Clinical Research Dictionary

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ADVERSE DRUG REACTION (ADR)AIn the preapproval clinical experience with a new medicinal product or its new usages,  Particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase ``responses to a medicinal product'' means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.
    Regarding marketed medicinal products: A response to a drug that is noxious and unintended and that occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function.
ADVERSE REACTIONA(Adverse Event.) An unwanted effect caused by the administration of drugs. Onset may be sudden or develop over time and that does not necessarily have a causal relationship with this treatment (See Side Effects).
ADVOCACY AND SUPPORT GROUPSAOrganizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.
APPLICABLE REGULATORY REQUIREMENTSAAny law(s) and regulation(s) addressing the conduct of clinical trials of investigational products of the jurisdiction where a trial is conducted.
APPROVAL (in relation to IRB or EC)AThe affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements
APPROVED DRUGSAIn the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application (See Food and Drug Administration).
ARMAAny of the treatment groups in a randomized trial. Most randomized trials have two "arms," but some have three "arms," or even more (See Randomized Trial).
AUDITAA systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOP's), good clinical practice (GCP), and the applicable regulatory requirement(s).
AUDIT REPORTAA written evaluation by the sponsor's auditor of the results of the audit.
AUDIT TRAILADocumentation that allows reconstruction of the course of events.
BASELINEB1. Information gathered at the beginning of a study from which variations found in the study are measured. 2. A known value or quantity with which an unknown is compared when measured or assessed. 3. The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values such as CD4 count are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.
BIASBWhen a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization (See Blind and Randomization).
BLINDBA randomized trial is "Blind" if the participant is not told which arm of the trial he is on. A clinical trial is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. (See Single Blind Study and Double Blind Study).
CASE REPORT FORM (CRF)CA printed, optical, or electronic document designed to record all of the protocol-required information to be reported to the sponsor on each trial subject.
CLINICALCPertaining to or founded on observation and treatment of participants, as distinguished from theoretical or basic science.
CLINICAL INVESTIGATORCA medical researcher in charge of carrying out a clinical trial's protocol.
CLINICAL TRIALCA clinical trial is a research study to answer specific questions about vaccines or new therapies or new ways of using known treatments. Clinical trials (also called medical research and research studies) 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. (See Phase I, II, III, and IV Trials).
CLINICAL TRIAL/STUDY REPORTCA written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report
COHORTCIn epidemiology, a group of individuals with some characteristics in common.
COMMUNITY-BASED CLINICAL TRIAL (CBCT)CA clinical trial conducted primarily through primary-care physicians rather than academic research facilities.
COMPARATORCAn investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.
COMPASSIONATE USECA 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.
COMPLEMENTARY AND ALTERNATIVE THERAPYCBroad range of healing philosophies, approaches, and therapies that Western (conventional) medicine does not commonly use to promote well-being or treat health conditions. Examples include acupuncture, herbs, etc. Internet Address
COMPLIANCE (in relation to trials)CAdherence to all the trial-related requirements, good clinical practice (GCP) requirements, and the applicable regulatory requirements.
CONFIDENTIALITY REGARDING TRIAL PARTICIPANTSCRefers 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.
CONTACT RESEARCH ORGANIZATION (CRO)CA person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions.
CONTRACTCA written, dated, and signed agreement between two or more involved parties that sets out any arrangements on delegation and distribution of tasks and obligations and, if appropriate, on financial matters. The protocol may serve as the basis of a contract.
CONTRAINDICATIONCA specific circumstance when the use of certain treatments could be harmful.
CONTROLCA control is the nature of the intervention control.
CONTROL GROUPCThe 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 TRIALSCControl 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.
COORDINATING INVESTIGATORCAn investigator assigned the responsibility for the coordination of investigators at different centers participating in a multicenter trial.
DATA SAFETY AND MONITORING BOARD (DSMB)DAn independent committee, composed of community representatives and clinical research experts, that reviews data while a clinical trial is in progress to ensure that participants are not exposed to undue risk. A DSMB may recommend that a trial be stopped if there are safety concerns or if the trial objectives have been achieved.
