C

Cadaver

The body of a deceased person.

Carcinogenicity

The ability or tendency to produce cancer. There are five categories of evidence of carcinogenic activity are used to summarize the strength of the evidence observed in each experiment: Positive results ("Clear Evidence" and "Some Evidence"); Uncertain findings ("Equivocal Evidence"); No observable effects ("No Evidence"); and Major flaws cannot be evaluated ("Inadequate Study").

CareWeb

A web-based clinical patient record that provides rapid access to patient data from a wide variety of clinical systems, including lab, radiology, medical records and others.  The CareWeb system was replaced by 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

CAT Scan

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

Cause

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.

Cell

The individual units from which tissues of the body are formed. All living organisms are composed of one or more cells.

Center for Biologics Evaluation and Research (CDER)

CBER is the Center within FDA that regulates biological products for human use under applicable federal laws, including the Public Health Service Act and the Federal Food, Drug and Cosmetic Act. CBER protects and advances the public health by ensuring that biological products are safe and effective and available to those who need them. CBER also provides the public with information to promote the safe and appropriate use of biological products.

Center for Information Technology
(CIT)

A NIH Center whose mission is to provide, coordinate, and manage information technology, and to advance computational science.

Centers for Disease Control and Prevention
(CDC)

An agency within PHS, CDC’s mission is collaborating to create the expertise, information, and tools that people and communities need to protect their health – through health promotion, prevention of disease, injury and disability, and preparedness for new health threats. CDC seeks to accomplish its mission by working with partners throughout the nation and the world to: monitor health, detect and investigate health problems, conduct research to enhance prevention, develop and advocate sound public health policies, implement prevention strategies, promote healthy behaviors, foster safe and healthful environments, and provide leadership and training.

Centers for Medicare and Medicaid Services (CMS)

The CMS is a federal agency within the DHHS that administers the Medicare program and works in partnership with state governments to administer Medicaid, the State Children's Health Insurance Program, and health insurance portability standards. In addition to these programs, CMS has other responsibilities, including the administrative simplification standards from the Health Insurance Portability and Accountability Act of 1996 (HIPAA), quality standards in long-term care facilities (more commonly referred to as nursing homes) through its survey and certification process, and clinical laboratory quality standards under the Clinical Laboratory Improvement.

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.

Chair(s)

Are the IRBMED Co-Chair(s), and Vice-Chair(s)

Characteristics (of the subject population being studied)

The traits, behaviors, symptoms, diseases, life experiences, or other qualities typically found in the persons comprising those eligible to participate in the study. Examples:

• Subjects 80-100 years old with characteristics that include a greater likelihood of death from cancer and cardiovascular disease than in people less than 80; retired from the paid work-force; brittle bones; higher rate of dementia.
• Males ages 9-15 with characteristics to include greater incidence of stitches and broken bones than males over age 25; prone to childhood diseases; likely to be computer and video game users.
• Subjects with cardiovascular disease--increased risk of death due to myocardial infarction.
• Adults 25-50 with a history of or active drug abuse--greater incidence of diseases such as hepatitis, increased rate of HIV infection, greater likelihood of unemployment, potential for death or hospitalization from drug overdose.

Children

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.

Class I, II, III Devices

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

Clinic

Facility for diagnosis and treatment of outpatients.

Clinical

• Pertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.
• Of, or relating to, or conducting in, or as if in, a clinic; involving direct observation of the patient; diagnosable by, or based upon, clinical observation.

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 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 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’.

Clinical Trials Office (CTO)

The Clinical Trials Office (CTO) serves as the centralized core facility of all clinical research trials conducted by investigators at the UM Comprehensive Cancer Center (UMCCC). This includes investigator-initiated, peer-reviewed clinical trials, NCI-CTEP approved protocols, pilot transitional institutional studies, cooperative group trials and industry sponsored trials. The CTO offers a broad range of expert services to investigators to help them facilitate the conduct of their studies according to federal regulations and GCPs.

Clinician

One qualified in the clinical practice of medicine, psychiatry or psychology.

