An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy).
Subjects' identities are unknown to the investigator, not requested, and not given. If the only time the investigator asks for a name is for a signature on a consent form, the investigator should use implied consent to preserve anonymity.
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 [Federal Policy §___.103].
Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others.
A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978.
An ethical principle 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.
A valued or desired outcome to the study that will be an advantage to the human subjects. Compensation is not considered a benefit.
The benefit comes as a direct result of the subject’s participation in the research. The benefit should be fairly immediate and the expectation of the benefit should be well-founded scientifically. 1 Typically, direct benefits are found in therapeutic or biomedical studies.
The benefit may be incidental to the subject’s participation. Some examples of indirect benefits are: contributing to knowledge, sharing ones experiences to benefit others, potentially affecting a condition, culture, point of view and feeling useful. 2 Many social behavioral research provide indirect benefits to human subjects.
Certificate of Confidentiality
A Certificate of Confidentiality helps researchers protect the privacy of human research participants enrolled in biomedical, behavioral, clinical and other forms of sensitive research. Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant. Any research project that collects personally identifiable, sensitive information and that has been approved by an IRB is eligible for a Certificate. Federal funding is not a prerequisite for Certificate. For more information: http://grants.nih.gov/grants/policy/coc/index.htm
A controlled study involving human subjects, designed to evaluate prospectively the safety and effectiveness of new drugs or devices or of behavioral interventions.
Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished.
Others, including 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, may also be compromised in their ability to make decisions in their best interests.
Payment or medical care provided to subjects injured in research; does not refer to payment for participation in research.
Technically, 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 that information, and to make a choice. (See also: Incompetence, Incapacity.)
Subjects' names are known to the investigator and are usually coded to a master list and/or kept separately from the data and results. This is usually used, for example, when the investigator must match test results with surveys or if there will be a follow-up survey. The investigator must have a need to know subjects' names.
Approved research will undergo review until the completion or termination of the research, including scheduled continual reviews of research that will occur at least annually.
Giving subjects previously undisclosed information about the research project following completion of their participation in research. (Note that this usage, which occurs within the behavioral sciences, departs from standard English, in which debriefing is obtaining rather than imparting information.)
The protocol is designed to withhold complete information when consent is obtained.
Any study that is not truly experimental (e.g., quasi-experimental studies, correlational studies, record reviews, case histories, and observational studies).
Directly or Indirectly Identifiable
Identities of individual subjects are kept by the investigator. If subjects' identities are inseparable from data, then data is directly identifiable. If subjects' identities are kept separate from data, with information connecting them maintained by codes and a master list, then data is indirectly identifiable. In either case, the investigator must assure that confidentiality will be maintained, and must explain how subjects' identities will be protected.
Direct identifiers in research data or records include names; postal address information ( other than town or city, state and zip code); telephone numbers, fax numbers, e-mail addresses; social security numbers; medical record numbers; health plan beneficiary numbers; account numbers; certificate /license numbers; vehicle identifiers and serial numbers, including license plant numbers; device identifiers and serial numbers; web universal resource locators ( URLs); internet protocol (IP) address numbers; biometric identifiers, including finger and voice prints; and full face photographic images and any comparable images.
Identifiable data or records
contains information that reveals or can likely associate with the identity of the person or persons to whom the data or records pertain. Research data or records with direct identifiers removed, but which retain indirect identifiers, are still considered identifiable.
Indirect identifiers in research data or records include all geographic identifiers smaller than a state, including street address, city, county, precinct, Zip code, and their equivalent postal codes, except for the initial three digits of a ZIP code; all elements of dates ( except year ) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates ( including year) indicative of such age, except that such age and elements may be aggregated into a single category of age 90 or older.
Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed [Federal Policy §___.111(a)(3)].
Ethnography is the study of people and their culture. Ethnographic research, also called fieldwork, involves observation of and interaction with the persons or group being studied in the group's own environment, often for long periods of time. (See also: Fieldwork.)
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 [Federal Policy §___.110].
A true experimental study is one in which subjects are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation. (See also: Quasi-Experimental Study).
Food and Drug Administration; an agency of the federal government established by Congress in 1912 and presently part of the Department of Health and Human Services.
Behavioral, social, or anthropological research involving the study of persons or groups in their own environment and without manipulation for research purposes (distinguished from laboratory or controlled settings). (See also: Ethnographic Research.)
Full Board Review
Review of proposed research at a convened meeting at which a majority of the membership of the IRB is 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 [Federal Policy §___.108].
Tests to identify persons who have an inherited predisposition to a certain phenotype or who are at risk of producing offspring with inherited diseases or disorders.
Refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence. (See also: Incompetence.)
Technically, a legal term meaning inability to manage one's own affairs. Often used as a synonym for incapacity. (See also: Incapacity.)
The conditions of an experiment that are systematically manipulated by the investigator.
A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence [Federal Policy §116; 21 CFR 50.20 and 50.25].
Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).
Institutionalized Cognitively Impaired
Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the retarded).
Includes communication or interpersonal contact between investigator and subject.
Includes both physical procedures by which data is gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
The determination by the IRB that the research has been reviewed and may be conducted within the constraints set forth by the IRB and other Institutional and federal requirements.
A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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 [Federal Policy §___.102(i)]. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults. [See 45 CFR 46.303(d) and Guidebook Chapter 6, Section E, "Prisoners."]
The scientist or scholar with primary responsibility for the design and conduct of a research project. (See also: Investigator.)
An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution [45 CFR 46.303(c)].
Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Studies designed to observe outcomes or events that occur subsequent to the identification of the group of subjects to be studied. Prospective studies need not involve manipulation or intervention but may be purely observational or involve only the collection of data.
The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
A study that is similar to a true experimental study except that it lacks random assignments of subjects to treatment groups. (See also: Experimental Study.)
A systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge [Federal Policy §___.102(d)].
Respect for Persons
An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.
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. Federal regulations define only "minimal risk."
Step-by-step, methodical procedure presented or formulated as a coherent body of ideas or principles.
Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.