An abstention is neither a "yes" nor a "no" vote and is cast when a member is not comfortable in voting either way. Any member is free to abstain at any time. An abstention counts toward quorum but does not count toward a super majority.
Therapy provided to enhance the effect of a primary therapy; auxiliary therapy.
See "Consent Document(s)"
Any serious adverse effect on health or safety, any life-threatening problem or death caused by or associated with a device, or any other serious problem associated with a device that relates to the rights, safety, or welfare of research participants
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).
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; Any untoward or unfavorable medical occurrence in a clinical research study participant, including any abnormal sign (e.g. abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participants’ involvement in the research, whether or not considered related to participation in the research.
Flyers, letters, emails, notices, posters, radio/TV spots, newspaper ads, signs, brochures, internet postings that are used to invite potential participants into research studies.
Any change to a protocol from what was previously approved during the period for which approval was given. Changes in research procedures, the informed consent process, and/or the consent/assent document cannot be initiated by the investigator without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject. Amendment requests are reviewed at the same level the initial study was approved under. If the amendment changes the risk profile to participants or procedures that require additional levels of review, then a new review level will be implemented for the protocol.
An approved drug/device means the drug/device being studied has been cleared by the U.S. Food and Drug Administration (FDA) for marketing
A membership organization for individuals interested in ethical issues relating to medicine and research
also "Study Arm": A group or subgroup of participants in a clinical trial that receives specific interventions, or no intervention, according to the study protocol. This is decided before the trial begins.
Agreement to participate in research obtained from an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person). An assent form is like an informed consent form but is tailored to the status/age of the individual not competent to give consent. It is only binding in conjunction with parent/guardian consent.
See "Consent Document(s)"
A document written in language that is appropriate to the child subject's maturity and cognitive level and used as part of the assent process to:
A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with regulations governing the protection of human subjects in research. Assurance is the word used in the Federal Policy (Common Rule). See "Federalwide Assurance
An institution with a Federalwide Assurance (FWA) that is approved by the DHHS Office for Human Research Protections (DHHS OHRP).
A systematic and independent examination of research activities and documents, to verify that the activities were conducted according to the protocol, sponsor's expectations, institutional procedures, good clinical practice (GCP), and applicable regulatory requirement(s).
Personal capacity to consider alternatives, make choices, comprehend information, and act without undue influence or interference of others.
