Glossary of Terms

• Nothing was done to the patient(s) with prior research intent.
• The case report does not contain elements of a systematic investigation (e.g. statistical methods).
• The case report describes an interesting treatment, presentation or outcome.
• The published article will not contain any identifiable information or authorization has been obtained.

• Phase 1 Trial: Includes the initial introduction of an investigational new drug into humans. These studies are typically conducted with healthy volunteers. Phase 1 trials are designed to determine the metabolic and pharmacological actions of the drug in humans, the side effects associated with increasing doses (to establish a safe dose range), and, if possible, to gain early evidence of effectiveness. The ultimate goal of Phase 1 trials is to obtain sufficient information about the drug's pharmacokinetics and pharmacological effects to permit the design of well-controlled, sufficiently valid Phase 2 studies. Other examples of Phase 1 studies include studies of drug metabolism, structure-activity relationships, and mechanisms of actions in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes.
• Phase 2 Trial: Includes controlled clinical studies conducted to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the drug. These studies are typically well controlled, closely monitored, and conducted with a relatively small number of patients, usually involving no more than several hundred subjects.
• Phase 3 Trial: Involves the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, efficacy, and appropriate dosage. They are performed after preliminary evidence of effectiveness has been obtained, and are intended to gather necessary additional information about effectiveness and safety for evaluating the overall benefit-risk relationship of the drug, and to provide and adequate basis for physician labeling. In Phase 3 studies, the drug is used the way it would be administered when marketed. When these studies are completed and the sponsor believes that the drug is safe and effective under specific conditions, the sponsor applies to the FDA for approval to market the drug. Phase 3 trials usually involve several hundred to several thousand patient-subjects.
• Phase 4 Trial: Studies conducted after a drug has been approved by FDA, to delineate additional information about the drug's risks, benefits, and optimal use. These studies could include, but would not be limited to, studying different doses or schedules of administration than were used in Phase 2 studies, use of the drug in other patient populations or other stages of the disease, or use of the drug over a longer period of time.

• That people who participate as subjects in covered research are selected equitably and give their fully informed, fully voluntary written consent; and
• That proposed research be reviewed by an independent oversight group referred to as an Institutional Review Board (IRB), and approved only if risks to subjects have been minimized and are reasonable in relation to anticipated benefits, if any, to the subjects, and the importance of the knowledge that may reasonably be expected to result.

• Adult Informed Consent: This is required when subjects are 18 years and older. This should be written to the subject using appropriate language ("you").
• Parental Permission Document:This is required when subjects are 17 years and younger. This should be written to the parent/guardian using appropriate language ("your child").
• Assent Document: Assent is an agreement by an individual not competent to give legally valid informed consent (e.g., a child aged 7+ or cognitively-impaired person) to participate in research. This is required for children enrolled in studies that are 7-17 years of age. If the board deems appropriate, this can be requested for younger children.

HIPAA Terminology:

• Human subjects research subject to FDA regulation: Activities are human research subject to FDA regulations when they meet the FDA definition of "clinical investigations" and involve a "subject" as defined in FDA regulation.
  
  Under FDA regulation activities are "clinical investigations" when they involve:
  1. Use of a drug other than the use of an approved drug in the course of medical practice
  2. Use of a medical device other than the use of an approved medical device in the course of medical practice
  3. Gather data that will be submitted to or held for inspection by FDA in support of a FDA marketing permit for a food, including a dietary supplement that bears a nutrient content claim or a health claim, an infant formula, a food or color additive, a drug for human use, a medical device for human use, a biological product for human use, or an electronic product.
  In the above criteria "approved" means "approved by the FDA for marketing."
  
  Under FDA regulations, individuals are considered "subjects" when they become a participant in research, either as a recipient of the test article or as a control. If the research involves a medical device, individuals are considered "subjects" when they participate in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control.
• Human subjects research subject to DHHS regulation: Activities are human subject research subject to DHHS regulations when they meet the DHHS definition of "research and involve a "subject" as defined in DHHS regulations.
  
  Under DHHS regulations activities are "research" when they are a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
  
  Under DHHS regulations "subjects" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
  
  Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
  
  Interaction included communication or interpersonal contact between investigator and subject.
  Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

• Support a new indication for use, establish safety or efficacy of the drug, support a change in the approved route of administration (including method of assembly) or dosage level;
• Support a change in the approved patient population (e.g. pediatric vs. adults) or a population at greater/increased risk (e.g. immunocompromised, elderly, etc.);
• Support a change in the promotion/advertising/labeling/packaging of an approved drug.

• Admission, discharge, and service dates;
• Dates of birth and, if applicable, death;
• Age (including age 90 or over); and
• Five-digit zip code or any other geographic subdivision, such as state, county, city, precinct and their equivalent geocodes (except street addresses).

• establishes the permitted uses and disclosures of such information by the recipient, consistent with the purposes of research, public health, or health care operations;
• limits who can use or receive the data; and
• requires the recipient to agree not to re-identify the data or contact the individuals.

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes." (http://www.fda.gov/MedicalDevices/default.htm).

• Moderate Risk: The subject will undergo procedures that will increase their risks above those normally encountered in daily life. Equivalent term is "more than minimal risk." These can include but are not limited to clinical drug trials, device trials, genetic studies, risks that include insurability and employability.
• Minimal Risk: The subject will undergo procedures that do not appear to increase the risks above those normally encountered in daily life. These can include but are not limited to studies that involve survey, questionnaire, interview, medical records review, observation of behaviors, drawing a small amount of blood from a healthy individual, etc.
• Exempt: These studies are not usually reviewed by board members, but are reviewed by the chairman. These have been determined to fit certain federal regulations as exempt from IRB review.

• All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip code if, according to the current publicly available data from the Bureau of the Census: the geographic unit formed by combining all zip codes with the same three initial digits contains more than 20,000 people; and [t]he initial three digits of a zip code for all such geographic units containing 20,000 or fewer people is changed to 000.
• All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older;
• Voice and fax telephone numbers;
• Electronic mail addresses;
• Medical record numbers, health plan beneficiary numbers, or other health plan account numbers;
• Certificate/license numbers;
• Vehicle identifiers and serial numbers, including license plate numbers;
• Device identifiers and serial numbers
• Internet Protocol (IP) address numbers and Universal Resource Locators (URLs);
• Biometric identifiers, including finger and voice prints;
• Full face photographic images and any comparable images; and
• Any other unique identifying number, characteristic, or code.

• Unforeseen (not expected by the researcher or the research participant) given the research procedures and the subject population being studied.
• Related or probably related to participation in the research or if the event or problem probably or definitely affects the safety, rights and welfare of current participants; and
• Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic or social harm) than was previously known or recognized.