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Human Subjects Rights Protections Glossary
Adverse event (AE): Any undesirable and unintended (although not necessarily unexpected) effect occurring as a result of interventions, interactions, or collection of identifiable private information in research.
Affiliated: IRB membership status designating association with the university. Note: A member (or alternate) is considered to be affiliated if he/she or a member of his/her immediate family is a current or past (within the last 2 years): employee (full or part-time); adjunct or visiting faculty member or instructor; paid or unpaid member of a university governing panel or board (not including the IRBs); volunteer working at the university (unrelated to IRB service); or university consultant or advisor (paid or unpaid). An emeritus faculty or retired staff member is also considered to be affiliated if he/she has been retired or involved in paid or unpaid university activities (including research or service) within the last 2 years. Current undergraduate, graduate, and postdoctoral students are also considered to be affiliated.
Allegation of noncompliance: An unconfirmed report of noncompliance.
Alternate: An individual appointed to the IRB to serve in the same capacity as the specific IRB member(s) for whom the alternate is named, who substitutes for the member at convened meetings when the member is not in attendance. Note: IRB members and alternates have equal responsibilities in terms of required education, service, and participation.
Anonymous: Unidentified (i.e., personally identifiable information was not collected, or if collected, identifiers were not retained and cannot be retrieved); information or materials (e.g., data or specimens) that cannot be linked directly or indirectly by anyone to their source(s).
Appeal: Request for reconsideration of an IRB determination in research involving human subjects, including (but not limited to) decisions regarding approval status, conditions for approval, or noncompliance. Note: An appeal is reviewed by the convened IRB responsible for the determination being appealed; for a decision made by expedited review, the corresponding convened IRB may review the appeal.
Approval Date: The first date that research can be performed (following notification from the IRB), consistent with federal regulations, state and local laws, and university policy. The approval date is the date that the research is approved by convened or expedited review, or if modifications are required (to secure approval), the date that modifications/conditions are met by the investigator. See also Approval Period.
Approval Period: For initial review, the interval that begins on the day research is approved by convened or expedited review, or if modifications are required (to secure approval), the date that modifications/conditions are met by the investigator. For continuing review, the interval that begins on the day research is re-approved (by convened or expedited review) or modifications are required. Note: An approval period for initial or continuing review may not be longer than one year.
Approved: An IRB action taken when the required determinations are made that allow research involving human subjects to proceed consistent with federal regulations, state and local laws, and university policy.
Assent: Agreement to participate in research expressed by an individual (e.g., a child) who cannot provide legally effective informed consent to participate on his/her own behalf. Note: Failure to object does not constitute assent.
Audit: A systematic review, inspection, or verification, typically conducted by an independent individual or group.
Bank: Also: repository. Collection of data and/or specimens obtained and stored for future research uses and/or distribution, including a collection not originally or primarily obtained for research purposes.
Child/Children: Person(s) 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. For purposes of IRB policy, individuals under 18 years of age are considered children in New York unless they meet the definition of emancipated minors.
CITI Program: The Collaborative Institutional Training Initiative, a program which researchers at The College at Brockport use for mandatory human subjects research training.
Coded: Direct personal identifiers have been removed (e.g., from data or specimens) and replaced with words, letters, figures, symbols, or a combination of these (not derived from or related to the personal information) for purposes of protecting the identity of the source(s); but the original identifiers are retained in such a way that they can be traced back to the source(s) by someone with the code. Note: A code is sometimes also referred to as a “key,” “link,” or “map.”
Coercion: Persuasion (i.e., of an unwilling person) to do or agree to something by using obvious or implied force or threats.
Compensation: Payment, merchandise, class credit, or other gift or service provided to research participants or their legally authorized representatives to reimburse them for their time, effort, and/or for any out-of-pocket expenses associated with research participation. Note: Compensation is sometimes distinguished from an incentive or inducement, which is generally thought of as a payment or other offering that is “over and above” reimbursement and intended to encourage research participation.
Confidentiality: In the context of human subjects research, the condition that results when data are maintained in a way that prevents inadvertent or inappropriate disclosure of participants’ identifiable information.
