Glossary of Terms

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Adverse Event/Effect (AE)

An undesirable and unintended, although possibly expected result of therapy or other intervention. A physical, psychological, or social injury to a participant in a research study.


Affiliated with the Department of State Health Services
Research that is affiliated with the Department of State Health Services (DSHS) is:
  1. Research sponsored or co-sponsored by DSHS, or
  2. Research conducted by or under the direction of any employee or agent of DSHS in connection with institutional responsibilities, or
  3. Research conducted by or under the direction of any employee or agent of DSHS using any DSHS property or facility, or
  4. Research that involves the use of DSHS nonpublic information to identify or contact human research subjects or prospective subjects.


Age of Majority
The age at which an individual has the full legal right to make all decisions for him/herself, based on state law.


Any change to a study protocol other than typographical errors. An Institutional Review Board must review amendments before the modification is implemented.


A child's affirmative agreement to participate in research. Mere failure to object should not be construed as assent.


Belmont Report

The document that serves as the basis for the Federal Regulations for protecting human research participants (45 CFR 46). Published in 1979 as a result of the Belmont Commission, this report was the culmination of a Presidential Commission established to set ethical guidelines for protecting human research subjects in federally-funded research.


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 not harm; and
  2. Protect from harm by maximizing possible benefits and minimizing possible risks of harm.


A valued or desired outcome; an advantage.


Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.


Code of Federal Regulations (45 CFR 46)
Department of Health and Human Services (DHHS) regulations for the protection of all human participants of research supported or otherwise subject to regulation by any Federal Department or Agency which takes appropriate administrative action to make the policy applicable for such research.


Common Rule
Subpart A of the Federal Regulations for protecting human research participants (45 CFR 46).


Completion of Study
The point at which all research activity, including data analysis, is over.


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 written permission in ways that are inconsistent with the understanding of the original disclosure.


Conflict of Interest
A situation that may occur when an investigator’s personal goal or role obligation conflicts with an obligation to uphold another party’s interest, thereby compromising objectivity and impartiality.


The right of persons who participate in research to know what shall or shall not happen to them. The Institutional Review Board (IRB) must judge whether three conditions are met: disclosure of information (participant has been provided full information regarding the research), comprehension (participant fully understands all ramifications of the research), and voluntariness (participant is volunteering free of coercion and undue influence).


Continuing Noncompliance
Extended noncompliance, even after the noncompliance has been addressed by the IRB. Continuing noncompliance may result in suspension of research, or termination if the level of noncompliance is at a serious level.



Data & Safety Monitoring Board
A committee of scientists, physicians, statisticians, and others that collects and analyzes data during 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 subjects about new information that might affect their willingness to continue in the trial.


Data Use Agreement
An agreement into which the covered entity enters with the intended recipient of a limited data set that establishes how the information in the limited data set may be used and how it will be protected.


Declaration of Helsinki
International doctrine, written in 1964 by the World Medical Organization, defines basic tenets of human rights in biomedical research involving human subjects.


The decision by the DSHS Institutional Review Board to postpone approval and table further discussion concerning a protocol until certain information/instruments are submitted for review.


The Department of Health & Human Services


DSHS Program Contact
A DSHS employee who is authorized to release the data needed by the requestor.



"Engage in Research"
An institution becomes engaged in human subjects research when its employees or agents (i) intervene or interact with living individuals for research purposes, or (ii) obtain individually identifiable private information for research purposes. An institution is automatically considered to be engaged in human subjects research whenever it receives a direct Health and Human Services (HHS) award to support such research. In such cases, the awardee institution bears ultimate responsibility for protecting human subjects under the award.


Ethics Advisory Board
An interdisciplinary group that advises on general policy matters and on research proposals (or classes of proposals) that pose ethical problems.


Systematic application of scientific and statistical procedures for measuring program conceptualization, design, implementation, and utility; making comparisons based on these measurements; and the use of the resulting information to optimize program outcomes.


Exemption/Exempt Research
A term used in the Federal Regulations to describe six categories of research to which the Federal Regulations do not apply.


Expedited Review
Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research. In the context of research review by an IRB, expediting does not necessarily mean quick or fast.



Federal Wide Assurance (FWA)
A document that fulfills the requirements of 45 CFR Part 46 and is approved by the Secretary of Health and Human Services. The Texas Department of State Health Services IRB's FWA# is FWA00008616 and is on file with DHHS.


Full Board Review
Review of proposed research at a convened meeting at which a majority of the members of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.



Generalizable Knowledge
The information gained from research that can be applied outside of the group involved in the research.


An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.



Injury, damage, or hurt to a participant in a research study.


HIPAA Privacy Rule and Research
The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule is the first comprehensive Federal protection for the privacy of personal health information. Research organizations and researchers may or may not be covered by the HIPAA Privacy Rule.


HIPAA Privacy Rule and Public Health
New national health information privacy standards have been issued by the U.S. Department of Health and Human Services (DHHS), according to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The new regulations protect the privacy of certain individually identifiable health data, referred to as protected health information (PHI).


Human Subjects
Human subject 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.


Human Subject Protection Education
The DSHS IRB #1 must ensure that all principal investigators maintain continuing knowledge of, and comply with, relevant Federal regulations, Office of Human Research Protections (OHRP) guidance, other applicable guidance, State and local law, and IRB determinations and policies for the protection of human subjects. The DSHS IRB #1 must have documentation of such training for the principal investigator as a condition for conducting human subject research. This requirement can be met by completing a computer-based training program, or a seminar or class on human subjects protections and regulations.



Identifiable Private Information
Data for which there is a reasonable expectation of knowing by the researcher or by some other person, either directly or indirectly, who the research participant is.


