14 Calendar days

The IRBMED office should receive reports within 14 calendar days of the event or investigator's receipt of notification of the event. (Because the reporting of Adverse Events can be a time-sensitive issue researchers are encouraged to establish a system for logging or date-stamping information related to Adverse Event notifications and reports from subjects, sponsors and other sources.)

21 CFR…

Title 21 - Food and Drugs: Title 21 of the Code of Federal Regulations houses all the regulations related to the Food, Drug and Cosmetics Act can be found.  Some of the more popular are:

Part:
11: Electronic Records; Electronic Signatures
50: Protection of Human Subjects
54: Financial Disclosure by Clinical Investigators

Part:
56: Institutional Review Boards
312: Investigational New Drug Application
812: Investigational Device Exemptions

45 CFR 46

Title 45, Part 46 of the Code of Federal Regulations covers the Protection of Human Subjects. These regulations govern human subject research conducted by all federal agencies. Together, this body of regulations governs the conduct of human subject research today. 45 CFR 46 Subpart A is often called the Common Rule as nearly all divisions, centers or institutes within the DHHS has agreed to follow the regulations in the protection of human subjects.

510(K) Device

A medical device that is considered substantially equivalent to a device that was or is being legally marketed. A sponsor planning to market such a device must submit notification to the FDA 90 days in advance of placing the device on the market. If the FDA concurs with the sponsor, the device may then be marketed. 510(k) is the section of the Food, Drug and Cosmetic Act that describes premarket notification; hence the designation "510(k) device."

7 Calendar days

The IRBMED office should receive reports within 7 calendar days of the event or investigator's receipt of notification of the event. (Because the reporting of Adverse Events can be a time-sensitive issue researchers are encouraged to establish a system for logging or date-stamping information related to Adverse Event notifications and reports from subjects, sponsors and other sources.)

A

A-21

Cost Principles for Educational Institutions, a circular published by the federal Office of Management and Budget that establishes the principles for determining the costs applicable to grants, contracts, and other government agreements with educational institutions (also known as sponsored projects).

Abbreviated New Drug Application (ANDA)

An ANDA is an application for a US generic drug approval for an existing licensed medication or approved drug. The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. A generic drug product is one that is comparable to an innovator drug product in dosage, form, strength, route of administration, quality, performance characteristics and intended use.

Abnormal Preclinical Finding

A finding in a pre-clinical animal or in-vitro study that suggests a significant risk for human subjects, including reports of mutagenicity (anchor), teratogenicity (anchor), or carcinogenicity (anchor) (21 CFR 312.32 (c)(2)); or findings of contamination in vaccines or other administered agents. Sometimes referred to as an "abnormal laboratory finding," this reportable event does not refer to a value outside the normal range of values for routine clinical laboratory tests. Such lab results that refer a particular subject should be reported to the extent that they are a part of an event that would be categorized as an adverse event overall and/or when unexpected patterns are noted across subjects.

Abuse-Liable

Pharmacological substances that have the potential for creating abusive dependency. Abuse-liable substances can include both illicit drugs (e.g., heroine) and licit drugs (e.g., methamphetamines).

Adjuvant Therapy

Therapy provided to enhance the effect of a primary therapy; auxiliary therapy.

Adverse Drug Reaction (ADR)

All harmful and unintended responses to a research use of a medicinal product (drug) related to any dose should be considered adverse drug reactions. The phrase "responses to a medicinal product" means that a causal relationship between the drug and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out.

Adverse Event (AE)

Any experience or abnormal finding that has taken place during the course of a research project and was harmful to the subject participating in the research, or increased the risks of harm from the research, or had an unfavorable impact on the risk/benefit ratio. The FDA also includes in its definition abnormal preclinical or laboratory findings which may not yet have resulted in direct harm to subjects (e.g., a bacteria is identified in a culture from the same batch of cells used to produce a vaccine which has been administered, even if no cases of infection have been reported). The event may or may not be caused by an intervention (e.g., headache following spinal tap, death from the underlying disease, car collision). Adverse Events also include psychological, social, emotional, and financial harms. See also Serious Adverse Event, Adverse Drug Reaction, and abnormal preclinical finding.

