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.
R01 - Standard NIH Investigator Initiated Research
Project Grant
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.
|