Co-investigator: Any individual member of the research team designated and supervised by the Principal Investigator to perform study-related procedures and/or make important study-related decisions (e.g. research fellows). Please click here for more information.
Collaborator: An individual who provides scientific advice or consultation and may not be directly involved in the research activities. A collaborator's role is different from that of a co-investigator; please click here for more information.
Human Subjects: According to US Federal regulations, a human subject is defined as a living individual about whom a researcher obtains:
- data through an intervention or interaction with the individual; or
- identifiable private information
Informed Consent: A process by which a subject voluntarily confirms his/her willingness to participate in a research study, after having been informedof all aspects of the study that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed and dated informed consent form.
Investigational New Drug or Device: A drug or device permitted by the Health Sciences Authority (HSA) of Singapore to be tested in humans but that is not yet determined to be safe and effective for a particular use in the general population, and not yet licensed for marketing.
Investigator: See Principal Investigator.
Investigator-Sponsor: Individual with responsibilities of both initiating and conducting a clinical investigation; The obligations of an Investigator-Sponsor include both those of a Sponsor and those of an Investigator. Please refer to section 2 of the Medicines Act, sections 4 and 5 of the Singapore Guideline for Good Clinical Practice (SGGCP) and the Medicines (Clinical Trials) Regulations for more information.
Investigator's Brochure: A compilation of the clinical and non-clinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. It provides Principal Investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, methods of administration and safety monitoring procedures.
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 involved in the research.
Life-threatening: Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted and diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival. The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened meeting of the IRB is feasible.
Minimal risk: A risk is minimal where 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.
Monitoring: The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections.
Multi-site/ multi-centered studies: Studies conducted by the NUS PI and researchers (PIs) from another institution that is not affiliated with NUS using the same or very similar research protocol. These studies usually involve some form of collaboration with sites or individuals external to NUS and outside the oversight of NUS as an Research Institute. Each site will have to have its own ethics approval.
Principal Investigator: The person responsible for the conduct of the research and assumes responsibility for the research study. Please click here for more information.
Non-significant Risk Device: An investigational medical device that does not present significant risk to the patient. (See also Significant Risk Device.)
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. Persons receiving care in a medical treatment setting who are also "prisoners", as defined above, can be considered for enrollment in research only as permitted for other prisoners as subjects.
Protocol: The formal design or plan of an experiment or research activity; specifically the plan submitted to the IRB for review. The protocol includes a description of the rationale and objectives of the research, the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the potential risks and benefits to subjects, subject recruitment and compensation plans, study management, and the proposed methods of analysis that will be performed on the collected data.
Protocol Amendment: Changes or clarifications made in writing to the original protocol.
Radioactive Materials: Radioactive materials includes radioactive drugs, any substance defined as a drug that exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons, including any non-radioactive reagent kit or nuclide generator that is intended to be used in the preparation of a radioactive drug. Drugs containing trace quantities of naturally occurring radio-nuclides are not considered radioactive drugs.
Recruitment: Planned outreach program and the method for attracting subjects into a study, and the act of enrolling subjects with the proper inclusion criteria.
Research: The IRB defines “research” to mean any systematic investigation with the intention of developing or contributing to generalisable knowledge. Such activity may or may not differ in any significant way from customary medical or other professional practice. Research extends to (i) clinical research regulated by various regulatory bodies, e.g. HSA, hospital institutional review boards; as well as (ii) clinical research that supports applications for research or marketing permits for products regulated by the HSA, including drugs, medical devices, and biological products for human use.
Risk: The probability of harm or injury (including 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.
Safety Reports: Written report to the HSA required for any serious and unexpected adverse experience associated with the use of the drug.
Sensitive Topics: are defined as topics that have the potential to illicit a negative response in participants, or may pose a risk to either the PI or participants that may make the collection, storage or dissemination of the research data problematic. Such topics may elevate the risk level of the study beyond “minimal risk”. Sensitive topics could include issues related to race, religion, sexual behavior, domestic violence, illegal conduct, criminal activity etc. Whether a topic is sensitive or not may depend on the nature of the research and participants. For example, asking participants to state their religion may be minimal risk to the general adult population, but asking questions about negative stereotypes associated with a particular religion could cause distress. Another example could be a survey on rape myths. Questions asked may be minimal risk to a general adult population but more than minimal risk to a survivor as such questions may trigger emotional distress.
Serious Adverse Event: Any adverse experience associated with the study article that results in any of the following outcomes: death, a life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening or require hospitalization may be considered a serious adverse event when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition.
Severely Debilitating: Diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness, loss of arm, leg, hand or foot, loss of hearing, paralysis or stroke.
Single centre/ single site study: Studies where a single PI is conducting research at a premise (or premises) that fall under NUS' jurisdiction. The PI has the responsibility of obtaining ethics approval before that research begins.
Special Population: Particularly vulnerable subjects including children, prisoners, pregnant women, cognitively impaired persons, or educationally disadvantaged persons who require special consideration to protect their welfare.
Sponsor: Individual, company, institution or organization that initiates a clinical investigation and takes responsibility for the management and financing of the study.
Subject: Participant in a study. See Human Subject.
Unexpected Adverse Event: Any adverse experience associated with the study for which the specificity or severity is not consistent with the current investigator brochure, or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information described in the general investigational plan or elsewhere in the current application, as amended. "Unexpected" refers to an adverse experience that has not been previously observed.
Voluntary: Free of coercion, duress, or undue inducement.
Vulnerable Subjects: Refers to subjects who may be unduly influenced to participate (e.g., students, subordinates and patients). See Special Population.
Data Protection Terms
Data collected is classified (based on the protection of confidentiality and privacy of subjects) as follows:
Identified data: Means data are still attached to a readily available subject identifier such as a name, identity card no., address, telephone number, medical record number, etc.
Coded data: Means that collected data are unidentified for research purposes by use of a random or arbitrary alphanumeric code but the data may still be linked to their sources through use of a key to the code available to an investigator or collaborator.
De-identified data: Means identifiers that directly identify an individual are removed from the collected data. A de-identified dataset may still be re-identified when combined with data from other sources. The data may still be linked to their sources through use of a key to the code held by a Trusted Third Party or collaborator, with an effective barrier restricting the investigator (researcher) access to the re-identification key.
Anonymisation/ Anonymised data: Means human data that were initially collected with identifiers but, prior to research use, have been irreversibly stripped of all identifiers by use of an arbitrary or random alphanumeric code and the key to the code is destroyed, thus making it impossible for anyone to link the data to the sources. This process does not preclude linkage with existing demographic information before subject identifiers are removed.
Unidentified/ Anonymous data: Means that the data were collected without identifiers of any kind. Data may retain demographic or diagnostic information and still be considered unidentified if such information cannot be used to reveal the identity of the source.
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