DEFINITIONS

Administrative Hold: An action initiated by the Investigator in response to an IRB request to place specific research activities on hold temporarily to allow for additional information to be obtained.

Adverse Event: An untoward or undesirable experience associated with the use of a medical product in a patient.

Alternate Member: Alternate 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 which 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.

Assurance Agreement: A contract or agreement that establishes standards for human subjects research as approved by the Office for Human Research Protection (OHRP).

Authorization Agreement (AA): A formal agreement between Mayo Clinic and another institution that identifies the Mayo Clinic Institutional Review Board as the IRB of Record for that institution and defines the responsibilities for both the Mayo Clinic IRB and the other institution.

Children: Federal regulations define children as "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."

Clinical Investigation: FDA has defined 'clinical investigation' to be synonymous with 'research'. 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 / 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.

Conflicting Interest: Any interest that could reasonably be expected to affect the objectivity of a member with regard to a research study. A conflicting interest could include financial interests, personal or ethical beliefs, or other factors.

Continuing Non-compliance: A pattern of repeated actions or omissions taken by an Investigator that indicates a deficiency in the ability or willingness of an Investigator to comply with Federal regulations, Mayo Clinic IRB Policy, or determinations or requirements of the Mayo Clinic IRB.

Continuing Review: Periodic review of research activities at intervals appropriate to the degree of risk, but not less than once per year. The criteria for approval is defined by Federal regulations.

Continuous Quality Improvement (CQI): A methodology employed by the IRB Quality Team, when needed, to improve existing processes by identifying the root cause of a problem, developing and implementing an action plan, and evaluating the outcome to assure problem resolution. The methodology will use the PDSA cycle, which incorporates the following process: Plan, Do, Study, Act.

Cooperative Research Project: Research Projects which 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, administrative, or coordinating functions of a multi-center research project.

Covered Entity: HIPAA regulations apply to health plans, health care clearinghouses and health care providers who transmit health information. Any individual creating or accessing Protected Health Information (PHI) for the delivery of healthcare at Mayo Clinic is within the covered entity.

Custom Device: Custom device means a device that:

1. 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;
2. Is not generally available to, or generally used by, other physicians or dentists;
3. Is not generally available in finished form for purchase or for dispensing upon prescription;
4. Is not offered for commercial distribution through labeling or advertising; and
5. 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

DHHS: The Department of Health and Human Services.

Data Safety Monitoring Board (DSMB): A Data Safety Monitoring Board (DSMB) is 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/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 comprised 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 Data and Safety Monitoring Plan (DSMP) is meant to assure 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 insure the safety of the participants, the validity and integrity of the data, and the appropriate termination of studies for which significant benefits or risks have 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 can be as simple as the investigator annually submitting a narrative summary of his/her non-UPIRTSOs to the IRB or as complex as having a Data and Safety Monitoring Board (DSMB).

Data Use Agreement: An agreement between Mayo Clinic and the recipient of the PHI. This agreement establishes who is permitted to use or receive the limited data set; and provides that the limited data set recipient will:

1. Not use or further disclose the information other than as permitted by the data use agreement or as otherwise required by law;
2. Use appropriate safeguards to prevent use or disclosure of the information other than as provided for by the data use agreement;
3. Report to the covered entity any use or disclosure of the information not provided for by its data use agreement of which it becomes aware;
4. Ensure that any agents, including a subcontractor, to whom it provides the limited data set agrees to the same restrictions and conditions that apply to the limited data set recipient with respect to such information; and
5. Not identify the information or contact the individuals.

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 could not 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:

1. The code is not derived from or related to the information about the individual;
2. The code could not be translated to identify the individual; and
3. The covered entity does not use or disclose the code for other purposes or disclose the mechanism for re-identification.

List of 18 Identifiers

1. Names;
2. All geographical subdivisions smaller than a state, including street address, city, county, precinct, ZIP code, and their equivalent geocodes, except for the initial three digits of a ZIP code, if according to the current publicly available data from the Bureau of the Census: (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 is changed to 000;
3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, 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/license numbers;
12. Vehicle identifiers and serial numbers, including license plate numbers;
13. Device identifiers and serial numbers;
14. Web Universal 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; and
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.