Conflict of Interest: A financial interest or other opportunity for tangible personal benefit of an individual or his/her immediate family that may exert a substantial and improper influence on the individual’s professional judgment in exercising any institutional duty or responsibility, including the review of research. Note: For IRB members and consultants, financial and non-financial interests/opportunities are included.
Continuing noncompliance: Noncompliance (serious or non-serious) that has been previously reported, or a pattern of ongoing activities that indicate a lack of understanding of human subjects protection requirements that may affect research participants or the validity of the research and suggest the potential for future noncompliance without intervention. Examples of continuing noncompliance may include, but are not limited to the following: repeated failures to provide or review progress reports resulting in lapses of IRB approval, inadequate oversight of ongoing research, or failure to respond to or resolve previous allegations or findings of noncompliance.
Convened IRB Review: Review of proposed human subjects research by an Institutional Review Board that meets the membership requirements specified in federal regulations regarding the number, qualifications, diversity, and affiliation of its members, at which a majority of the members are present including at least one member whose primary concerns are in nonscientific areas.
Data and Safety Monitoring: The process for reviewing data collected as research progresses to ensure the continued safety of current and future participants as well as the scientific validity and integrity of the research.
Data and Safety Monitoring Plan: The plan for reviewing research data to ensure the safety of participants and scientific validity of the research, including who will perform the monitoring, the type and frequency of review, and procedures for notifying appropriate entities (e.g., investigators, sponsor, etc.) of the results.
Deferred: An IRB action taken when the IRB cannot fully evaluate the research under review and make the determinations required for approval without modifications to the protocol and/or informed consent document, or submission of clarifications or additional materials prior to reconsideration of the research. Note: Convened IRB review of the investigator’s response(s) is required.
De-identified: All direct personal identifiers are permanently removed (e.g., from data or specimens), no code or key exists to link the information or materials to their original source(s), and the remaining information cannot reasonably be used by anyone to identify the source(s).
Diminished decision-making capacity: As it applies to informed consent, lacking the ability to provide valid informed consent to participate in research, e.g., as a result of trauma, intellectual disability, certain mental illnesses, cognitive impairment, or dementia. Note: Diminished decision-making capacity may be temporary, permanent, progressive, or fluctuating.
Directed (For-Cause) Audit/Review: An audit of research and/or investigators initiated at the request of the IRB or Institutional Official to obtain or verify information necessary to ensure compliance with regulations and institutional requirements and to inform decisions about the conduct of human subjects research and/or human subjects protection.
Disapproved: An IRB action taken when the determinations required for approval of research cannot be made, even with substantive clarifications or modifications to the protocol and/or informed consent process/document. Note: Research cannot be disapproved by expedited review.
Emancipated Minors: For purposes of IRB policy, the following persons under the legal age of 18, who because of their unique circumstances have the legal rights of adults, including the right to consent to treatments or procedures involved in research:
· Persons under the age of 18 on active duty in the military
· Married persons under 18 years of age.
Note: Pregnancy or childbirth outside of marriage does not emancipate a minor in New York.
Engaged: Involved in human subjects research in such a way (or to the extent) that the ethical and regulatory requirements for human subjects protection are applicable. An individual (or organization) becomes engaged in human subjects research when for the purposes of non-exempt research the individual (or organization’s employee or agent) obtains any of the following:
· Data about research participants through intervention or interaction
· Identifiable private information about research participants
· Informed consent of research participants.
Note: An organization is also engaged in human subjects research whenever it receives a direct federal award to support the research.
Exculpatory Language: As it applies to informed consent, any written or verbal communication through which a research participant (or his/her legally authorized representative) is asked to waive or appear to waive any of the participant’s legal rights or to release (or appear to release) the investigator, sponsor, or institution or its agents from liability for negligence.
Exempt research: Research that involves human subjects that is not subject to regulations requiring IRB review and approval. Categories of research activities that may be determined to be exempt from review by the IRB are defined by federal regulations and university policy. Note: Investigators performing exempt research must comply with the requirements of The College at Brockport IRB even when the research is exempt.