Adverse Reaction

An undesirable and unintended effect, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy). Onset may be sudden or develop over time. See Adverse Event, Side Effects

Advocacy and Support Groups

Organizations and groups that actively support participants and their families with valuable resources, including self-empowerment and survival tools.

Affiliated

IRB membership status designating association with the University. A member (or alternate) is considered to be affiliated if he/she or a member of his/her immediate family is a current or past: employee (full or part-time); clinical, adjunct, or visiting faculty member or instructor; healthcare provider holding credentials to practice; volunteer working at the University (unrelated to IRB service); or University consultant or advisor (paid or unpaid). An emeritus faculty or retired staff member is also considered to be affiliated if he/she has been retired or involved in paid or unpaid University activities (including research or service). Current undergraduate, graduate, and postdoctoral students are also considered to be affiliated, as described by UM HRPP policy.

Agency

In relation to sponsored projects, the sponsoring organization that provides funds to support research, training, or public service activities.

Agency for Healthcare Research and Quality (AHRQ)

The AHRQ is a part of the US DHHS, which supports research designed to improve the outcomes and quality of health care, reduce its costs, address patient safety and medical errors, and broaden access to effective services. It sponsors, conducts, and disseminates research to help people make more informed decisions and improve the quality of health care services. It also acts as the regulator for Patient Safety Organizations that are certified under the Patient Safety and Quality Improvement Act. The agency performs Health Outcomes Research. AHRQ's mission is to improve the quality, safety, efficiency and effectiveness of healthcare for Americans.

Allegation of noncompliance

An unconfirmed report of noncompliance.

Allocable Costs

Those allowable costs that actually benefit the grant or contract to which they are charged.

Allowable Costs

Those categories of costs that are allowable as a charge on a grant or contract as determined by the terms and conditions of the award and/or appropriate cost principles. Certain types of costs, such as the cost of alcoholic beverages are not allowable and may not be charged to a contract or grant.

Alternate Member

An individual appointed to the IRB to serve in the same capacity as the specific IRB member(s) for whom the alternate is named, who substitutes for the member at convened meetings when the member is not in attendance. IRB members and alternates have equal responsibilities in terms of required education, service, and participation.

Amendment (AME)

A change in the terms and conditions of a grant or contract mutually agreed upon by the agency and the recipient organization; may also be referred to as a modification. Amendments are completed in eResearch in order to modify an already approved project. Some examples of changes include updates to the protocol or informed consent, or changes to the study team.

American Dental Association (ADA)

The ADA is the oldest and largest national dental society in the world. Since then, the ADA has grown to become the leading source of oral health related information for dentists and their patients. The ADA is recognized for its commitment to the public’s oral health, ethics, science and professional advancement and access to care for all Americans. Over 300 oral health products, including toothpastes, dental floss, toothbrushes, mouth rinses, denture adherents and chewing gum carry the ADA Seal of Acceptance, universally recognized by consumers as a symbol of safety and effectiveness.

American Heart Association (AHA)

The mission of the AHA is to reduce disability and death from cardiovascular diseases and stroke.

American Medical Association (AMA)

A professional organization of physicians whose core purpose is to promote the science and art of medicine and the betterment of public health.

American Veterinary Medical Association (AVMA)

An association dedicated to advancing the science and art of veterinary medicine, including its relationship to public health, biological science, and agriculture.

Anonymity

Anonymity exists when there are no identifiers on project materials which could link the data with individual subjects. Even the research investigator cannot know the identity of participants.

Anonymous

Anonymous means entirely without name or identifier, so the individual cannot be discerned in any way by anyone. No one can link an individual person to the responses of that person, including the investigator. For this reason, face-to-face interviews are never anonymous. If phone numbers are not stored, then telephone interviews could be considered anonymous. Questionnaires that are returned via US Mail are considered anonymous only if no tracking codes are used.

Appeal (Decision)

Request for reconsideration of an IRB determination in research involving human subjects, including (but not limited to) decisions regarding approval status, conditions for approval, and noncompliance. An appeal is reviewed by the convened IRB responsible for the determination being appealed; for a decision made by expedited review, the corresponding convened IRB may review the appeal. PIs may submit a request for reconsideration if a decision is not positive.

