Glossary

Campus Institutional Review Board 483 McReynolds University of Missouri Columbia, MO 65211 573 882-9585 phone 573 884-0663 fax umcresearchcirb@missouri.edu

Administrative Hold: A voluntary action by an investigator to temporarily or permanently stop some or all approved research activities in response to a request by the convened Campus IRB or IRB designee to take such action. Administrative holds are not suspensions or terminations. The convened Campus IRB, IRB Chair or Campus IRB Compliance Officer may also place research activities on Administrative Hold.

Adverse Event: A harmful or unfavorable outcome occurring to a human subject as a result of participation in a research study that is both (1) unexpected; and (2) related to the research.

Anonymous Secondary Datasets: Data which contains no identifiers.

Approve: The activities may begin or continue to be conducted as originally approved. There has been a determination that the Corrective Action Plan proposed, is approved if applicable. EXEMPT, EXPEDITED, OR FULLBOARD REVIEW LEVEL

Approve with Contingencies: The activities may begin or continue to be conducted PENDING the investigator satisfying the requested "information/documentation" required by the Campus IRB. It may also involve a determination that the Corrective Action Plan proposed, is approvable once conditions are satisfied, if applicable. EXEMPT, EXPEDITED, OR FULLBOARD REVIEW LEVEL

Assent: Means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Autonomy: Legally effective informed consent is obtained, unless the requirements for waiver of informed consent are met by adequate and appropriate methods in accordance with the provisions of applicable regulations.

Beneficence: The sum of the benefits to the subject and the importance of the knowledge to be gained so outweigh the risks to the subjects as to warrant a decision to allow the subject to accept these risks.

Certification means the official notification by the institution to the supporting department or agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance.

Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

Cognitively Impaired Persons: Cognitively impaired adults are individuals who have a diminished capacity for judgment and reasoning. Certain situations may render other individuals to be considered cognitively-impaired or decisionally-impaired or have limited decision-making ability. Other individuals may be considered cognitively-impaired or decisionally impaired because the are either under the influence of drugs or alcohol, suffering from degenerative diseases affecting the brain, are terminally ill, or have disabling physical handicaps.

Confidentiality: is defined as the treatment of information that an individual has disclosed in a relationship of trust, and with the reasonable expectation that it will not be disclosed to others in ways that are inconsistent with the understanding of the original disclosure without permission. In research, confidentiality refers to the agreement between the investigator and he participant in how data will be managed and used.

Continuing noncompliance: is noncompliance indicating a pattern of disregard, activities or omission of an act that indicates a lack of the ability or willingness to comply with the governing regulations, or that suggests that instances of noncompliance will continue without intervention.

Dead fetus: means a fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles, nor pulsation of the umbilical cord.

Delivery: means complete separation of the fetus from the woman by expulsion or extraction or any other means.

Denial of Approval: A directive that must be approved by the convened IRB. If the IRB disapproves a proposed research activity, written notification must be provided to the investigator with a statement of the reasons for its decision, with the opportunity for the investigator to respond. Activities may be denied as a result of newly learned information, or during the course of an initial proposal, CRR, Amendment, deviation, or compliance breach. These activities will be docketed on the agenda of the next available convened IRB meeting. If may also involve projects whereby additional proposals are denied until IRB criteria have been met. Denial may include use of data or publication. FULLBOARD LEVEL

Department or agency head: means the head of any federal department or agency and any other officer or employee of any department or agency to whom authority has been delegated.

DHHS: means the Department of Health and Human Services.

• DHHS Definition of Human Subject: "Human Subject" as defined by DHHS regulations means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102(f)]
• Intervention: as defined by DHHS regulations means both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. [45 CFR 46.102(f)]
• Interaction: as defined by DHHS regulations means communication or interpersonal contact between investigator and subject. [45 CFR 46.102(f)]
• Office for Human Research Protections (OHRP): The office under the Department of Health and Human Services responsible for implementing DHHS regulations (45 CFR 46) governing biomedical and behavioral/social science research involving human subjects.
• Private information: as defined by DHHS regulations means information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). [45 CFR 46.102(f)]
  • NOTE: Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order to be considered information to constitute research involving human subjects. This may include identifiable private information obtained from a primary subject about a third party.
• Identifiable information: as defined by DHHS means information that is individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information).

DHHS Definition of Research: "Research" as defined by DHHS regulations means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. [45 CFR 46.102(d)]. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

• Research subject to regulation: and similar terms are intended to encompass those research activities for which a federal department or agency has specific responsibility for regulating as a research activity, (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a federal department or agency solely as part of the department's or agency's broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor).