Existing: Available or “on the shelf” (e.g., data, specimens) at the time the research is submitted for a determination of whether the research is exempt.
Expedited Review: Process by which designated IRB members, on behalf of the full IRB, approve a limited class of research activities through reviews conducted outside of the convened IRB meeting.
Expiration Date: The date that the IRB’s approval of research has lapsed and research can no longer be performed. Note: An expiration date may not be longer than one year from the date the approval period begins.
External event: An event occurring in research at a site(s) other than The College at Brockport, over which another (non-College at Brockport) IRB has jurisdiction.
Family Member: For purposes of the waiver of informed consent for emergency research, any one of the following legally competent persons: spouse, parent, child (including an adopted child), brother, sister, spouse of a brother or sister, and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.
Financial Conflict of Interest: An interest of an individual (or his/her immediate family) of monetary value that would reasonably appear to be affected by the research or an individual’s interest in any entity whose financial interests would reasonably appear to be affected by the research. Note: Financial interests include (but are not limited to) salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).
Finder’s Fee: Payment made by an investigator or sponsor to an organization or individual (including non-research personnel or a research participant) for identifying and/or referring potential participants for research.
Finding of noncompliance: An occurrence or determination of noncompliance that does not require further confirmation or investigation (e.g., failure to respond to the IRB within established deadlines, allegation of noncompliance determined by the IRB to be true).
Generalizable Knowledge: Information from which one may infer a general conclusion; knowledge brought into general use or that can be applied to a wider or different range of circumstances. For example, publication and presentation are typical methods used to disseminate research findings, thereby contributing to “generalizable knowledge.” However, not all information that is published or presented represents generalizable knowledge. Generalizable knowledge is also interpreted to include data intended for general use, regardless of its eventual distribution or acceptance.
Guardian: An individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care. In New York, a guardian may be a grandparent, other family member, or other person, association, or agency other than the biological or adoptive parents who has been formally appointed as a guardian or legal representative by a court to care for a child, including to consent on behalf of a child to general medical care. Note: Grandparents or other family members who are not formally appointed as guardians or legal representatives by a court generally do not have the authority to provide consent on behalf of a child without consent by the child’s parents.
Human Subject (DHHS definition for social and behavioral research): 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.
Immediate Family: For purposes of IRB policy, an IRB member or consultant’s spouse or domestic partner and dependent children.
Individually Identifiable: The identity of the participant is or may readily be ascertained by the investigator or the investigator’s staff, or is associated with the information, including if the information contains one or more data elements that can be combined with other reasonably available information to identify an individual (e.g., Social Security number). Limited data sets released from data repositories with IRB approval to release such data sets are not considered to be individually identifiable.
Informed Consent: Agreement to participate in research expressed by an individual (or his/her legally authorized representative) authorized under applicable law to make such decisions, based on sufficient information (e.g., regarding possible risks and benefits of the research) and adequate opportunity to consider voluntary participation. Also: legally effective informed consent.
Interaction: Communication or interpersonal contact between an investigator and participant.
Internal event: An event occurring at The College at Brockport or a site under The College at Brockport's jurisdiction.
Intervention: Physical procedure by which data are gathered, or manipulation of the participant or the participant’s environment for research purposes.
IRB Authorization Agreement (IAA): A written agreement between organizations collaborating in non-exempt human subjects research that describes each organization’s responsibilities for IRB review and oversight of the research.
IRB Policies and Procedures: Policies and procedures of The College at Brockport IRB Office that apply to the conduct, review, and oversight of human subjects research and describe the roles and responsibilities of those involved in these activities.
Legally Authorized Representative: 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. For purposes of IRB policy, the following are recognized in New York as legally authorized representatives:
· Court-appointed guardians
· Next of kin in the following order: spouse, adult child, parent, and adult sibling.
Limited Data Set: Health information that excludes certain direct identifiers, but may include city, state, and ZIP code; elements of date; and other numbers, characteristics, or codes that cannot be used to identify an individual or the individual’s relatives, employers, or household members.
