Research A to Z

A form of longitudinal study used in medicine and social science

Entities engaged in human subject research by virtue of subject accrual, transfer of identifiable information, and/or in exchange of something of value, such as material support (e.g., money, drugs, or identifiable specimens, co-authorship, intellectual property, or credits).

Is designed as an instrument to be used to document AEs identified through a combination of clinical and laboratory evaluation. CTCAE is NOT a tool to assist with data extraction from source documents without the direct participation and supervision of clinical investigators. AE grading and attribution require documentation by medical personnel who are directly involved in the clinical care of protocol subjects.  Each CTCAE term in the current version is a unique representation of a specific event used for medical documentation and scientific analysis and is a single MedDRA Lowest Level Term.                                  

Grade is an essential element of the Guidelines and, in general, relates to severity for the purposes of regulatory reporting to NCI as follows: Grade Description: 0: No AE (or within normal limits). 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. 2: Moderate; minimal, local, or noninvasive intervention (e.g., packing, cautery) indicated; limiting age-appropriate instrumental activities of daily living. 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. 4: Life-threatening consequences; urgent intervention indicated. 5: Death related to AE.

A severe AE, as defined by the above grading scale, is NOT the same as serious AE which is defined in Section 2.1.22 (FDA, 21 CFR 312.32; ICH E2A and ICH E6).

Payment, merchandise, class credit, or other gift or service provided to research participants or their legally authorized representatives to reimburse them for their time, effort, and/or for any out-of-pocket expenses associated with research participation. Compensation is sometimes distinguished from an incentive or inducement, which is generally thought of as a payment or other offering that is “over and above” reimbursement and intended to encourage research participation.

Proposals that are submitted for the first time or unfunded proposals that are resubmitted; either must compete for research funds. Ongoing projects must compete again if the term of the original award has expired.

In relation to research: Adherence to all relevant trial-related requirements, good clinical practice (GCP) requirements, and the applicable institutional, state and federal regulatory requirements.

Withholding of full information of the study. Misleading or omitted information might include the purpose of the research, the role of the researcher, or what procedures in the study are actually experimental. The IRB recognizes that deception or concealment may be necessary for certain types of behavioral research. Because people act differently depending on circumstances, full knowledge by the subject might bias the results in some cases.

(See: Deception and Concealment)

Treatment (e.g., surgery, drug) a subject is receiving while participating in a research study that is not the treatment under investigation; treatment the subject would be offered even if not enrolled in the research study. For example, in a comparison study of two anti-nausea drugs in cancer patients, the chemotherapy would be the "concurrent standard therapy" and the anti-nausea drugs would be the "investigational therapy."

• Pertains to 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 written permission in ways that are inconsistent with the understanding of the original disclosure. (OHRP)
• Right of privacy and of non-release of disclosed personal information. The investigator should protect subjects against invasion of privacy and loss of confidentiality. Lack of secure handling of completed personality tests, questionnaires, interview protocols or data and recorded materials augments risk and must be avoided.

• A COI occurs when an individual or organization is involved in multiple interests, one of which could possibly corrupt the motivation for an act in another. A COI can only exist if a person or testimony is entrusted with some impartiality; a modicum of trust is necessary to create it. The presence of a COI is independent from the execution of impropriety. Therefore, a COI can be discovered and voluntarily defused before any corruption occurs. A conflict could be financial and it includes both actual and perceived conflicts.
• A conflict of interest is a situation in which an employee has the opportunity to influence a University decision that could lead to financial or other personal advantage, or that involves other conflicting official obligations. A COI can also occur when the conduct of research or other sponsored activities is or has the potential to be influenced by the outside financial interests of an investigator.
• A financial interest or other opportunity for tangible personal benefit of an individual or his/her immediate family that may exert a substantial and improper influence on the individual's professional judgment in exercising any University duty or responsibility, including the review of research.

For IRBMED members, financial and non-financial interests/opportunities are evaluated.

Date that the patient signs consent (main) (device studies)

Individuals hired to give professional advice or services for a fee as long as they are not an employee of the University. Consultants do not perform a portion of the programmatic work.

Non-compliance (serious or non-serious) that has been previously reported, or a pattern of ongoing activities that indicate a lack of understanding of human subjects protection requirements that may affect research participants or the validity of the research and suggest the potential for future noncompliance without intervention. Examples of continuing non-compliance may include but are not limited to: repeated failures to provide or review progress reports resulting in lapses of IRB approval, inadequate oversight of ongoing research, or failure to respond to or resolve previous allegations or findings of noncompliance.

Disadvantageous, perhaps dangerous; a treatment that should not be used in certain individuals or conditions due to risks (e.g., a drug may be contraindicated for pregnant women and persons with high blood pressure).

In Science: Scientific control allows for comparisons of concepts. It is a part of the scientific method. Scientific control is often used in discussion of natural experiments. For instance, during drug testing, scientists will try to control two groups to keep them as identical and normal as possible, and then allow one group to try the drug. Another example might be testing plant fertilizer by giving it to only half the plants in a garden (the plants that receive no fertilizer are the control group, because they are kept normal).

In Research: 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.

Control is a standard against which experimental observations may be evaluated. In clinical trials, one group of participants is given an experimental drug, while another group (i.e., the control group) is given either a standard treatment for the disease or a placebo.

An award similar to a grant, but in which the sponsor's staff may be actively involved in proposal preparation, and anticipates having substantial involvement in research activities once the award has been made.

Research projects covered by 45 CFR 46 that involve more than one institution. In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human subjects and for complying with federal policy [45 CFR 46.114].

CPT Codes or Current Procedural Terminology Codes are the billing code numbers associated with medical procedures