Definition of Terms
- Adverse Event (AE)
Any untoward occurrence in a research participant. The occurrence need not have a clear causal relationship with the individual’s participation in the research; an AE can be any unfavorable and unintended sign, symptom, event, or occurrence affecting a participant’s physical, mental, social, financial, legal, or psychological well-being. An unanticipated AE should be reported to the committee as soon as possible after it is identified.
Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. An assent is typically paired with permission from a parent or guardian, and together they comprise the informed consent to participate.
- Authorized Institutional Official
An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research.
- Belmont Report
- A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1979. View a summary of the Belmont Report. The Belmont Report principles permeate human subjects research to this day.
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 associated with a research project. Anticipated benefits may express the probability that subjects and society may benefit from the research procedures. Research may benefit the individual or society as a whole. If research will not benefit individuals, it is required to provide a reasonable likelihood of resulting in benefits to society. UNLV’s human research application requests information about the direct benefits accruing to the research participants and to society. Compensation and incentives given to participants are not considered benefit.
- Certificate of Confidentiality
This is a certificate issued by the National Institutes of Health that protects identifiable research information of a sensitive nature from forced disclosure. It is typically requested when the researcher believes his/her research objectives could not be met without this form of protection. For additional information, please see the NIH Certificates of Confidentiality website.
Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted [45 CFR 46 46.401(a)]. In Nevada, individuals younger than 18 years of age are considered children for most research situations, and informed consent then consists of the child’s assent and the parent’s permission.(See “Assent.”)
The act of forcing or compelling one to take action against one’s will. Coercion can be overt or perceived, and it can occur when the researcher is in a position of authority or power over the subject (for example, teachers over students or physicians over patients). It can also occur when incentives become so great that the participant will only participate to attain the incentive.
- Cognitively Impaired
Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
- Collaborative Research
Human subjects research projects conducted by more than one institution. Each institution is responsible for safeguarding the rights and welfare of human subjects. Arrangements for joint review, relying upon one qualified IRB, or similar arrangements are acceptable. (Please contact the ORI-HS staff if this situation occurs; they can assist with the arrangements.)
Payment for participation in research. Compensation should be appropriate for the amount of effort involved, and not excessive and thereby coercive. Compensation is NOT considered a benefit.
Technically, a legal term, used to denote capacity to act on one’s own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. (See also: Incompetence, Incapacity)
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.
- Conflict of Interest
Defined as a set of conditions in which an investigator’s judgment concerning a primary interest (e.g., subject welfare, integrity of research) could be biased by a secondary interest (e.g., personal or financial gain). See information regarding UNLV’s Conflict of Interest/Compensated Outside Services Policy.
See “Informed Consent.”
- Control (Subjects) or Controls
Subject(s) used for comparison who are not given the treatment under study or who do not have a given condition, background, or risk factor that is the object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.
- Co-Principal Investigator (Co-PI)
The other primary scholar or researcher involved in conducting the research. Co-PIs must also meet the UNLV PI eligibility requirements.
Giving subjects previously undisclosed information about the research project following completion of their participation in research.
- Declaration of Helsinki
A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised most recently in 2008.
- Descriptive Study
Any study that is not truly experimental (e.g., quasi-experimental studies, correlational studies, record reviews, case histories, and observational studies).
- Emancipated Minor
A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as marriage, procreation, or being self-supporting and not living at home. (See also “Mature Minor.”)
Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
- Exempt Review
The code of federal regulations (45 CFR 46.101(b)) identifies several categories of minimal risk research as exempt from the Federal Policy for the Protection of Research Subjects. This determination must not be made by the PI, but by the IRB or someone appointed by the IRB. For more information, see the U.S. Health and Human Services website, “Exempt Research and Research That May Undergo Expedited Review.”
- Expedited Review
The code of federal regulations (45 CFR 46.110 and 21 CFR 56.110) identifies several categories of minimal risk research that may be reviewed through an expedited review process. For more information, see the U.S. Health and Human Services website on “Guidance on Expedited Review Procedures.”
- Family Educational Rights and Privacy Act (FERPA)
This act defines the rights of students and parents concerning reviewing, amending, and disclosing educational records and requires written permission to disclose personally identifiable information from a student’s education record, except under certain circumstances such as an order of subpoena.1
- Federal Policy for the Protection of Human Subjects
The federal policy that provides regulations for the involvement of human subjects in research. The policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the policy applicable to such research. Currently, 16 federal agencies have adopted this policy, commonly referred to as “The Federal Policy,” but also known as the “Common Rule.”
- Federalwide Assurance (FWA)
A formal written, binding commitment that is submitted to the Department of Health and Human Services (DHHS) Office of Human Research Protections (OHRP) in which an institution agrees to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved. UNLV’s assurance number is FWA00002305.
- Full Board Review
Review of proposed research at a convened meeting at which a majority of the membership 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. Generally, studies that undergo full board review are studies involving greater than minimal risk, risky, or novel procedures or vulnerable populations.
An individual who is authorized under applicable state or local law to give permission on behalf of a child for general medical care. In Nevada, under NRS 159.0805, guardians may not give permission for a child to enter into a research study unless a court order has been obtained.