Informed Consent
A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution, or agents thereof from liability for negligence.


Harm, for human subjects' research purposes, physical harm to a participant in a research study.


Any public or private entity or Agency (including Federal, State, and other agencies).


Institutional Review Board (also IRB)
A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research.


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 includes communication or interpersonal contact between the investigator and the subject.


IRB Approval
The determination of the Institutional Review Board (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, State, and Federal requirements.



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/Legal Guardian
An individual or judicial or other body authorized under applicable State law who may act on behalf of another individual to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.


Local IRB
Institutional review board responsible for oversight of the research in the geographic proximity of where the research is to be conducted.



Minimal Risk
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.



New Submission
A protocol presented to a specific Institutional Review Board (IRB) that has not been reviewed by that IRB before.


Nonaffiliated Member
Member of an Institutional Review Board who has no ties to the parent institution, its staff, or faculty. This individual is usually from the local community (e.g., minister, business person, attorney, teacher, homemaker).


Not following the IRB-approved set procedures or the regulations outlined in 45 CFR 46.


An individual who does not hold a degree in a scientific discipline and does not practice science.


Nuremberg Code
A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.



The Office for Human Research Protections. This is an office in the Office of the Secretary of Health and Human Services that is responsible for regulatory oversight of human subject research.



A child's biological or adoptive guardian.


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


Personal Identifiers
Information obtained and recorded in such a manner that human subjects can be recognized, directly or through links to the subjects. Examples include names, social security numbers, and codes.


Primary Reviewer
Institutional Review Board member responsible for making a presentation describing the research, including any important human participants' protection issues.


Principal Investigator (PI)
The scientist or scholar with primary responsibility for the design and conduct of a research project, and the protection of the human subjects.


An individual involuntarily confined in a penal institution, including persons:
  1. Sentenced under a criminal or civil statute;
  2. Detained pending arraignment, trial, or sentencing; and
  3. Detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution.


Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.


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) for obtaining the information to constitute research involving human subjects.


For human subjects purposes used to describe the likelihood of risk (harm) to occur to a participant in a research study; must be balanced with the magnitude of the risk.


Program Evaluation
Essential organizational practice in public health using a systematic approach to improve and account for public health actions.


For human subjects' purposes, any other thing that may encompass two or more protocols on the same subject matter.


Protected/Personal Health Information (PHI)
Individually identifiable health information about an individual, including demographic information, which relates to the individual’s past, present, or future physical or mental health condition, provision of health care, or payment for the provision of health care.


The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.


Public Use Data Files
Data files prepared by investigators or data suppliers with the intent of making them available for public use. The data available to the public are not individually identified or maintained in a readily identifiable form.



For an Institutional Review Board to vote on a protocol, 50% + 1 of the members must attend. One of the attendees must be a nonscientist.



Submission of a protocol that an IRB has previously approved. The submission shows the progress of the study and can contain proposed amendments. The approval needs to be renewed at specified intervals or the study will be suspended or terminated.


Review (of Research)
The concurrent oversight of research periodically by an IRB. In addition to the at least annual reviews mandated by federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis.


Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.


Research (subject to regulation)
And similar terms are intended to encompass those research activities for which a Federal or State Department or Agency has specific responsibility for regulating as a research activity. It does not include research activities that are incidentally regulated by a Federal or State Department or Agency solely as part of the Department's or Agency's broader responsibility to regulate certain types of activities whether research or non-research in nature.


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. Federal regulations define only "minimal risk." (See also: Minimal Risk.)



Scientific Review Group/Panel
A group of highly regarded experts in a given field convened to advise on the scientific merit of application data requests. Scientific review groups are also required to review the ethical aspects of the proposed involvement of human subjects. Various kinds of scientific review groups exist and are known by different names in different institutes.


Serious Noncompliance
Noncompliance resulting in negative consequences for participants. Serious noncompliance may result in the termination of the research.


Student Investigator
An individual enrolled in a university program where a research project is required for graduation. The individual is the research project’s principal investigator.


For human subjects' purposes, a research protocol.


See Human Subjects.


Subpart A of 45 CFR 46
"Core" of the Federal Regulations for the protection of research participants; includes requirements for Assurances of Compliance, IRB composition, informed consent, etc.


Subparts B-D of 45 CFR 46
Federal Regulations where added protections can be found for selected vulnerable populations (Subpart B - pregnant women, human fetuses, and neonates; Subpart C - prisoners; Subpart D - children).


Ongoing, systematic collection, analysis, and interpretation of outcome-specific data, closely integrated with the timely dissemination of these data to those responsible for preventing and controlling disease or injury.


Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.


Interruption of research; the DSHS Institutional Review Board (IRB) has the authority to interrupt research when it is found that a previously approved research protocol is not being conducted in accordance with the IRB’s requirements or the federal regulations outlined in 45 CFR 46.



Stopping research; the DSHS IRB #1 has the authority to stop research when it is found that the research has been associated with unexpected serious harm to participants.



Unanticipated Problem
Unanticipated problems include but are not limited to, breakdowns in the consent process, violations of confidentiality of the data, complaints by research participants, adverse events, injuries, side-effects, deaths, or other problems, which were not expected and involved risk to participants or others.


Unanticipated harm to human research participants.



For human subjects' purposes, the act of freely consenting to be in a research study, 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 Population
Groups of persons who may lack the capacity to freely decide whether to participate in research due to any number of circumstances such as age, health status, etc. 45 CFR 46 identifies prisoners; children; pregnant women, and human fetuses and neonates as vulnerable populations; however, mentally handicapped, educationally and economically deprived individuals are also vulnerable populations.



Forgo the requirement of a particular rule, regulation, or condition in a protocol and/or consent document.