Data and Safety Monitoring Board (DSMB)A committee of scientists, physicians, statisticians, and others that collects and analyzes data during the course of a clinical trial to monitor for adverse effects and other trends (such as an indication that one treatment is significantly better than another, particularly when one arm of the trial involves a placebo control) that would warrant modification or termination of the trial or notification of participants about new information that might affect their willingness to continue in the trial.Data Use AgreementsData for a Limited Data Set must be collected according to the terms of "an agreement into which the covered entity enters with the intended recipient of a limited data set that establishes the ways in which the information in the limited data set may be used and how it will be protected." The data use agreement is the means by which a covered entity obtains satisfactory assurance that the recipient of the limited data set will use or disclose the PHI in the data set only for specific purposes. (See also: Limited Data Sets.)Dead FetusAn 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.DebriefingGiving participants previously undisclosed information about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information.)Declaration of HelsinkiA code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989. (http://www.healthscience.net/resources/declaration-of-helsinki/)Department of Health and Human Services (DHHS or USDHHS or HHS)A federal agency formerly known as the Department of Health, Education and Welfare (DHEW). (http://www.hhs.gov/)Department of Health, Education and Welfare (DHEW)A federal agency reorganized in 1980 as the Department of Health and Human Services (DHHS) and the Department of Education.Dependent VariablesThe 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 StudyAny study that is not truly experimental (e.g., quasi-experimental studies, correlational studies, record reviews, case histories, and observational studies).Device (Medical)See: Medical Device.Diagnostic (Procedure)Tests used to identify a disorder or disease in a living person.Direct Identifiers Not Allowed in Limited Data Sets (HIPAA)A limited data set is described as health information that excludes certain, listed direct identifiers (see below) but that may include city; state; ZIP Code; elements of date; and other numbers, characteristics, or codes not listed as direct identifiers. The direct identifiers listed in the Privacy Rule's limited data set provisions apply both to information about the individual and to information about the individual's relatives, employers, or household members. The following identifiers must be removed from health information if the data are to qualify as a limited data set:
(From http://privacyruleandresearch.nih.gov/pr_08.asp, "HIPAA Privacy Rule and Its Impacts on Research"Direct Identifiers That Must Be Removed for Data to be "De-Identified" (HIPAA)The following 18 identifiers must be removed for the information to be de-identified:
* See Limited Data Sets regarding these identifiers.Double-Masked DesignA study design in which neither the investigators nor the participants know the treatment group assignments of individual participants. Sometimes referred to as "double-blind."DrugAny 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.