A-C, D-F, G-M, N-O, P-R, S-Z
Permission given to participate in a research study where the individual is not able to legally consent. Such individuals can include children and persons with diminished cognitive capacity. Assent is obtained from the individual (where possible) and consent is obtained from an individual who is legally able to do so.
A renewable permit granted by the federal government to an institution or research center to conduct clinical trials.
Something that promotes well-being. In research, a study can benefit the community, the individual participant, or both. A benefit for an individual may include access to medications that are known to be effective, or access to education materials that are known to improve learning. Payment for participation in a study is not considered a benefit of the study and often there is no guaranteed benefit for participating.
The process through which one or more parties to a clinical trial are unaware of the treatment assignments. In a single-blinded study, usually the subjects are unaware of the treatment assignments. In a double-blinded study, both the subjects and the investigators are unaware of the treatment assignments. Also, in a double-blinded study, the monitors and sometimes the data analysts are unaware. "Blinded" studies are conducted to prevent the unintentional biases that can affect subject data when treatment assignments are known.
Certificate of Confidentiality
A legal document issued by the National Institute of Health (NIH) to protect researchers and participants from legal subpoena. Researchers do not have the same legal privileges that doctors and lawyers have. Information provided to a researcher, even if told in confidence, can be subpoenaed by a court. The Certificate provides protection against compelled disclosure of identifying information about subjects of biomedical, behavioral, clinical and other research. If a research study is protected by a Certificate of Confidentiality, the consent form will include specific information about the Certificate and its implications. In some cases, the researcher may still be required to disclose information in cases such as child abuse.
Persons who have not attained the legal age for consent as determined under the applicable law of the jurisdiction in which the research will be conducted.
A systematic study designed to evaluate a product (drug, device, or biologic) using human subjects, in the treatment, prevention, or diagnosis of a disease or condition, as determined by the product's benefits relative to its risks. Clinical investigations can only be conducted with the approval of the Food and Drug Administration (FDA).
Study of drug, biologic or device in human subjects with the intent to discover potential beneficial effects and/or determine its safety and efficacy. Also called clinical study and clinical investigation. Note that in this manual, this term is used in its narrow sense as used by the FDA. Thus, it does not encompass all the research that is carried out in the clinical setting (e.g., health services research).
Clinical Research Coordinator (CRC)
Site administer for the clinical study. Duties are delegated by the investigator. Also called research, study or healthcare coordinator, and data manager, research nurse or protocol nurse.
Any investigation in human subjects intended to determine the clinical pharmacological, pharmacokinetic, and/or other pharmacodynamic effects of an investigational agent, and/or to identify any adverse reactions to an investigational agent to assess the agent's safety and efficacy.
Confederate (non-medical research only)
An individual who pretends to be one of the participants but is in fact part of the non-medical research team in a "deception study."
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 permission in ways that are inconsistent with the understanding of the original disclosure.
A document explaining all relevant study information to assist the study volunteer in understanding the expectations and requirements of participation in a clinical trial. This document is presented to and signed by the study subject.
A comparison group of study subjects who are not treated with the investigational agent. The subjects in this group may receive no therapy, a different therapy, or a placebo.
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This term is legally defined according to the institution. It generally refers to recorded information regardless of form. Most institutions hold title to data while researchers have rights to access the data.
Debrief (non-medical research only)
Giving participants of non-medical research (social, behavioral, education research) previously undisclosed information about the research project following completion of their participation. In studies involving deception, if the participants are not informed of the deception in the informed consent, the UVa IRB for Social and Behavioral Science Research (IRB-SBS) requires a signed post-debrief consent form for each participant following completion of his/her participation in the study.
Deception (non-medical research only)
Withholding particular information about the non-medical (social, behavioral, education) research project from participants until completion of their participation when prior knowledge would adversely affect the integrity of the data gathered. IRB policy states that when deception is justified in a research study, a researcher must either inform the participant of deception in the informed consent, or provide a debriefing period and post-debrief consent form following subject participation.
