Glossary of Terms

a certificate issued by the National Institutes of Health that protects identifiable research information of a sensitive nature from forced disclosure. It is typically requested when the researcher believes his/her research objectives could not be met without this form of protection. For additional information, please see the NIH Certificates of Confidentiality website.

Persons who have not attained the legal age for consent to research; individuals under the age of 18 in Virginia are considered children for most research situations.

A biomedical or behavioral research study of human subjects designed to answer specific questions about diagnostic procedures or therapeutic interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). Clinical trials are used to determine whether new diagnostic procedures or therapeutic interventions are safe, efficacious, and effective.

Identifying information (such as name or social security number) that would allow a researcher to readily ascertain the identity of the individual to whom the private information/data/specimens pertain has been replaced with a number, letter, or combination thereof (i.e., the code); a key to decipher the code exists, enabling linkage of the identifying information to the private information/data/specimens.

The act of forcing or compelling one to take action against one’s will. Coercion can be overt or perceived, and it can occur when the researcher is in a position of authority or power over the subject (for example, teachers over students or physicians over patients). It can also occur when incentives become so great that the participant will only participate to attain the incentive.

Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders, or dementia) or a developmental disorder 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.

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.

An individual involved in research review is automatically considered to have a conflicting interest when the individual or the individual’s Immediate Family have any of the following: Involvement in the design, conduct, or reporting of the research; Ownership interest, stock options, or other ownership interest Related to the Research of any value exclusive of interests in publicly-traded, diversified mutual funds; Compensation Related to the Research of any amount in the past year or of any amount expected in the next year, including compensation for costs directly related to conducting research; Proprietary interest Related to the Research including, but not limited to, a patent, trademark, copyright or licensing agreement; Any other reason for which the individual believes that he or she cannot be independent. In addition to complying with university policies and procedures related to human subjects, investigators with conflicting interests may need to comply with university policy 4001.

A non-IRB member who, at the request of RDIA or the IRB, provides advice or serves as an ad hoc reviewer of IRB applications. Consultants may have access to all project related documents and participate in IRB discussions but may not vote and are not counted towards quorum.

A pattern of Non-Compliance that indicates a deficiency likely to result in further Non-Compliance or a circumstance in which an investigator fails to cooperate with investigating or correcting Non-Compliance.

Periodic review of research activities at intervals appropriate to the degree of risk, but not less than once per year.