Glossary of Terms

45 CFR 46 (the Code of Federal Regulations, Title 45 Public Welfare, Part 46 Protection of Human Subjects): First published in 1974, 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

Ad Hoc Disclosures: Disclosures of actual, potential, or apparent conflicts of interest made via modification request after the initial application has been submitted and within 30 days of acquiring the interest

Administrative Records: All related correspondence, initial and revised applications, 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 PHHI, modification and continuation requests, progress reports, statements of significant new findings provided to subjects, reports of unanticipated problems, post approval monitoring findings, and current training (CITI, biosafety, etc.) certifications

Adverse Event: 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, as well, Serious Adverse Events and Unexpected Adverse Event)

Anonymous: Data are collected and recorded such that no identifier whatsoever exists to link a subject’s identity to that subject’s response

Assent: Agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research

Assurance: 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

Assured Institution: An institution with an IRB working under a federalwide assurance (FWA) negotiated with the Office for Human Research Protections (OHRP) of the National Institutes of Health (NIH)

Authorized Institutional Official: 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

Belmont Report: A statement of basic ethical principles governing research involving human subjects used by the National Commission for the Protection of Human Subjects in 1978

Beneficence: Ethical principle to do no harm and protect subjects from harm by maximizing possible benefits and minimizing possible risks of harm

Benefit: A valued or desired outcome; an advantage

Cede Review: An agreement whereby one assured IRB relinquishes its oversight responsibilities to a second institution’s assured IRB for collaborative human subjects research between investigators at both institutions

Children: 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 MA)

CITI: See Collaborative Institutional Training Initiative

Clinical Trial: A prospective, biomedical or behavioral research study of human subjects that is designed to evaluate the effect of an intervention on the human subjects and evaluate a health-related biomedical or behavioral outcome

Coded Data: Data where identifying information (such as a subject’s name) has been replaced with a code and a key to decipher the code is available, which can link the identifying information to the data

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

Cognitively Impaired: 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)

Collaborative Institutional Training Initiative: A program that provides research ethics and compliance education to meet institutional, regulatory, and sponsor training requirements for investigators

Collaborative Research: Human subjects research conducted by an investigator at an institution with an assured IRB and an investigator not affiliated with this same institution

Common Rule: The Federal Policy for the Protection of Human Subjects published in 1991 and codified in separate regulations by 15 federal departments and agencies

Compensation: Payment in the form of money, gifts, services, or course credit given - not to be confused with a benefit

Competence: 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 

Confidential: 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

Conflict Management Plan: 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

Conflict of Interest: A situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity

Consent: Permission for something to happen or agreement to do something

Consent Form: 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

Continuing Noncompliance: 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

Covered EntitiesA 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 

Debriefing: Giving subjects previously undisclosed information (such as when deception has been used) about the research project following completion of their participation in research

Deception: Intentionally misleading subjects, giving subjects false information about the purpose of the research or omitting information about the purpose of the research

Declaration of Helsinki: A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries

De-identification: The process by which all personally identifiable information is severed from data

DHHS: The United States Department of Health and Human Services

Economically Disadvantaged: Persons who struggle to provide basic necessities for themselves and their families or communities

Educationally Disadvantaged: Persons with educational deficits, learning disabilities, or cultural backgrounds that limit communication with a researcher

Enrolled Subjects: 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

Equitable: Fair or just; used in the context of the selection of subjects to indicate that the benefits and burdens of research are fairly distributed

Exclusion Criteria: Those characteristics that disqualify prospective subjects from participation in a study

Exempt Research: 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 IRB)

Expedited Review: An IRB 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

Family Educational Rights and Privacy Act: A federal law that protects the privacy of student education records (20 USC § 1232g; 34 CFR Part 99

FERPA: See Family Educational Rights and Privacy Act

Fetus: The product of conception from the time of implantation until delivery

Full Board Review: An IRB review procedure of research involving greater than minimal risk and requiring review by the fully convened IRB

Generalizable Knowledge: Data designed to apply to a population beyond the research subjects themselves and contribute to current academic understanding

Greater than Minimal Risk: 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. 

