Glossary OVERVIEW The following are terms commonly used in research. The terms and definitions are gathered from various resources. Numerical The WMed IRB office should receive reports within 14 calendar days of the event or investigator's receipt of notification of the event. (Because the reporting of Adverse Events can be a time- 14 Calendar days sensitive issue researchers are encouraged to establish a system for logging or date-stamping information related to Adverse Event notifications and reports from subjects, sponsors and other sources.) Title 21 - Food and Drugs: Title 21 of the Code of Federal Regulations houses all the regulations related to the Food, Drug and Cosmetics Act can be found. Some of the more popular are: Part: 11: Electronic Records, Electronic Signatures 21 CFR… 50: Protection of Human Subjects 54: Financial Disclosure by Clinical Investigators 56: Institutional Review Boards 312: Investigational New Drug Application 812: Investigational Device Exemptions Title 45, Part 46 of the Code of Federal Regulations covers the Protection of Human Subjects. These regulations govern human subject research conducted by all federal agencies. Together, this body of regulations governs the conduct of human subject 45 CFR 46 research today. 45 CFR 46 Subpart A is often called the Common Rule as nearly all divisions, centers or institutes within the DHHS has agreed to follow the regulations in the protection of human subjects. A medical device that is considered substantially equivalent to a 510(K) Device device that was or is being legally marketed. A sponsor planning to market such a device must submit notification to the FDA 90 1 days in advance of placing the device on the market. If the FDA concurs with the sponsor, the device may then be marketed. 510(k) is the section of the Food, Drug and Cosmetic Act that describes premarket notification; hence the designation "510(k) device." The WMed IRB office should receive reports within 7 working days of the event or investigator's receipt of notification of the event. (Because the reporting of Adverse Events can be a time- 7 Calendar days sensitive issue researchers are encouraged to establish a system for logging or date-stamping information related to Adverse Event notifications and reports from subjects, sponsors and other sources.) A All harmful and unintended responses to a research use of a medicinal product (drug) related to any dose should be Adverse Drug considered adverse drug reactions. The phrase "responses to a Reaction (ADR) medicinal product" means that a causal relationship between the drug and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio. The FDA also includes in its definition abnormal preclinical or laboratory findings which may not yet have resulted in direct harm to subjects (e.g., a bacteria is identified in a culture from Adverse Event the same batch of cells used to produce a vaccine which has (AE) been administered, even if no cases of infection have been reported). The event may or may not be caused by an intervention (e.g., headache following spinal tap, death from the underlying disease, car collision). Adverse Events also include psychological, social, emotional, and financial harms. See also Serious Adverse Event, Adverse Drug Reaction, and abnormal preclinical finding. An undesirable and unintended effect, although not necessarily unexpected, result of therapy or other intervention (e.g., Adverse headache following spinal tap or intestinal bleeding associated Reaction with aspirin therapy). Onset may be sudden or develop over time. See Adverse Event, Side Effects 2 An individual appointed to the IRB to serve in the same capacity as the specific IRB member(s) for whom the alternate is named, Alternate who substitutes for the member at convened meetings when the Member member is not in attendance. IRB members and alternates have equal responsibilities in terms of required education, service, and participation. A change in the terms and conditions of a grant or contract mutually agreed upon by the agency and the recipient organization; may also be referred to as a modification. Amendment Amendments are completed in iMedRIS in order to modify an (AME) already approved project. Some examples of changes include updates to the protocol or informed consent, or changes to the study team. Anonymity exists when there are no identifiers on project materials which could link the data with individual subjects. Even Anonymity the research investigator cannot know the identity of participants. Anonymous means entirely without name or identifier, so the individual cannot be discerned in any way by anyone. No one can link an individual person to the responses of that person, including the investigator. For this reason, face-to-face Anonymous interviews are never anonymous. If phone numbers are not stored, then telephone interviews could be considered anonymous. Questionnaires that are returned via US Mail are considered anonymous only if no tracking codes are used. Request for reconsideration of an IRB determination in research involving human subjects, including (but not limited to) decisions regarding approval status, conditions for approval, and Appeal noncompliance. An appeal is reviewed by the convened IRB (Decision) responsible for the determination being appealed; for a decision made by expedited review, the corresponding convened IRB may review the appeal. PIs may submit a request for reconsideration if a decision is not positive. A scheduling deviation is a reportable occurrence if and when a procedure or intervention did not take place in accordance with the time frame established in the protocol for safety and/or Appointment / scientific purposes of testing and evaluation. Protocol Visit Deviation descriptions of treatment(s) to be administered, dosing schedule(s), treatment period(s), and follow-up period(s) should reflect reasonable flexibility in accordance with sound experimental design. Deviations are reported using the 3 Interim/Event Reporting Form. This is found on the WMed IRB website. The first date that research could be performed (following notification from the IRB).For research reviewed by the convened IRB, the approval date is the date that the research was approved at a convened meeting, or if modifications were required (to secure approval), the date that modifications were Approval Date met by the investigator. For research reviewed using expedited procedures, the approval date is the date that the research was approved by expedited review, or if modifications were required, the date that modifications were met by the investigator. See also Approval Period. An IRB action taken when the required determinations are made Approved that allow research involving human subjects to proceed (Decision) consistent with federal regulations, state and local laws, and University policy. The FDA must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety Approved Drugs and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application. Any of the treatment groups in a research project. Many projects Arms have two "arms," but some have three "arms," or even more. 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. • Assent means a child's affirmative agreement (verbal or written) to participate in a clinical investigation. Children Assent age 10 and up are generally able to provide their assent. • Assent is an adult's affirmative agreement (verbal or written) to participate in a clinical investigation. Adults may be assented (instead of consent) if they have a cognitive disability rendering them unable to consent for themselves. Steps should be in place to assure that all participants are given the opportunity to consent or assent. Association for The AAHRPP promotes high quality research through an the Accreditation accreditation process that helps organizations worldwide 4 of Human strengthen their human research protection programs. An Research independent, non-profit accrediting body, AAHRPP uses a Protection voluntary, peer-driven, educational model to ensure that HRPPs Programs meet rigorous standards for quality and protection. To earn (AAHRPP) accreditation, organizations must provide tangible evidence, through policies, procedures, and practices, of their commitment to scientifically and ethically sound research and to continuous improvement. A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with Assurance applicable regulations governing research with human subjects and use of animals and stipulates the procedures through which compliance will be achieved. Personal capacity to consider alternatives makes choices, and Autonomy act without undue influence or interference of others. B Collection of data and/or specimens obtained and stored for Bank future research uses and/or