Administrative Hold (initiated by the investigator)
A voluntary action by the investigators to put research activities on hold temporarily while additional information is obtained.
Administrative Hold (initiated by the IRB)
An action initiated by the IRB to place specific research activities on hold temporarily to allow for additional information to be obtained. An administrative hold is a form of Suspension of IRB approval.
Adverse Event
A public announcement usually by a printed notice or voice or data broadcast that describes a research study including contact information. Typically this is used for recruitment purposes for a research study.
Advertising
A public announcement usually by a printed notice or voice or data broadcast that describes a research study including contact information. Typically this is used for recruitment purposes for a research study.
Agent
An individual employed by Syracuse University (SU) who is authorized to act on its behalf.
Amendment
Any change to an IRB-approved study protocol regardless of the level of review it receives initially.
Assent
The affirmative agreement to participate in a research study given by a child, or an adult who lacks full decision-making capacity or authority to give legal informed consent. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Assurance
A contract or agreement that establishes standards for human participants research as approved by the Office for Human Research Protections (OHRP).
Children
By regulatory definition, children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under applicable law of the jurisdiction in which the research will be conducted. Generally the law considers any person under 18 years old to be a child.
Clinical Trial
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes (as defined by both LINK: NIH policy and the LINK: Common Rule).
Collaborative IRB Training Initiative (CITI)
An internet-based set of educational modules on the protection of human participants in research. It is sponsored by a consortium of IRB professionals and investigators from universities and medical schools across the country and is administered by the University of Miami.
Confidentiality
Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust with the expectation that it will not be divulged to others in ways that are inconsistent with the understanding of the original disclosure without permission.
Conflict of Interest (COI)
A conflict of interest exists when any investigator or personnel listed in this research protocol’s financial interests may reasonably be affected by research, scholarship, educational or other externally funded activity. Or, when the immediate family* of anyone in such a role, have significant financial interests that may compromise, or have the appearance of compromising, an investigator’s professional judgment that could directly and significantly affect the design, conduct, or reporting of the research proposed, or funded.
Federal Guidelines emphasize the importance of assuring there are no conflicts of interest in research projects that could affect the welfare of human participants. If this study involves or presents a potential conflict of interest, additional information will need to be provided to the Vice President for Research.
LINK: SOP-032 - Institutional Conflict of Interest (COI)
*Immediate family means a spouse, domestic partner, or dependent children.
Conflicting Interest
IRB Members and consultants are considered to have a conflicting interest if they have any:
* Significant financial interest;
* Role in the conduct of the research or immediate family with a role in
the conduct of research;
* Other individual conflict of interest.
Continuing non-compliance
A pattern of repeated actions or omissions taken by an Investigator that indicates a deficiency in the ability or willingness of an Investigator to comply with Federal regulations, Syracuse University IRB Policy, or determinations or requirements of the SU IRB.
Continuing Review
Periodic review of a research study by an IRB to evaluate whether risks to participants remain reasonable in relation to potential benefits and to verify that the study continues to meet organizational and regulatory requirements. Federal regulations stipulate that continuing review should be conducted at intervals appropriate to the level of risk involved in the study, and not less than once per year.
Data and Safety Monitoring
A plan to oversee the implementation of a study protocol for compliance monitoring.
Decision-Making Capacity
A potential research participant’s ability to:
*Make and express a choice
*Understand relevant information
*Appreciate the significance of the information relative to the participant’s own situation
*Reason with this relevant information in making decisions
Decision-making capacity is a spectrum, with some individuals more capable of understanding and reasoning than others. Decision-making capacity is variable within groups and may change throughout the course of a study: Someone with early Alzheimer’s disease may be capable of providing consent, but as the disease progresses, their capacity will likely diminish.
Department of Health & Human Services (DHHS)
The United States government's agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.
Deviation
An incident involving noncompliance with the protocol, but one that typically does not have a significant effect on the participant’s rights, safety or welfare, or on the integrity of the resultant data. Deviations may result from the action of the participant, Investigator or staff.
Directed Audit
These audits are conducted by the ORIP Director and IRB Chair to assess the Investigator’s compliance with federal regulations, state and local laws, and SU IRB policies and procedures. These audits of IRB approved research studies are in response to identified concern(s). Concerns may be identified by an IRB Committee, an external source (e.g. OHRP, or Sponsor), or an internal source (e.g. participant, family member, or Institutional personnel).
Dissent
An individual’s negative expressions, verbal and/or non-verbal, that they object to participation in the research or research activities.
Exempt Review
Studies determined by the IRB to meet the exempt criteria as defined by the Federal regulations. Exempt studies do not require periodic review by the IRB unless a change in the project is planned which requires the completion of an amendment application.
Expedited Review
Studies determined by the IRB to meet the expedited criteria as defined by the Federal regulations.
Experts
Persons who, by virtue of their training or expertise, have information and knowledge in a substantive area beyond that of the average person and who regularly share this information and knowledge through consultation, teaching or public speaking, or publications and written reports.
Expired Study
When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. The study expires on the date specified on the approval letter and the informed consent document. No activities can occur after the expiration date.
Federal-Wide Assurance (FWA)
An agreement between a federally funded institution and OHRP that stipulates method(s) by which the organization will protect research participants.
Finder’s Fee
Compensation of any type (cash, office or medical supplies, educational stipends, gift certificates, priority in authorship listings, travel reimbursement, or anything else of value) to an individual made in exchange for referral or recruitment of a participant to a research study. Such payments, generally, are made to residents, physicians, nurses, or others in a position to identify potential participants that might qualify for enrollment into a study. The fee is paid only for participants who are actually enrolled into the study.
Full Board Review
Studies reviewed by the full, convened IRB with a recorded vote and corresponding minutes to document the discussion.
Generalizable Knowledge
Those designed to draw general conclusions, inform policy, or apply findings to populations outside of the specific study population.
Health Care Decision-Maker
In the case of an incompetent individual, or an individual who lacks decision-making capacity, the individual’s health care decision-maker is designated in order of preference as one of the following: the individual’s court-appointed legal guardian or conservator with health care decision-making authority (e.g., Durable Power of Attorney for Health Care); the individual’s health care agent as specified in an advance directive; or the individual’s Health Care Decision-Maker.
Human Research Protection Program (HRPP)
A system that includes all structural units, policies, and activities critical to protecting individuals studied in research and that is managed in accordance with these standards and with applicable federal, state and local laws.
Human Subject/Participant
The definition of Human Subject as defined by the Department of Health and Human Services (DHHS) regulations (45 CFR 46.102(e):
"Human Subject means a living individual about whom an investigator (whether professional or student) conducting research:
i. Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; or
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g. - venipuncture) and manipulations of the participant's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between the investigator and the participant.
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 that has been provided for specific purposes by an individual that the individual can reasonably expect will not be made public.
Identifiable private information is information or biospecimens for which the identity of the participant is or may be readily ascertained by the investigator or associated with the information or biospecimens.
Human Subject/Participant Research
Any research which requires the review of the University’s Institutional Review Board (IRB).
Immediate Family Member
Spouse, domestic partner, or child.
Incomplete Disclosure or Deception
Deception studies intentionally provide misleading or false information, e.g., participants complete a quiz and are falsely told that they did poorly, regardless of their performance.
Incomplete disclosure studies withhold information about the true purpose or nature of the research, e.g., participants are asked to take a quiz for research, but they are not told the research question involves how background noise affects their ability to concentrate.
Individual Conflict of Interest
A circumstance such that any action or decision in which an individual is substantially involved may have a direct or predictable effect on a financial interest of the individual, spouse, minor child, or organization in which the individual serves as an officer, trustee, partner or employee.
Individuals with impaired decision-making capacity or lacking the capacity to consent
In the context of human subject research, an adult with diminished capacity for judgment and reasoning such that they are unable to make an informed, voluntary decision to participate in research. The impairment which leads to this diminished capacity may be a temporary acute condition, may fluctuate, or may be a more long-term or permanent condition. It may be the result of a psychiatric disorder, an organic impairment, a developmental disorder, or severe acute illnesses associated with cognitive impairment.
