing a request for proposals.

RFP - Requests for Proposals are 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.

RPG - Research Project Grants are research grants awarded to an institution. R series are single research project grants; P series are multi-project grants or U series are cooperative agreements . Unlike a multi-project award, a single project award addresses a single research topic even if it involves multiple sites.

SC- Steering Committees in clinical research are generally 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.

SOP - Standard Operating Procedures in clinical research are defined by the International Conference on Harmonisation (ICH) as "detailed, written instructions to achieve uniformity of the performance of a specific function". SOPs are necessary for a clinical research organization to achieve maximum safety and efficiency of the performed clinical research operations.

SRA - Scientific Review Administrator presides over a scientific review group, and coordinates and reports the initial peer review of each grant application assigned to it. They act as intermediaries between applicants and reviewers, and prepare summary statements for all applications reviewed.

Standard Form 424 (SF424)

Steering Committee - A committee that sets agendas and schedules of business for a Network or clinical study. In a Network, it is usually composed of investigators from each site and perhaps the NHLBI Program Director when the Network is funded as a cooperative agreement. In clinical studies, it may be composed of various members of the study leadership.

Study section - panel of experts established according to scientific disciplines or current research areas for the primary purpose of evaluating the scientific and technical merit of grant applications. Also called scientific review groups (SRGs).

Summary Statement - Official document showing the outcome of initial peer review, containing priority scores and percentiles, codes for various areas of concern (e.g., human subjects research), and a recommended budget. Summary statements generally have a short synopsis prepared by a scientific review administrator using peer reviewer critiques.

Subcontract - A contract between a primary award recipient and a subcontractor to furnish supplies or services.

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. Third party in-kind contributions may be in the form of real property, equipment, supplies and other expendable property, and the value of goods and services directly benefiting and specifically identifiable to the project or program.

Unobligated Balance - The portion of the funds authorized by an awarding agency that has not been obligated by the recipient and is determined by deducting the cumulative obligations from the cumulative funds authorized.