Terms and Definitions

Terms are from the NIH training web page

Adverse Event – an unwanted and unintended occurrence affecting a human participant during research. Adverse events may be unexpected or expected.

Adverse Event Report – Researcher reports of all serious adverse events, injuries, and/or deaths given to the sponsor, the IRB, the FDA, and the NIH.

Assent – Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.

Assurance – A written, binding commitment filed with a Federal agency by an institution that wishes to conduct human research. The institution promises to comply with applicable regulations governing human subject research and stipulates the procedures through which compliance will be achieved

Autonomy – Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.

Belmont Report
 – The report entitled Ethical Principles and Guidelines for the Protection of Human Participants of Research generated by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979. The ethical principles identified in this document: respect for persons, beneficence, and justice became the cornerstone of Federal regulation of protection for research participants.

Beneficence – An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do no harm; and (2) protect from harm by maximizing anticipated benefits and minimizing possible risks of harm.

Benefit – A benefit in research is a valued or desired outcome enjoyed by the participant (therapeutic benefit), or accruing to a group under study, or to their family members, or to scientific knowledge (non-therapeutic benefit).

Certification – The official notification by the institution to the supporting Department or Agency, in accordance with the requirements of 45CFR46, that a research project or activity involving human participants has been reviewed and approved by an Institutional Review Board in accordance with an approved assurance.

Child or Children – Persons who have not attained the legal age for consent to treatments or procedures involved in research under the applicable law of the jurisdiction in which the research will be conducted. Special rules and protections govern the participation of children in research.

Common Rule – The “Common Rule” refers to Federal statutes governing the protection of human subjects in research, enacted in 1991 and adopted by 17 Federal agencies. The Common Rule is set forth in the Code of Federal Regulations, 45 CFR 46, and covers all federally funded research supported by the Departments of Agriculture, Energy, Commerce, HUD, Justice, Defense, Education, Veterans Affairs, Transportation, and HHS, as well as NSF, NASA, EPA, AID, Social Security Administration, CIA, and the Consumer Product Safety Commission. The provisions are identical to the DHHS Regulations (45 CFR 46, Subpart A).

Data – Multiple facts (usually, but not necessarily, empirical) used as a basis for inference, testing, analysis, etc. or used as the basis for decision-making.

Data and Safety Monitory Board (DSMB) – An independent committee 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, that would warrant modification or termination of the trial, or notification of subjects about new information that might affect their willingness to continue in the trial. DSMBs are required by NIH for all Phase III clinical trials but may also be appropriate for Phase I and Phase II clinical trials if the studies have multiple clinical sites, are blinded (masked), or employ particularly high-risk interventions or vulnerable populations.

Data and Safety Monitory Plan – A plan with a general description of data and safety monitoring of a clinical research study. The plan is developed by the researcher, included in the protocol, and submitted to the IRB for review and approval before the study begins. An appropriate plan reflects the risks of the study, including its size and complexity

Declaration of Helsinki – Statement of ethical principles for human participation in biomedical research. The Declaration was first adopted in 1964 by the World Medical Association. The Declaration has been revised five times, most recently in 2000. Like the Nuremberg Code that preceded it, the Declaration of Helsinki makes consent a central requirement of ethical research. The Declaration initially established a distinction between the standards for therapeutic and non-therapeutic research; however, this has been eliminated in recent revisions

Department or Agency Head – The head of any Federal Department or Agency and any other officer or employee of any Department or Agency to whom authority has been delegated

Double Masked Design or “Double Blind” Design – A study design in which neither the investigators nor the subjects know the treatment group assignments of individual subjects

Embryo – The developing organism from conception or implantation until approximately the eighth week of pregnancy.

Epidemiology – A scientific discipline that studies the factors determining the causes, frequency, and distribution of diseases in a community or specified population.

Expedited Review – Review of proposed research by the IRB Chair or a designated voting member or group of voting members rather than the entire IRB.

Exclusion Criteria – The list of elements in a person’s medical history that would prevent an individual from participating in a specific clinical trial.

Expected Adverse Event – For approved and marketed drugs or devices, those adverse events described in the approved Package Insert (Label). For investigational new drugs or devices, those adverse events described in the FDA Investigator’s Brochure. In clinical research studies, information on expected adverse events is summarized in the protocol and the consent form.

Fetus – The product of conception from the end of the eighth week of pregnancy until birth or expulsion.

Food and Drug Administration (FDA) – An agency within the Department of Health and Human Services (DHHS) that monitors the manufacture, import, transport, storage, and sale of goods regulated under the Food, Drug and Cosmetics Act and related Federal public health laws.

Guardian – An individual entitled or authorized to make decisions affecting the health or medical care of another, including the ability to consent.

Human Participants (subject) – A living individual about whom an investigator conducting research obtains (1) data through intervention or interaction, or (2) identifiable private information.

Inclusion criteria – The list of elements in a person’s medical history necessary to allow an individual to participate in a specific clinical trial.

Informed Consent – A person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research. Informed consent also refers to the process of information exchange between researcher and participant prior to participation in research. The information to be conveyed to the participant is factual information, including an assessment of the risks of participation, eight specific elements required by Federal regulations, a description of the procedures that will be performed, and the persons responsible. The information conveyed by the participant to the researcher is an indication of his or her comprehension of the process, the voluntary nature of participation, and understanding of his or her rights, including the right to withdraw. The informed consent form is a written document, signed by participants in research studies prior to commencement of the study. The form is presented to and signed by the participant, who should have a chance to ask questions regarding the research prior to the commencement of the study.

