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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

COI

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

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 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)

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).

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.

Competing Protocols

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.

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.

Compliance Committee

the committee charged with reviewing and approving compliance matters for the Medical School and Health System

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.

(See: Deception and Concealment)

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.

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."

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 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 at Age of Majority

Conditional Field for Pediatric Studies Only: Select Yes if children should be re-consented near their 18th birthday.

Consented

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

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).

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

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].

Covered Entity

covered entity (individual, organization, or agency) is a health care provider, health plan, or health care clearinghouse regulated by HIPAA. Covered entities must comply with the HIPAA Privacy Rule to protect the privacy and security of health information.

The University of Michigan is a "hybrid" covered entity because some of its units are regulated by HIPAA

A health care provider is a person or organization — such as a doctor dentist, nurse, pharmacy, dialysis center, DME provider, hospital, clinic, nursing home or ambulatory care facility — who provides clinical care, coordination, and treatment to individuals.

CPT Codes

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

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