Research A to Z

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. See also: Retrospective Studies

Centers for Disease Control

Certificates of Confidentiality are issued to protect identifiable research information from forced or compelled disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in civil, criminal, administrative, legislative, or other proceedings, whether federal, state, or local. Certificates of Confidentiality protect subjects from compelled disclosure of identifying information but do not prevent the voluntary disclosure of identifying characteristics of research subjects. Researchers, therefore, are not prevented from voluntarily disclosing certain information about research subjects, such as evidence of child abuse or a subject's threatened violence to self or others. However, if a researcher intends to make such voluntary disclosures, the consent form should clearly indicate this.

the United States Code of Federal Regulations

Persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted. In Michigan, the legal age is 18 years old with some exceptions.

Classification by the FDA of medical devices according to degree of potential risks or hazards.

A clinical investigator involved in a clinical research project is responsible for ensuring that an investigation is conducted according to the signed investigator statement, the investigational plan, and applicable regulations; for protecting the rights, safety, and welfare of subjects under the investigator's care; and for the control of drugs under investigation. The qualifications must be outlined in a current resume and readily available for auditors.

The mission of CRAO is to complete analysis for all human subject research that have billable items and services to assure consistency and to allow for the appropriate adjudication of charges. CRAO supports and collaborates with researchers and study teams to produce a uniform process for the Research Billing Calendar, Budget and Enrollment. CRAO ensures the Clinical Research Billing process is utilized throughout the research continuum and ensuring that UM is compliant.

• A prospective study involving human subjects designed to answer specific questions about the effects or impact of particular biomedical or behavioral interventions; these may include drugs, treatments, surgical procedures, devices, behavioral or nutritional strategies. Clinical trials are typically conducted by investigators who have entered into an agreement with a sponsor to conduct the study. For clinical drug and device trials, investigators agree to conditions regarding the conduct of the study outlined by FDA.
• A clinical trial is a research study to answer specific questions about vaccines, new therapies or new ways of using known treatments. Clinical trials are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted clinical trials are the fastest and safest way to find treatments that work in people. Trials are in four phases: Phase I tests a new drug or treatment in a small group; Phase II expands the study to a larger group of people; Phase III expands the study to an even larger group of people; and Phase IV takes place after the drug or treatment has been licensed and marketed. (hyperlink each Phase)

Not all human subject research projects are ‘clinical trials’.

Centers for Medicare and Medicaid Services

Any individual member of the clinical trial team designated and supervised by the principal investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions. See also Investigator

The CFR is a 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.

Persuasion (i.e., of an unwilling person) to do or agree to something by using obvious or implied force or threats.

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.

a conflict of interest, and may consist of a financial conflict of interest or a conflict of commitment; it includes both actual and perceived conflicts of interest

the Federal Policy for the Protection of Human Subjects, as set forth in 45 CFR 46, subpart A, and parallel regulations promulgated by agencies such as the Food and Drug Administration (FDA)

• A method of providing experimental therapeutics prior to final FDA approval for use in humans. This procedure is used with very sick individuals who have no other treatment options. Often, case-by-case approval must be obtained from the FDA for "compassionate use" of a drug or therapy.
• Use of an investigational drug or biologic or unapproved medical device for a single subject (or small group of subjects) with a serious disease or condition, who does not meet the requirements for inclusion in a clinical investigation, and for whom no standard acceptable treatment is available. Prior FDA and IRB approval are required for compassionate use.

Note: The terms compassionate use and emergency use are not synonymous.

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. Competence may fluctuate as a function of the natural course of a mental illness, response to treatment, effects of medication, general physical health and other factors. Therefore, mental status should be reevaluated periodically. As a designation of legal status, competence or incompetence pertains to an adjudication in court proceedings that a person’s abilities are so diminished that his or her decisions or actions (e.g., writing a will) should have no legal effect. Such adjudications are often determined by inability to manage business or monetary affairs and do not necessarily reflect a person’s ability to function in other situations.

List competing protocols by entering their protocol numbers and clicking the Add button. If there are no competing protocols, check the No Competing Protocol? checkbox.