Guardian: An individual who is authorized under applicable state or local law to give permission on behalf of a child (see, as well, Legally Authorized Representative)

HIPAA Privacy Rule: Health Insurance Portability and Accountability Act privacy regulation that protects the confidentiality of a person’s PHI obtained from or through health care providers and organizations by giving the person the right to limit who may have access to it

HRPP: See Human Research Protection Program

Human Research Protection Program: The overarching program overseeing human subjects research, consisting of the IRB, the Institutional Official (IO), the Research Integrity team of the Office of Research Administration, and the Vice Provost for Research

Human Subject: A living individual about whom an investigator conducting research obtains one of the following: 1) Data through intervention or interaction with the individual, or 2) Identifiable private information about the individual

IAA: See IRB Authorization Agreement

Identifiable: The identity of the subject is or may readily be ascertained by the investigator or others, or associated with the information

IIA: See Individual Investigator Agreement

Independent Investigator: A collaborating investigator who is not acting under the auspices of any institution with respect to his/her involvement in the research

Inclusion Criteria: Those characteristics that prospective subjects must have if they are to be included in a study

Individual Investigator Agreement: A formal written agreement in which an assured IRB agrees to serve as the IRB of record for collaborative human subjects research between an investigator at its institution and an independent or institutional investigator 

Informed Consent: A person’s voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research

Institutional Official: 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 IO is legally authorized to represent the institution, is the signatory official, and assumes the obligations of the institution’s Assurance

Institutional Investigator: A collaborating investigator affiliated with an institution without an assured IRB

Institutional Review Board: A local 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

Interaction: Communication or interpersonal contact between investigator and subject

Intervention: Physical procedures by which data are gathered, and manipulations of the subject or the subject’s environment that are performed for research purposes

IRB: See Institutional Review Board

IRB Authorization Agreement: A formal written agreement in which an assured IRB 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

IRB of Record: An agreement whereby one institution’s assured IRB assumes oversight responsibilities of another institution’s assured IRB, or an independent or institutional investigator

Joint Review: When the assured IRBs 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

Justice: Distributing the risks and potential benefits of research equally among those who may benefit from the research

LAR: See Legally Authorized Representative 

Legally Authorized Representative: A person authorized either by statute or by court appointment to make decisions on behalf of another person

Master List: 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

Mentally Disabled: (See cognitively impaired)

Minimal Risk: 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

Minor: 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 MA, <18 years of age)

Neonate: Newborn child

Noncompliance: 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 IRB, or its designee (see, as well, Serious Noncompliance, Non-serious Noncompliance, and Continuing Noncompliance)

Non-serious Noncompliance: Noncompliance that does not increase risk or decrease the benefits to research participants, compromise participants’ rights or welfare, or affect the integrity of the research/data.

Nuremberg Code: 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

Office for Human Research Protections: The Department of Health and Human Services (HHS) office that oversees the regulation of research involving human research participants

OHRP: See Office for Human Research Protections

Participant: See Human Subject

Personally Identifiable Information: Any data that could potentially identify a specific individual

PHI: See Protected Health Information

PI: See Principal Investigator 

PII: See Personally Identifiable Information

Pregnancy: The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus

Principal Investigator: The  faculty or staff scientist or scholar (as well as other staff with appropriate expertise and prior IRB approval) with primary responsibility for the design and conduct of a research project

Prisoner: An individual involuntarily confined in a penal institution or other facility under statutes or commitment procedures

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

Prospectively Assigned: A pre-defined 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 

Protected Health Information: Any information about health status, provision of health care, or payment for health care that is created or collected by a "Covered Entity" (or a business associate of a Covered Entity), and can be linked to a specific individual

Quorum: The minimum number of committee members that must be present at a meeting to make the proceedings of that meeting valid

Recruitment: The process of advertising a study and making contact with potential participants (distinct from the process of informed consent)

Remuneration: Payment for participation in research

Research: A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge

Research DataHuman 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

Research Personnel: All non-PI/Student Researcher faculty, staff, students, and/or scholars participating on the research team

Respect for Persons: Treating individuals as autonomous agents and protecting persons with diminished autonomy

Review of Research: The concurrent oversight of research on a periodic basis by an IRB

Risk: The probability of harm or injury (physical, psychological, social, legal, or economic) occurring as a result of participation in a research study

Sensitive Data: 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

Serious Adverse Events: Any adverse event that results in one of the following: Death, immediate risk of death, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, jeopardization of the subject's health which may require medical or surgical intervention to prevent one of the other outcomes listed in this definition

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

SOP: See Standard Operating Procedures

Standard Operating Procedures: Eestablished or prescribed methods to be followed routinely for the performance of designated operations or in designated situations

Student Researcher: The undergraduate or graduate student or postdoctoral scholar initiating the research under the supervision of the principal investigator

Unanticipated Problem Involving Risks to Subjects or Others: An incident, experience, or outcome that meets all of the following criteria: 1) 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, 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

Unexpected Adverse Event: 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

Vulnerable Population: Populations which are likely to be vulnerable to coercion or undue influence and require special consideration and protection, such as children, prisoners, pregnant women, mentally disabled persons, economically or educationally disadvantaged persons

Voluntarism: Free of coercion, duress, or undue inducement