Glossary of Terms
Shorthand for the Code of Federal Regulations, Title 45 Public Welfare, Part 46 Protection of Human Subjects, the government policy for ensuring that the human subjects of behavioral and biomedical research receive the protections to which they are entitled and to minimize risks to them.
Disclosures of actual, potential or apparent conflicts of interest made via modification request after the initial protocol has been submitted and within 30 days of acquiring the interest.
All related correspondence, initial and revised protocols, principal investigator or student and faculty assurance, sample consent/information documents (including scripts), sample recruitment materials, study instruments, translation certifications, permissions/agreements (letters, DUAs, MOUs, MTAs, IAAs, IIAs, confidentiality agreements, etc.), international research addendums, statement of HIPAA protected health information use, application for waiver or modification of authorization for use or disclosure of PHI, modification and continuation requests, progress reports, statements of significant new findings provided to subjects, reports of unanticipated problems, postapproval monitoring findings and current training (CITI, biosafety, etc.) certifications.
Any untoward or unfavorable occurrence (either physical or psychological) in a human subject, including any abnormal sign, 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 (see also, Serious Adverse Event and Unexpected Adverse Event).
Data are collected and recorded such that no identifier whatsoever exists to link a subject's identity to that subject's response.
Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research.
A formal written, 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.
An institution with an institutional review board working under a federalwide assurance negotiated with the Office for Human Research Protections of the National Institutes of Health.
A written agreement between two or more institutions that is used to document the delegation of IRB review responsibilities (regulatory and administrative institutional review).
An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in research.
A statement of basic ethical principles governing research involving human subjects used by the National Commission for the Protection of Human Subjects in 1978.
Ethical principle to do no harm and protect subjects from harm by maximizing possible benefits and minimizing possible risks of harm.
A valued or desired outcome; an advantage.
A behavioral intervention that is brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact and which the investigator has no reason to think the subjects will find offensive or embarrassing.
An agreement whereby one assured institutional review board relinquishes its oversight responsibilities to a second institution's assured IRB for collaborative human subjects research between investigators at both institutions.
Persons who have not attained the legal age for consent to treatment or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted (18 in Massachusetts).
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 the interventions on biomedical or behavioral health-related outcomes.
Data where identifying information (such as a subject's name) has been replaced with a code, and a key to decipher the code, which can link the identifying information to the data, is available.
Overt or implicit threat of harm intentionally presented by one person to another in order to obtain compliance.
Having either a psychiatric or developmental disorder that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished (may include, as well, persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients and persons with severely disabling physical handicaps).
Human subjects research conducted by an investigator at an institution with an assured institutional review board and an investigator not affiliated with this same institution.
The Federal Policy for the Protection of Human Subjects, published in 1991 and codified in separate regulations by 15 federal departments and agencies.
Payment in the form of money, gifts, services or course credit given as remuneration for time and inconvenience of participation; not to be confused with a benefit.
A legal term used to denote capacity to act on one's own behalf; the ability to understand information presented, to appreciate the consequences of acting (or not acting) on the information and to make a choice.
The treatment of information that an individual has disclosed to the investigator with the expectation that it will not be divulged to others without permission.
An agreement that sets out limits and restrictions on the investigator for the purpose of reducing or eliminating a conflict of interest that could directly and significantly affect the design, conduct or reporting of institutional research.
A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity.
Permission for something to happen or agreement to do something.
A form defining the elements of consent for research subjects, describing the research and what subjects' participation consists of if they choose to participate, as well as outlining their right to disengage from the research at any time.
Noncompliance 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.
A Health Insurance Portability and Accountability Act (HIPAA) privacy rule designation for institutions, organizations or persons who are 1) health plans, 2) health care clearinghouses or 3) health care providers, and who electronically transmit transactional health information.
A resubmission of an initial protocol that is already approved. De Novo protocols are to be submitted every five years, or on request from the HRPP office, to re-examine and clarify procedures. They are generally assigned a new protocol number, and the previous protocols should be terminated upon approval of the de novo protocol.
Giving subjects previously undisclosed information (such as when deception has been used) about the research project following completion of their participation in research.
Intentionally misleading subjects by giving subjects false information about the purpose of the research.
A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries.
The process by which all personally identifiable information is severed from data.
The U.S. Department of Health and Human Services.
Persons who struggle to provide basic necessities for themselves and their families or communities.
Persons with educational deficits, learning disabilities or cultural backgrounds that limit communication with a researcher.
All subjects who have consented to participate in the study, including those that did not qualify after screening and those that dropped out after consent.
Fair or just; used in the context of the selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
Those characteristics that disqualify prospective subjects from participation in a study.
Research activities that involve no more than minimal risk to subjects, and which are exempt from the Federal Regulations on the Protection of Human Subjects in Research. (Note that the determination of exempt status is an administrative review process handled by the Institutional Review Board.)
An Institutional Review Board review procedure through which certain kinds of research, and changes to research, may be reviewed and approved without convening a meeting of the full IRB.
A federal law that protects the privacy of student education records (20 USC § 1232g; 34 CFR Part 99).
The product of conception from the time of implantation until delivery.
An Institutional Review Board review procedure of research involving greater than minimal risk and requiring review by the fully convened IRB.
Data designed to apply to a population beyond the research subjects themselves and contribute to current academic understanding.