Applied Research

Research that attempts to exploit scientific discoveries or improvements in technology, materials, processes, devices or techniques.

Appointment / Visit Deviation

A scheduling deviation is a reportable occurrence if and when a procedure or intervention did not take place in accordance with the time frame established in the protocol for safety and/or scientific purposes of testing and evaluation. Protocol descriptions of treatment(s) to be administered, dosing schedule(s), treatment period(s), and follow-up period(s) should reflect reasonable flexibility in accordance with sound experimental design. Deviations are reported in eResearch as an ORIO.

Approval Date

The first date that research could be performed (following notification from the IRB).For research reviewed by the convened IRB, the approval date is the date that the research was approved at a convened meeting, or if modifications were required (to secure approval), the date that modifications were met by the investigator. For research reviewed using expedited procedures, the approval date is the date that the research was approved by expedited review, or if modifications were required, the date that modifications were met by the investigator. See also Approval Period.

Approved (Decision)

An IRB action taken when the required determinations are made that allow research involving human subjects to proceed consistent with federal regulations, state and local laws, and University policy.

Approved Drugs

The FDA must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application.

Arms

Any of the treatment groups in a research project. Many projects have two "arms," but some have three "arms," or even more.

Assent

Agreement to participate in proposed research, given by an individual not competent to give legally valid informed consent (e.g., a child or mentally limited person). Mere failure to object may not be construed as assent.

• Assent means a child's affirmative agreement (verbal or written) to participate in a clinical investigation. Children age 10 and up are generally able to provide their assent.
• Assent is an adult's affirmative agreement (verbal or written) to participate in a clinical investigation. Adults may be assented (instead of consent) if they have a cognitive disability rendering them unable to consent for themselves. Steps should be in place to assure that all participants are given the opportunity to consent or assent.

Association for the Accreditation of Human Research Protection Programs (AAHRPP)

The AAHRPP promotes high quality research through an accreditation process that helps organizations worldwide strengthen their human research protection programs. An independent, non-profit accrediting body, AAHRPP uses a voluntary, peer-driven, educational model to ensure that HRPPs meet rigorous standards for quality and protection. To earn accreditation, organizations must provide tangible evidence, through policies, procedures, and practices, of their commitment to scientifically and ethically sound research and to continuous improvement. 

Association of Clinical Research Professionals (ACRP)

ACRP’s mission is to provide global leadership to promote integrity and excellence for the clinical research profession.  The ACRP is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. ACRP was founded to address the distinct educational and networking needs of research nurses and others who supported the work of clinical investigations.

Assurance

A formal written, binding commitment that is submitted to a federal agency in which an institution promises to comply with applicable regulations governing research with human subjects and use of animals and stipulates the procedures through which compliance will be achieved.

Attending Veterinarian

Individual with the authority to implement the veterinary care program and to oversee the adequacy of all other aspects of animal care and use, e.g., animal husbandry, nutrition, sanitation practices, zoonosis control, and hazard containment.

Attribution

A determination made by the investigators about the cause of an AE, specifically whether an AE is or is not related to a test article or other research intervention. (see also Cause, Relatedness)

Audit

A systematic review, inspection, or verification, typically conducted by an independent individual or group. An audit may also include examination of compliance with applicable award terms, laws, regulations and policies.

Authorized Institutional Official

An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and behavioral research.

Autonomy

Personal capacity to consider alternatives makes choices, and act without undue influence or interference of others.

Autopsy

Examination by dissection of the body of an individual to determine cause of death and other medically relevant facts.

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B

Bank

Collection of data and/or specimens obtained and stored for future research uses and/or distribution, including a collection not originally or primarily obtained for research purposes.

Baseline

The initial time point in a clinical trial, just before a participant starts to receive the experimental treatment which is being tested. At this reference point, measurable values are recorded. Safety and efficacy of a drug are often determined by monitoring changes from the baseline values.

Basic Research

Research directed toward more complete knowledge of a particular subject without regard to application.

Behavioral Research

The scope and diversity of research areas in the behavioral and social sciences is quite broad. Some research is readily applicable to human affairs; other studies may broaden understanding without any apparent or immediate application. Some research is designed to test hypotheses derived from theory; other research is primarily descriptive. Still other research may be directed at evaluating an intervention or social program. Behavioral research involving human subjects generates data by means of questionnaires, observation, studies of existing records, and experimental designs involving exposure to some type of stimulus or intervention.