The design of a study in which neither the investigator or the subject knows which medication (or placebo) the subject is receiving.
As defined by the Food, Drug and Cosmetic Act, drugs are "articles (other than food) intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or to affect the structure or any function of the body of man or other animals."
The dose of an investigational agent that produces the outcome considered "effective," as defined in the study protocol. This could mean a cure of the disease in question or simply the mitigation of symptoms.
A product's ability to produce beneficial effects on the duration or course of a disease. Efficacy is measured by evaluating the clinical and statistical results of clinical tests.
An independent group of both medical and non-medical professionals who are responsible for verifying the integrity of a study and ensuring the safety, integrity, and human rights of the study participants.
Refers to the characteristics that would prevent a subject from participating in a clinical trial, as outlined in the study protocol.
Food and Drug Administration (FDA)
Within the Department of Health and Human Services. Enforces Food, Drug and Cosmetics Act and related federal public health laws. Grants IND, IDE, PMA and NDA approvals.
Food Drug and Cosmetic Act (FD & C Act )
States only drugs, biologics and devices proven safe and effective can be marketed.
A medicinal product with the same active ingredient, but not necessarily the same inactive ingredients as a brand-name drug. A generic drug may only be marketed after the original drug's patent has expired.
Good Clinical Practice (GCP)
International ethical and scientific quality standard for designing, conducting, monitoring, recording, auditing, analyzing and reporting studies. Insures that the data reported is credible and accurate, and that subject's rights and confidentiality are protected.
A patient or healthy individual participating in a research study. A living individual about whom an investigator obtains private information or data through intervention or interaction.
Information that can identify an individual including: name, birth date, social security number, address, telephone number, email address, computer id, medical record number, and so forth.
A list of criteria that must be met by all study subjects.
The voluntary verification of a participant's willingness to participate in a medical research study or in a non-medical research study, along with the appropriate documentation. This verification is requested only after complete, objective information has been given about the research study, including an explanation of the study's objectives, potential benefits, risks and inconveniences, alternative therapies available, and of the subject's rights and responsibilities in accordance with the current revision of the Declaration of Helsinki. In giving consent, subjects may not waive or appear to waive any of their legal rights, or release the investigator, the sponsor the institution or agents thereof from liability for negligence.
Location of research. Retains ultimate responsibility for human subject regulation compliance.
Institutional Review Board (IRB)
An independent group of professionals and community members designated to review and approve the research protocol, informed consent forms, study advertisements, and/or patient brochures, to ensure that the study is safe and effective for human participation. It is also the IRB's responsibility to ensure that a clinical trial adheres to the FDA's regulations.
A medical professional, usually a physician but may also be a nurse, pharmacist or other health care professional, under whose direction an investigational drug is administered or dispensed. A principal investigator is responsible for the overall conduct of the clinical trial at his/her site.
A study conducted over a long period of time.
Material Release Form (non-medical research only)
An additional consent form seeking permission to use data from the study for purpose beyond research in a non-medical study. Materials can include videos, photographs, audio tapes, art work, transcribed interviews, digital materials, etc. For example, a researcher may want to archive interviews in a library, or a professor may want to use a video recording as classroom material. Deciding to release materials to the researcher should not affect a participant’s ability to participate in a study.
An FDA program designed to monitor adverse events (AE) from drugs marketed in the U.S. Through the MedWatch program, health professionals may report AEs voluntarily to the FDA. Drug manufacturers are required to report all AEs brought to their attention.
A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Reviewing a clinical study, ensuring conduct, proper records and reports are performed as stated in the clinical protocol, standard operating procedures, GCP and by regulatory requirements.
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National Research Act
Act created by the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research in 1974 and mandated review of studies by institutional review boards and subject protection by informed consent.
National Institutes of Health (NIH)
Agency within DHHS that provides funding for research, conducts studies and funds multi-site national studies.
New Drug Application (NDA)
The compilation of all non-clinical, clinical, pharmacological, pharmacokinetic and stability information required about a drug by the FDA in order to approve the drug for marketing in the U.S.