- Health Insurance Portability and Accountability Act (HIPAA)<sup>2</sup>
The rule which protects the privacy of individually identifiable health information. The privacy rule provides federal protections for personal health information held by covered entities and gives patients specific rights with respect to that information.
- Human Subjects
Individuals whose physiological or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations, human subjects are defined as living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.
- Federal regulations define identifiable to mean that the identity of the individual subject is or may readily be ascertained by the investigator or may be associated with the information.
This refers to a person’s mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. The term is often used as a synonym for incompetence.
A legal term meaning inability to manage one’s own affairs, and often used as a synonym for incapacity.
- 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.
- Institutional Research
Institutional research (also called internal research) is the gathering of data from or about UNLV students, faculty, and staff by university offices or organizations, with the sole intent of using the data for internal informational purposes or for required data-collection purposes. This data would not be made generalizable. Examples include surveys to improve university services or procedures; ascertain the opinions, experiences, or preferences of the university community; or to provide necessary information to characterize the university community. This kind of data gathering does not require IRB review unless respondents are queried about sensitive aspects of their own behavior. For debatable projects, investigators should submit an exclusion review form to the ORI-HS.
- Institutional Review Board (IRB)
A specially constituted, federally mandated review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. UNLV has two IRBs – Social/Behavioral and Biomedical.
The federal regulations define interaction as “communication or interpersonal contact between investigator and subject.”
The federal regulations define intervention as 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.
This refers to a researcher conducting the project. Investigators can be principal investigators or co-principal investigators. Students are always listed as student investigators.
- IRB Authorization Agreement
A formal agreement between UNLV and another FWA-holding institution that allows the one IRB to serve as the “IRB of Record” for protocols involving collaborative research between UNLV and the other institution.
- IRB of Record
A term utilized when an institution assumes the IRB responsibilities for a human subject research protocol conducted at another institution. An IRB authorization agreement signed by institutional officials at both institutions is required.
An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; those that bear the burdens of research should also receive the benefits. There must be fair and equitable selection of subjects.
- Legally Authorized Representative
A person authorized either by statute or by court appointment to make decisions on behalf of another person. In human subjects research, an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research.
- Mature Minor
Someone who has not reached adulthood (as defined by state law) but who may be treated as an adult for certain purposes (e.g., consenting to medical care). Note that a mature minor is not necessarily an emancipated minor. (See also “Emancipated Minor.”)
- Minimal Risk
A risk is minimal when 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. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. Note: The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults.
Any change to an IRB-approved study protocol, regardless of the level of review it receives initially.
- Nonaffiliated Member
A federally mandated 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., business person, attorney, or teacher).
- 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.
- Office of Human Research Protection
The office within the Department of Health and Human Services that is responsible for implementing DHHS regulations (45CFR46) governing research involving human subjects.
- Office of Research Integrity – Human Subjects (ORI-HS)
The UNLV office, formerly known as the Office for the Protection of Research Subjects (OPRS), that serves as an administrative hub for the UNLV IRB’s oversight of human subjects research.
The agreement of parent(s) to the participation of their child in research.
- Principal Investigator (PI)
The scientist or scholar with primary responsibility for the design and conduct of a research project. See UNLV’s PI Eligibility Policy for those who are eligible for automatic PI status and how to apply for PI status.
An individual involuntarily confined in a penal institution, including persons: 1) sentenced under a criminal or civil statue; 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. Note that this includes adjudicated youth.
Control over the extent, timing, and circumstances of disclosing personal information (physical, behavioral, or intellectual) with others.
- Private Information
Defined by the federal regulations to include information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. It also includes information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g., 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 the acquisition of the information to constitute research involving human subjects.
- Prospective Studies
Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.
- Protection of Pupil Rights Amendment
Applies to survey research conducted in schools and states that parents have the right to inspect surveys and questionnaires distributed within schools. This amendment also specifies that parental permission must be obtained to have minors participate in surveys that disclose certain types of sensitive information.1
The formal design or plan of an experiment or research study; 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.
A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.
- Respect for Persons
An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and persons with diminished autonomy be protected.
- Retrospective Studies
Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research. This requires IRB review, as long as it involves private information about humans.
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. Risks include immediate risks of study participation as well as risks of long-term effects.
- Secondary Data
This involves two types of data: 1) data collected by someone other than the principal investigator for a research or non-research purpose, or 2) data that was collected by the principal investigator, but when collected was not intended to be used for human subjects research. For data to be considered secondary data, the data must exist prior to the initiation of the current research study or be “on the shelf” at the time of study initiation. Principal investigators must submit and receive approval for use of secondary human subjects data prior to initiation of the project.
- Site Visit
A visit by agency officials, representatives, or consultants to the location of a research activity to assess the adequacy of IRB protection of human subjects or the capability of personnel to conduct the research.
- Subject (Human)
“Participant” is the preferred term since it more correctly portrays the participatory aspects of research. Sometimes “subject” more accurately describes the role.
Free of coercion, duress, or undue inducement or influence. Used in the research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.
- Bankert, Elizabeth A., and Robert J. Amdur. Institutional Review Board: Management and Function. Sudbury, MA: Jones and Bartlett, 2006. Print.
- “Health Information Privacy.” United States Department of Health and Human Services. Web. 17 Mar. 2011.