Glossary | Human Research Protections

Case Report Form (CRF):

A printed, optical, or electronic (eCRF) document designed to capture all protocol-required information for a study.

Case Report or Case Study:

A case report is one in which three or fewer records are accessed. Case reports do not meet the definition for human subjects research and do not require oversight by the IRB if the project meets the following criteria (note: An IRB determination of NHSR is required, however):

Nothing was done to the patient(s) with prior research intent.
The case report does not contain elements of a systematic investigation (e.g. statistical methods).
The case report describes an interesting treatment, presentation or outcome.
The published article will not contain any identifiable information or authorization has been obtained.

Case-Control Study:

A study comparing persons with a given condition or disease (the cases) and persons without the condition or disease (the controls) with respect to antecedent factors

CAT Scan:

Abbreviation for Computerized Axial Tomography, an X-ray technique for producing images of internal bodily structures through the assistance of a computer.

CDC:

Centers for Disease Control and Prevention; an agency within the Public Health Service, Department of Health and Human Services.

Cell Lines:

A cell-line refers to a collection of a participant's white blood cells that are kept alive, usually stored in a freezer. Researchers are able to study these cells repeatedly for many years.

Certificate of Confidentiality (CoC):

A document issued by the NIH that provides additional protection of data from legal subpoena. The Certificate provides protection against compelled disclosure of identifying information or other identifying characteristics of a research participant enrolled in biomedical, behavioral, clinical, and other forms of sensitive research.

Children:

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.

Class I, II, III Devices:

Classification by the Food and Drug Administration of medical devices according to potential risks or hazards.

Classified Research:

Research sponsored by a Federal government entity that involves restrictions imposed, by agreement or otherwise, on the distribution or publication of the research findings, or results for a specified period or for an indefinite duration following completion of the research.

Clinical Investigation (FDA Definition):

Any experiment that involves a test article and one or more human subjects and is subject to requirements for submission to the Food and Drug Administration. Clinical investigations must not be initiated unless that investigation has been reviewed and approved by an IRB.

Clinical Research (NIH Definition):

The NIH defines clinical research as:

Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: (a) mechanisms of human disease, (b) therapeutic interventions, (c) clinical trials, or (d) development of new technologies.
Epidemiologic and behavioral studies.
Outcomes research and health.

Clinical Research or Study Coordinator (CRC)::

An individual that handles the administrative and day-to-day responsibilities of a clinical trial and acts as a liaison for the clinical site. This person may collect the data or review it before it is entered into a study database.

Clinical Trial:

The definition of a clinical trial according to the revised Common rule and NIH is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

The FDA definition of a clinical investigation does not encompass some studies, such as behavioral interventions and surgical procedures. The FDA regulates safety/efficacy for only some kinds of therapies and diagnostics that are related to pharmaceuticals, devices and biologics. Therefore, there are some studies that will not meet the definition of a clinical investigation according to the FDA but are still considered a clinical trial according to the revised Common Rule and the NIH.

Phase 1 Trial: Includes the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers, typically in a very small number of individuals (e.g. 20-80 people). Phase 1 trials are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses (to establish a safe dose range), and, if possible, to gain early evidence of effectiveness. The ultimate goal of Phase 1 trials is to obtain sufficient information about the drug's pharmacokinetics and pharmacological effects to permit the design of well-controlled, sufficiently valid Phase 2 studies. Other examples of Phase 1 studies include studies of drug metabolism, structure-activity relationships, and mechanisms of actions in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.
Phase 2 Trial: Includes controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred subjects.
Phase 3 Trial: Involves the administration of a new drug to a larger number of patients (e.g. several hundred - several thousand) in different clinical settings to determine its safety, efficacy, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained, and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide and adequate basis for physician labeling. An NIH-defined Phase III clinical trial is a broadly based prospective Phase III clinical investigation, usually involving several hundred or more human subjects, for the purpose of evaluating an experimental intervention in comparison with a standard or controlled 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. In Phase 3 studies, the drug is used the way it would be administered when marketed. When these studies are completed and the sponsor believes that the drug is safe and effective under specific conditions, the sponsor applies to the FDA for approval to market the drug.
Phase 4 Trial: Studies conducted after a drug has been approved by FDA, to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time. 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.