Normal Educational Practice
Research conducted in established or commonly accepted educational setting involving instructional methods that would normally occur in a classroom. This type of study is considered “minimal risk.” Researchers are generally only required to send notification to parents about the study instead of obtaining full parent consent and child assent.
As a result of the medical experimentation conducted by Nazis during World War II, the U.S. Military Tribunal in Nuremberg in 1947 set forth a code of medical ethics for researchers conducting clinical trials. The code is designed to protect the safety and integrity of study participants.
Office for Human Research Protection (OHRP)
A federal government agency that issues Assurances and overseas compliance of regulatory guidelines by research institutions.
Written text describing what will be told to subjects when oral consent is necessary. Oral consent may be used for persons who cannot read or feel uncomfortable signing forms for cultural reasons.
A designation of the FDA to indicate a therapy developed to treat a rare disease (one which afflicts a U.S. population of less than 200,000 people). Because there are few financial incentives for drug companies to develop therapies for diseases that afflict so few people, the U.S. government offers additional incentives to drug companies (i.e. tax advantages and extended marketing exclusivity) that develop these drugs.
Drugs available for purchase without a physician's prescription.
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Parent/ Guardian Consent
Consent form provided to parents in order to allow their child to participate in a study. For children 7 and older, an assent form is also provided to the child.
Individual seeking medical care.
Monies or gifts given to participants for being in a research study. Payment is not considered to be a benefit of participation. It is also not a form of compensation in the case of injury.
Phase I Study
The first of four phases of clinical trials, Phase I studies are designed to establish the effects of a new drug in humans. These studies are usually conducted on small populations of healthy humans to specifically determine a drug's toxicity, absorption, distribution and metabolism.
Phase II Study
After the successful completion of phase I trials, a drug is then tested for safety and efficacy in a slightly larger population of individuals who are afflicted with the disease or condition for which the drug was developed.
Phase III Study
The third and last pre-approval round of testing of a drug is conducted on large populations of afflicted patients. Phase III studies usually test the new drug in comparison with the standard therapy currently being used for the disease in question. The results of these trials usually provide the information that is included in the package insert and labeling.
Phase IV Study
After a drug has been approved by the FDA, phase IV studies are conducted to compare the drug to a competitor, explore additional patient populations, or to further study any adverse events.
An inactive substance designed to resemble the drug being tested. It is used as a control to rule out any psychological effects testing may present. Most well-designed studies include a control group which is unwittingly taking a placebo.
Post-Debrief Consent (non-medical research only)
Consent form provided to participants in a non-medical deception study. Information that was withheld from participants at the beginning of a deception study is revealed in the debriefing period after the data is collected. Participants have the option to not allow the researcher to use their data after they learn the true nature of the study.
A detailed plan that sets forth the objectives, study design, and methodology for a clinical trial. A study protocol must be approved by an IRB before investigational drugs may be administered to humans.
Study participants are usually assigned to groups in such a way that each participant has an equal chance of being assigned to each treatment (or control) group. Since randomization ensures that no specific criteria are used to assign any patients to a particular group, all the groups will be equally comparable.
Act of enrolling subjects with the proper inclusion criteria.
Systematic investigation designed to develop or contribute to generalizable knowledge. Includes Clinical Research.
Investigator, subinvestigator and clinical research coordinator involved with study.
The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant, depending on the specific study.
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Individual, company, institution or organization taking responsibility for initiation, management and financing of study.
The currently accepted treatment or intervention considered to be effective in the treatment of a specific disease or condition.
Participant in a study. See "Human Subject."
Free of coercion, duress, or undue influence. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.
Group/individual that cannot give informed consent because of limited autonomy (e.g., children, mentally ill and prisoners). Also refers to subjects who may be unduly influenced to participate (e.g., students, subordinates and patients).
Freedom to leave a study at any time, without penalty or punishment. Withdrawing from a study should not affect a patient's ability to receive medical care, employment status, student status, etc.
Subject's physical and mental soundness.
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