Definition of Terms

The Mayo Clinic Institutional Review Board's definition of terms explains legal definitions related to research guidelines and the protection of human research subjects, including advocate, conflict of interest, emergency treatment, informed consent and more.

• Abbreviated investigational device exemption requirements. The FDA considers an investigation of a nonsignificant risk device to have an approved IDE when an IRB concurs with the initial nonsignificant risk determination of the sponsor or investigator and approves the study. Therefore, both the sponsor and the investigator are expected to comply with 21 CFR 812.2(b), the abbreviated FDA requirements for IDEs. If the study is investigator initiated, then the investigator is also acting as the sponsor.
• Accrual. The number of subjects who have completed or are actively in the process of completing a study at Mayo Clinic. This does not include screen failures. It does include withdrawals. Example: You enroll 100 to accrue 25.
• Administrative hold. A voluntary action initiated by the principal investigator whenever specific research activities, including subject enrollment, are placed temporarily on hold.
• Adverse event. An untoward or undesirable experience associated with the use of a medical product, such as a drug, device or biologic, in a patient or research subject.
• Advocate. An individual who has the background and experience to act in, and agrees to act in, the best interest of the child for the duration of the child's participation in the clinical investigation.
• Agent. For purposes of this document, an institution's employees or agents refers to individuals who (1) act on behalf of the institution, (2) exercise institutional authority or responsibility, or (3) perform institutionally designated activities. Employees and agents can include staff, students, contractors and volunteers, among others, regardless of whether these individuals are receiving compensation. A student's affiliation with an academic institution makes them an agent of that institution; and thus the academic institution is engaged in the research regardless of where the research takes place.
• Allegation of noncompliance. An unproven assertion of noncompliance.
• Alternate member. Alternate IRB committee members may be designated, as needed, for regular voting members. The appointment of alternate members should be based on expertise similar to that of the regular voting member. An alternate member may vote only when the regular voting member is absent.
• Anonymous data. Information that was previously recorded or collected without any of the 18 identifiers as defined by HIPAA, and no code is assigned that would allow data to be traced to an individual.
• Assent. A child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
• Assured institution. An institution with an FWA that has filed with the federal OHRP. Employees and agents of the institution holding an approved FWA are covered whenever they are involved in the conduct of the research covered by the FWA. Employees and agents are individuals performing institutionally designated activities and acting on behalf of the institution or exercising institutional authority or responsibility.
• Belmont Report. Report by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research identifying the basic ethical principles underlying the conduct of research involving human subjects, that is, respect for persons, beneficence and justice.
• Beneficence. Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. Two general rules have been formulated as expressions of beneficent actions (Belmont Report, 1978): (1) Do no harm, and (2) maximize possible benefits and minimize possible harms.
• Biologic product. A biological product (biologic) is a medical product. Many biologics are made from a variety of natural sources, such as humans, animals or microorganisms. Like drugs, some biologics are intended to treat diseases and medical conditions. Other biologics are used to prevent or diagnose diseases. Examples of biological products include:
  • Vaccines.
  • Blood and blood products for transfusion and or manufacturing into other products.
  • Allergenic extracts, which are used for both diagnosis and treatment, such as allergy shots.
  • Human cells and tissues used for transplantation, such as tendons, ligaments and bone.
  • Gene therapies.
  • Cellular therapies.
  • Tests to screen potential blood donors for infectious agents, such as HIV.
  • In general, the term "drugs" includes therapeutic biological products.
• Children. People 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.
• Clinical investigation. The FDA has defined clinical investigation to be synonymous with research. The FDA defines clinical investigation as 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 FDA or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit.
• Coded information and data. Identifying information that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol or combination thereof and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.