Belmont Report

A document that is part of the Federal Register that sets forth fundamental ethical principles that form the foundation for rules for all government funded research involving human subjects. There are three basic ethical principles that are particularly relevant to the protection of human participants.  They are: Respect for persons, Beneficence, and Distributive Justice. (hyperlink each term)

Beneficence

An ethical principle discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (l) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.

Benefit

A valued or desired outcome; an advantage.

Bequests

A type of donation or gift. Bequests and gifts are awards given with few or no conditions specified. Gifts may be provided to establish an endowment or to provide direct support for existing programs. Frequently, gifts are used to support developing programs for which other funding is not available.

Bias

When a point of view prevents impartial judgment on issues relating to the subject of that point of view. In clinical studies, bias is controlled by blinding and randomization. See Blind and Randomization

Biologic(s)

• A biological product subject to licensure under the Public Health Service Act is any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment or cure of diseases or injuries to humans. Examples include, but are not limited to, bacterial and viral vaccines, human blood and plasma and their derivatives, and certain products produced by biotechnology.
• Any therapeutic serum, toxin, antitoxin, or analogous microbial product applicable to the prevention, treatment, or cure of diseases or injuries.

Biological

• Of or related to life or to living organisms
• A drug derived from a biological source.

Biological product

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.  Biological products also include immunoglobulin products, monoclonal antibodies, products containing cells or microorganisms, and most proteins intended for therapeutic use.

Biological Safety Officer (BSO)

An individual appointed by an institution to oversee management of biosafety risks. The NIH Guidelines require that a BSO be appointed when the institution is engaged in large-scale research or production activities, or in research requiring containment at BL-3 or BL-4.

Biomedical Research

Biomedical research employs many methods and research designs. Studies designed to evaluate the safety, effectiveness, or usefulness of an intervention include research on therapies (e.g., drugs, diet, exercise, surgical interventions, or medical devices), diagnostic procedures (e.g., CAT scans or prenatal diagnosis through amniocentesis), and preventive measures (e.g., vaccines, diet, or fluoridated toothpaste). Research on normal human functioning and development can include studies of the human body while exercising, fasting, feeding, sleeping, or learning, or responding to such things as stress or sensory stimulation. Subjects of some biomedical studies engage in ordinary tasks while measurement of physiological and bodily functions are made. Some biomedical studies, particularly those conducted to evaluate new therapies or treatments, use such rigorous experimental methods as random assignment to treatment and control groups.

Biosafety Level (BL)

A description of the degree of physical containment being employed to confine organisms containing recombinant DNA molecules and to reduce the potential for exposure of laboratory workers, persons outside of the laboratory, and the environment. In the NIH Guidelines, these are graded from BL-1 (the least stringent) to BL-4 (the most stringent).

Blind

A randomized study is "Blind" if the participant is not told which arm of the study he is on. A clinical project is "Blind" if participants are unaware on whether they are in the experimental or control arm of the study; also called masked. See Single Blind Study and Double Blind Study

Blinded Study Design

A study in which one party, either the investigator or participant, is unaware of what medication or study arm the participant is assigned to (Single-Blind study). A clinical study design in which neither the participating individuals nor the study staff knows which participants are receiving the experimental drug and which are receiving a placebo or another therapy (Double-Blind study). Double-blind studies are thought to produce more objective results, since the impact of expectations of the doctor and the participant about the experimental drug are minimized. Also referred to as a "masked" study.

Broad Agency Announcement (BAA)

An announcement of a federal agency's general research interests that invites proposals and specifies the general terms and conditions under which an award may be made.

Budget

A list of anticipated project costs that represent the Principal Investigator's best estimate of the funds needed to support the work described in a grant or contract proposal.

Budget Justification or Narrative

A written description of the cost estimation methods used in preparing a budget that also explains or describes the types of individual costs that make up a larger budget category.

Budget Adjustment

The act of amending the budget by moving funds from one category or line item to another. See also: Re-budget.

Budget Period

The interval of time--usually twelve months--into which the project period is divided for budgetary and funding purposes.