Department of Health and Human Services (DHHS): The United States government's agency for protecting the health of all Americans and providing essential human services, especially for those who are least able to help themselves.

Designated Record Set: A group of records maintained by Mayo Clinic that includes medical and billing records about an individual for the purpose of treatment, payment, or provision of health care. Research records that are not contained in the participant's medical record are not likely to be part of the designated record set.

Directed Assessment: These assessments are conducted by the IRB Quality Team for the purpose of assessing the Investigator's compliance with: Federal regulations; state and local laws; and, Mayo Clinic Office for Human Research Protection – IRB – policies and procedures. These assessments of IRB approved research studies are in response to identified concern(s). Concerns may be identified by an IRB Committee, an external source (e.g. participant, family member or legal representative, OHRP, FDA or Sponsor), or an internal source (e.g. Mayo personnel).

Disclosure of PHI: The release, transfer, or provision of access to, or divulging in any manner of information outside the covered entity.

Emergency Research: Research conducted in participants who are in a life-threatening or emergent situation, where available treatments are unproven or unsatisfactory, and the collection of valid scientific evidence, which may include evidence obtained through randomized placebo-controlled investigations, is necessary to determine the safety and effectiveness of particular interventions.

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: The use of an investigational drug, agent, biologic, or device with a human subject in an immediate serious life-threatening situation in which no standard acceptable treatment is available and in which there is not sufficient time to obtain IRB approval.

Executive Committee: A representative group of IRB Members, IRB Staff, and IRB Administration that work in partnership to assure the protection of human research participants, maintain compliance with Federal regulations, and to promote consistency between IRB Committees.

Exempt Review: 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.

Ex Officio/Administrative Member: Ex officio and administrative members on the IRB Committees may include persons who are automatically members by virtue of the position held. These individuals do not have voting privileges and do not count toward quorum.

Expedited Review: Studies determined by the IRB to meet the expedited criteria as defined by the Federal regulations.

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.

Federalwide Assurance (FWA): A contract or agreement that establishes standards for human subjects research as approved by the Office for Human Research Protection (OHRP). Same definition as assurance agreement

Fetus: The product of conception from implantation until delivery.

Food and Drug Administration (FDA): The office responsible for implementing regulations governing the use of investigational drugs, biologics, devices and radiological procedures including radioactive drugs in clinical investigations with humans. The FDA is the federal oversight agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

Full Committee Review: Studies reviewed by the full, convened IRB Committee with a recorded vote and corresponding minutes to document the discussion.

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

Greater than Minimal Risk: Where the research involves greater than minimal risk to subjects, the mechanism of obtaining local research context differs depending on whether the local research context involves intervention or interaction with subjects and whether the principal risk associated with the local research context is limited to the potential harm resulting from a breach of confidentiality.

HIPAA Authorization: A customized document/form, that gives permission to use specified protected health information (PHI) for a specific purpose, or to disclose PHI to a third party specified by the Investigator other than for treatment, payment or healthcare operations.

Human Subject: A living individual about whom an Investigator (whether professional or student) conducting research obtains data through intervention or interaction with an individual or with his/her identifiable private information or an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.

1. Intervention: Includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subjects' environment that are performed for research purposes.
2. Interaction: Includes communication or interpersonal contact with a subject or their private identifiable information.
3. 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, which has been provided for specific purposes by an individual, and the individual can reasonably expect will not be made public (e.g., 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.
4. 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 Subjects Research: Any research that involves humans as subjects or any 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 in the United States per year.

Humanitarian Use Device Exemption (HDE): A Food and Drug Administration (FDA) approval for a physician to use a HUD in clinical treatment or as the subject of a clinical investigation.

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, and/or health care clearinghouse that relates to the past, present or future physical or mental health or condition of an individual, or 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 identifies the individual and/or to which there is reasonable basis to believe that the information can be used to identify the individual.

Informed Consent: An individual's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research.