• Conflict of interest. Any interest that could reasonably be expected to affect the objectivity of an IRB member or consultant in relation to an application or other matter under IRB review. An IRB member or consultant has a conflict of interest if the individual:
  • Is or will be an investigator or member of the research team (that is, listed on the IRB application)
  • Has an immediate family member (that is, spouse, dependent children) or personal relationship with an individual serving as the principal investigator or co-principal investigator of the research
  • Has a financial or managerial interest in a sponsoring entity or product being evaluated or provided by a commercial entity in the research, as defined by Mayo Clinic Conflict of Interest Policy
  • Has received or will receive compensation with value (as defined by Mayo Clinic Conflict of Interest Policy) that may be affected by the outcome of the research project
  • Has a proprietary interest in the research, such as a nonprovisional patent application, patent, trademark, copyright or licensing agreement as defined by Mayo Clinic Conflict of Interest Policy
  • Has a nonfinancial interest (personal circumstance, ethical belief or other factor) that may be conflicting, for example, the IRB member has an interest that they believe conflicts with their ability to review a project objectively
  • Has responsibility for institutional business development, such as raising funds or garnering support for research or as an officer within the Department of Development
• Consent capacity. An individual's ability to understand and process information relevant to making an informed, voluntary decision to participate in research. Several kinds of information are crucial to such decisions, including an understanding of the purpose of the study, its experimental nature, risks and anticipated benefits, the right to withdraw, alternatives to participation, confidentiality protections, and the safeguards used to minimize risks. A wide variety of diseases, disorders, conditions, situations and injuries can affect a person's ability to understand such information, to weigh the advantages and disadvantages of participation in research, and to reach an informed decision regarding study participation.
• Consent document. A structured, written description in lay terms of relevant research project information. The written consent document is not consent itself; it is the record of what has been communicated to a prospective subject. It is the document, based on a template provided by the IRB and approved by the IRB, that ensures all regulatory elements are present and communicated to a potential subject. When signed by the potential subject, the consent document is a record of the receipt of research-related information by the subject. It also serves as reference material for the subject as the research project progresses. It is not legally binding, and the subject may choose to withdraw consent at any time.
• Consultant. A scientist or nonscientist from within or external to Mayo Clinic who has special expertise to act — at the request of the IRB — as an ad hoc reviewer of a human research project application. These individuals have access to all documents relevant to the specific project under review and may participate in the deliberations and make recommendations on the project but may not vote and are not counted toward quorum.
• Continuing noncompliance. Continuing noncompliance is a pattern of noncompliance that continues to occur after a report of noncompliance and a corrective action plan have been reviewed and approved by the IRB. Continuing noncompliance may also be a pattern of noncompliance that continues to occur after the IRB has directed the investigator to correct the issue(s).
• Continuing review. Periodic review of research activities at intervals appropriate to the degree of risk but not less than once a year. The criteria for approval are defined by federal regulations.
• Cooperative research project. Research projects that involve more than one institution as defined by federal regulations.
• Coordinating center. An institution, department or center that agrees to be responsible for the conduct and administrative or coordinating functions of a multicenter research project.
• Co-principal investigator (co-PI). Mayo Clinic investigator who plays a key role in scientific development and conduct of the study. The co-PI collaborates with the principal investigator who has overall responsibility for study conduct at Mayo Clinic (all campuses). Conditions of eligibility for the role of co-PI are the same as those for a PI. Students, residents, fellows and research temporary professional personnel (appointees) are not eligible to be a PI or co-PI on IRB or IACUC-approved research.
• Covered entity. HIPAA regulations apply to health plans, health care clearinghouses and health care providers who transmit health information. Any individual creating or accessing PHI for the delivery of health care at Mayo Clinic is within the covered entity.
• Custom device. Custom device means a device that:
  • Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist;
  • Is not generally available to, or generally used by, other physicians or dentists;
  • Is not generally available in finished form for purchase or for dispensing upon prescription;
  • Is not offered for commercial distribution through labeling or advertising; and
  • Is intended for use by an individual patient named in the order of a physician or dentist and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice (such as a particular operating tool).

• Data safety monitoring board (DSMB). An independent committee set up specifically to monitor data throughout the duration of a study to determine if continuation of the study is appropriate scientifically and ethically. Factors that suggest a DSMB is needed:

  1. A large study population.
  2. Multiple study sites. It is more difficult to recognize a pattern of increased or unusual problems or events when investigators treat small fractions of the population separately.
  3. Highly toxic therapies or dangerous procedures.
  4. High expected rates of morbidity or mortality in the study population.
  5. High chance of early termination of the study.

  DSMB membership is usually composed of experts in the fields of medicine and science that are applicable to the study — statistical experts, lay representatives and others who can offer an unbiased assessment of the study progress.