Cloning

The process of asexually producing a group of cells (clones), all genetically identical, from a single ancestor. In recombinant DNA technology, the use of DNA manipulation procedures to produce multiple copies of a single gene or segment of DNA is referred to as cloning DNA.

Close Out

The act of completing all internal procedures and sponsor requirements to terminate or complete a research project.

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.

Code Set

The term 'code set' means any set of codes used for encoding data elements, such as tables of terms, medical concepts, medical diagnostic codes, or medical procedure codes.

Coded

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).

Coercion

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

Cognitively Impaired

A person having a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., 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 post-traumatic or 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. See the UM HRPP Operations Manual, Part 7 for details on UM policies regarding these subjects.

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.

Cohort Study

A form of longitudinal study used in medicine and social science

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, Sub-Investigator.

Collaborating Entities

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).

Common Rule

The ‘Common Rule’ is 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 FDA.

Common Terminology Criteria for Adverse Events (CTCAE)

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).

Community of Science (COS)

A web server containing information about scientific expertise, funded scientific research, and funding opportunities for research.

Community-Based Clinical Trial (CBCT)

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

Compassionate Use

• 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.

Compensation

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.

Competence

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.

Competing Proposals

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.

Complementary and Alternative Therapy

Broad range of healing philosophies, approaches, and therapies that conventional medicine does not commonly use to promote well-being or treat health conditions (e.g., acupuncture, herbs, etc.).

Compliance

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.

Comprehensive Cancer Center (CCC)

The UM Comprehensive Cancer Center is one of only 40 US centers to earn the NCI’s "Comprehensive" designation by meeting strict guidelines for:

• Extensive, interactive and innovative clinical and laboratory research;
• Participation in NCI testing of new therapies;
• Significant cancer prevention and control research;
• Provision of patient education, community service and outreach as well as training for health professionals.

The UM CCC is a founding member of the National Comprehensive Cancer Network, a consortium of 21 premiere cancer centers formed to develop national guidelines to ensure consistent, high-quality and cost-effective cancer care.

Concealment

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.

Concurrent Standard Therapy

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."

Concurrent Reporting

Reporting should occur in parallel or no later than 5 calendar days to all oversight bodies or agencies. Exceptions to this rule may be requested by submitting a study-specific reporting plan for IRB approval.

Confidential

Confidential means that the investigator can (or could) identify individuals who participated in a study, perhaps through a code. Although the identities may be recorded, data can be kept confidential if they are carefully coded, if face sheets and consent documents are separated from survey instruments, if computer sheets and other papers are properly disposed, if access to identifiable data is limited, if research staff are educated about the importance of protecting confidentiality, and if records are stored in secured locations. More elaborate procedures may be appropriate for research involving sensitive data that may involve a greater risk should confidentiality be breached, and investigators may want to seek Certificates of Confidentiality to protect such data from subpoena.
Unless federal statutes mandate this confidentiality confidential surveys that are not anonymous are not eligible for exemption using these criteria. Confidential surveys may still be eligible for exemption if any disclosure of the human subjects' responses outside the research could not possibly place them at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation.

Confidentiality

• 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.

Confidentiality Regarding Trial Participants

Refers to maintaining the confidentiality of trial participants including their personal identity and all personal medical information. The trial participants' consent to the use of records for data verification purposes should be obtained prior to the trial and assurance must be given that confidentiality will be maintained.

Conflict of Commitment

An outside activity, whether professional or non-professional, compensated or uncompensated, that interferes with successful performance of the faculty member's or other employee's duties. This is often related to the time and effort of the individual.

Conflict of Interest (COI)

• 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.

Consent

See: Informed Consent.

Consortium Agreement

Group of collaborative investigators/institutions; arrangement can be formalized with specified terms and conditions.

Consultant

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.

Continuation Project (Non-Competing)

Applicable to grants and cooperative agreements only. A project approved for multiple-year funding, although funds are typically committed only one year at a time. At the end of the initial budget period, progress on the project is assessed. If satisfactory, an award is made for the next budget period, subject to the availability of funds. Continuation projects do not compete with new project proposals and are not subjected to peer-review beyond the initial project approval.

