The grants community is diverse, and so is the terminology we use to talk about roles and aspects of the grants lifecycle. Below are terms and phrases that you may encounter during the life of your proposal — development, compliance, post-award, etc. Please keep in mind that the terminology here are specific to the grant process at Cal State Fullerton and may differ from the interpretation or meaning used in general.
An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or emotional distress following an interview about family violence).
Costs that are reasonable, necessary allocable and consistently applied. Certain types of costs (e.g., alcoholic beverages) are not allowable and may not be charged to a contract or grant.
An expense is reasonable if the purchase is necessary, allocable and appropriate in quantity and fairly prices. Occasionally a purchase which on its own may look unreasonable, may be reasonable when examined in context with its necessity.
An expense is necessary if the purchase is needed to carry out the project. Will the project be harmed if this purchase is not made? The sponsor considers all expenses specifically identified in the approved budget necessary expenses.
A cost is allocable if the goods or services involved are chargeable in accordance with benefits received, or if it is incurred solely to advance the work under the project. Costs that benefit more than one project are not allocable when it cannot be determined how much each project benefits. Allocable costs may not be shifted to other sponsored projects to meet deficits caused by overruns. Nor may those costs be shifted to avoid restrictions imposed by law of the sponsored project. Allocable funds may not be shifted for reasons of simple convenience either.
Collection of data from individuals wherein no identifiers will be linked to the participant and therefore cannot in any way be traced to the participant. “Anonymity” and “confidentiality” do not have the same meaning and are not interchangeable. Anonymous data collection means that even the researcher does not know the identity of the subjects.
Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. An assent is typically paired with a parental consent form or permission from a guardian, and together they comprise the informed consent to participate.
Aformal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved. CSUF’s Assurance No. is FWA00015384 and was approved Feb. 8, 2013.
Authorized Institutional Official
An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research. At CSUF, the Authorized Institutional Official is President Mildred Garcia.
A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.
An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
A valued or desired outcome; an advantage. CSUF's IRB application requests information about benefits as they relate to research participants.
Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted 45 CFR 46 46.401(a)].
Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also compromised in their ability to make decisions in their best interests.
Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research. (for comparison, see Remuneration.)
Technically, a legal term, used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. (see also Incompetence, Incapacity)
The treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure. Confidential data collection means that the researcher knows the identity of the subjects either directly or through the use of a master list used for coding but will not release identifying information when sharing the data with others.
Control (Subjects) or Controls
Subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.
Co-Principal Investigator (Co-PI)
The other primary scholar or researcher involved in conducting the research; if the project is for a thesis or dissertation, the student is the Co-PI.
Defined as any project cost not borne by the sponsor. Cost-sharing often comes in the form of a financial contribution made by an institution (agreed to by the dean of the college) to a project supported primarily by a grant or contract. It can come in the form of cash match or in-kind match. Cash match is an actual cash contribution. In-kind match is a non-cash contribution (e.g., the value of equipment or the value of goods and services directly benefiting the project and specifically identifiable to it). There are three types of cost sharing: mandatory cost sharing; voluntary committed cost sharing; and voluntary uncommitted cost sharing.
Mandatory Cost Sharing
Cost sharing required by a sponsor as a condition of making an award. The requirement is usually expressed in terms of a percentage of the total project cost or as a fixed dollar amount. Mandatory cost sharing must be identified and reported to the sponsor.
Voluntary Committed Cost Sharing
Cost sharing the university may offer in a proposal to make a proposal competitive or to show the resources necessary to complete a project. The offer becomes a part of the award. Voluntary committed cost sharing must be identified.
Voluntary Uncommitted Cost Sharing
N/A (contact us or check back later)
Giving subjects previously undisclosed information about the research project following completion of their participation in research. (note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information.)
Declaration of Helsinki
A code of ethics for clinical research approved by the World Medical Association in 1964, and widely adopted by medical associations in various countries. It was revised in 1975 and 1989.
Any study that is not truly experimental (e.g., quasi-experimental studies, correlational, studies, record reviews, case histories, and observational studies).
Costs that can be identified specifically with a particular project. Typical direct costs include, but are not limited to salary, travel and supplies.
Alegal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities, such as being self-supporting and not living at home, marriage or procreation.
Fair or just; used in the context of selecting subjects to indicate that the benefits and burdens of research are fairly distributed.
Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
Facilities and Administrative (F&A) Costs (also called IDC- indirect costs)
Costs incurred in conducting or supporting externally funded activities, but not directly attributable to a specific project. F&A costs include, but are not limited to general administration and sponsored programs administration.
Federal Policy (The)
The federal policy that provides regulations for the involvement of human subjects in research. The policy applies to all research involving human subjects conducted, supported or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the policy applicable to such research. Currently, 16 federal agencies have adopted the Federal Policy. (also known as the “Common Rule”)
Full Board Review
Review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.
Information obtained from research that can be applied outside of the population involved in the research (i.e., findings are analyzed and disseminated in a way so that findings may be presented as new or beneficial to groups outside of the original research study).
An individual who is authorized under applicable state or local law to give permission on behalf of a child to general medical care.
The Health Insurance Portability and Accountability Act of 1996, and the privacy regulations promulgated under the act.
Individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under federal regulations, human subjects are defined as: living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.
Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence.
A legal term meaning inability to manage one’s own affairs, and often used as a synonym for incapacity.
A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.
Institutional Review Board (IRB)
A specially constituted, federally mandated review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.
A researcher conducting the project. Investigators can be Principal Investigators or Co-Principal Investigators. Students are always Co-Principal Investigators.
Legally Authorized Representative
A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subjects research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
Memorandum of Understanding
An instrument used when two or more agencies enter into a joint project in which each agency contributes its own resources, or in which there is not exchange of goods or services between agencies.
Where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. Note: The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults.
A document that modifies any aspect of an existing award. Examples include, but are not limited to a change in PI or an approval of a carry-forward request.
An extension of the period of performance beyond the expiration date. This allows the PI time to finish the project. Usually, no additional costs are provided.
A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
Office for Protection from Research Risks (OPRR)
The office within the National Institutes of Health, an agency of the Public Health Service, Department of Health and Human Services, responsible for implementing DHHS regulations (45 CFR 46 Part 46) governing research involving human subjects. In 2000, this office was renamed the Office of Human Research Protection (OHRP).
Office of Human Research Protection (OHRP)
The new name of OPRR when it was elevated in 2000 to report to the Secretary of DHHS.
The agreement of parent(s) or guardian to the participation of their child or ward in research.
Principal Investigator (PI)
The scientist or scholar with primary responsibility for the design and conduct of a research project.
An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution. Note that this includes adjudicated youth.
Control over the extent, timing and circumstances of sharing oneself (physically, behaviorally or intellectually) with others.
Project Director/Principal Investigator
The individual(s) designated by the awarding agency to be responsible for ensuring compliance with the academic, scientific, technical, financial and administrative aspects for the day-to-day management of the sponsored project.
Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.
The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s) and the proposed methods of analysis that will be performed on the collected data.
Payment for participating in research. Remuneration should be appropriate for the amount of effort involved and not excessive and thereby coercive. Remunerations are not considered a benefit.
A systematic investigation (i.e., gathering and analyzing information) designed to develop or contribute to generalizable knowledge.
Respect for Persons
An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records or employment records) or by obtaining information about past events elicited through interviews or surveys.
Review (of Research)
Concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis.
The probability of harm or injury (physical, psychological, social or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Federal regulations define only “minimal risk” (see also: Minimal Risk).
A visit by agency officials, representatives or consultants to the location of a research activity to assess the adequacy of IRB protection of human subjects or the capability of personnel to conduct the research.
The organization that funds a project.
Sponsor Payment Types:
A cost reimbursable award indicates that the sponsor will reimburse for actual costs incurred. Any unspent funds revert to the sponsor. Since it is difficult to estimate the cost of a research project, most sponsored projects are cost reimbursable.
A fixed-price award indicates that the sponsor will provide a set amount of money, and in turn the PI agrees to accomplish project objectives within a specific timeframe. The award amount remains constant even if actual costs for the project are above or below the agreed amount. Unspent funds do not revert to the sponsor.
A document written under authority of the sponsored project, which transfers a portion of the substantive effort to another institution or organization.
Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing or similar procedures.
Types of Awards:
Provides financial support with few formal detailed stipulations as to the direction of the project and does not define a specific outcome or deliverable.
An agreement for which there are specific obligations for both the sponsor and the recipient. The sponsor has more involvement in the award and defines a specific outcome or deliverable.
An agreement by which the sponsor and grantee work together to achieve a specific objective. The sponsor has substantial involvement in the project.
Free of coercion, duress or undue inducement or influence. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.