Minimal Risk: 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. Note: The regulatory definition of “minimal risk” for research involving prisoners differs from the definition of minimal risk for research involving participants who are not prisoners.
Minor Changes: Changes to research that in the judgment of the IRB do not affect assessment of the risks and benefits of the study by substantially altering any of the following: research aims or methodology, nature of subject participation, level of risk, proposed benefits, participant population, qualifications of the research team, or the facilities available to support the safe conduct of the research. Note: A minor change does not increase risk more than minimally or add procedures in research categories other than those that qualify for expedited initial review.
Modifications Required: An IRB action that specifies conditions under which research can be approved, pending the following: confirmation of specific understandings by the IRB about how the research will be conducted, submission of additional documentation, precise language changes to the protocol and/or informed consent document(s), and/or substantive changes to documents with specific parameters the changes must satisfy. Note: Verification that the investigator’s response(s) satisfies the conditions for approval set by the IRB may be performed by the IRB Chair and/or other designated individual(s). Also: contingent approval, approval with conditions.
Noncompliance: Failure (intentional or unintentional) to comply with applicable federal regulations, state or local laws, the requirements or determinations of the IRB, or university policy regarding research involving human subjects. Noncompliance can result from action or omission. Noncompliance may be non-serious (minor) or serious, and may also be continuing.
Non-Financial Conflict of Interest: An interest other than monetary of an individual (or his/her immediate family) in the design, conduct, or reporting of the research or other interest that competes with an IRB member’s (or consultant’s) obligation to protect research participants and potentially compromises the objectivity and credibility of the research review process.
Non-Scientist: An individual appointed to the IRB who (due to training, background, and/or occupation) is inclined to view research activities from the standpoint of someone outside the scientific or scholarly discipline of the IRB on which he/she serves.
Non-serious or minor noncompliance: Noncompliance that does not increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human research protection program. Examples of minor noncompliance may include, but are not limited to the following: lapses in continuing IRB approval, failure to obtain exempt determination before exempt research involving human subjects is conducted, minor changes in or deviations from an approved protocol, or administrative errors.
Off-Site Research: Human subjects research sponsored or performed at a location/site that is not owned by or under the direct control of the organization responsible for the research.
Organizational Conflict of Interest (OCOI): A situation in which the financial investments or holdings of an organization (including licenses, royalties, intellectual property rights, patents, certain gifts) or the personal financial interests or holdings of a key leader might affect or reasonably appear to affect organizational processes for the design, conduct, reporting, review, or oversight of human subjects research.
Parent: A child’s biological or adoptive mother or biological or adoptive father.
Permission: The agreement of a parent(s) or legal guardian to the participation of his/her child or ward in research.
Policy: Formal statement of principles on which action(s) for a specific issue are based.
Pre-review: The process performed by IRB staff to determine that a submission for IRB review is complete, including the required materials, copies, and signatures, and that institutional requirements, such as completion of human subjects protection education and conflict of interest disclosure, have been met.
Principal Investigator (PI): An individual with the appropriate scientific and/or scholarly training and expertise to assume direct responsibility for the ethical conduct of a study involving human subjects, providing technical and administrative oversight of the research and making important study-related decisions.
Prisoner: An individual involuntarily confined or detained in a penal institution (e.g., prison, jail, or juvenile offender facility), with restricted ability to leave the institution. The term is intended to encompass individuals 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.
Prisoner of War (DOD): Individuals under the custody and/or control of the Department of Defense as defined in the Geneva Convention Relative to the Treatment of Prisoners of War of August 12, 1949, Articles 4 and 5. In particular, one who, while engaged in combat under orders of his government, is captured by the armed forces of the enemy. Note: Research involving a detainee (as defined in DOD Directive 2310.01E) as a human subject is prohibited.
Privacy: The state of being free from the observation, intrusion, or attention of 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 (such as a public restroom) and information that has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (such as medical or academic records or personal journals).
Procedure: A series of actions conducted in a certain order or manner; operational method by which policy is put into practice.