Continuing Non-Compliance

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.

Continuing Review (CR)

DHHS Regulations, 45 CFR 46, require at Section 46.109(e) that "an IRB shall conduct continuing review …at intervals appropriate to the degree of risk, but not less than once per year…" Continuing review must be substantive and meaningful. Review by the convened IRB, with recorded vote, is required unless the research is otherwise appropriate for expedited review under Section 46.110. Also known as a Scheduled Continuing Review (SCR).

Contract

A mechanism for procurement of a product or service with specific obligations for both sponsor and recipient. Typically, a research topic and the methods for conducting the research are specified in detail by the sponsor, although some sponsors award contracts in response to unsolicited proposals. An agreement; as used here, an agreement that a specific research activity will be performed at the request, and under the direction, of the agency providing the funds. Research performed under contract is more closely controlled by the agency than research performed under a grant. Not the exact same as 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).

Contraindication

A contraindication is a condition or factor that serves as a reason to withhold a certain medical treatment. Some contraindications are absolute, meaning that there are no reasonable circumstances for undertaking a course of action. For example, children and teenagers with viral infections should not be given aspirin because of the risk of Reye's syndrome; and a person with an anaphylactic food allergy should never eat the food to which they are allergic. Other contraindications are relative, meaning that the patient is at higher risk of complications, but that these risks may be outweighed by other considerations or mitigated by other measures. For example, a pregnant woman should normally avoid getting X-rays, but the risk may be outweighed by the benefit of diagnosing (and then treating) a serious condition such as tuberculosis.

Control

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 Group

The standard by which experimental observations are evaluated. In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo. See Placebo and Standard Treatment

Controlled Trials

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.

Convened IRB Review

Review of proposed human subject research by an IRB that meets the membership requirements specified in federal regulations regarding the number, qualifications, diversity, and affiliation of its members, at which a majority of the members are present including at least one member whose primary concerns are in nonscientific areas.

Cooperative Agreement

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.

Cooperative Protocol Research Program (CPRP)

Programs involving multi-protocol, multi-site research, in which data from standardized protocols are pooled across institutions. These protocols, conducted or sponsored by DHHS, are approved and monitored by DHHS Protocol Review Committees that are recognized by OHRP as satisfactorily addressing the quality of human subject protections.

Cooperative Research Projects

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].

Copyright ©

A copyright is a set of exclusive legal rights authors have for "original works of authorship" including literary, dramatic, musical, artistic, architectural, and certain other intellectual works, both published and unpublished. Under the federal copyright act, copyright protection is secured from the time the work is created in fixed form. Copyright ensures that the owner has the exclusive right to reproduce the work, to prepare derivative works, to distribute by sale or otherwise copies of the work, to perform publicly, and to display. Registration is not a requirement for copyright protection. Copyright does not protect ideas, only the tangible work itself.

Cost Accounting Standards (CAS)

Included in OMB Circular A-21, CAS outlines government requirements for education institutions to use consistent cost accounting practices for classifying, estimating, accumulating and reporting costs for sponsored agreements.

Cost-Reimbursement Type Contract / Grant

A contract/grant for which the sponsor pays for the full costs incurred in the conduct of the work up to an agreed-upon amount.

Cost-Sharing

A term that can describe virtually any type of arrangement in which more than one party supports research, equipment acquisition, demonstration projects, programs, institutions. Example: A university receives a grant for a project estimated to have a total cost of $100,000. The sponsor agrees to pay 75% ($75,000) and the university agrees to pay 25% ($25,000). The $25,000 is the cost-sharing component.

Council on Governmental Relations (COGR)

An association of research universities whose primary function is to help develop policies and practices that fairly reflect the mutual interest and separate obligations of federal agencies and universities in federal research and training.

Cross-Over 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.

Current Procedural Terminology Codes (CPT Codes)

The CPT code set is maintained by the AMA through the CPT Editorial Panel. The CPT code set describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes. CPT coding is similar to ICD-9 coding except that it identifies the services rendered rather than the diagnosis on the claim.