• Data safety monitoring plan (DSMP). A quality-assurance plan for a research study. A DSMP is meant to ensure that each clinical investigation has a system for appropriate oversight and monitoring of the conduct of the clinical investigation. The purpose of a DSMP is to ensure the safety of the participants, the validity of the data and integrity of the study, and the appropriate termination of studies for which significant benefits or risk has been uncovered or when it appears that the investigation cannot be concluded successfully. A DSMP is commensurate with the risks involved with the research study. The DSMP may include a DSMB.
• Data use agreement. An agreement into which Mayo Clinic and the investigator enter with the intended recipient of a limited data set that establishes the ways in which the information in the limited data set may be used and how it will be protected.
• dbGaP.  The National Institutes of Health (NIH) Genome-Wide Association Studies (GWAS) data repository is designated as the database of genotypes and phenotypes (dbGaP) at the National Center for Biotechnology Information (NCBI), a component of the National Library of Medicine (NLM).
• Dead fetus. A fetus that exhibits neither heartbeat, spontaneous respiratory activity, spontaneous movement of voluntary muscles nor pulsation of the umbilical cord.
• De-identified health information. Health information that has been stripped of all 18 identifiers as defined by HIPAA so that the information cannot be traced back to an individual. De-identified data also pertains to health information that has been assigned and retains a code or other means of identification provided that:
  • The code is not derived from or related to the information about the individual;
  • The code could not be translated to identify the individual; and
  • The covered entity does not use or disclose the code for other purposes or disclose the mechanism for re-identification.
  • The 18 identifiers:
    1. Names
    2. All geographical subdivisions smaller than a state, including street address, city, county, precinct, and ZIP code and equivalent geocodes, except for the initial three digits of a ZIP code if according to the current, publicly available data from the U.S. Census Bureau:
       1. The geographic unit formed by combining all ZIP codes with the same three initial digits contains more than 20,000 people, and
       2. The initial three digits of a ZIP code for all such geographic units containing 20,000 or fewer people are changed to 000
    3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, and date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older
    4. Phone numbers
    5. Fax numbers
    6. Electronic mail addresses
    7. Social Security numbers
    8. Medical record numbers
    9. Health plan beneficiary numbers
    10. Account numbers
    11. Certificate and license numbers
    12. Vehicle identifiers and serial numbers, including license plate numbers
    13. Device identifiers and serial numbers
    14. Web Uniform Resource Locators (URLs)
    15. Internet Protocol (IP) address numbers
    16. Biometric identifiers, including finger and voice prints
    17. Full-face photographic images and any comparable images
    18. Any other unique identifying number, characteristic or code (note this does not mean the unique code assigned by the investigator to code the data)
• Delivery. Complete separation of the fetus from the woman by expulsion or extraction or any other means.
• Device. An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory, that is:
  • Recognized in the official United States Pharmacopeia and National Formulary (USP-NF) or the United States Pharmacopeia, or any supplement to them;
  • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease in humans or other animals; or
  • Intended to affect the structure or any function of the body of humans or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of humans or other animals and which is not dependent on being metabolized for the achievement of any of its primary intended purposes.
• Disclosure of PHI. The release, transfer or provision of access to or divulging in any manner of information outside the covered entity.
• Documentation. The act or an instance of furnishing or authenticating with documents. Documentation of informed consent includes use of a written consent form approved by the IRB and signed and dated by the subject or the subject's legally authorized representative.
• Emergency research. Planned research involving human subjects who have a life-threatening medical condition that necessitates urgent intervention (for which available treatments are unproved or unsatisfactory), and who, because of their condition (such as traumatic brain injury) cannot provide informed consent.
• Emergency treatment IDE. A mechanism through the FDA for providing eligible participants with investigational devices for the treatment of an immediate serious or life-threatening illness for which there are no satisfactory alternatives.
• Emergency treatment IND. A mechanism through the FDA for providing eligible participants with investigational drugs, agents or biologics for the treatment of an immediate serious or life-threatening illness for which there are no satisfactory alternatives.
• Emergency use. Use of a test article on a human subject in a life-threatening situation in which no standard acceptable treatment is available, and in which there is not sufficient time to obtain IRB approval [21 CFR 56.102(d)].
  • Life-threatening includes both life-threatening and severely debilitating diseases or conditions where likelihood of death is high unless the course of the disease is interrupted, and diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival.
  • The criteria for life-threatening do not require the condition to be immediately life-threatening or to immediately result in death. Rather, the subjects must be in a life-threatening situation requiring intervention before review at a convened IRB meeting is feasible.
  • Severely debilitating: Diseases or conditions that cause major irreversible morbidity, such as blindness; loss of arm, leg, hand or foot; loss of hearing; paralysis; or stroke.
• Engagement of institutions in human subject research. An organization is considered engaged in human research when its employees or agents, for the purposes of the nonexempt research project, obtain:
  • Data about the subjects of the research through intervention or interaction with them;
  • Identifiable private information about the subjects of the research;
  • The informed consent of human subjects for the research; or
  • When the institution receives a direct federal award to conduct human subject research, even when all activities involving human subjects are carried out by a subcontractor (that is, employees or agents of another institution). See Engagement of Institutions in Human Subjects Research (2008).
• Enrollment. Occurs when an eligible, informed potential participant undergoes the initial informed consent process and voluntarily agrees to participate in a research project. Example: You enroll 100 to accrue 25. See also Accrual.
• Exempt human subjects research. Studies determined by the IRB to meet the exempt criteria as defined by the federal regulations. Exempt studies do not require periodic review by the IRB unless a change in the project is planned.
• Expedited review. A review of research involving human subjects by the IRB chair or by one or more experienced reviewers designated by the chair from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.
• Experimental subject as defined by the Department of Defense. Research involving a human being as an experimental subject is an activity for research purposes in which there is an intervention or interaction with a human being for the primary purpose of obtaining data regarding the effect of the intervention or interaction [32 CFR.210.102 (f) reference (c)]. Examples include, but are not limited to, a physical procedure, a drug, a manipulation of the subject or subject's environment, and the withholding of an intervention that would have been undertaken if not for the research purpose.
• Expired study. When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. The study expires on the date specified on the approval letter and the consent document. No activities can occur after the expiration date.
• External UPIRTSO. A problem or event involving research subjects enrolled by other institutions in multicenter research projects that fall under the purview of an external IRB, that is, not the Mayo Clinic IRB.
• Federalwide assurance (FWA). A formal, written, binding attestation in which an institution ensures the U.S. Department of Health and Human Services that it will comply with applicable regulations governing research with human subjects.
• Fetus. The product of conception from implantation until delivery.
• Final report. A report the principal investigator may elect to submit to the IRB to serve as a final record of any pertinent activity since the last continuing review report and to record research project completion.
• Fluctuating capacity. Capacity to consent may alter as a function of the natural course of an illness, response to treatment, effects of medication, general physical health and other factors. Therefore, a participant's ability to provide ongoing informed consent must be reevaluated periodically throughout the course of their participation in a study.
• Food and Drug Administration (FDA). The regulatory authority in the United States that oversees the pharmaceutical and medical device industries. The FDA is responsible for ensuring that the drugs and medical devices marketed in the U.S. are safe and have a greater benefit than risk when used according to manufacturer's directions.
• Full committee review. Studies reviewed by the full, convened IRB committee with a recorded vote and corresponding minutes to document the discussion.
• Genome-wide association study (GWAS). The National Institutes of Health policy defines GWAS as any study of genetic variation across the entire human genome that is designed to identify genetic associates with observable traits or the presence or absence of a disease or condition. This policy applies to genome-wide association research using genetic materials and data collected both prospectively and retrospectively.
• Greater than minimal risk. The research involves more than minimal risk to subjects.
• Guardian. An individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care when general medical care includes participation in research.
• HIPAA authorization. A customized document or form that gives permission to use specified PHI for a specific purpose, or to disclose PHI to a third party specified by the investigator other than for treatment, payment or health care operations.
• Human biospecimens. A quantity of tissue, blood, urine or other human-derived material. A single biopsy may generate several biospecimens, including multiple paraffin blocks or frozen biospecimens. The molecular makeup of such specimens reflects the physiological or pathological condition of the person from whom they derive; therefore, they provide sensitive and specific insight into the biological state of the donor. A biospecimen can include subcellular structures (such as DNA), cells, tissue (such as bone, muscle, connective tissue and skin), organs (such as liver, bladder, heart and kidney), blood, gametes, embryos, fetal tissue, and waste (such as urine and stool). Portions or aliquots of a biospecimen are referred to as samples. (Derived from National Cancer Institute Best Practices for Biospecimen Research.)
• Humanitarian use device exemption (HDE). An FDA approval for a physician to use a HUD in clinical treatment or as the subject of a clinical investigation.
