Definitions

 

The purpose is to provide definitions of the most common terms used by the Institutional Review Board (IRB) or Exempt Review Committee (ERC) at Marywood University.

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ADVERSE EVENT
Any untoward or unfavorable occurrence in a human subject, including any abnormal sign (e.g., physical exam or lab finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research; can encompass physical and/or psychological effects; occurs more often in biomedical research, but may also occur in social and behavioral research

ANONYMOUS
A status of research information where subjects' identities are not known by the investigator and/or may not be associated with the information collected

ASSENT (see also PARENTAL PERMISSION OR LAR)
An agreement by subjects who are not competent to give legally-valid informed consent (e.g., children or cognitively impaired individuals) to participate in a research study; mere failure to object by the individual should not, absent affirmative agreement, be construed as assent; those granting assent need a parent or legally authorized representative (LAR) to give informed consent

AUTONOMY
Freedom of choice and the right of an individual to determine in what activities he/she will or will not participate

BENEFITS
Valued or desired outcomes that will be advantageous to the subjects participating, and/or to the field of study; compensation or other incentives cannot be considered benefits for subjects to weigh against risks when deciding whether or not to participate

CERTIFICATE OF CONFIDENTIALITY
Covering health research only, a document which allows investigators to refuse to disclose names or other identifying characteristics of subjects in response to legal demands, such as court orders and subpoenas; issued by the National Institutes of Health and other Department of Health and Human Services (HHS) agencies to researchers to help protect the privacy of human subjects enrolled in sensitive projects; federal funding is not a prerequisite. See NIH’s COC page.

CODE OF FEDERAL REGULATIONS
The codification of the general and permanent rules and regulations (administrative law) published in the Federal Register by the departments and agencies of the federal government of the United States. It is divided into 50 titles that represent broad areas subject to Federal regulation.

COERCION
Overt or implicit threat of harm intentionally presented by one person to another in order to obtain compliance

COMMON RULE (45 CFR 46, SUBPART A)
The federal regulations governing the protection of human subjects in research; adopted by eighteen federal departments and agencies which require institutions that receive their support to comply with these regulations

COMPENSATION (or INCENTIVE)
Payment (e.g., money) or gifts given to subjects for participation in research, such as for travel or time; may also refer to money or medical treatment provided to subjects injured by the research; cannot be considered as a benefit for subjects to weigh against risks when deciding whether or not to participate

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CONFIDENTIAL
Privacy of human subjects and efforts to control access to information related to their participation in order to protect their privacy; subjects’ names are known to the investigator and are usually coded to a master list and/or kept separately from the data and results (e.g., when pre and post surveys are matched or test results matched to surveys); an investigator must have a need to know subjects' names

CONTINUING REVIEW
A review which is conducted after a project has received initial review and approval by the Institutional Review Board (IRB) or Exempt Review Committee and until it is completed or terminated; for research covered by regulations, must be conducted at intervals appropriate to the degree of risk to human subjects, but not less than once per year

DATA
Information that is collected for analysis or used to reason or make a decision

DEBRIEFING
A part of the informed consent process where the investigator provides subjects with previously undisclosed information (e.g., research employing deception or incomplete disclosure) about the research project following completion of their participation

DECEPTION
An intentional misleading of others through misrepresentation or falsehood, which may happen when an investigator provides research subjects with false information in order to obtain unbiased results

DEVIATION
An unintentional change to or noncompliance with an approved research protocol that does not have a significant effect on the subject's rights, safety or welfare, and/or on the integrity of the data; may result from the action of the subject, investigator, or research staff; examples include incomplete study visits, failure to collect certain measures (e.g., questionnaire, baseline weight, etc.).