Custom Device

A device that necessarily deviates from devices generally available or from an applicable performance standard or pre-market approval requirement to comply with the order of an individual physician or dentist and that is:

• Not generally available or generally used by other physicians or dentists;
• Not generally available in finished form for purchase or for dispensing upon prescription;
• Not offered for commercial distribution through labeling or advertising; and
• 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.

D

Data

When data is anonymous, they are not linked to the identity of individual subjects in any way that would make it possible to connect the information to the individual from whom it came. Anonymous data does NOT have direct identifiers like names, addresses, clinic or hospital number, Social Security Number, or insurance agency numbers. Data that is linked to subjects via a CODE are NOT anonymous. When data is confidential, there is a link between data and the individuals who provide it, but the link is obscured by coding or other procedures so that even someone who has access to the raw data cannot identify a subject without also having access to the link between the subject code and the subject's identity.

Data and Safety Monitor

An individual assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. The individual should have expertise in the relevant medical, ethical, safety and scientific issues.

Data and Safety Monitoring Board (DSMB)

An appointed independent group consisting of at least three (3) members assigned to conduct interim monitoring of accumulating data from research activities to assure the continuing safety of research participants, relevance of the study question, appropriateness of the study, and integrity of the accumulating data. Membership should include expertise in the relevant field of study, statistics, and research study design. Also known as a Data and Safety Monitoring Committee (DSMC).

Data and Safety Monitoring Plan (DSMP)

A defined process to protect the safety of human subjects and maintain the scientific integrity of human subject research and the validity of the data. A DSMP may be a stand-alone document or the section of a protocol that describes the steps to identify physical, social, or psychological occurrences that may result from participation in the research study and explains in detail how such occurrences will be handled and reported. A DSMP describes the timing, tools and/or method(s) for monitoring and evaluation, procedures for treatment or resolution (including circumstances which would result in halting or terminating research). It includes procedures for and timing of reports to oversight bodies, and description of oversight bodies involved with the study (e.g., study team, FDA, IRB, or DSMB). It describes the frequency with which each oversight group reviews the collected information. A study does not need to have a DSMB to have a DSMP.  The purpose of a DSMP is to minimize risks for subjects to the extent possible by explicating procedures for monitoring their safety. A DSMP would formalize action items such as:

• methodology for notifying an attending physician of emergent events
• obtaining psychiatric consults for findings of likely suicide
• procedures and education for staff regarding protection of private information
• procedures to follow when subjects experience significant social or emotional upset in response to the research interaction (e.g., a panic attack after an interview and questionnaire)

Note that data collected for safety monitoring (or for research purposes) does not necessarily have to be submitted to IRB as an adverse event report.

Data Points

Any text or numbers generated during a study.

Data Use Certification (DUC)

A DUC is the application a user submits for consideration for authorized use of controlled dbGaP data. The DUC should include a list of the controlled data set(s) required by the user and a brief description of the proposed research use of the requested data. The user must also offer the following assurances in the DUC that:

• the data will only be used for approved research;
• data confidentiality will be protected;
• all applicable laws, local institutional policies, and terms and procedures specific to the study's data access policy for handling dbGaP data will be followed;
• no attempts will be made to identify individual study participants from whom data were obtained;
• controlled-access data from dbGaP will not be sold or shared with third parties;
• the contributing investigator(s) who conducted the original study and the funding organizations involved in supporting the original study will be acknowledged in publications resulting from the analysis of those data;
• all NIH supported genotype/phenotype data and conclusions derived directly from them will remain in the public domain, without licensing requirements;
• an annual research progress report will be submitted.

The completed DUC must be co-signed by a designated official representing the institution for which the applicant works.

Database of Genotypes and Phenotypes (dbGaP)

dbGaP was developed to archive and distribute the results of studies that have investigated the interaction of genotype and phenotype. Such studies include genome-wide association studies, medical sequencing, molecular diagnostic assays, as well as association between genotype and non-clinical traits. The advent of high-throughput, cost-effective methods for genotyping and sequencing has provided powerful tools that allow for the generation of the massive amount of genotypic data required to make these analyses possible.