Publically available: Intended to refer to record sets that are truly readily available to the broad public, such as census data. An investigator should not assume information qualifies as "publicly available" merely because it has been posted on an electronic website and can be accessed without authorization.
Quality Improvement: A process initiated to develop/enhance a practice or procedure and to institutionalize the practice or procedure.
Recruiting Methods: Materials, compensation, and other practices or procedures used to inform potential participants about research. Note: Methods for recruiting research participants are generally distinguished from those of marketing, advertising, or public relations’ efforts, which have promoting a product, service, or idea as goals.
Recruitment Bonus: Payment, merchandise, or other gift or service offered by a sponsor as an incentive or reward to an organization, investigator, or key personnel conducting research designed to accelerate recruitment that is tied to enrollment rate, timing, or numbers.
Recruitment Materials: Announcements; advertisements; flyers; posters; scripts for telephone or other oral communication; letters or email messages; bulletin board tear-offs; Internet postings; newspaper, radio, television, or video broadcasts, or other media used to attract potential participants for research.
Repository: Also: bank. Collection of data and/or specimens obtained and stored for future research uses and/or distribution, including a collection not originally or primarily obtained for research purposes.
Research (Social and Behavioral research): A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.
Research Involving a Human Being as an Experimental Subject (DOD): An activity, for research purposes, where there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Note: This definition applies only to activities that are considered to be research involving human subjects and does not include activities that meet the exemption criteria at 32 CFR 219 (Common Rule) or research involving the collection or study of existing data, documents, records, or specimens from living individuals. Research involving a human being as an experimental subject is a subset of research involving human subjects; used only when 10 USC 980 (Limitation on Use of Humans as Experimental Subjects) applies.
Secondary Research: Study of existing information or materials (e.g., data or specimens) that have been previously collected for a purpose (including non-research purposes) other than the currently proposed activity.
Serious noncompliance: Noncompliance that has the potential to increase risk to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data or the human research protection program. Examples of serious noncompliance may include, but are not limited to the following: conducting or continuing non-exempt human subjects research without IRB approval; lack of legally effective informed consent from research participants; failure to report or review serious adverse events, unanticipated problems, or substantive changes in research; or inappropriate oversight of the research to ensure the safety of human subjects and the integrity of the research/data.
Specific Component (DOD): Any one of the military branches or organizational entities within the Department of Defense, including the Army, Navy, Air Force, Coast Guard, or Marine Corps.
Suspension: An action taken by the IRB Chairs, Vice Chairs, or convened IRBs to withdraw approval for some research activities, temporarily or permanently, or all research activities temporarily, short of permanently withdrawing approval for all research activities. The Institutional Official may also suspend research on an urgent basis. Note: Similar actions taken by investigators or sponsors to stop research activities are not suspensions as described by IRB policy.
Systematic Investigation: A planned scientific or scholarly activity involving qualitative or quantitative data collection and/or data analysis that sets forth an objective(s) and a set of procedures intended to reach the objective(s), i.e., to acquire knowledge, develop a theory, or answer a question.
Tabled: An IRB “action” that indicates that review was not initiated or was not completed, resulting in postponement of IRB review, usually due to loss of quorum or other administrative issue. Research tabled at a convened meeting will be reviewed at a future convened meeting.
Termination: An action taken by the convened IRBs to permanently withdraw approval for all research activities (except for those follow-up procedures that may be necessary to protect the health and/or welfare of participants). Note: Similar actions taken by investigators or sponsors to stop research activities are not terminations as described by IRB policy.
Unanticipated problems involving risks to subjects or others: Unforeseen events (given the nature of the research procedures and subject population) that suggest subjects, research staff, or others are placed at greater risk by the research than previously expected. Unanticipated problems involving risks to subjects or others may be medical or non-medical in nature, and include – but are not limited to – serious, unexpected, and related adverse drug events and unanticipated adverse device effects.
Undue Influence: Excessive or inappropriate reward or other incentive in which a person is induced to act otherwise than by his/her own free will or without adequate consideration of the consequences.
Unrelated: Unassociated or without a timely relationship; evidence exists that an outcome is definitely related to a cause other than the event in question.