*(See Decision-Making Capacity)*
Informed Consent
An agreement to participate in research that is made voluntarily by an individual with legal and mental competence and the capacity to understand the information transmitted and its implications, after having been informed of the physical, psychological and personal risks and potential benefits entailed by the research protocol. Informed consent is usually demonstrated by signing a consent form, but it may be oral (under specific criteria approved by an IRB).
Institutional Conflict of Interest
When the institution, any of its senior management or trustees, or a department, school, or other sub-unit, or an affiliated foundation or organization, has an external relationship or financial interest in a company that itself has a financial interest in a faculty research project. Senior managers or trustees may also have conflicts when they serve on the boards of (or otherwise have an official relationship with) organizations that have significant commercial transactions with the University.
Institutional Official (IO)
The individual authorized to act for the institution and, on behalf of the institution, obligates the institution to the terms of the assurance.
Institutional Review Board (IRB)
An independent committee comprised of scientific, non-scientific, and non-affiliated members established according to the requirements outlined in 45 CFR 46. The SU IRB is formally designated by the Vice President for Research to review, approve, and conduct continuing review of research involving human participants at Syracuse University.
Interaction
Includes communication or interpersonal contact between investigator and subject.
Intervention
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.
Investigators
Those responsible for the design, conduct, or reporting of research.
IRB Approval
The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
IRB Associate Chair or Designee
The individual appointed by the Vice President for Research to assist the IRB Chair in overseeing the review functions of the IRB.
IRB Chair or Designee
The individual appointed by the Vice President for Research to oversee the review functions of the IRB.
IRB Member
An individual serving as an IRB Member including Chairs, the IRB scientific and non-scientific reviewers, alternates or expert consultants regardless of voting privileges.
IRB of Record
An IRB is considered the IRB of Record when it assumes IRB responsibilities for another institution and is designated to do so through an approved Assurance with OHRP. A Memorandum of Understanding (MOU) is required, designating the relationship, for SU to serve as the IRB of Record.
Legal Guardian
An individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.
Legally Authorized Representative
An individual, judicial or other body authorized under applicable law to consent on behalf of a prospective participant to that individual’s participation in research.
Local Research Context
Knowledge of the institution and community environment in which human participant research will be conducted.
Major Amendment
A proposed change in research related activities that materially affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.
Memorandum of Understanding (MOU)
A formal agreement between SU and another institution that identifies the SU Institutional Review Board as the IRB of record for that institution or identifies another institution’s IRB as the IRB of record for SU.
Minimal Risk
The probability and magnitude of harm or discomfort anticipated in the 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. An example of minimal risk is the risk of drawing a small amount of blood from a healthy individual for research purposes (because the risk of doing so is no greater than the risk of doing so as part of a routine physical examination). In research involving prisoners, minimal risk is also defined as 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.
Minors
Individuals under the age or 18.
Minor Amendment
A proposed change in research related activities that does not materially affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study.
Minor Modifications
A proposed change in research related activities that does not materially affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study.
Non-compliance
Failure to comply with Federal regulations, Syracuse University IRB Policy, or the determinations or requirements of the SU IRB.
New Less Than Once Per Year
All research proposals, with the exception of application exempt from review, must receive IRB continuing review at a minimum of once every 365 days, per Federal regulations. There are no exceptions or grace periods allowed.
Office for Human Research Protections (OHRP)
The office under the Department of Health and Human Services responsible for implementing DHHS regulations (45 CFR 46) governing biomedical and behavioral/social science research involving human participants.
Office of Research Integrity & Protections (ORIP)
The office at Syracuse University which encompasses the administrative aspects of the IRB and the HRPP program.
Off-site Sponsored Research
Activities conducted by non-SU faculty or staff supported by subcontracts or subawards to another organization, governed by a prime agreement to SU.
ORIP Director
The individual responsible for directing the operations of the Office of Research Integrity and Protections, which encompasses administrative aspects of the HRPP program.
