Terminology

Researchers often develop terminology unique to their discipline, including those involved in art. This glossary (arranged alphabetically) is designed to help readers understand key terms they may encounter while developing a research proposal. This is not a comprehensive list. Further details are available online, and via other resources. 

45 CFR part 46: (Code of Federal Regulations TITLE 45: Public Welfare, Department of Health and Human Services PART 46: Protection of Human Subjects)

Adverse / Unanticipated Event: Any noteworthy unfavorable or unexpected occurrence (physical, psychological, or behavioral), in a human subject associated with the subject’s participation in the research.

Analysis: The process of systematically applying statistical and/or logical techniques to describe and evaluate data.

CITI (Collaborative Institutional Training Initiative): The CITI Program is dedicated to promoting the public’s trust in the research enterprise by providing high quality, peer-reviewed, and web-based educational courses in research, ethics, regulatory oversight, responsible conduct of research, research administration, and other topics pertinent to the interests of member organizations and individual learners. 

Coded Data: Identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain that has been replaced with a number, letter, symbol, or combination thereof (i.e., the code).  A separate key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.

Confidentiality: Is a form of privacy that covers the safe-keeping of and access to identifiable personal data connected to research participants.

Collaborating Institutions:  Any IRBs associated with collaborating institutions that may be involved in the data gathering or analysis relating to a proposed project.

Collaborating IRBs: Any IRBs associated with collaborating institutions that may be involved in the review of a proposed project.

Common Rule: The Federal Policy for the Protection of Human Subjects or the “Common Rule” was published in 1991 and codified in separate regulations by 15 Federal departments and agencies, as listed below. The HHS regulations, 45 CFR part 46, include four subparts: subpart A, also known as the Federal Policy or the “Common Rule”; subpart B, additional protections for pregnant women, human fetuses, and neonates; subpart C, additional protections for prisoners; and subpart D, additional protections for children.

Data: Any information that has been purposefully collected, observed, or created to validate research findings.

Exclusion Criteria: Characteristics that disqualify prospective subjects from inclusion in a given study.

Federal Agencies: U.S. governmental agencies and departments that have signed onto the Common Rule. Human subject research conducted or supported by each federal agency is governed by the regulations of that agency. The head of that agency retains final judgment as to whether a particular activity it conducts or supports is covered by the Common Rule.

Generalizable Knowledge: The concept that findings from a study can “generalize” (be applied to) similar people in similar circumstances. 

Health & Human Services (HHS): The United States government's principal agency for protecting the health of all Americans & providing essential human services, especially for those who are least able to help themselves.  Guidelines for the formation and regulation of IRBs fall under their purview.

Human Subject (Human Participant): HHS regulations define human subject at 45 CFR 46.102(f) as: “Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains 1. data through intervention or interaction with the individual, or 2. identifiable private information.”  While HHS tends to us “subject” many other researchers prefer the term “participant”, which has a connotation of active involvement. 

Hypothesis / Research Question: A specific, clear, and testable proposition or predictive statement about the possible outcome of a scientific research study.

Inclusion Criteria: Characteristics that prospective subjects must have in order to be included a given study.

Informed Consent: “Informed” means that subjects, to the degree that they are capable, must be given the opportunity to choose what shall or shall not happen to them.  “Consent” means that they agree to the type of participation being proposed.  Consent must include three elements: information, comprehension, and voluntariness.

InteractionCommunication or interpersonal contact between investigator and subject. 

Intervention: Both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.

IRB (Institutional Review Board): (also called “Human Subjects Committee”, “Independent Ethics Committee”, or “Ethical Review Board”).  Established by the National Research Act of 1974 to protect research participants  board members are charged with assessing the ethics and safety of studies proposed to be conducted under their institutional jurisdiction.

Literature Review: A comprehensive survey and summary of scholarly articles, books, and other sources relevant to a particular research project.

Office for Human Research Protections (OHRP): provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). 

PI (Primary Investigator): The lead researcher on a given project. The PI typically serves as the main author of the Proposal and designated contact person regarding IRB matters.

Protected Health Information (PHI): Private information relating to a research participants’ healthcare history. 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). PHI is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) and obtaining such information as a form of data collection constitutes human subject research.

Purpose: The rationale for conducting the study as relates to the hypothesis/research question. The steps toward achieving these goals are articulated in the methodological design of the proposed research.

Research: HHS regulations define research at 45 CFR 46.102(d) as follows: “Research means a systematic investigation, including research development, testing & evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes.” 

Research Design: A systematic plan (“method”) for collecting, analyzing, and disseminating research data.

Research Ethics: The agreed upon principles and standards of conduct to be adhered to by the research team members during the course of the study. The goal of ethics is to protect the dignity, rights, and welfare of research participants. Citprogram.

Research Methodology: The overarching theoretical framework that guides the researcher in the design and implementation of the study. Various qualitative and quantitative methodologies have their origins in a wide range of scholarly disciplines and provide philosophical as well as strategic structure when considering the “whys” and “hows” of research. 

Review Categories: The initial step toward determining approval of a proposed study is to decide on the type of review required based on the study’s scope and risk level. The three HHS categories (Exempt, Expedited, and Full Review) are generally interpreted as follows. 

  • Exempt Review: Very minimal or no risk to the human participants
  • Expedited Review: Minimal risk
  • Full Review: More than minimal risk

(See: Review: Step-by-Step for further details)

Risk/Benefit Ratio: An analysis that seeks to understand the balance between the potential risks to participants and possible benefits of proposed research. Research ethics demand that benefits outweigh the potential risks.

Safety: Conditions put in place to protect research participants from harm and adverse events.

Study Personnel (Research Collaborators): All individuals and groups involved in conducting the research study with the PI (Primary Investigator). This includes the activities of design as well as data collection and analysis.

Study Site (Collaborating Institution): The location or locations at which the research study is conducted; most specifically, where interventions are implemented, and data is collected.  

Supplementary Documents: While the Research Proposal (Form 1) is the primary document used in the approval process, additional information (specific to a given study) many also be necessary to understanding the project.  Agreement letters from collaborating sites and sample questionnaires are common supplementary documents that should be anticipated and included with the initial review materials.

Systematic Investigation: A defining characteristic of research is that there Is some kind of organized plan to collect “data” for later analysis and dissemination.

Vulnerable Populations (Special Populations): Certain groups of people are considered to be at greater risk of potential harm due to factors relating to age, health, cognitive, social, or economic factors and special care is to be taken when considering involving them in research.  These “vulnerable” groups include: (1) children and minors; (2) cognitively impaired persons; (3) prisoners; (4) traumatized patients; (5) terminally ill patients; (6) elderly and aged persons; (7) economically disadvantaged persons; (8) underrepresented or at-risk persons; (9) students or employees whose instructors or employers are engaged in research; (10) international, non-English speaking persons; and (11) pregnant women.