DIETARY SUPPLEMENT (NUTRITIONAL SUPPLEMENT)
A product taken by mouth that contains a "dietary ingredient" intended to supplement the diet; under FDA regulations, some dietary supplements are considered drugs, depending on the purpose of use

EXCLUSION CRITERIA
Those characteristics that disqualify prospective subjects from participation in a study

EXEMPT REVIEW
A classification of human subject research review which is not subject to federal human research regulations, but is still subject to state laws, institutional policies, and the requirements for ethical conduct of research;  required review which is conducted by trained individuals as part of, or as assigned by, the Exempt Review Committee (ERC); a research study's activities must fall entirely within one or more of six federal categories for exemption and must also not place subjects at greater than minimal risk or involve a population prohibited from exemption

EXPEDITED REVIEW
A classification of human subject research review permitted by the federal regulations at 45 CFR 46.110 for certain types of non-exempt research involving no more than minimal risk, or for minor changes in approved research; performed outside of a convened monthly meeting of the Institutional Review Board (IRB) by one member of the IRB and professional staff

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FEDERALWIDE ASSURANCE (FWA)
A formal, written, and binding commitment that is submitted to a federal agency, in which an institution promises to comply with applicable regulations governing research with human subjects and stipulates the procedures through which compliance will be achieved

FULL REVIEW
A classification of human subject research review required in the Code of Federal Regulations at 45 CFR 46, 21 CFR 50 and 21 CFR 56 and performed at a convened monthly meeting of the Institutional Review Board (IRB) for research posing greater than minimal risk to subjects, clinical investigations regulated by the FDA, or for research involving any activities which are not allowed under an expedited process or exemption

GENERALIZABLE KNOWLEDGE
Information contributing to a theoretical framework of an established body of facts and experiences, with the expectation that it may be broadly applied to a larger population beyond the site of data collection or the population studied; results intended to be replicated in other settings

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA)
United States legislation, signed into law in August 1996, which provides data privacy and security provisions for safeguarding individually identifiable health information for both the living and the deceased; applies to organizations that are considered HIPAA-covered entities, including health plans, healthcare clearinghouses and healthcare providers

HUMAN SUBJECT (or PARTICIPANT)
A living individual about whom an investigator (whether professional or student) conducting research obtains:

  • Data through intervention or interaction with the individual, or
  • Identifiable private information

IDENTIFIABLE
The recognition of a particular person, which may readily be ascertained by the investigator or others, or associated with the information gathered during research

If subjects' identities are inseparable from data, then data is directly identifiable. If they are kept separate from data, with information connecting them maintained by codes or a master list, then data is indirectly identifiable. In both situations, the investigator must assure that confidentiality will be maintained, and explain how subjects' identities will be protected. Research data or records with direct identifiers removed, but which retain indirect identifiers, are still considered identifiable.

INCENTIVE (or COMPENSATION)
Payment (e.g., money) or gifts given to subjects for participation in research, such as for travel or time; cannot be considered as a benefit for subjects to weigh against risks when deciding whether or not to participate

INCLUSION CRITERIA
Those characteristics that prospective subjects must have if they are to be included in a study

INCOMPLETE DISCLOSURE
Occurs when an investigator withholds information about the specific purpose or nature of the research, usually to prevent bias in results

INFORMED CONSENT (see also PARENTAL PERMISSION)
A process by which a knowing, legally effective agreement to participate in research is made by any individual or the individual's legally authorized representative; may be obtained only under circumstances that provide the prospective subject or representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence

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INTERPRETER (see also TRANSLATOR)
An agent of the investigator who assists in the facilitation of communication between the investigator and subjects who are not fluent in the language of the investigator(s), and who performs such communications live in real time

INSTITUTIONAL REVIEW BOARD (IRB)
An administrative body established in response to the National Research Act of 1974 to protect the rights and welfare of human subjects recruited to participate in biomedical or behavioral research

INTENTIONALLY IDENTIFIED
Subjects' names are identified in connection with the data when the research results are presented to the public; common for journalistic-type interview studies, where subjects are public figures or in oral histories; in such cases, the investigator should seek explicit consent from the subjects for the use of their names in connection with their data