ORIP/IRB Administrator
The individual responsible for assisting the ORIP Director in the administration of HRPP program.
ORIP/IRB Assistant
The individual responsible for assisting the ORIP Director and ORIP Administrator in the clerical aspects of the HRPP.
Parent
A child’s biological or adoptive parent.
Periodic Compliance Review
Random assessments of the internal IRB department and external departments or sites involved in the conduct of human subjects research at SU conducted by the IRB Compliance Team. These reviews are used to evaluate proper execution and accurate documentation of an IRB approved research project. Internal compliance reviews monitor the adherence to federal regulations, state and local law, and IRB policies and procedures as well as accurate documentation between the IRB database and the IRB paper files. External compliance reviews monitor the adherence to federal regulations, state and local law, SU IRB policies and procedures, adherence to the study protocol, accurate documentation and reporting of study related activities, and evaluation/observation of the informed consent process.
Permission
The agreement of parent(s) or guardian to the participation of their child or ward in research.
PRIM&R: Public Responsibility in Medicine & Research
LINK:
Public Responsibility in Medicine and Research Website
Primary Reviewer
Institutional Review Board member responsible for making a presentation at the Committee meeting, including any important human participants protection issues.
Principal Investigator (PI)
An individual(s) who has responsibility for the design, conduct, data collection, management, analysis, or reporting of research; and has responsibility for supervising staff and carrying out a protocol at a specific site.
Prisoner
Any individual involuntarily confined or detained in a penal 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 which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.
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) in order for obtaining the information to constitute research involving human participants.
QA Activities
These activities focus on assessing compliance with the HRPP by the IRB and the investigators involved with human participant research.
Quality Assurance (QA)
Assessment of whether individuals are following HRPP policies and procedures (compliance). Evaluation and correction of individual problems.
Quality Assurance Reviews
Quality Assurance reviews are performed by the IRB Teams to verify that the electronic database is consistent with the IRB paper files and the paper files are collated in accordance with IRB policy and procedure.
Quality Control (QC)
Assessment of whether mechanisms work correctly or are optimized. Evaluation and correction of basic functioning. Examples are ORIP Staff responsibilities to examine the ORIP website for broken links, make sure the latest forms are posted on the internet, and ensure the Standard Operating Procedures are updated and available.
Quality Improvement (QI)
Assessment of whether changes made to the HRPP improve its effectiveness or quality. Evaluation and correction of the system.
Recruitment
Seeking individuals to enroll or participate in a research project.
Related
An event is “related” if it is likely to have been caused by the research procedures.
Research
To be considered a "Systematic Investigation", the concept of a research project must:
* Attempt to answer research questions (in some research, this would be a hypothesis).
* Be methodologically driven, that is, it collects data or information in an organized and consistent way.
* Analyze data or information in some way, by it quantitative or qualitative data.
* Draw conclusions from the results.
"Generalizable knowledge" would include one or more of the following concepts:
* The knowledge contributes to a theoretical framework of an established body of knowledge.
* The primary beneficiaries of the research are other researchers, scholars and practitioners in the field of study.
* Publication, presentation or other distribution of the results is intended to inform the field of study.
* The results are expected to be generalized to a larger population beyond the site of data collection.
* The results are intended to be replicated in other settings.
* Web based publication for professional purposes.
* Web based publication intended to display student work.
Research Misconduct
Any fabrication, falsification, or plagiarism in proposing, performing, or reviewing research, or in reporting research results.
Research Payment
Cash or non-cash payments for reimbursement of time and expenses associated with participation in research activities (Payments may include monetary payment, course credit, gift certificates, toys or educational materials for children, and other items or services).
Risk-Potential Benefit Profile
A summary of the risks and potential benefits that may occur during the course of the study.
Secretary
The Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services (DHHS) to whom authority has been delegated.
Serious Adverse Event (SAE)
Any event that results in death, a life-threatening situation, hospitalization or prolonged hospitalization, persistent or significant disability/incapacity or a congenital anomaly/birth defect or requires medical intervention to prevent one of the outcomes listed above.