Expiration of approval: If an investigator has failed to provide continuing review information to the IRB or the IRB has not reviewed and approved a research study by the continuing review date specified by the IRB, such research is said to have expired approval.

FDA Definition of Human Subject: "Human Subject" as defined by FDA regulations means an individual who is or becomes a subject in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3(g), 21 CFR 56.102(e)] A human subject includes an individual on whose specimen a medical device is used. [21 CFR 812.3(p)]

FDA Definition of Research: "Research " as defined by FDA regulations means any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or need not meet the requirements for prior submission to the Food and Drug Administration under these sections of the Federal Food, Drug, and Cosmetic Act, but the results of which are intended to be later submitted to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. The terms research, clinical research, clinical study, study, and clinical investigation are synonymous for purposes of FDA regulations. [21 CFR 50.3(c), 21 CFR 56.102(c)]

• "Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act" means any use of a drug other than the use of an approved drug in the course of medical practice. [21 CFR 312.3(b)]
• "Experiments that must meet the requirements for prior submission to the Food and Drug Administration under section 520(g) of the Federal Food, Drug, and Cosmetic Act" means any activity that evaluates the safety or effectiveness of a medical device. [21 CFR 812.2(a)]
• "Any activity in which results are being submitted to or held for inspection by FDA as part of an application for a research or marketing permit is considered to be FDA-regulated research. [21 CFR 50.3(c), 21 CFR 56.102(c)]"

Fetus: means the product of conception from implantation until delivery.

Financial Conflict of Interest – When an individual possesses a financial interest in a research proposal.

Greater Than Minimal Risk: this level of risk is defined as what is considered extensive, significant, or large. The IRB may consider a project to have substantial or significant risk if the risks to which subjects are exposed to as a result from participation in the research are either major or considerable under the given circumstances.

Guardian: means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

Incomplete Application: is an IRB submission that is either insufficient, requires additional information, inadequate responses to the IRB requests for information, or lacks sufficient documentation that will permit the IRB to adequately review the proposal.

Information-gathering interviews: Where the interview questions focus on things, products, or policies rather than about people (or their thoughts regarding themselves or their experience with the product) the activity is not human subject's research. Example: canvassing librarians about inter-library loan policies or rising journal costs. If the question relates to an individual's experience or thoughts about the product, thing or policies it may be subject to IRB review. Contact the IRB if they have questions as to whether their activities are considered research subject to IRB review.

Institution: means any public or private entity or agency (including federal, state, and other agencies).

Institutional Conflict of Interest: when the institution possesses an interest which may impact a decision made about the research project.

Internal Classroom Activities: Many classroom activities are not subject to IRB review. These activities are conducted solely for pedagogical purposes and intended to contribute to the learning environment of the student. If such activities will be used for internal classroom purposes only, and are not conducted with the intent to develop or contribute to generalizable knowledge, it fails to meet the definition of human subject research and doesn't require IRB review.

Internet Research: Online website(s) or venues that are set up for the purposes of collecting research data that will contribute to generalizable knowledge and contain identifiers which are recorded by the investigator in such a manner that subjects may be identified, directly or through identifiers linked to the subjects. These identifiers may include, but are not limited to, the IP address, email, zip code, paw print, or any other information that would regarding a particular topic. This may include the completion of questionnaires/surveys, personal data, etc.

IRB approval: means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

IRB Designee: The Campus IRB Chair, Campus IRB Vice-Chair, Campus IRB Compliance Officer, Institutional Official, or any person designated to carry out the aim of the Campus IRB charge.

IRB: means an institutional review board established in accord with and for the purposes expressed in this policy.

Journalistic Reporting: Newspaper reporting generally is not subject to IRB review when the activities are a fact-finding investigative process that is not designed to contribute to generalizable knowledge. Some journalistic activities may fall under the purview of the IRB when a research component meeting the definition of human subject research will be included in the activities. Students should contact the IRB if they have questions as to whether their activities are considered research subject to IRB review.

Journalism Research Projects: Students, who will conduct either traditional scholarly research or a professional analysis examining areas related to the Journalism profession, which involves human subjects and is designed to contribute to generalizable knowledge, may be subject to IRB review.

Justice: The selection of subjects is equitable and is representative of the group that will benefit from the research.

Lay Membership: A lay member shall be a member of the community who demonstrates concern for human rights and ethical issues. A lay member shall have no direct affiliation with the University of Missouri-Columbia, but may participate in activities with the University in a non-scientific capacity.

Legally authorized representative: means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

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.

Minor noncompliance: is noncompliance that is considered diminutive or administrative in nature.