Dead Fetus

An expelled or delivered fetus that exhibits no heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, or pulsation of the umbilical cord (if still attached) [45 CFR 46.203(f)]. Generally, some organs, tissues, and cells (referred to collectively as fetal tissue) remain alive for varying periods of time after the total organism is dead.

Dean

Is the Dean of the Medical School

Death

Reports generally refer to the death of a research subject but also death of another (a person not enrolled in the study) that is definitely, probably, or possibly related to the study must be reported (e.g., in a study of anti-psychotic medications, the study drug is found to increase irritability and the research subject commits murder).

Debriefing (in Research)

Giving subjects previously undisclosed information about the research project following completion of their participation in research.

Deception

The intentional misleading of a subject about the nature of the study. Deception increases ethical concerns and should be used with discretion, because it interferes with the ability of the subject to give informed consent. 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.

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.  The fundamental principle is respect for the individual, their right to self-determination and the right to make informed decisions regarding participation in research, both initially and during the course of the research. The investigator's duty is solely to the patient or volunteer, and while there is always a need for research, the subject's welfare must always take precedence over the interests of science and society, and ethical considerations must always take precedence over laws and regulations. The recognition of the increased vulnerability of individuals and groups calls for special vigilance. It is recognized that when the research participant is incompetent, physically or mentally incapable of giving consent, or is a minor, then allowance should be considered for surrogate consent by an individual acting in the subject's best interest, in which case their assent should still be obtained if at all possible.

Deemed export

A release of controlled technology or source code to a foreign national, regardless of the physical location involved. An export of technology or source code (except encryption source code) is "deemed" to take place when it is released to a foreign national within the US.

Defense Advanced Research Projects Agency (DARPA)

DARPA is the central research and development organization for the Department of Defense (DoD). It manages and directs selected basic and applied research and development projects for DoD, and pursues research and technology where risk and payoff are both very high and where success may provide dramatic advances for traditional military roles and missions.

Defense Contract Audit Agency
(DCAA)

The Defense Contract Audit Agency, under the authority, direction, and control of the Under Secretary of Defense, is responsible for performing all contract audits for the Department of Defense, and providing accounting and financial advisory services regarding contracts and subcontracts to all DoD Components responsible for procurement and contract administration. These services are provided in connection with negotiation, administration, and settlement of contracts and subcontracts. DCAA also provides contract audit services to some other Government Agencies.

Deferred

An IRB action that specifies conditions under which research can be reconsidered for approval, pending substantive clarifications or modifications to the protocol and/or informed consent process/document, without which the IRB could not fully evaluate the research under review.

Deficit

The result of expenditures exceeding the project funds available.

Definitely related

An Adverse Event that is clearly related to the investigational agent(s) or research intervention: the adverse event has a temporal relationship to the administration of the investigational agent(s) or research intervention, follows a known pattern of response, and no alternative cause is present.

De-identified

All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s). For purposes of the HRPP policy, health information is de-identified when it does not contain any of the 18 identifiers specified by the HIPAA Privacy Rule at 45 CFR 164 (or has been determined to be de-identified by a statistician in accordance with the standards established by the Privacy Rule).

Delivery

The process of giving birth; complete separation of the fetus from the woman by any means.

Deoxyribonucleic Acid (DNA)

The molecule that encodes genetic information. DNA is a double-stranded molecule held together by weak bonds between base pairs of nucleotides. The four nucleotides in DNA contain the bases: adenine (A), guanine (G), cytosine (C), and thymine (T). In nature, base pairs form only between A and T and between G and C; thus the base sequence of each single strand can be deduced from that of its partner.

Department of Defense (DoD)

The mission of the DoD is to provide the military forces needed to deter war and to protect the security of our country. The Secretary of Defense is the principal defense policy advisor to the President. Under the direction of the President, the Secretary exercises authority, direction, and control over the DoD. The DoD is America's oldest and largest government agency. With their military tracing its roots back to pre-Revolutionary times, the DoD has grown and evolved with our nation. There are many additional regulations when dealing with the DoD.