• Humanitarian use device (HUD). A device that is intended to benefit patients by treating or diagnosing a disease or condition that affects fewer than 4,000 individuals a year in the U.S..
• Human specimen research repository. A collection of human specimens and associated data for research purposes, the physical structure where the collection is stored, and all relevant processes and procedures.
• Human subject as defined by the Department of Health and Human Services. A living individual about whom an investigator conducting research obtains data through intervention or interaction with them or with identifiable private information, or an individual who is or becomes a subject in research, either as a recipient of the test article or as a control.
  • Intervention: Includes both physical procedures through which data are gathered (for example, venipuncture) and manipulations of the subjects' environment that are performed for research purposes.
  • Interaction:  Includes communication or interpersonal contact with a subject or their private identifiable information.
  • Private information:  Includes information about behavior that occurs in a setting in which an individual can reasonably expect that no observation or recording is taking place. It includes information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (such as a medical record). Private information must be individually identifiable 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.
• Human subject as defined by the Department of Defense. This is defined as:
  • Research involving a human being as an experimental subject. An activity for research purposes in which there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction.
  • Research involving human subjects. An activity that both includes a systematic investigation designed to develop or contribute to generalizable knowledge and involves a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information.
• Human subject as defined by the FDA. 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. A human subject includes an individual on whose specimen a medical device is used.
  • Test article: Any drug (including a biological product for human use), medical device for human use, human food additive, color additive, electronic product or any other article subject to FDA regulation.
• Human subject identifier. Any word, number, symbol, or combination of words, numbers or symbols that can be used by a third party to uniquely identify an individual, such as name, Social Security number, address or patient registration number that is provided for use in a research protocol.
• Impaired consent capacity. Impaired consent capacity may involve partial impairment, impairment that fluctuates over time or complete impairment. For example, consent capacity can be affected by a wide range of disorders and conditions, such as dementia, stroke, traumatic brain injury, developmental disorders, serious mental illness, intoxication and delirium.
• Individually identifiable health information. Any information collected from an individual (including demographics) that is created or received by a health care provider, health plan, employer or health care clearinghouse that relates to the past, present or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present or future payment for the provision of health care to an individual and that identifies the individual or for which there is reasonable basis to believe that the information can be used to identify the individual.
• Informed consent. An ongoing process of communication between the participant and the study team. Informed consent is a continuing process through which a participant, after having been informed, voluntarily confirms their willingness to participate in a research project and can demonstrate understanding of all aspects of the research project that are relevant to the participant's decision to participate.
• Institutional official (IO). The IO who is the signatory on the FWA filed with the OHRP to ensure compliance with regulations governing protection of human subjects. The OHRP requires the institutional official to be a high-level official who has the authority to represent the institution named in the FWA.
• Institutional review board (IRB). A specifically constituted review body established or designated by an entity to protect the rights and welfare of human subjects recruited to participate in biomedical or behavioral or social science research.
• Interaction. Includes communication or interpersonal contact with a subject or their private identifiable information.
• Intervention. Physical procedures (such as venipuncture) through which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.
• Investigational agent. A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial. This includes products with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, products used for an unapproved indication, or products used to gain further information about an approved use.
• Investigational device. A device, including a transitional device, that is the object of an investigation.
• Investigational device exemption (IDE). Application document submitted to the FDA proposing human clinical research to study an unapproved significant risk device or a cleared or approved device for use other than its approved indication or intent. The FDA grants permission so a device that otherwise would be required to comply with a performance standard or to have premarket approval can be shipped lawfully for the purpose of conducting investigations of that device. This FDA permission is evidenced by the assignment of an IDE number.
• Investigational drugs or investigational biologics. New drugs or biologics that have not yet been approved by the FDA or approved drugs that have not yet been approved for a new use and are in the process of being tested for safety and effectiveness.
• Investigational new drug (IND). Application document submitted to the FDA proposing human clinical research to study an unapproved drug or an approved product for a new indication or in a new patient population in a research study. This includes new drugs that have not yet been approved by the FDA or approved drugs that have not yet been approved for a new use and are in the process of being tested for safety and effectiveness. This FDA permission is evidenced by the assignment of an IND number by the FDA or the granting of an IND exemption.
• IRB authorization agreement (IAA). A formal, written agreement in which the reviewing IRB agrees to serve as the IRB of record for a relying organization.