Code of Federal Regulations (CFR):

The Code of Federal Regulations is an annual codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government. The CFR is divided into 50 titles representing broad areas subject to Federal regulation. Each Title is divided into chapters that are assigned to agencies issuing regulations pertaining to that broad subject area. Each chapter is divided into parts and each part is then divided into sections -- the basic unit of the CFR. The purpose of the CFR is to present the official and complete text of agency regulations in one organized publication and to provide a comprehensive and convenient reference for all those who may need to know the text of general and permanent Federal regulations (National Archives).

Coded Data or Specimens:

Replacement of identifiable private information with a number, letter, symbol, or combination thereof (i.e., identification code) when a key to decipher the code is maintained thus linking the identification code (and coded data or specimen) to private information.

Coercion:

The act of using force or threats, whether actual, implied, perceived or indirect, to encourage an individual to participate in a research study.

Cognitively Impaired:

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 be compromised in their ability to make decisions in their best interests.

Cohort:

A group of subjects initially identified as having one or more characteristics in common who are followed over time. In social science research, this term may refer to any group of persons who are born at about the same time and share common historical or cultural experiences.

Collaborating Investigator:

An individual who is not otherwise an employee or agent of an assured institution and who is conducting collaborative research activities with a University or affiliate investigator. Collaborating investigators may be either:

"Collaborating Institutional Investigators" who are acting as an employee or agent of a non-assured institution that does not routinely conduct human subjects research or
"Collaborating Independent Investigators" who are not acting as an agent or employee of any institution.

Collaborative IRB Training Initiative (CITI):

An internet-based set of educational modules on the protection of human participants in research. It is sponsored by a consortium of IRB professionals and researchers from universities and medical schools across the country and is administered by the University of Miami (see: www.citiprogram.org).

Common Rule:

The Common Rule, which governs research with human subjects conducted or supported by 15 federal departments and agencies including EPA, establishes a comprehensive framework for the review and conduct of proposed human research to ensure that it will be performed ethically. The central requirements of the Common Rule are:

That people who participate as subjects in covered research are selected equitably and give their fully informed, fully voluntary written consent; and
That proposed research be reviewed by an independent oversight group referred to as an Institutional Review Board (IRB), and approved only if risks to subjects have been minimized and are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result.

Community Based Clinical Trial (CBCT):

A clinical trial conducted primarily through primary-care physicians rather than academic research facilities.

Community Member (a.k.a. "Non-Affiliated Member"):

A member of an Institutional Review Board who has no ties to an institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker, etc.).

Company Protocol:

A document used to define and manage the trial usually sent by the Industry Sponsor or the lead site if it is a multi-center study. Not all studies will include a protocol, but studies that involve investigational drugs; investigational devices will always have this document. The protocol describes the scientific rationale, objective(s), design, methodology, statistical considerations and organization of the planned trial. The protocol contains a precise study plan to assure safety and health of the trail subjects and to provide an exact template for trial conduct by investigators. This allows data to be combined across all investigators/sites. The format and content of clinical trial protocols sponsored by pharmaceutical, biotechnology, or medical device companies in the United States, European Union, or Japan have been standardized to follow Good Clinical Practice guidance.

Compassionate Use:

A method of providing experimental therapeutics prior to the final FDA approval. This allows treatment for sick individuals who have no other options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug, therapy or device. For more information about compassionate use, visit the FDA website

Compassionate Use of Investigational Devices:

The FDA defines "compassionate use" as the use of a test article on a human subject with a serious disease or condition for which there is no acceptable treatment available. FDA and IRB approval for compassionate use is required. The IRB will not approve an application for compassionate use until it has been approved by the FDA.

Compensation:

Payment for participation in research.

Competence (i.e. Capacity to Consent):

Denotes 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.

Compliance:

Adherence, in this case, to federal regulations, state laws, institutional policies and sponsor requirements.

Concomitant Medication:

Prescription and over-the-counter drugs and supplements a study participant has taken along with the study intervention. This information may be collected as a history item as well as during the study. Some studies may collect only those medications that may interact with the study or intervention or that may exclude an individual from participating in a study.

Confidentiality:

The maintenance of information in keeping with the investigator's agreement with the research participant regarding how the participant's involvement in research and their identifiable private information will be handled, managed, disseminated and protected from release or access by others. Confidentiality becomes part of the agreement between the researcher and the research participant, and is described in the consent documents and is detailed during the consent process.

Conflict of Interest (COI):

The real or apparent interference of one person's interests with the interests of another person, where potential bias may occur due to prior or existing personal or professional relationships. A conflict of interest occurs when individuals involved with the conduct, reporting, oversight, or review of research also have financial or other interests, from which they can benefit, depending on the results of the research.

