Research Definition of Terms

DEFINITIONS OF COMMON RESEARCH-RELATED TERMS Abuse-liable: Pharmacological substances that have the potential for creating abusive dependency. Abuse-liable substances can include both illicit drugs (e.g., heroine) and licit drugs (e.g. methamphetamines). Adverse Effect: An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention. Anonymity: Anonymity exists when there are no identifiers on project materials that could link the data with individual subjects. Even the research investigator cannot know the identity of participants. Assent: Agreement to participate in proposed research, given by an individual not competent to give legally valid informed consent (e.g., a child or mentally limited person). Mere failure to object may not be construed as assent. Assurance: A formal, written statement submitted to a federal agency attesting that an institution will comply with applicable rules governing research with human subjects. Autonomy: Personal capacity to consider alternatives, make choices, and act without undue influence or interference of others. Belmont Report: A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1978. Benefit: A valued or desired outcome. An advantage. Biologic: Any virus, therapeutic serum, toxin, antitoxin or analogous product used for the prevention, treatment or cure of diseases or injuries of humans. Case Report Forms: The study-specific forms used for data collection during a research trial. Children: Those who have not attained the legal age for consent to treatments or procedures involved in the research, as determined under the applicable law of the jurisdiction in which the research will be conducted. Class I, II, III Devices: Classification by the FDA of medical devices according to degree of potential risks or hazards. Clinical Research Associate (CRA): An individual who represents