Research A to Z

University Subcommittee on the Human Use of Radioisotopes

An investigational device that is:

• Intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
• For use in supporting or sustaining human life and represents a potential for serious risk to the health, safety, or welfare of a subject;
• For a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
• Otherwise presents a potential for serious risk to a subject.

Typically, a study design in which the investigator, but not the subject, knows the identity of the treatment assignment. Occasionally the subject, but not the investigator, knows the assignment. Sometimes called "single-blind design."

Single Member Review

Standard Operating Procedure

University of Michigan Standard Practice Guide

An individual who both initiates and actually conducts, alone or with others, a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject. The term does not include any person other than an individual, e.g., it does not include a corporation or agency. The obligations of a sponsor-investigator under this part include both those of a sponsor and those of an investigator. (FDA)

Is a medical or psychological treatment guideline, and can be general or specific. It specifies appropriate treatment based on scientific evidence and collaboration between medical and/or psychological professionals involved in the treatment of a given condition. Some common examples include: treatment standards applied within public hospitals to ensure that all patients receive appropriate care regardless of financial means; or treatment standards for gender identity disorders

Express IRB provisions that must be satisfactorily addressed before a human subject research project can be approved and any involvement of human subjects in the research may begin. Under no circumstances do stipulations constitute contingent approval of the research project—approval is neither given nor implied until the PI has received written notice of IRB approval.

The drug under investigation in a research study (includes approved and unapproved drugs).

Sub-Investigator; see also Co-I (Co-Investigator)

Right and understanding of a subject that private data or protected health information will be divulged only as noted in the informed consent document, and/or as necessary for subject's health and safety, and/or as necessary by law. Investigators should take steps to protect subjects' confidentiality including where appropriate removal of patient specific identifiers (patient name, registration number, social security number, etc.) in reports to the IRBMED. Subject initials, unique coding specific to a study, and/or age are acceptable alternatives to names and registration numbers in IRBMED reports, and useful in correlating subject/patient specific information.

Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.

An action taken by the IRB Chairs, Vice Chairs, or convened IRBs to withdraw approval for some research activities, temporarily or permanently, or all research activities temporarily, short of permanently withdrawing approval for all research activities. The Institutional Official may also suspend research on an urgent basis.

An IRB “action” that indicates that review was not initiated or was not completed, resulting in postponement of convened IRB review, usually due to loss of quorum or other administrative issue. Research tabled at a convened meeting will be reviewed at a future convened meeting.

The person (or role) responsible for completing the task. This may be a particular person (user) in OnCore or a role (such as CTSU Coordinator), which allows any user in that role (with access to the protocol) to be notified about Active or Upcoming Tasks.

Tech Transfer is a process involving assessing an invention disclosure (technology), patenting the technology, marketing and finally licensing the technology or forming start-up companies based on technology.

An action taken by the convened IRBs to permanently withdraw approval for all research activities (except for those follow-up procedures that may be necessary to protect the health and/or welfare of participants). This may occur on a particular study or on all studies where an investigator is named PI.

The research physician’s intent to provide some benefit to improving a subject’s condition (e.g., prolongation of life, shrinking of tumor, or improved quality of life, even though cure or dramatic improvement cannot necessarily be effected). This term is sometimes associated with Phase I drug studies in which potentially toxic drugs are given to an individual with the hope of inducing some improvement in the patient’s condition, as well as assessing the safety and pharmacology of a drug.