Consent Document(s):

Commonly referred to as the "ICF" or "Informed Consent Form." These are the documents presented to a subject or parent guardian prior to beginning a study. Most studies will have this document submitted with the proposal, unless requesting a Waiver (see below). The IRB has provided a template on the web site for investigators to prepare their documents.

Adult Informed Consent: This is required when subjects are 18 years and older. This should be written to the subject using appropriate language ("you").
Parental Permission Document:This is required when subjects are 17 years and younger. This should be written to the parent/guardian using appropriate language ("your child").
Assent Document: Assent is an agreement by an individual not competent to give legally valid informed consent (e.g., a child aged 7+ or cognitively-impaired person) to participate in research. This is required for children enrolled in studies that are 7-17 years of age. If the board deems appropriate, this can be requested for younger children.

Continuing Noncompliance:

A pattern of noncompliance that, in the judgment of the IRB Chair, designee or convened Board,

Indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants and others,
Compromises the scientific integrity of a study such that important conclusions can no longer be reached,
Suggests a likelihood that noncompliance will continue without intervention, or
Involves repeated or frequent instances of minor noncompliance.

Continuing noncompliance may also include failure to respond to a request from the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance

Continuing Review:

Periodic review of a research study by an IRB to evaluate whether risks to participants remain reasonable in relation to potential benefits and to verify the study continues to meet regulatory and institutional requirements. Continuing review shall be conducted at intervals appropriate to the degree of risk but not less than once per year. (45 CFR 46.109(e); 21 CFR 56.109(f))

Contract:

An agreement that a specific research activity will be performed under the direction of an entity providing funds. Research performed under a contract is more closely controlled by the entity than research performed under a grant.

Contraindicated:

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).

Control Group:

The group of individuals in a clinical trial assigned to a comparison intervention.

Controlled Trial:

A type of clinical trial in which observations made during the trial are compared to a standard (called the control). The control may be observations from a group of participants in the same trial or observations from outside the trial (for example, from an earlier trial, called a historical control).

Convenience Sample:

Convenience sampling selects a particular group of people based on aspects of the potential participants' situation which renders them more easily accessed by the investigator or more likely to complete research participation without regard for the representativeness of the sample. Convenience sampling does not come close to sampling all of a population or a representative sample of a population. Convenience sampling may unfairly expose a population to research related risks.

Coordinating Center:

A group organized to coordinate the planning and operational aspects of a multi-center clinical trial. CCs may also be referred to as Data Coordinating Centers (DCCs) or Data Management Centers (DMCs).

Covered Entity:

Health care providers who conduct certain financial and administrative transactions electronically, such as billing and fund transfers; also, all health plans and health care clearinghouses (45 CFR 160.103). Covered Entities must comply with HIPAA regulations. Weill Cornell Medicine's Covered Entity includes Weill Cornell Medical College and New York Presbyterian.

Crossover Design:

A type of clinical trial in which each subject experiences, at different times, both the experimental and control therapy. For example, half of the subjects might be randomly assigned first to the control group and then to the experimental intervention, while the other half would have the sequence reversed.

Crossover Design:

Describes a clinical trial in which groups of participants receive two or more interventions in a particular order. For example, a two-by-two crossover design involves two groups of participants. One group receives drug A during the initial phase of the trial, followed by drug B during a later phase. The other group receives drug B during the initial phase, followed by drug A during a later phase. So during the study, participants "cross over" to the other drug. All participants receive drug A and drug B at some point during the study, but in a different order, depending on the group to which they are assigned.

Custom Device:

A device that

In order to comply with the order of an individual physician or dentist, deviates from devices generally available, or from an applicable performance standard or premarket approval requirement;
Is not generally available to, or generally used by, other physicians or dentists;
Is not generally available in finished form for purchase or for dispensing upon prescription;
Is not offered for commercial distribution through labeling or advertising; and
Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.

Cytogenetic Testing:

Cytogenetics is the study of the structure of chromosome material. When cytogenetic testing is used, typically study doctors want to know about changes in the chromosomes seen by microscope with either G-banding (conventional staining of the chromosomes) and/or fluorescent in situ hybridization (FISH). This assists study doctors in identifying chromosomal abnormalities that might affect the development of a particular condition and its treatment. In some forms of cancer, especially hematological malignancies, cytogenetics can determine which chromosomal translocations are present in the malignant cells, facilitating diagnosis and susceptibility to treatment.