Neonate: means a newborn

Non-Scientific Membership: A member who possesses relevant information in a nonscientific area to assist the board in deliberations, but is not considered an expert from an Academic Academy within a specific scientific community. The non-scientific member does not represent an area of expertise to demonstrate the scientific merit in the respective academic area. A non-scientific member may have a direct affiliation with the University of Missouri-Columbia. A convened IRB Meeting is prohibited from conducting business in the absence of the Non-Scientific Member.

Nonviable neonate: means a neonate after delivery that, although living, is not viable.

Others: Individuals who are not research subjects.

Parent: means a child's biological or adoptive parent.

Permission: means the agreement of parent(s) or guardian to the participation of their child or ward in research.

Personal Conflict of Interest: When an individual possesses a personal opinion or idea about another individual, which may impact a decision made about that individual.

Pilot Studies: Activities involving only one individual or small groups of individual(s) may be subject to the same scrutiny as a full scale research project and subject to IRB review. Such activities will be reviewed on a case-by-case basis to determine if they meet the definition of "human subject research." When the researcher intends to use the data derived from the pilot activity to be included in the full scale human subject research project design in order to contribute to generalizable knowledge it will be subject to IRB review.

Pregnancy: encompasses the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.

Prisoner: means any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

Privacy: can be defined in terms of having control over the extent, timing, and circumstances of sharing oneself with others.

Professional Conflict of Interest: When an individual's professional opinion or idea about another individual, may impact a decision made about that individual.

Publicly Available Anonymous Datasets: Research involving the collection or study of anonymous existing data, documents, records, pathological specimens, or diagnostic specimens.

Public Datasets: Publicly available datasets subject to IRB review involves a systematic investigation of a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information., including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. These activities meet the definition of "human subject research" requiring IRB review. NOTE: These activities may be eligible for an exempt determination.

Related: An event that is more than likely associated or caused by the research procedures.

Research involving cadavers: When activities involve autopsy material or bio-specimens from deceased individuals it is not considered human subjects research subject to IRB review. (Note: If the research activities will provide private, health, or medical information about live relatives, IRB review may be required. Investigators should contact the Campus IRB for further information). (Example: Some archeological excavations.)

Restricted Approval: The activities may begin or continue to be conducted WITH RESTRICTIONS as stipulated, and ONLY after the investigator meets the requested "restrictions" or is "prohibited from conducting certain activities" required by the Campus IRB. It may also involve a determination that the Corrective Action Plan proposed, is approvable once conditions are satisfied, if applicable. May include use of data or publication EXEMPT, EXPEDITED, OR FULLBOARD REVIEW LEVEL

Risks: The occurrence of harm or probability that harm might occur. The harm may be physical, psychological, financial, social, economic, or legal.

Scientific Membership: A member who is considered an expert from an Academic Academy within specific scientific community. The scientific member shall have the relevant expertise to demonstrate an appreciation for the scientific merit of the proposed activities within their respective area. A scientific member shall have a direct affiliation with the University of Missouri-Columbia.

Secretary: means the Secretary of Health and Human Services and any other officer or employee of the Department of Health and Human Services to whom authority has been delegated.

Serious: An event that resulted in or required intervention to prevent death, a life threatening event, injury, hospitalization, prolongation of hospitalization, emergency visit, a persistent or significant/incapacity, medical treatment, or a congenital anomaly/birth defect. An event may be serious if it results in grave or severe harm to a subject or others.

Serious noncompliance: is noncompliance that negatively affects a participants' rights and welfare, and/or negatively impacts the anticipated risks or benefits to research participants.

Suspension: A directive of the convened IRB or IRB designee either to temporarily or permanently stop some or all previously approved research activities short of stopping permanently some previously approved research activities. Suspended protocols remain open and require continuing review. Suspended activities are eligible for reinstatement of IRB approval.

Table: The board needs additional information before it can make a decision regarding the activities. The matter will be docketed on a board meeting agenda once the requested information has been submitted. FULLBOARD REVIEW LEVEL.

Termination: A directive must be approved by the convened IRB to stop permanently all activities in a previously approved research protocol. Terminated protocols are considered closed and no longer require continuing review. The investigator will be required to submit a "Completion Report" providing a summary of the research activities. Terminated activities are not eligible for reinstatement of IRB approval. A new application will be required for IRB approval consideration. See "Suspension and Termination of IRB Approval."

Unaffiliated Membership: Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution.

Unanticipated Problem or Event: Any information, event, or activity that at the time of its occurrence, is either (1) unexpected; or (2) unforeseeable based on the information that was proposed or previously provided to the IRB.

Unanticipated problems involving risks to participants or others: Any event that (1) was unforeseen and (2) indicates that the research procedures increased the risk to participants or others.

Viable: as it pertains to the neonate, means being able, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration.