E

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.

Electronic Research Administration (ERA)

Conducting research administration by utilizing electronic resources such as the internet, the world wide web, form templates, databases, and other electronic tools.

Eligibility Criteria

Summary criteria for participant selection. See Inclusion/Exclusion Criteria

Emancipated Minor

A legal status conferred upon persons who have not yet attained the age of legal competency as defined by state law (for such purposes as consenting to medical care), but who are entitled to treatment as if they had by virtue of assuming adult responsibilities such as being self-supporting and not living at home, marriage, or procreation. See also: Mature Minor

Embryo

Early stages of a developing organism, broadly used to refer to stages immediately following fertilization of an egg through implantation and very early pregnancy (i.e., from conception to the eighth week of pregnancy). See also: Fetus

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.

Encumbrance

Funds that have been set aside or "claimed" for projected expenses pending actual expenditure of the funds.

Endowment

A fund usually in the form of an income-generating investment, established to provide long-term support for faculty/research positions (e.g., endowed chair).

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.

End-use

A detailed description of how the ultimate consignee intends to use the commodities being exported.

End-user

A person abroad that receives and ultimately uses the exported or re-exported items. The end-user is not a forwarding agent or intermediary, but may be the purchaser or ultimate consignee.

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.

Environmental Protection Agency (EPA)

EPA's mission is to protect human health and to safeguard the natural environment - air, water, and land - upon which life depends.

Epidemiology

The study of the distribution and patterns of health-events, health-characteristics and their causes or influences in well-defined populations. It is the cornerstone method of public health research, and helps inform policy decisions and evidence-based medicine by identifying risk factors for disease and targets for preventive medicine. Epidemiologists are involved in the design of studies, collection and statistical analysis of data, and interpretation and dissemination of results (including peer review and occasional systematic review). Major areas of epidemiological study include outbreak investigation, disease surveillance and screening (medicine), bio-monitoring, and comparisons of treatment effects such as in clinical trials. Epidemiologists rely on a number of other scientific disciplines such as biology (to better understand disease processes), biostatistics (to make efficient use of the data and draw appropriate conclusions), and exposure assessment and social science disciplines (to better understand proximate and distal risk factors, and their measurement).

Equipment

Defined as an article of nonexpendable, tangible personal property having a useful life of more than one year and an acquisition cost of $5000 or more per unit.

Equitable

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

eResearch Animal Management system (eRAM)

eRAM system is a web-based system developed that accommodates the electronic management of UCUCA animal use research protocols and the associated ordering, census, and invoicing of animals for ULAM.

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.

Ethics Advisory Board

An interdisciplinary group that advises the Secretary, HHS, on general policy matters and on research proposals (or classes of proposals) that pose ethical problems.

Ethnographic Research

Ethnography is the study of people and their culture. Ethnographic research involves observation of and interaction with the persons or group being studied in the group's own environment, often for long periods of time. See also: Fieldwork

Everyday event

As used in the context of particular subject populations, this term refers to the magnitude or frequency of events that would be expected in that population (i.e., broken hips in geriatric population).

Everyday life

As used in the reporting of mild adverse events only, this term refers to the magnitude or frequency of an otherwise mild untoward occurrence (e.g., a headache) that is outside the expected norm for subjects in the study.

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 #2-7for 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 Guidanceand 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 signifying the end of the performance period.

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.

Export

To send or take controlled tangible items, software or technology out of the US in any manner, to transfer ownership or control of controlled tangible items, software or technology to a foreign person, or to disclose information about controlled items, software or information to a foreign government or foreign person. The controlled tangible item, software or technology being sent or taken out of the US is also referred to as an "export."

Extension

An additional period of time authorized by the sponsor (or awardee institution, as appropriate) to an organization for the completion of work on an approved grant or contract. An extension allows previously allocated funds to be spent after the original expiration date.

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.

Externally Funded

Any research funded by an agency external to the University.

Extra Material

Material collected during a clinical or diagnostic procedure but, solely for investigative purposes, in quantities above and beyond what was needed for the procedure.

F

Facilities and Administrative Costs (F&A)

Costs that are incurred for common or joint objectives and, therefore, cannot be identified readily and specifically with a particular sponsored project, an instructional activity, or any other institutional activity. F&A costs are synonymous with Indirect Costs.

False Negative

When a test wrongly shows an effect or condition to be absent (e.g., that a woman is not pregnant when, in fact, she is).

False Positive

When a test wrongly shows an effect or condition to be present (e.g. that is woman is pregnant when, in fact, she is not).

Familial / Social Relations

Relationships of significance in the life of the research subject such as parent-child, spousal, employer-employee relations. Harms to these relationships (associated with the research study) are adverse events. When relevant, the study protocol or Data Safety Monitoring Plan should address protection of such relations (e.g., in a genetic study, a plan for how discovery of non-paternity of the assumed father would be handled by the researchers).

Family Education Rights and Privacy Act (FERPA)

FERPA (20 US 1232g; 34 CFR 99) is a Federal law that protects the privacy of student education records. The law applies to all schools that receive funds under an applicable program of the US Department of Education.
FERPA gives parents certain rights with respect to their children's education records. These rights transfer to the student when he or she reaches the age of 18 or attends a school beyond the high school level. Students to whom the rights have transferred are "eligible students."