DIAGNOSTIC TRIALSDRefers to trials that are 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.
DIRECT ACCESSDPermission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsors, monitors, and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor's proprietary information.
DOCUMENTATIONDAll 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.
DOSE-RANGING STUDYDA 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.
DOUBLE-BLIND STUDYDA 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. See Blinded Study, Single-Blind Study, and Placebo.
DRUG-DRUG INTERACTIONDA 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.
DSMBDSee Data Safety and Monitoring Board.
EFFICACYE(Of a drug or treatment). The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Phase II clinical trials gauge efficacy, and Phase III trials confirm it (See Food and Drug Administration (FDA), Phase II and III Trials).
ELIGIBILITY CRITERIAESummary criteria for participant selection; includes Inclusion and Exclusion criteria. (See Inclusion/Exclusion Criteria)
EMPIRICALEBased on experimental data, not on a theory.
ENDPOINTEOverall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death.
EPIDEMIOLOGYEThe branch of medical science that deals with the study of incidence and distribution and control of a disease in a population.
ESSENTIAL DOCUMENTSEDocuments that individually and collectively permit evaluation of the conduct of a study and the quality of the data produced
ETHICAL COMMITTEEEAn independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. (See also: Institutional Review Board)
EXCLUSION/INCLUSION CRITERIAESee Inclusion/Exclusion Criteria.
EXPANDED ACCESSERefers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.
EXPERIMENTAL DRUGEA drug that is not FDA licensed for use in humans, or as a treatment for a particular condition (See Off-Label Use).
FDAFSee Food and Drug Administration.
FOOD AND DRUG ADMINISTRATION (FDA)FThe U.S. Department of Health and Human Services agency responsible for ensuring the safety and effectiveness of all drugs, biologics, vaccines, and medical devices, including those used in the diagnosis, treatment, and prevention of HIV infection, AIDS, and AIDS-related opportunistic infections. The FDA also works with the blood banking industry to safeguard the nation's blood supply. Internet address
GOOD CLINICAL PRACTICE (GCP)GA standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected
HYPOTHESISHA supposition or assumption advanced as a basis for reasoning or argument, or as a guide to experimental investigation.
IMPARTIAL WITNESSIA person, who is independent of the trial, who cannot be unfairly influenced by people involved with the trial, who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
INCLUSION/EXCLUSION CRITERIAIThe medical or social standards determining whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to reject people personally, but rather to identify appropriate participants and keep them safe.
INDISee Investigational New Drug.
INDEPENDENT DATA MONITORING COMMITTEE (IDMC)IAn independent data monitoring committee that may be established by the sponsor to assess at intervals the progress of a clinical trial, the safety data, and the critical efficacy endpoints, and to recommend to the sponsor whether to continue, modify, or stop a trial. Also named as Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee, Data Review Committee.
INFORMED CONSENTIThe process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study.
INFORMED CONSENT DOCUMENTIA document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
INSPECTIONIThe act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor's and/or contract research organization's (CRO's) facilities, or at other establishments deemed appropriate by the regulatory authority(ies).
INSTITUTIONAL REVIEW BOARD (IRB)I1. A committee of physicians, statisticians, researchers, community advocates, and others that ensures that a clinical trial is ethical and that the rights of study participants are protected. All clinical trials in the U.S. must be approved by an IRB before they begin. 2. Every institution that conducts or supports biomedical or behavioral research involving human participants must, by federal regulation, have an IRB that initially approves and periodically reviews the research in order to protect the rights of human participants.
INTENT TO TREATIAnalysis of clinical trial results that includes all data from participants in the groups to which they were randomized (See Randomization) even if they never received the treatment.
INTERIM CLINICAL TRIAL/STUDY REPORTIA report of intermediate results and their evaluation based on analyses performed during the course of a trial.
INTERVENTION NAMEIThe generic name of the precise intervention being studied.