Department of Health and Human Services (DHHS)

The DHHS is a department of the US government with the goal of protecting the health of all Americans and providing essential human services. Its motto is "Improving the health, safety, and well-being of America".

Department of Transportation
(DOT)

The mission of DOT is to serve the US by ensuring a fast, safe, efficient, accessible and convenient transportation system that meets our vital national interests and enhances the quality of life of the American people, today and into the future.

Dependent Variables

The outcomes that are measured in an experiment. Dependent variables are expected to change as a result of an experimental manipulation of the independent variable(s).

Descriptive Study

Any study that is not truly experimental (e.g., quasi-experimental studies, correlational studies, record reviews, case histories, and observational studies).

Design Patent

Description of a patent that relates to patent protection of new, original, and ornamental designs for articles of manufacture (for example, athletic shoe, a bicycle helmet, and the Star Wars characters).

Developmental Research

Systematic use of scientific and technical knowledge in the design, development, testing or evaluation of a potential new product or service.

Deviation

An incident involving noncompliance with the protocol, but one that does not have a significant effect on the subject's rights, safety or welfare, and/or on the integrity of the data. Deviations may result from the action of the participant, researcher, or staff.

Diagnostic (procedure)

Tests used to identify a disorder or disease in a living person.

Diagnostic Trials

Refers to trials that are conducted to find better tests or procedures for diagnosing a particular disease or condition. Diagnostic trials usually include people who have signs or symptoms of the disease or condition being studied.

Diminished Decision-Making Capacity

In informed consent: lacking the ability to provide valid informed consent to participate in research, e.g., as a result of trauma, intellectual disability, certain mental illnesses, cognitive impairment, or dementia. Diminished decision-making capacity may be temporary, permanent, progressive, or fluctuating.

Direct Costs

Clearly identifiable costs related to a specific project. General categories of direct costs include but are not limited to salaries and wages, fringe benefits, supplies, contractual services, travel and communication, equipment, and computer use.

Disability

An individual with a disability means any individual who:

• has a physical or mental impairment that substantially limits one or more of the individual’s major life activities;
• has a record of this impairment; or
• is regarding as having this impairment.

Disapproved (Decision)

An IRB action taken when the determinations required for approval of research cannot be made, even with substantive clarifications or modifications to the protocol and/or informed consent process/document.

Documentation

All records, in any form (including, but not limited to, written, electronic, magnetic, and optical records; and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.

Donation

Transfer of equipment, money, goods, services, or property with or without specifications as to its use. Sometimes donation is used to designate contributions that are made with more specific intent than is usually the case with a gift, but the two terms are often used interchangeably. Also see: Gift

Dose Limiting Toxicity (DLT)

Size-effects severe enough to prevent giving more of the treatment.

Dose-Ranging Study

A clinical trial in which two or more doses of an agent (such as a drug) are tested against each other to determine which dose works best and is least harmful.

Dosimetrist

Individual with special training in radiation safety and in the accurate determination of radiation dosages.

Double-Blind Study

A clinical trial 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 trials are thought to produce objective results, since the expectations of the doctor and the participant about the experimental drug do not affect the outcome; also called double-masked study.

Double-Masked Design

A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects. Sometimes referred to as "double-blind."

Drug

Any chemical compound that may be used on or administered to humans as an aid in the diagnosis, treatment, cure, mitigation, or prevention of disease or other abnormal conditions.

Drug Enforcement Agency (DEA)

The mission of the DEA is to enforce the controlled substances laws and regulations of the US and bring to the criminal and civil justice system of the US, or any other competent jurisdiction, those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the US; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets.

Drug Research

The scientifically designed experimental study of the action of drugs or potentially beneficial effect. Initial testing of a drug is usually performed on animals. Before research on a new drug in human beings may be conducted, the sponsor must submit an informative proposal to the FDA.

Drug-Drug Interaction

A modification of the effect of a drug when administered with another drug. The effect may be an increase or a decrease in the action of either substance, or it may be an adverse effect that is not normally associated with either drug.

Dual use

Tangible items, software, and/or technology that have both a civilian and military use.