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Belmont Report

The Belmont Report is a document that is part of the Federal Register that sets forth fundamental ethical principles that form the foundation for rules for all government funded research involving human subjects. There are three basic ethical principles that are particularly relevant to the protection of human participants.  They are: Respect for persons, Beneficence, and Distributive Justice.


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: (l) 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.


A type of donation or gift. Bequests and gifts are awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available.


Hospital Biomedical Engineering Unit


When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization. See Blind and Randomized Control Study.

Billing Grid

Billing Grid is the terminology that should be used instead of "UM Billing Calendar". This is the name of the calendar tab in OnCore. "Billing Grid" is also somteimes used interchangeably with "Specification" - which is the foundation calendar that Nimblify builds that CRAO imports into OnCore. The end result of CRAO's Michigan-ized calendar in OnCore is the Billing Grid


  • A biological product subject to licensure under the Public Health Service Act is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment or cure of diseases or injuries to humans. Examples include, but are not limited to, bacterial and viral vaccines, human blood and plasma and their derivatives, and certain products produced by biotechnology.
  • Any therapeutic serum, toxin, antitoxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.


  • Of or related to life or to living organisms
  • A drug derived from a biological source.

Biological product

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.  Biological products also include immunoglobulin products, monoclonal antibodies, products containing cells or microorganisms, and most proteins intended for therapeutic use.

Biomedical Research

Biomedical research employs many methods and research designs. Studies designed to evaluate the safety, effectiveness, or usefulness of an intervention include research on therapies (e.g., drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans or prenatal diagnosis through amniocentesis), and preventive measures (e.g., vaccines, diet, or fluoridated toothpaste). Research on normal human functioning and development can include studies of the human body while exercising, fasting, feeding, sleeping, or learning, or responding to such things as stress or sensory stimulation. Subjects of some biomedical studies engage in ordinary tasks while measurement of physiological and bodily functions are made. Some biomedical studies, particularly those conducted to evaluate new therapies or treatments, use such rigorous experimental methods as random assignment to treatment and control groups.


A randomized study is "Blind" if the participant is not told which arm of the study he is on. A clinical project is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. See Single Blind Study and Double Blind Study

Blinded Study Design

A study in which one party, either the investigator or participant, is unaware of what medication or study arm the participant is assigned to (Single-Blind study). A clinical study design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or another therapy (Double-Blind study). Double-blind studies are thought to produce more objective results, since the impact of expectations of the doctor and the participant about the experimental drug are minimized. Also referred to as a "masked" study.


A web-based clinical patient record system (which has been replaced by the MiChart system) that provided rapid access to patient data from a wide variety of clinical systems, including lab, radiology, medical records and others. See MiChart.

Case Report Form (CRF)

A paper or electronic questionnaire specifically used in clinical trial research. The CRF is the tool used by the sponsor of the clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.

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. See also: Retrospective Studies


An assessment made by the investigator and/or sponsor regarding the proper attribution of an adverse event. Examples: Study intervention (e.g., drug, device, or therapy); Concurrent non-research therapy; Disease progression; Other or unknown source.


Centers for Disease Control

Central Institutional Review Board (CIRB)

The CIRB is designed to help reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. A local IRB's use of the CIRB facilitated review mechanism enables an investigator to enroll patients into studies significantly faster than when employing traditional method of IRB review.

Certificate of Confidentiality (CoC)

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.

Certified Translation

A certified translation is one that has been formally verified by a licensed translator or translation company for use in official purposes. Certified translators attest that the target-language text is an accurate and complete translation of the source-language text. Certified translation of consent documents ensures that the tone, meaning and content of the translated documents remain consistent with the IRB-approved English version.


the United States Code of Federal Regulations


The IRBMED Chair, Co-Chair(s), and Vice-Chair(s) of the Board


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.


Central Institutional Review Board

Class I, II, III Devices

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

Clinical and Translational Science Award (CTSA)

Working together as a national consortium, at least 60 CTSA institutions have committed to improve human health by streamlining science, transforming training environments and improving the conduct, quality and dissemination of clinical and translational research. The CTSA program is part of the NIH.

Clinical Investigator

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.

Clinical Research Associate

Individual who manages the study protocol (i.e. consenting, IRB applications, scheduling patients, monitor visits, data entry, query resolution, etc.)

Clinical Research Calendar Review Analysis Office (CRAO)

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.

Clinical Research Nurse

Individual who manages the study protocol (i.e. consenting, IRB applications, scheduling patients, monitor visits, data entry, query resolution, etc.)

Clinical Trial

  • 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’.

Close out

A study that no longer has active subjects.


Centers for Medicare and Medicaid Services


Co-Investigator; see also Sub-I (Sub-Investigator)

Co-investigator (Co-I)

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


 Certificate of Confidentiality

Code of Federal Regulations (CFR)

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.


Direct personal identifiers have been removed (e.g., from data or specimens) and replaced with words, letters, figures, symbols, or a combination of these (not derived from or related to the personal information) for purposes of protecting the identity of the source(s), but the original identifiers are retained in such a way that they can still be traced back to the source(s).


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