INTERACTION
Actions, including communication or interpersonal contact, between an investigator and subject; may take place in person or remotely (e.g., Internet surveys)

INTERVENTION
Actions including both physical procedures by which data are gathered (e.g., blood draw) and manipulations of the subject or the subject's environment that are performed for research purposes

INVESTIGATIONAL NEW DRUG (IND)
A request for authorization from the FDA to administer an investigational drug or biological product to humans

INVESTIGATIONAL NEW DRUG SAFETY REPORT (also see ADVERSE EVENT)
A type of adverse event report used in clinical trial studies; required by the Food & Drug Administration (FDA) to be sent by trial sponsors to the FDA and all investigators for any serious and unexpected adverse event taking place during a trial, regardless of the location of the event; must also be reported to the IRB

INVESTIGATOR (OR RESEARCHER)
Refers to an individual performing various tasks related to the conduct of human subject research activities, such as obtaining informed consent from participants, interacting with participants, and communicating with the Institutional Review Board or Exempt Review Committee. For the purposes of the HHS regulations, the Office of Human Research Protections interprets an "investigator" to be an individual who is involved in conducting research with human subjects. Such involvement includes, but is not limited to:

  • obtaining information about living individuals by intervening or interacting with them for research purposes
  • obtaining identifiable private information about living individuals for research purposes
  • obtaining the voluntary informed consent of individuals to be participants in research
  • studying, interpreting, or analyzing identifiable private information or data for research purposes

IRB APPROVAL
The determination by the Institutional Review Board (IRB) that the research has been reviewed and may be conducted within the constraints set forth by the IRB, and other institutional, state and federal requirements

LEGALLY AUTHORIZED REPRESENTATIVE (LAR)
An individual, 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

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MINIMAL RISK
The probability and magnitude of harm or discomfort anticipated in the proposed study is 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

MINIMAL RISK FOR PRISONERS
The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons

MODIFICATIONS (AMENDMENTS)
Changes or additional information requested by the Institutional Review Board (IRB) or Exempt Review Committee (ERC) to any part of a research application or supplementary materials after review has been conducted, but before approval may be granted

NEONATE
A newborn, whether viable or non-viable          

NOT RESEARCH
A type of determination that is made by an administrator of the Institutional Review Board about a given project; the determination means:

  • It does not fit the federal definition of either research or human subject
  • No further review is required; and
  • The investigator may begin the project, assuming that the institution has not disapproved

ORAL HISTORY
A method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life [National Oral History Association], and which is biographical in nature; includes a recorded conversation about the past with named individuals in which knowledge about specific events and individual lives is narrated in story form and made available to the public through deposit in archives

PARENTAL PERMISSION (see also ASSENT)
A process by which a knowing, legally effective agreement to participate in research is made by any individual’s parent or parents; may be obtained only under circumstances that provide the parent(s) sufficient opportunity to consider whether or not to allow the child to participate and that minimize the possibility of coercion or undue influence

PERSONALLY IDENTIFIABLE HEALTH INFORMATION
Health or medical data or information that can be linked directly or inferentially to an individual

POPULATION
A group of people in society meeting certain criteria to be eligible as subjects in a research project

PRINCIPAL INVESTIGATOR (PI)
The individual with primary responsibility for the design and conduct of a research study

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PRISONER
Any individual involuntarily confined or detained in a penal institution, and encompassing individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing

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

PRIVATE INFORMATION
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 (e.g., a medical record)

PROTECTED HEALTH INFORMATION
Individually identifiable health information recorded in any form or medium that is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse and relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual

PROTOCOL
The formal design or plan of a study's activity, which includes a description of the design or methodology to be employed, the eligibility requirements and recruitment details for prospective subjects and controls, the informed consent process, the proposed methods of data analysis, and a description of records retention

PUBLICLY AVAILABLE DATA
Public sources of data, such as census data

RESEARCH
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge; a project designed to test a hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge, which  may be expressed in theories, principles, and statements of relationships

