Definitions

Below are additional definitions to those provided by the Department of Health & Human Services: http://grants.nih.gov/grants/policy/hs/glossary.htm.

Adverse Effect: Any physical, psychological or social outcome of an investigation which is detrimental to a subject. Also referred to as "adverse event," or "side effect."

Anonymity: "Anonymity" means that no member of the research group knows the identity of the subject, and that identification of subjects is not possible by the procedures employed or by the information obtained from subjects.

Assent: A child's agreement to participate in research after an adequate explanation has been provided. Assent shall not be assumed simply because a child does not object. If a child assents to participation, a parent or guardian consent form, for the child, is also required.

Beneficence: An ethical principal discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

Benefit: A valued or desired outcome; and advantage.

Confidentiality: Pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure.

Consent: Please see "Informed Consent"

Deception: Deception occurs whenever information about a research activity is deliberately withheld from subjects.

Expedited Review: Review of proposed research by the IRB chair or a designated voting member or group of voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.

Full Board Review: Review of the proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.

Generalizable Knowledge: Although HHS regulations do not define "generalizable knowledge," it is reasonable to assume that the term applies to generalizations which contribute to the larger body of knowledge in any given form of scholarly inquiry and human communication.

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

Incompetent: In the context of the human subjects review process, an individual who is unqualified to give or is incapable of giving informed consent (see definition below) is considered to be "incompetent." An incompetent individual may be a minor, an adult who has been declared legally incompetent, or an adult whose competency may be questioned because of an illness or an unusual circumstance.

Informed Consent: Informed consent is the agreement of a subject to take part in research after the procedures, costs, and potential risks and benefits have been explained in a manner that the subject can understand.

Institutional Review Board (IRB): Institutional Review Board (IRB) is a committee that has been formally designated by an institution to review and approve research involving human subjects. It is also known as the Committee for the Protection of Human Subjects (CPHS) at CSUMB.

Minimal Risk: "Minimal risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (from Title 45, Code of Federal Regulations, Part 46.102(g)).

Minor: A person under eighteen years of age is legally a minor, unless that person has been declared an "emancipated minor." Investigators who propose to use "emancipated minors" should check with the CPHS about consent requirements.

Personal and Sensitive Information: This term includes any information about an individual which, if known to unauthorized persons or the general public, might reasonably be expected to cause embarrassment or discomfort, jeopardize that person's prospects of employment or education, or affect his/her financial or social status.

Practica or Research Practicum: A course of study that involves the supervised practical application of previously studied theories of research method (based on Webster's New Collegiate Dictionary). A number of departments offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purpose of these course projects is to train students and provide them with a closer view of social, educational, or psychological processes, and an opportunity to practice various research methods. Such projects typically do not lead to generalizable knowledge and are not undertaken with that goal in mind. Therefore, the CPHS does not consider them to be research and IRB review and approval are not required.

Principal Investigator (PI): The scientist or scholar with primary responsibility for the design and conduct of a research.

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.

Research: 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.

Risk: The probability of harm or injury (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.

Subject: A person whose physical, intellectual, emotional or behavioral characteristics are investigated for any purpose other than for the sole purpose of benefiting the subject as an individual. If a person, such as a family member, employer, or teacher, is asked to provide information about another individual, then both individuals are considered to be subjects.

Subject Advocate: An individual who assists an adult subject who has not been declared legally incompetent, but whose ability to give informed consent is in question. The subject advocate should know the subject well enough to be able to attest to the subject's probable agreement to participate.

Voluntariness: An agreement to participate in research constitutes a valid consent, only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another, in order to obtain compliance.