The risk that the probability and magnitude of harm or discomfort anticipated in the research are greater in and of themselves than those ordinarily encountered in daily life or in the performance of routine physical or psychological examinations or tests.
An individual who is authorized under applicable state or local law to give permission on behalf of a child (see also Legally Authorized Representative).
Health Insurance Portability and Accountability Act privacy regulation that protects the confidentiality of a person's protected health information obtained from or through health care providers and organizations by giving the person the right to limit who may have access to it.
A living individual about whom an investigator conducting research: 1) obtains information or biospecimens through intervention or interaction with the individuals and uses, studies or analyzes the information or biospecimens, or 2) obtains, uses, studies, analyzes or generates identifiable private information or identifiable biospecimens.
The identity of the subject is or may readily be ascertained by the investigator or others, or associated with the information.
Those characteristics that prospective subjects must have if they are to be included in a study.
Intentionally misleading subjects by omitting information about the purpose of the research.
A collaborating investigator who is not acting under the auspices of any institution with respect to his/her involvement in the research.
A person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research.
The university official responsible for ensuring the Human Research Protection Program has the resources and support necessary to comply with all federal regulations and guidelines that govern human subjects research. The institutional official is legally authorized to represent the institution, is the signatory official and assumes the obligations of the institution’s assurance.
A collaborating investigator affiliated with an institution without an assured institutional review board.
Communication or interpersonal contact between investigator and subject.
Both physical procedures by which information or biospecimens are gathered (e.g., venipuncture), and manipulations of the subject or the subject's environment that are performed for research purposes.
A formal written agreement in which an assured institutional review board agrees to serve as the IRB of record for collaborative human subjects research between an investigator at its institution and a collaborating investigator at another institution with an assured IRB.
An agreement whereby one institution's assured institutional review board assumes oversight responsibilities of another institution's assured IRB, or an independent or institutional investigator.
When the assured institutional review boards of two or more institutions with investigators participating in collaborative research retain oversight of the portion of a research project in which their investigator is engaged.
Distributing the risks and potential benefits of research equally among those who may benefit from the research.
A document that lists the subjects' identifying information (e.g., name, address, phone number, Social Security number) along with their unique identifier (code), linking the two.
Where the probability and magnitude of harm or discomfort anticipated in the proposed research is not greater, in and of itself, than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Persons who have not attainted the legal age for consent to treatments or procedures involved in research under applicable law of the jurisdiction in which the research will be conducted (in Massachusetts, less than 18 years old).
Newborn child.
Failure to fully comply with all laws and regulations governing human subject research activities, as well as the policies, procedures or determinations of the Brandeis University Institutional Review Board, or its designee (see also Serious Noncompliance, Nonserious Noncompliance and Continuing Noncompliance).
A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
See Human Subject.
The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus.
An individual involuntarily confined in a penal institution or other facility under statutes or commitment procedures.
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 and which the individual can reasonably expect will not be made public.
A predefined process (e.g., randomization) that stipulates the assignment of research subjects (individually or in clusters) to one or more arms (e.g., intervention, placebo or other control) of a clinical trial.
The minimum number of committee members that must be present at a meeting to make the proceedings of that meeting valid.
The process of advertising a study and making contact with potential participants (distinct from the process of informed consent).
A written agreement between two or more institutions that is used to document the delegation of IRB review responsibilities (regulatory and administrative institutional review).
Payment for participation in research.
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subjects' data; documentation of subject eligibility; original signed and dated consent forms (or record of consent if verbal); master keys; and findings review logs, as well as ancillary materials such as administrative and financial records.
Human subjects' data, documentation of subject eligibility, original signed and dated consent forms (or record of consent, if verbal), master keys and findings review logs, as well as ancillary materials such as administrative and financial records.
Treating individuals as autonomous agents and protecting persons with diminished autonomy.
The concurrent oversight of research on a periodic basis by an institutional review board.
The probability of harm or injury (physical, psychological, social, legal or economic) occurring as a result of participation in a research study.
Reusing identifiable information and identifiable biospecimens that are collected for some other "primary" or "initial" activity.
Data regarding such things as illegal activities, sexual attitudes, genetics or religious beliefs, as well as data that could damage subjects' financial standing, employability, insurability, reputation or be stigmatizing.
Any adverse event that results in one of the following: death; immediate risk of death; inpatient hospitalization or prolongation of existing hospitalization; or persistent or significant disability/incapacity; congenital anomaly/birth defect or jeopardization of the subject's health that may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
An incident, experience or outcome that meets all of the following criteria:
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Unexpected (in terms of nature, severity or frequency) given the research procedures that are described in the protocol-related documents and the characteristics of the subject population being studied.
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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).
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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.
An offer of excessive or inappropriate compensation or other overture in order to obtain compliance.
Occurring in one or more subjects participating in a research protocol, the nature, severity or frequency of which is not consistent with either 1) the known or foreseeable risk of adverse events associated with the procedures involved in the research as described in either the protocol-related documents or other relevant sources of information, such as product labeling and package inserts, and 2) the expected natural progression of any underlying disease, disorder or condition of the subject experiencing the adverse event and the subject's predisposing risk factor profile for the adverse event.
Subjects vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity or economically or educationally disadvantaged persons.
Free of coercion, duress or undue inducement.