Examples of systematic investigations may include, but are not limited to:

  • surveys and questionnaires
  • interviews and focus groups
  • analyses of existing data or biological specimens
  • epidemiological studies
  • evaluations of educational or social programs
  • cognitive and perceptual experiments
  • medical chart review studies

Research activity would normally include the following:

  • Persons or programs requesting extramural (federal, state, or private) funds for research or training
  • Individual faculty members (as well as members of the staff and administration) engaged in research as part of their professional role within the University or as part of their job assignment
  • Graduate and doctoral students doing research, which is of the nature of a thesis or dissertation and is part of a degree program
  • Students performing research as part of an independent study or the honors program
  • Individuals (including students or persons from outside the University other than faculty, staff, or administration) conducting research at Marywood University

RESEARCH MISCONDUCT
Fabrication, falsification, or plagiarism that is committed while proposing, performing or reviewing research or while reporting results; does not include honest error or differences of opinion

REVISIONS
Changes requested by the Principal Investigator (PI) or funding sponsor to a project which was previously approved by the Institutional Review Board or Exempt Review Committee

RISK
The probability and magnitude of harm or injury (physical, psychological, social or economic) occurring as a result of participation in research; may vary from minimal to significant

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SIGNIFICANT RISK
A potential for serious probability of harm or injury (physical, psychological, social or economic) to the health, safety or welfare of the subjects

SECURE SOCKETS LAYER ENCRYPTION (SSL)
The standard security technology for establishing an encrypted link between a web server and a browser; ensures that all data passed between the web server and browsers remain private and integral; an industry standard used by millions of websites in the protection of online transactions with customers

SYSTEMATIC
A step-by-step, methodical procedure presented or formulated as a coherent body of ideas or principles

TRANSLATOR (see also INTERPRETER)
An agent of the investigator who assists in the facilitation of communication between the investigator and subjects who are not fluent in the language of the investigator(s), by means of translation of written documents into a written format that may be read and understood by the subjects

UNANTICIPATED PROBLEM
Any incident, experience, or outcome that meets all of the following (1) unexpected event (in terms of nature, severity, or frequency) given the described procedures and characteristics of the subject population being studied, (2) related or possibly related to participation in the research (where there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research), and (3) suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized

UNDUE INFLUENCE
An offer of excessive or inappropriate compensation or other overture in order to obtain compliance

VIOLATION
An accidental or unintentional change to or noncompliance with the IRB approved protocol that increases risk or decreases benefit and/or affects the subject's rights, safety, welfare, and/or the integrity of the data; examples include enrolling a participant who does not meet eligibility criteria; obtaining verbal consent before the initiation of study procedures when the IRB requires signed, written informed consent, etc.

VOLUNTARY
Free of coercion, duress, or undue inducement and refers to a subject's decision to participate, or to continue participation, in a research activity

WAIVER OF DOCUMENTATION OF INFORMED CONSENT
Waiver of the federal human research requirement to obtain a signature of the subject or subject’s legally authorized representative to participate in research under certain circumstances; may be appropriate for minimal risk research with telephone or Internet procedures, or where a signed document could have a negative consequence for the participants if it is the only link to participation and the primary risk is a breach of confidentiality; does not apply to FDA-regulated research except in certain emergency research

WAIVER OR ALTERATION OF INFORMED CONSENT
Waiver of the federal human research requirement to obtain informed consent in its entirety from a subject or a subject’s legally authorized representative, or alteration of an element or several elements of informed consent; allowed only if four points are met, as follows: 1) proposed research presents no more than minimal risk of harm to participants, 2) waiver or alteration of consent will not adversely affect the rights and welfare of the participants, 3) research could not practicably be carried out without the waiver or alteration, and 4) whenever appropriate, participants will be provided with additional pertinent information after participation; does not apply to FDA-regulated research except in certain emergency research

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History

07/18/2017 - Added definitions
08/31/2017 - Added definitions