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Effective Dose

A measure used to estimate the risk resulting from an exposure of ionizing radiation, calculated as a weighted average of exposure to different body tissues. The effective dose is measured in rems or sieverts.

Efficacy

Of a drug or treatment: The maximum ability of a drug or treatment to produce a result regardless of dosage. A drug passes efficacy trials if it is effective at the dose tested and against the illness for which it is prescribed. In the procedure mandated by the FDA, Phase II clinical trials gauge efficacy and Phase III trials confirms it. See Phase II and III Trials .

In medicine:  Is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.

EFIC

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

Eligibility Criteria

Summary criteria for participant selection. See Inclusion/Exclusion Criteria

Eligible

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

Emergency and/or Urgent Treatment

For purposes of Adverse Event reporting: An event that was not life-threatening but still warranted urgent professional treatment for physical or psychological trauma or injury such as treatment in an emergency room, urgent care center, psychiatrist's office, psychologist office, or other facility providing immediate care (e.g., battered women's shelter).

 

Emergency Use

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.

Empirical

Denotes information acquired by means of observation or experimentation. Empirical data are data produced by an observation or experiment.  A central concept in modern science and the scientific method is that all evidence must be empirical, or empirically based, that is, dependent on evidence or consequences that are observable by the senses. It is usually differentiated from the philosophic usage of empiricism by the use of the adjective empirical or the adverb empirically. The term refers to the use of working hypotheses that are testable using observation or experiment. In this sense of the word, scientific statements are subject to, and derived from, our experiences or observations.

Encryption

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

Encryption software

Software whose main task is encryption and decryption of data, usually in the form of files on hard drives and removable media, or email messages sent over computer networks or the Internet.

Endpoint

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.

Engaged

Involved in human subject research in such a way (or to the extent) that the ethical and regulatory requirements for human subject protection are applicable. An individual (or organization) becomes engaged in human subject research when for the purposes of non-exempt research the individual (or organization’s employee or agent) obtains any of the following:

  • Data about research participants through intervention or interaction
  • Identifiable private information about research participants
  • Informed consent of research participants.

Note: An organization is also engaged in human subject research whenever it receives a direct federal award to support the research.

Enrolling

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.

Entity

For conflict of interest matters, this term refers to the company or organization in which an investigator is disclosing their financial interests. An "entity" may be, but is not necessarily, a "sponsor" of a project.

Equitable

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

eRAM

eResearch Animal Management system.

eResearch Proposal Management (eRPM)

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

eResearch Regulatory Management (eRRM)

eRRM is the web-based system that centralizes the review and approval process for Human Subjects Research Applications and IBC Biosafety Registrations.

eRPM

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

eThority

a tool to assist researchers with one point of data entry for building a clinical research budget and billing calendar and tracking your subject enrollment

 

EVPMA

the Executive Vice President for Medical Affairs

Exception from Informed Consent (EFIC)

FDA regulation 21 CFR 50.24 provides a narrow exception to the requirement for informed consent from each human subject, or his or her legally authorized representative, prior to initiation of an experimental intervention. The exception would apply to a limited class of research activities involving human subjects who are in need of emergency medical intervention but who cannot give informed consent because of their life-threatening medical condition, and who do not have a legally authorized person to represent them. The intent of the new regulation is to allow research on life-threatening conditions for which available treatments are unproven or unsatisfactory and where it is not possible to obtain informed consent, while establishing additional protections to provide for safe and ethical studies.

Exempt Review

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.

Existing

Available data (or specimens) at the time the research is submitted for a determination of exempt.

Expanded Access

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.

Expanded Availability

Policy and procedure that permits individuals who have serious or life-threatening diseases for which there are no alternative therapies to have access to investigational drugs and devices that may be beneficial to them. Examples of expanded availability mechanisms include Treatment INDs, Parallel Track, and open study protocols.

Expected Event

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.

Expedited IRB Reviewer

The IRB Chair and those experienced IRB members designated by the Chair who may perform some or all types of expedited reviews.

Expedited Review

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.

Experienced IRB Member

An IRB member determined by the IRB Chair to be qualified to perform reviews using expedited procedures. The following criteria are considered when determining whether an IRB member is experienced: length of IRB service, training regarding expedited review procedures, research experience/expertise, and/or work with the research participants being studied.

Experiment

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.

Experimental

A term often used to denote a therapy (drug, device or procedure) that is unproven or scientifically un-validated with respect to safety and efficacy. A procedure may be considered “experimental” without necessarily being part of a formal study to evaluate its usefulness. Synonymous with Research.

Experimental Study

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

Expiration Date

The date that the IRB’s approval of research has lapsed and research can no longer be performed; an expiration date may not be longer than one year from the date the approval period begins.

External Adverse Event

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).

External event

An event occurring in research at a site(s) other than UM, over which another IRB has jurisdiction.

FDA Oversight

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.

Federal Demonstration Partnership(FDP)

The FDP is a cooperative initiative among federal agencies and institutional recipients of federal funds. It was established to increase research productivity by streamlining the administrative process and minimizing the administrative burden on principal investigators while maintaining effective stewardship of federal funds.

Federal Policy

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."

Federal Wide Assurance

The Policy for the Protection of Human Subjects requires that each institution "engaged" in Federally-supported human subject research file in "Assurance" of protection for human subjects. The Assurance formalizes the institution's commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions. The UM's FWA number is 00004969. The expiration date changes regularly as IRBs update their Rosters.

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