Research A to Z

EFIC means an Exception from Informed Consent concerning FDA-regulated activity as set forth in 21 CFR 50.24

Date the sponsor approves the patient to be eligible (device studies)

Use of an investigational drug or biologic or unapproved medical device for a human subject in a life-threatening situation for which no standard acceptable treatment is available and when there is not sufficient time to obtain full IRB approval. An urgent page to the IRB Chair on Call can replace the IRB approval prior to use.  Please note: After the Emergency Use is accomplished; an eResearch application still needs to be completed to notify the IRB of the use.

The process of encoding a message so that it can be read only by the sender and the intended recipient.

In clinical research: Overall outcome that the protocol is designed to evaluate. Common endpoints are severe toxicity, disease progression, or death. In a clinical research project, an endpoint generally refers to occurrence of a disease, symptom, sign or laboratory abnormality that constitutes one of the target outcomes of the trial, but may also refer to any such disease or sign that strongly motivates the withdrawal of that individual or entity from the trial, and then often termed humane (clinical) endpoint.

The act of signing up participants into a study. Generally this process involves evaluating a participant with respect to the eligibility criteria of the study and going through the informed consent process.

Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.

eRPM is used to accommodate the electronic routing, approval, and submission of funding proposals to external sponsors, including Grants.gov.

the eResearch Proposal Management, used to accommodate the electronic routing, approval, and submission of funding proposals to external sponsors, including Grants.gov

the Executive Vice President for Medical Affairs

The federal government has identified certain categories of research involving human subjects that qualify for exemption from federal regulations. UM is authorized by the federal government to determine whether studies thought by the PI to be exempt from federal regulations -- actually qualify for exemption. Only the IRB has authority to make a determination that a study is exempt from federal regulations and from IRB review and approval. When the IRB notifies a PI that a research project is EXEMPT, it also notifies the PI that the research is approved for initiation or continuation. In order to qualify for exemption, a research study must fall entirely within one or more of the six categories for exemption and it cannot place subjects at greater than minimal risk. If the research involves prisoners, then it does not qualify for exemption from federal regulations and IRB review.

What Exemption Means: "Exemption" as used in this document means exemption from the requirements set forth in Regulations for the Protection of Human Subjects (45 CFR 46), such as the requirement for a written informed consent document.

What Exemption Does Not Mean: "Exemption" does not mean that the research activity is exempt from the law, and it does not mean that the research need not conform to the canons of sound research ethics.

For additional information regarding Exempt Review categories, see OHRP Decision Charts #2-7 for Exempt Categories.

Refers to any of the FDA procedures, such as compassionate use, parallel track, and treatment IND that distribute experimental drugs to participants who are failing on currently available treatments for their condition and also are unable to participate in ongoing clinical trials.

An event that is expected in that it has been addressed or described in one or more of the following: Informed consent document(s) for this study, IRB application for this study, grant application or study agreement, protocol or procedures for this study, investigators' brochure or equivalent (for FDA regulated drugs or devices), DSMB Reports, published literature, other documentation, or characteristics of the study population. If an 'expected' event is of unexpected duration, magnitude, or frequency then the occurrence(s) should be reported within the timeframe of an unexpected Adverse Event.

A procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. An IRB may use the expedited review procedure to review either or both of the following:                                  

• Some or all of the research appearing on the list of categories of research and found by the reviewer(s) to involve no more than minimal risk,
• Minor changes in previously-approved research during the period for which approval is authorized.

The following criteria must be met in order for research to be considered for expedited review:

• The research activities must present no more than minimal risk to human subjects. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
• All of the research activities involve only procedures listed in one or more of the research categories established in the Federal Register. The categories in this list apply regardless of the age of subjects, except as noted. Categories one (1) through (7) pertain to both initial and continuing IRB review.

For additional information regarding expedited review categories, see OHRP Guidance and OHRP Decision Chart #8.

Any use of a drug except for the use of a marketed drug in the course of medical practice or any evaluation of the safety and efficacy of a medical device.

An experimental study is one in which subjects are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation. See also: Quasi-Experimental Study

From the perspective of an Investigator engaged in a multicenter clinical trial, external adverse events are those adverse events experienced by subjects enrolled by investigators at other institutions engaged in the clinical trial (not under IRBMED authority).

The FDA has oversight over clinical trials involving investigational drugs, devices, and biologics, and some trials involving approved drugs, devices and biologics. Contact the IRBMED Office if there is any question regarding whether FDA oversight of a clinical trial is required.

The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Sixteen federal agencies have adopted the Policy known as the "Common Rule."