• IRB of record. A reviewing IRB that assumes IRB responsibilities for another organization and is designated to do so through an approved FWA on file with the federal OHRP. Note: Commercial IRBs will not have FWAs but must be registered with the OHRP.
• Label. The FDA-approved label is the official description of a drug or biologic product that includes indication (what the product is used for); who should take it; adverse events (side effects); instructions for uses in pregnancy, children and other populations; and safety information for the patient. Labels are often found inside product packaging.
• Legally authorized representative (LAR). 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 procedures involved in the research.
• Legally effective informed consent. A potential participant has been provided enough information to make a decision, the potential participant has the capacity to make a decision, the potential participant understands the consequences of his or her decision, and the potential participant can communicate that decision.
• Limited data set. A limited data set allows retention of specific elements of identifying private information: geographic subdivision, town, city, state, ZIP code, dates, age. Limited data sets are not considered to be de-identified information.
• Local research context. Knowledge of the institution and community environment in which human subjects research will be conducted.
• Material transfer agreement (MTA). A contract that governs the transfer of tangible research materials between two organizations when the recipient intends to use the materials for their own research purposes.
• Mayo Clinic. Mayo Clinic locations in Arizona, Florida and Rochester; Mayo Clinic Health System; and all owned and affiliated clinics, hospitals and entities.
• Medical device. A medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory that is:
  • Listed in the online FDA database Devices@FDA.
  • Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, in humans or other animals, or
  • Intended to affect the structure or any function of the body of humans or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of humans or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes [21 U.S.C. 321(h)].
• Minimal risk. 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.
• Minimal risk for prisoners. The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives or in the routine medical, dental or psychological examination of healthy persons.
• Modification. Any change to an IRB-approved study protocol regardless of the level of review it receives initially.
• Neonate. A newborn 0 to 28 days old.
• Nonaffiliated member. Any IRB member who is not currently affiliated with Mayo Clinic and whose immediate family members are not affiliated with Mayo Clinic. Examples of Mayo Clinic affiliation include employment, participation as a student in a Mayo Clinic academic program, or receipt of post-employment benefits, such as health and wellness or a pension.
• Noncompliance. An act or omission in the conduct or oversight of human subject research that represents a failure to follow (1) federal, state or local regulations, (2) institutional policies relevant to human subject research, (3) the approved research plan, and/or (4) the determinations of the IRB.
• Nonsignificant risk (NSR) device study.  A study of a device that does not meet the definition for a significant risk device and does not present a potential for serious risk to the health, safety or welfare of participants.
• Non-UPIRTSO. A reportable event that does not meet the Mayo Clinic IRB's definition of a UPIRTSO. See also Unanticipated problem involving risk to subjects or others (UPIRTSO).
• Nonviable neonate. A neonate after delivery that, although living, is not viable.
• Notification. Process of notifying research subjects of changes in the research by letter or phone.
• Office for Human Research Protection (OHRP). The office under the Department of Health and Human Services (HHS) responsible for implementing HHS regulations (45 CFR 46) governing biomedical and behavioral or social science research involving human subjects.
• Oral (verbal) consent. A spoken presentation of the elements of informed consent to the prospective subject or their legally authorized representative. The presentation may be based on information contained within an oral consent script or the written consent document. Oral consent is often associated with waiving the documentation of consent. Oral consent is usually recorded in the research project files.
• Permission. The agreement of parents or guardians to the participation of their child or ward in research.
• 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 a missed menses, until the results of a pregnancy test are negative or until delivery.
• Preparatory to research. Any action taken in assessing the research question or hypothesis, such as accessing medical records or querying databases for any type of individually identifiable health information, or any activity in which PHI is accessed to prepare a research protocol.
• Principal investigator (PI). Adheres to federal regulations, state and local laws, institutional policies, IRB policies, and procedures regarding the safety and protection of human subjects, and good clinical practice (GCP) guidelines. The principal investigator ensures adherence by:
  1. Supervising the research process.
  2. Taking responsibility for ensuring that key study personnel are properly trained and qualified and have appropriate facilities and resources to conduct the research.
  3. Ensuring adherence to the study protocol.
  4. Monitoring the informed consent process.
  5. Communicating regularly and effectively with the research staff.
  6. Taking responsibility for protecting the safety and welfare of research subjects.
• Prisoner. 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 that provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial or sentencing.