Institutional Review Board (IRB) – A specially constituted review body established to protect the welfare of human participants in research. Federal law states that all institutions supported by a Department or Agency to which the Common Rule applies must establish an IRB to review and approve research involving human subjects.

IRB Approval – The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements.

Intervention – An action that produces an effect or that is intended to alter the course of a pathologic process. Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the participant or the participant’s environment performed for research purposes

Institution – Any public or private entity or Agency (including Federal, state, and other agencies); location of research.

Investigator – In clinical trials, an individual who actually conducts an investigation [21 CFR 312.3]. Any interventions (e.g., drugs) involved in the study are administered to subjects under the immediate direction of the Investigator.

Justice – An ethical principle discussed in the Belmont Report requiring fairness in the distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.

Legally Authorized Representative – An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective participant to his or her participation in the procedure(s) involved in the research.

Minor – A person who has not attained the age of majority in a particular jurisdiction.

Minimal Risk – The probability and magnitude of harm or discomfort normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons.

National Institutes of Health (NIH) – The federal government’s primary agency for advancing knowledge in biomedical and behavioral sciences in order to understand and treat human diseases. The NIH is part of the U.S. Public Health Service (PHS) within the Department of Health and Human Services.

National Research Act – The law that authorized the creation of the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research in 1974 and mandated review of research studies by institutional review boards.

Normal “Control” Volunteers – Volunteer subjects used to study normal physiology and/or behavior or who do not have the condition under study in a particular protocol. Normal volunteers may be studied for comparison with subjects who have the condition under study.

Nuremberg Code – A code of research ethics developed during the trials of Nazi war criminals following World War II. This code became the first international standard for the conduct of research and began the modern era of protection for human research participants.

Office for Human Research Protections (OHRP) – The office within the Department of Health and Human Services responsible for implementing DHHS regulations (45 CFR Part 46) governing research involving human subjects. The OHRP has oversight and educational responsibilities wherever DHHS funds are used to conduct or support research involving human participants.

Office of Human Subjects Research (OHSR) – The office with the Department of Health and Human Services charged with interpreting and overseeing implementation of the regulations for the Protection of Human Subjects for research conducted at the Intramural Research Program (IRP) of the NIH.

Parent – A person’s biological or adoptive parent. In the conduct of research, the permission of the parent is generally necessary if the potential participant is a minor.

Permission – The agreement of parent(s) or guardian(s) to the participation of their child or ward in research.

Phases of a Clinical Drug Trial – Different stages of testing drugs in humans, from first application in humans (Phase I) through limited and broad clinical tests (Phase III), to post-marketing studies (Phase IV).

Phase I Trial – A clinical trial that serves as the initial introduction of an investigational new drug into humans. Phase I trials test physiologic factors, toxicity, and appropriate dosage. A Phase I trial often enrolls only a small number of patients.

Phase II Trial –Phase II trials include 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 III Trial -Phase III trials involve the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, efficacy, and appropriate dosage. Phase III trials often enroll large numbers of people and may be conducted at many doctors’ offices, clinics, and centers nationwide.

Pregnancy – The state of a female after conception or implantation until the birth of a baby or expulsion of the fetus.

Principal Investigator (PI) – The scientist or scholar with primary responsibility for the design and conduct of a research project, including preparation of the research protocol.

Prisoner – An individual involuntarily confined or detained in a penal institution. This includes persons sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

Private Information – Information that is individually identifiable (i.e., the identity of the participant is or may readily be ascertained by the investigator) about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).

Protocol – Documentation of research objective, design, methods, statistical methods, and organization-includes amendments made to the original document. The research plan must include provisions for the adequate protection of the rights and welfare of prospective subjects and ensure that pertinent laws and regulations are observed.

Randomization – Assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics). Random assignment of subjects to conditions is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.

Recruitment – The act of selecting and enrolling research participants for a study using proper inclusion criteria.

Research – A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of 45 CFR 46, even if they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Researcher – The individual who conducts and directs the study and carries the primary responsibility for the research. The Researcher is referred to as the Principal Investigator when acting as the leader of a research team.

Respect for Persons – An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.

Risks – 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.

Risk/Benefit Analysis – An analysis of the potential risks to participants considered against the potential benefits to the individual or to the research objectives of the study.

Sponsor – An individual, company, institution, or organization that initiates and finances a research study. A sponsor is not necessarily the entity that conducts the research.

Therapy – Treatment intended and expected to alleviate a disease or disorder.

Toxicity – Having to do with poison or something harmful to the body. Toxic substances usually cause unwanted side effects to an organ system and/or to the participant’s subjective status produced by therapy. Toxicities are graded numerically, with the lowest number representing no toxicity (e.g., 0 = none) and the highest number highest representing lethal toxicity (e.g., 5 = lethal).

Unexpected Adverse Event – An adverse event not described in the Package Insert, Investigator’s Brochure, published medical literature, protocol, or informed consent document.

Universal Declaration of Human Rights – An international declaration adopted in 1948 by the United Nations as the first comprehensive agreement among nations as to the specific rights and freedoms of all human beings.

Voluntary – Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.

Vulnerable Participants/Population – Individuals or groups of subjects who, by reason of disability, illness, age, or other status exhibit diminished personal autonomy. Neither the Federal regulations nor ethical codes, including the Belmont Report, proscribe inclusion of vulnerable persons as research subjects. However, DHHS regulations mandate special justification for research involving fetuses, pregnant women, and human in vitro fertilization [45 CFR 46 Subpart B]; prisoners [45 CFR 46 Subpart C]; and children [45 CFR 46 Subpart D].

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