INTERVENTIONSIPrimary interventions being studied types of interventions are Drug, Gene Transfer, Vaccine, Behavior, Device, or Procedure.
INVESTIGATIONAL NEW DRUGIA new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes.
INVESTIGATIONAL PRODUCTIA pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
INVESTIGATORIA person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal investigator
INVESTIGATOR BROCHUREIA compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects
IRBISee Institutional Review Board.
LEGALLY ACCEPTABLE REPRESENTATIVELAn individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject's participation in the clinical trial.
MASKEDMThe knowledge of intervention assignment. See Blind
MONITORINGMThe act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOP's), GCP, and the applicable regulatory requirement(s).
MONITORING REPORTMA written report from the monitor to the sponsor after each site visit and/or other trial-related communication according to the sponsor's SOP's.
MULTICENTER TRIALMA clinical trial conducted according to a single protocol but at more than one site, and, therefore, carried out by more than one investigator.
NANNNo Action Needed. Result of an FDA Audit. (Look. VOA)
NATURAL HISTORY STUDYNStudy of the natural development of something (such as an organism or a disease) over a period of time.
NEW DRUG APPLICATION (NDA)NAn application submitted by the manufacturer of a drug to the FDA - after clinical trials have been completed - for a license to market the drug for a specified indication.
OFF-LABEL USEOA drug prescribed for conditions other than those approved by the FDA.
OPEN-LABEL TRIALOA clinical trial in which doctors and participants know which drug or vaccine is being administered.
ORPHAN DRUGSOAn FDA category that refers to medications used to treat diseases and conditions that occur rarely. There is little financial incentive for the pharmaceutical industry to develop medications for these diseases or conditions. Orphan drug status, however, gives a manufacturer specific financial incentives to develop and provide such medications.
PEER REVIEWPReview of a clinical trial by experts chosen by the study sponsor. These experts review the trials for scientific merit, participant safety, and ethical considerations.
PHARMACOKINETICSPThe processes (in a living organism) of absorption, distribution, metabolism, and excretion of a drug or vaccine.
PHASE I TRIALSPInitial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
PHASE II TRIALSPControlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks.
PHASE III TRIALSPExpanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide and adequate basis for physician labeling.
PHASE IV TRIALSPPost-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use.
PLACEBOPA placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the treatment's effectiveness. (See Placebo Controlled Study).
PLACEBO CONTROLLED STUDYPA method of investigation of drugs in which an inactive substance (the placebo) is given to one group of participants, while the drug being tested is given to another group. The results obtained in the two groups are then compared to see if the investigational treatment is more effective in treating the condition.
PLACEBO EFFECTPA physical or emotional change, occurring after a substance is taken or administered, that is not the result of any special property of the substance. The change may be beneficial, reflecting the expectations of the participant and, often, the expectations of the person giving the substance.
PRECLINICALPRefers to the testing of experimental drugs in the test tube or in animals - the testing that occurs before trials in humans may be carried out.
PREVENTION TRIALSPRefers to trials to find better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vitamins, vaccines, minerals, or lifestyle changes.
PROTOCOLPA study plan on which all clinical trials are based. The plan is carefully designed to safeguard the health of the participants as well as answer specific research questions. A protocol describes what types of people may participate in the trial; the schedule of tests, procedures, medications, and dosages; and the length of the study. While in a clinical trial, participants following a protocol are seen regularly by the research staff to monitor their health and to determine the safety and effectiveness of their treatment (See Inclusion/Exclusion Criteria).
PROTOCOL AMENDMENTPA written description of a change(s) to or formal clarification of a protocol.
QUALITY ASSURANCE (QA)QAll those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with GCP and the applicable regulatory requirement(s).
QUALITY CONTROL (QC)QThe operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.
QUALITY OF LIFE TRIALS (or Supportive Care trials)QRefers to trials that explore ways to improve comfort and quality of life for individuals with a chronic illness.