• Prisoner of war. Any person captured, detained, held or otherwise under the control of Department of Defense (DOD) personnel (military and civilian, or contractor employee) except DOD personnel held for law enforcement purposes (DOD directive 3216.2, section 4.42).
• Privacy versus confidentiality. Privacy is about people and their choice to share personal information. It is a right in health care and research. Confidentiality is about data. It is the investigator's obligation to protect subjects' information.
• Private information. Information about behavior that occurs in a setting in which an individual can reasonably expect that no observation or recording is taking place. It includes information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public, such as a medical record. Private information must be individually identifiable 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.
• Protected health information (PHI). Individually identifiable health information recorded in any form, or media that is created or received by a health care provider.
• Protocol violation/deviation. Any change, divergence or departure from the study design or research procedures that has not been approved by the IRB. Most protocol violations/deviations are considered noncompliance.
  • Major protocol violation/deviation. Any change that affects the rights and welfare of subjects and others, increases risks to subjects and others, decreases potential benefits, compromises the integrity or validity of the research, or represents willful or knowing misconduct.
  • Minor protocol violation/deviation. Any change that did not increase the risk or decrease the benefit or significantly affect the subject's rights, safety or welfare and/or the integrity of research data (for example, a routine lab missed at a visit and redrawn, shortening the duration between a planned study visit; using an outdated HIPAA form or consent form when there are no differences between the two forms other than the approval date).
• Reconsenting. Process of notifying research subjects of changes in the research, including documentation of the subjects' continued informed consent through signature on a revised written consent form.
• Recruitment. Recruitment, a component of the consent process, is the process of distributing or presenting information that describes the research project and eligibility criteria so that a prospective subject may consider enrollment.
• Relying organization. A relying organization has entered into an IRB authorization agreement with another organization's IRB.
• Reportable event. A process (with an associated IRB form) used by investigator to report any problem or event or other act or omission to the IRB that in their opinion is a UPIRTSO.
• Research activities. Research activity includes all contact with the research subject (such as enrolling subjects, intervention or interaction), data collection and data analysis.
• Research as defined by the Department of Health and Human Services. A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
• Research as defined by the Department of Defense (DOD). An activity that both includes a systematic investigation designed to develop or contribute to generalizable knowledge and involves a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information, or activities covered by section 32 CFR 219.101 (including exempt research involving human subjects) and DOD Instruction 3216.02.
• Research as defined by the FDA. Any experiment that involves a test article and one or more human subjects and to which any one of the following applies:
  • Must meet the requirements for prior submission to the FDA under section 505(i) of the Federal Food, Drug, and Cosmetic Act, meaning any use of a drug other than the use of an approved drug in the course of medical practice
  • 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, meaning any activity that evaluates the safety or effectiveness of a device
  • Any activity the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit
• Research involving a human being as an experimental subject as defined by the Department of Defense (DOD). An activity for research purposes in which there is an intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction. Research involving a human being as an experimental subject is a subset of research involving human subjects. This definition relates only to the application of section 980 of Title 10 USC; it does not affect the application of 32 CFR 219. This definition does not include activities that are not considered research involving human subjects, activities that meet the exemption criteria at section 32 CFR 219.101(b), and research involving the collection or study of existing data, documents, records or specimens from living individuals. Section 980 of Title 10 USC imposes limitations on waiving informed consent when using DOD-appropriated funds. Section 980 of Title 10 USC is applicable only to DOD-funded research involving a human being as an experimental subject. Section 980 of Title 10 USC is not applicable to exempt research involving human subjects.
• Screen failures. Subjects who consented to participate in research but who were disqualified during screening procedures.
• Serious adverse event. Any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, or results in a congenital anomaly or birth defect.
• Serious noncompliance. Any noncompliance that results in or has the potential to (a) substantially compromise the rights and welfare of subjects, (b) substantially impact the integrity and validity of the study data, and (c) compromise the integrity and effectiveness of the Mayo Clinic Human Research Protection Program.
• Short-form consent document. A written consent document stating that the elements of consent have been presented orally. A witness to the oral presentation is required.
• Significant new information. Information that indicates a significant new serious risk or increased severity of known risk, or a safety issue that requires immediate action.
