NOHSP Definitions - D

A glossary of terms and concepts found in the Nemours HSP policies and procedures. References and resources are located in the policy noted by HSP### after each definition.

D

DSMB / DMC: Data Safety Monitoring Board or Data Monitoring Committee:A committee of qualified individuals charged with periodic review of study data and adverse event reports in order to assure that the safety of study participants is appropriately protected. A DSMB / DMC is appropriate in a study of sufficient duration to provide meaningful statistical output. (HSP#022)

Deception: A designed component of a research plan in which the investigator intentionally tells something untrue (not the truth)(a lie) to the participant. (HSP#053)

De-identified: Removal of personal identifiers associated with Protected Health Information in compliance with HIPAA Privacy regulations and Nemours Policy (5.6.3 HIPAA Research Use and Disclosure Policy )

Delivery: Complete separation of the fetus from the woman by expulsion or extraction or any other means. (HSP#070)

Department of Health & Human Services: The principal agency for protecting the health of all Americans. Comprising 12 operating divisions, HHS responsibilities include public health, biomedical research, HIPAA, Medicare and Medicaid, welfare, social services, and more. The DHHS regulations for the protection of human research subjects, Title 45, Part 46 of the Code of Federal Regulations (CFR), are referred to as the “Common Rule”. (HSP#043)

Deviation: See Protocol Deviation

Device: See Medical Device.

Dissent: A decision not to participate in the research. Anything other than an affirmative agreement must be interpreted as dissent. (HSP#033)

Direct benefit: See: Prospect of direct benefit

Disorder or condition: Generally, the concept of disorder or condition relates to a specific characteristic that describes a group of children, such as a physical or social condition affecting children or the risk of certain children developing a disease in the future based on diagnostic testing or physical examination. For example:

Prematurity, infancy, adolescence, poverty, living in a compromised physical environment, institutionalization, or having a genetic predisposition to future illness. (HSP#027)

Dispensing Drugs/Biologics: This occurs when a supply of drug/biologic that is not patient-specific or that requires manipulation (counting, mixing, preparing, etc.) is given to a specific patient. Examples of dispensing include: (a) selecting a quantity of drug from a general bulk supply and placing it in another container for a patient, and (b) reconstituting a drug with a quantity of water before giving it to the patient. (HSP-076) See: Drug Adminstration.

Drug Administration: A drug (or biologic) is distributed when it is given to the patient in a pre-labeled container with specific patient identification (patients name or patient- specific identification code), and does not require manipulation (counting, mixing, preparing, etc.) before giving it to the patient. (HSP-076) See: Dispensing Drugs/Biologics.