RANDOMIZATIONRA method based on chance by which study participants are assigned to a treatment group. Randomization minimizes the differences among groups by equally distributing people with particular characteristics among all the trial arms. The researchers do not know which treatment is better. From what is known at the time, any one of the treatments chosen could be of benefit to the participant (See Arm).
RANDOMIZED TRIALRA study in which participants are randomly (i.e., by chance) assigned to one of two or more treatment arms of a clinical trial. Occasionally placebos are utilized. (See Arm and Placebo).
REGULATORY AUTHORITIESRBodies having the power to regulate. In the ICH GCP guideline, the expression ``Regulatory Authorities'' includes the authorities that review submitted clinical data and those that conduct inspections. These bodies are sometimes referred to as competent authorities.
RISK-BENEFIT RATIORThe risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition being treated.
SCREENING TRIALSSRefers to trials which test the best way to detect certain diseases or health conditions.
SERIOUS ADVERSE EVENT (SAE)SOR Serious Adverse Drug Reaction (Serious ADR)
    Any untoward medical occurrence that at any dose:
    - Results in death,
    - Is life-threatening,
    - Requires inpatient hospitalization or prolongation of existing
    - Results in persistent or significant disability/incapacity,
    - Is a congenital anomaly/birth defect.
SIDE EFFECTSSAny undesired actions or effects of a drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental drugs must be evaluated for both immediate and long-term side effects (See Adverse Reaction).
SINGLE-BLIND STUDYSA study in which one party, either the investigator or participant, is unaware of what medication the participant is taking; also called single-masked study. (See Blind and Double-Blind Study).
SOURCE DATASAll information in original records and certified copies of original records of clinical findings, observations, or other activities in a clinical trial necessary for the reconstruction and evaluation of the trial. Source data are contained in source documents (original records or certified copies).
SOURCE DOCUMENTSOriginal documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medico-technical departments involved in the clinical trial).
SPONSORSAn individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical trial.
SPONSOR-INVESTIGATORSAn individual who both initiates and conducts, alone or with others, a clinical trial, and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The term does not include any person other than an individual (e.g., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator
STANDARD OPERATING PROCEDURES (SOP's)SDetailed, written instructions to achieve uniformity of the performance of a specific function.
STANDARD TREATMENTSA treatment currently in wide use and approved by the FDA, considered to be effective in the treatment of a specific disease or condition.
STANDARDS OF CARESTreatment regimen or medical management based on state of the art participant care.
STATISTICAL SIGNIFICANCESThe probability that an event or difference occurred by chance alone. In clinical trials, the level of statistical significance depends on the number of participants studied and the observations made, as well as the magnitude of differences observed.
STUDY ENDPOINTSA primary or secondary outcome used to judge the effectiveness of a treatment.
STUDY TYPESThe primary investigative techniques used in an observational protocol; types are Purpose, Duration, Selection, and Timing.
SUBINVESTIGATORSAny individual member of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or to make important trial-related decisions (e.g., associates, residents, research fellows).
SUBJECT IDENTIFICATION CODESA unique identifier assigned by the investigator to each trial subject to protect the subject's identity and used in lieu of the subject's name when the investigator reports adverse events and/or other trial-related data.
TOXICITYTAn adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat.
TREATMENT INDTIND stands for Investigational New Drug application, which is part of the process to get approval from the FDA for marketing a new prescription drug in the U.S. It makes promising new drugs available to desperately ill participants as early in the drug development process as possible. Treatment INDs are made available to participants before general marketing begins, typically during Phase III studies. To be considered for a treatment IND a participant cannot be eligible to be in the definitive clinical trial.
TREATMENT TRIALSTRefers to trials which test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.
TRIAL SITETThe location(s) where trial-related activities are actually conducted.
TRIAL SUBJECT/SUBJECTTAn individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.
UNEXPECTED ADVERSE DRUG REACTIONUAn adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochure for an unapproved investigational product or package insert/summary of product characteristics for an approved product).
VOAVVoluntary or Official Action Needed. Result of an FDA Audit
VULNERABLE SUBJECTVIndividuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.