Family Member

For purposes of the waiver of informed consent for emergency research, any one of the following legally competent persons: spouse, parent, child (including an adopted child), brother, sister, spouse of a brother or sister, and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship.

FDA Advisory Councils

Groups of experts which provide advice and recommendations to the FDA.

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 Aviation Administration
(FAA)

The FAA is the element of the US government with primary responsibility for the safety of civil aviation.

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.

Fetal Material

The placenta, amniotic fluid, fetal membranes, and umbilical cord.

Fetus

The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant [45 CFR 46.203(c)]. The term "fetus" generally refers to later phases of development; the term "embryo" is usually used for earlier phases of development. See also: embryo.

Fieldwork

Behavioral, social, or anthropological research involving the study of persons or groups in their own environment and without manipulation for research purposes (distinguished from laboratory or controlled settings). See also: Ethnographic Research

Final Report

The final technical or financial report required by the sponsor to complete a research project.

Financial Conflict of Interest

An interest of an individual (or his/her immediate family) of monetary value that would reasonably appear to be affected by the research or an individual’s interest in any entity whose financial interests would reasonably appear to be affected by the research. Financial interests include, but are not limited to: salary or other payments for services (e.g., consulting fees or honoraria), equity interests (e.g., stocks, stock options, or other ownership interests), and intellectual property rights (e.g., patents, copyrights, and royalties from such rights).

Financial Disclosure

Written declaration of external, financial interests of an individual that are related or potentially related to research or other sponsored activities taking place within the university. Disclosures are required under requirements promulgated by federal and state agencies and the IRB.

Finder’s Fee

Payment made by an investigator or sponsor to an organization or individual (including non-research personnel or a research participant) for identifying and/or referring potential participants for research.

Finding of Non-Compliance

An occurrence or determination of noncompliance that does not require further confirmation or investigation (e.g., failure to respond to the IRB within established deadlines, allegation of noncompliance determined by the IRB to be true).

Firm Commitment

An oral or written representation by the appropriate sponsor official that a formally executed award is forthcoming.

Fiscal Year

Any twelve-month period for which annual accounts are kept.  At UM, this is June 1 through May 31.

Fogarty International Center

The Fogarty International Center promotes and supports scientific research and training internationally to reduce disparities in global health.

Follow up report

A supplemental report from a sponsor or investigator providing additional information, clarification, or corrections to a previously reported (to IRBMED) Adverse Event.

Food and Drug Administration (FDA)

The FDA oversees safety of foods, drugs, devices, biologics and cosmetics for human use. The FDA also works with the blood banking industry to safeguard the nation's blood supply.

For-Cause Audit/Review

An audit of research and/or investigators initiated at the request of the IRB or Institutional Official to obtain or verify information necessary to ensure compliance with regulations and institutional requirements and to inform decisions about the conduct of human subject research and/or human subject protection.

Foreign national

Anyone who is not a “US person.” A “US person” is any one of the following:

• US citizen
• lawful permanent resident alien (green card holder)
• refugee
• protected political person or someone granted temporary residency under the amnesty provision.

NOTE: Any foreign entity not incorporated or organized to do business in the US falls within the definition of a foreign national. This includes any branch of a foreign government and also can include universities and research laboratories in other countries.

Form 483

The FDA-483 is the written notice of objectionable practices or deviations from the regulations that is prepared by the FDA investigator at the end of an inspection. The items listed on the form serve as the basis for the exit discussion with the researcher at which time the PI can either agree or disagree with the items and can offer possible corrective actions to be taken. The PI may also respond to the district office in writing after it has had sufficient time to properly study the FDA-483 (hyperlink). The receipt of and a PI’s response to the Form 483 is submitted to IRB as an ORIO (hyperlink).

For-Profit Organization

An organization, institution, corporation, or other legal entity that is organized and/or operated for the profit or financial benefit of its shareholders or other owners. Such organizations are also referred to as "commercial organizations."

Freedom of Information Act (FOIA)

The FOIA is a federal freedom of information law that allows for the full or partial disclosure of previously unreleased information and documents controlled by the US government. The Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute.

Fringe Benefits

Employee benefits paid by the employer. (e.g., FICA, Worker's Compensation, Withholding Tax, Insurance, etc.) Must be included in request for funding in proposal budgets.

Full Board / Committee Review

Review of proposed research at a convened meeting at which a majority of the membership of the IRB is present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting.

Full Review

If the study does not meet the criteria for exempt or expedited review, then it must be submitted for full review.

Full Time Equivalent (FTE)

Employees are given an ‘equivalent’ designation. A full time employee would be considered 1.0 FTE. A part time or 50% effort employee would be 0.5 FTE.

Fundamental research

Basic and applied research in science and engineering where the resulting information is ordinarily published and shared broadly within the scientific community. Under the State Department‘s narrower interpretation, “fundamental research” can only describe information and technology that already is in existence and in the public domain.

Funding Cycle

Range of time during which proposals are accepted, reviewed, and funds are awarded. If a sponsor has standing proposal review committees (or boards) that meet at specified times during the year, application deadlines are set to correspond with those meetings.