Serious
An event is “serious” if it involved a serious harm to one or more persons (who may or may not be participants) or required intervention to prevent one or more persons from experiencing serious harm.
Serious Non-compliance
An action or omission taken by an Investigator that any other reasonable Investigator would have foreseen as compromising the rights and welfare of a participant.
Significant Financial Interest (SFI)
Anything of monetary value – aggregated for the Investigator and the Investigator’s spouse, domestic partner, and dependent children – that reasonably appears to be related to the Investigator’s institutional responsibilities including but not limited to the following:
- exceeds $5,000 in value as determined through reference to public prices or other reasonable measures of fair market value (i.e., most recent sales price recognized by the company), or
- constitutes more than a 5% ownership interest in any single entity.
e. Reimbursed or sponsored travel (i.e., that which is paid on behalf of the investigator and is not reimbursed.
Sponsor-Imposed Suspension
A determination from the sponsor of the study to place specific research activities on hold.
Sponsors
The agencies, institutions, companies, organizations, foundations, or individual grantors responsible for the initiation, management, or financing of a research study. The term sponsor is understood to include any intermediaries, such as contract research organizations or coordinating centers, acting as agents of the sponsor in carrying out the responsibilities above. All research falling under these types of agreements is considered sponsored research.
Standard Operating Procedure (SOP)
A procedure written in a standardized format, giving detailed instructions, which describe a routine activity so that each person following the SOP will perform the activity in a consistent and repeatable manner.
Systematic Investigation
An activity that involves a prospective research plan which incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question.
Third Party Information
Information that is collected about persons other than the participants who have provided informed consent to be part of a study. For example, medical histories often collect information about conditions and diseases among a person’s relatives or sociological, anthropological, or psychological research may obtain information about people’s experiences with and perspectives on others in their lives. Persons who are not the primary subjects of research, but about whom information is collected are sometimes referred to as third parties or secondary subjects.
Unanticipated
An event is “unanticipated” when it was unforeseeable at the time of its occurrence. The word unanticipated is not a synonym for unexpected. A research protocol can monitor for an unexpected event but cannot monitor for an unforeseen event. All unanticipated events are unexpected, but not vice versa.
Unanticipated Problems (UP) or Unanticipated Events (UE)
Any unplanned occurrence that may affect the risks and/or potential benefits involved in the research study. Unplanned occurrences are usually related to study design or methods. Such occurrences can be favorable or unfavorable to participants and may or may not influence the study objectives or results (e.g., loss of identifiable data). Some adverse events in clinical trials are a subset of unanticipated problems. An event is “unanticipated” when it was unforeseeable at the time of its occurrence. The word unanticipated is not a synonym for unexpected. A research protocol can monitor for an unexpected event but cannot monitor for an unforeseen event. All unanticipated events are unexpected, but not vice versa.
Unanticipated Problems Involving Risk to Participants or Others
Any event that was (1) unanticipated, and (2) caused harm or increased risk of harm to participants or others (regardless of the level of seriousness of the harm).
Unexpected
An event is unexpected when its nature, severity or incidence are not accurately reflected in the information previously reviewed and approved by the IRB.
Unexpected Adverse Event (UAE)
Any adverse event that was unanticipated or not previously observed (e.g., not included in the consent form or investigator brochure). This includes adverse effects that occur more frequently or with greater severity than anticipated. Events that are unexpected and serious require prompt reporting to the Sponsor, the FDA and the IRB. An event is “unexpected” when its specificity, nature, severity or incidence are not accurately reflected in the information previously reviewed and approved by the IRB.
Vice President for Research
The individual appointed by the Chancellor to be the Institutional Official and to oversee all research activities at Syracuse University.
Violation
Accidental or unintentional changes to or not compliant with the IRB approved protocol that affect the participant’s rights, safety, welfare, or the integrity of the resultant data.
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.
Whistle-blower
An individual who reports sensitive information to the SU IRB regarding potential non-compliance issues or research activities that have potentially placed participants or others at increased risk in relationship to the conduct of the research.