Appendix 1: Definitions

Beneficence see Belmont Report  (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html)

Deception

  "Concealment" is involved when the researcher intentionally does not reveal initially to the participant all details of the protocol (not the whole truth).  "Deception" is involved when participants intentionally are told something untrue (not the truth).

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.

Informed Consent

is the term given to the communication process that allows individuals to make an informed choice about participation in a research study. This process is reflected in an informed consent document that contains specific, required information about the research study. The informed consent document serves as the formal authorization by an individual of their agreement to participate in the proposed research. Some research protocols may not require signed consent, or in some rare circumstances, the consent process may be waived. [Provide link to Templates]

Interaction

includes communication or interpersonal contact between the investigator and a subject such as by way of interviews or survey questionnaires.

Intervention

includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.

Justice see Belmont Report

 

Principal Investigator (PI)

is the lead person who is responsible for the design, conduct, and reporting of a research project. The PI is responsible for initiation of an IRB review, completing all required training, completing the IRB application form, and gathering all required documentation and signatures. The PI is also responsible for requesting IRB approval for any protocol changes after IRB approval and for reporting any adverse events taking place during the research. The PI must apply for IRB renewal for projects lasting longer than one year.

Private information

includes data about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, as well as information that has been provided for specific purposes by an individual in circumstances or conditions where the individual reasonably expects the information will not be made public. 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 subjects.

Protected health information

is individually identifiable health information maintained or transmitted by a covered entity in any form or medium and includes: demographic information; medical history; information relating to the past, present or future physical or mental health or condition of an individual that is identifiable; the provision of health care to an individual or the payment for the provision of health care; physical examinations, blood tests, x-rays; and other diagnostic and medical procedures.

Research

means a systematic investigation, including research development, testing and 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. For example, some demonstration and service programs may include research activities.

Systematic Investigations

are studies that are intended and designed to collect data about human subjects with the purpose of drawing conclusions and reporting research findings.

Respect for Persons

see Belmont Report

Risk

should be interpreted in a broad sense to mean not just physical risk but also legal, psychological, social, and economic risk. Discomfort, pain, and embarrassment should be minimized and justifiable in terms of anticipated benefit(s).

Minimal risk

means that 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. Designating a project "minimal risk" does not diminish the responsibilities of either the IRB or the investigators, nor does it eliminate the requirement for obtaining informed consent.

Vulnerable Populations

or circumstances resulting in vulnerability to coercion, manipulation, or undue influence and reduced or limited voluntariness may include:

  • Children/minors have a wide range of capacity depending on age, maturity and psychological state. There is potential for control, coercion, undue influence, or manipulation by parents, guardians, or investigators, particularly of young children.

  • Pregnant women (the concern is focused on the fetus).

  • Embryos and fetuses have absolutely no capacity and are under the direct control of the mother.

  • Prisoners "Prisoner means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under 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." [45 CFR 46.303 (c)] Included are individuals in hospitals or alcohol and drug treatment facilities under court order and individuals in work-release programs or in at-home detention programs. The definition applies to minors as well as to adults.

  • Mentally disabled individuals have problems with capacity, which may be continuous or fluctuating, depending on the disability. In addition, they may have limitations on voluntariness because often they are institutionalized or hospitalized, are economically and educationally disadvantaged, and suffer from chronic diseases. As a result, they are potentially subject to control, coercion, undue influence, or manipulation.