• Significant risk (SR) device study. A study of a device that presents a potential for serious risk to the health, safety or welfare of a participant and:
  1. Is intended as an implant;
  2. Is used in supporting or sustaining human life, or otherwise prevents impairment of human health;
  3. Is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or
  4. Otherwise presents a potential for serious risk to the health, safety or welfare of a participant.

• Sponsor-investigator. An individual who both initiates and conducts an investigation and under whose immediate direction:

  1. The investigational drug is administered or dispensed, or
  2. The investigational device is administered, dispensed or used.

  The term does not include any person other than an individual.

• Study expiration. If IRB approval of a specific study expires before continuing review and approval occur, investigators must stop all research activities involving human subjects related to that study except where they judge that it is in the best interests of already enrolled subjects to continue to participate. When investigators make this judgment, they must promptly notify the IRB. When the IRB reviews the investigator's decision, it may decide whether it is in the best interests of already enrolled subjects to continue to participate in the research by considering the best interests of subjects either one at a time or as a group. If an IRB determines that it is not in the best interests of already enrolled subjects to continue to participate, investigators must stop all human subjects research activities, including intervening or interacting with subjects or obtaining or analyzing identifiable private information about human subjects. Investigators may resume the human subjects research activity once continuing review and approval by the IRB have occurred.
• Surrogate consent. Consent obtained from the participant's legally authorized representative (LAR).
• Suspension for cause. An action initiated by the IRB to stop temporarily some or all research procedures pending future action by the IRB or by the investigator or their personnel. Examples of a suspension for cause might include:
  • Inappropriate involvement of human subjects in research
  • Violation of the rights or welfare of human subjects or others
  • Serious or continuing noncompliance with federal regulations or IRB policies
  • New information regarding increased risk to human subjects or others
• Termination for cause. An action initiated by the IRB to stop permanently some or all research procedures.
• Test article. Any investigational drug, biologic product — such as blood or a vaccine — or medical device for human use.
• Therapeutic misconception. This term is used to describe the assumption by research participants that decisions about their care are being made solely with their benefit in mind. Therapeutic misconception can be defined as the situation in which participants or LARs either overestimate the direct therapeutic benefits that may be gained by participation in the research or underestimate the risks, thereby compromising their ability to provide or maintain a voluntary and knowing informed consent. Investigators must be especially careful to make participants and their families or caretakers aware of the differences between individualized treatment versus research and the separate and distinct roles of the clinician and the research investigator.
• Treatment investigational device exemption (IDE). A mechanism through the FDA for providing eligible participants with investigational devices for the treatment of a serious or life-threatening illness for which there are no satisfactory alternatives.
• Treatment investigational new drug (IND). A mechanism through the FDA for providing eligible participants with investigational drugs for the treatment of a serious or life-threatening illness for which there are no satisfactory alternatives.
• Unanticipated problem involving risk to subjects or others (UPIRTSO). Any problem or event that in the opinion of the local investigator meets all three of these criteria:
  • Serious: Serious problems or events that result in significant harm (which may be physical, psychological, financial, social, economic or legal) or places subjects or others at a greater risk of harm than was previously known or recognized. Note that actual harm need not have occurred for there to be a change in the risk-to-benefit ratio.
  • Unanticipated: A problem or event is unanticipated when it was unforeseeable at the time of its occurrence and is:
    • Not already described as a potential risk in the approved informed consent
    • Not already described as a potential risk in the approved protocol
    • Not listed in the investigator's brochure
    • Not part of an underlying disease
    • Occurring at an increased frequency or at an increased severity than expected
  • Related: A problem or event is related if it is possibly related to the research procedures.
• 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 a heartbeat and respiration.
• Vulnerable populations in research. Vulnerable populations may include (but are not limited to) individuals who are pregnant; prisoners; individuals who have been involuntarily committed to a medical facility; children; subordinates such as students, trainees and employees; individuals who are economically or educationally disadvantaged; individuals who have a language barrier; individuals with a cognitive disability; and individuals with an illness for which all standard treatment options have been exhausted. Federal regulations state that "when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects" [45 CFR 46.111(b)]. FDA regulations expressly identify "mentally disabled persons" as a vulnerable category of subjects in clinical investigations for which IRBs may need to assume increased responsibilities [21 CFR 56.107(a) and 56.111(b)].
• Ward. A child who is placed in the legal custody of the state or other agency, institution or entity, consistent with applicable federal, state or local law.
• Withdrawals. Subjects who were accrued but later withdrew from the study, either before or after receiving a study drug, device or intervention. This does not include screen failures.