Institutional Official: The FWA Institutional Official is a high-level individual who has the authority to represent the institution named in the Federalwide Assurance (FWA), as well as all the institutional components listed in the FWA. The intent in OHRP requiring that the Institutional Official be a high-level individual is two-fold. First, OHRP encourages institutions to promote a culture of conscience for the ethical conduct of human subjects research at the highest level within the institution. Second, the Institutional Official should be at a level of responsibility that would allow authorization of necessary administrative or legal action should that be required. Finally the Institutional Official cannot be the chair or member of any IRB designated under 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/social science research.

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: Any healthcare product that does not achieve its primary intended purposes by chemical action or by being metabolized. A medical device that is the subject of a clinical study designed to evaluate the effectiveness and/or safety of the device. Investigational use also includes clinical evaluation of certain modifications or new intended uses of legally marketed devices

Investigational Device Exemption: A FDA approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have pre-market approval to be shipped lawfully for the purpose of conducting investigations of that device.

Investigational Drugs/Investigational Biologics (Test Articles): A new drug or biologic that is used in a clinical investigation. The term investigational biologic also includes a biological product that is used in vitro for diagnostic purposes. Investigational drugs, agents, or biologics may include:

1. Products that are not generally recognized as being safe and effective for any use under the conditions prescribed, recommended, or suggested by the FDA; or
2. Products already approved by the FDA as safe and effective for specific indications that are being studied for new indications (or doses, strengths, or frequency).

Investigational New Drug (IND): FDA granting of permission that a new drug, agent or biologic may be used in humans prior to FDA review of clinical data that has determined that a particular new drug, agent, or biologic is safe and effective for a specific use. This FDA permission is evidenced by the assignment of an IND number by the FDA or the granting of an IND exemption.

Invited Guests: Any individuals invited to a meeting by the Committee by virtue of special knowledge or area of expertise (e.g. expert consultant). These individuals do not have voting privileges and do not count toward quorum.

IRB Committee Member: IRB Committee members include:

1. Scientific Member: Any IRB member who has a terminal degree in a medical or scientific field.
2. Non-Scientific Member: Any IRB member who does not have a terminal degree in a medical or scientific field.
3. Non-Affiliated Member: Any IRB member who is not a current or former employee or student of Mayo Clinic and who does not have an immediate family who is a current or former employee or student of Mayo Clinic.

IRB Education Team: Missing information

IRB Executive Committee: A representative group of IRB Members, IRB Staff, and IRB Administration that work in partnership to assure the protection of human research participants, maintain compliance with Federal regulations, and to promote consistency between IRB Committees.

IRB Quality Team: Missing information

IRB of Record: An IRB is considered the IRB of Record when it assumes IRB responsibilities for another institution and is designated to do so through an approved Assurance with OHRP. An IRB Authorization Agreement is required, designating the relationship, for Mayo Clinic to serve as the IRB of Record.

Legally Authorized Representative: 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.

Limited Data Set: Protected health information that excludes direct identifiers of the individual or of relatives, employers, or household members of the individual, with the exception of city, state, ZIP code, elements of dates, and other numbers, characteristics, or codes not listed as direct identifiers.

Local Research Context: Knowledge of the institution and community environment in which human subjects research will be conducted.

Major Modification: A proposed change in research related activities that materially affects an assessment of the risks and benefits of the study or substantially changes the specific aims or design of the study.

Mayo Training Program (MTP): An internet-based education module on the protection of human participants in research.

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. An example of minimal risk is the risk of drawing a small amount of blood from a healthy individual for research purposes (because the risk of doing so is no greater than the risk of doing so as part of a routine physical examination).

Minimal Risk for Prisoners: Minimal risk is 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

Minor Modification: A proposed change in research related activities that does not materially affect an assessment of the risks and benefits of the study and does not substantially change the specific aims or design of the study.

Modification: Any change to an IRB-approved study protocol regardless of the level of review it receives initially.

National Institutes of Health (NIH): Founded in 1887, the National Institutes of Health today is one of the world's foremost medical research centers, and the Federal focal point for medical research in the United States. The NIH, comprising 27 separate Institutes and Centers, is one of eight health agencies of the Public Health Service which, in turn, is part of the U.S. Department of Health and Human Services. The goal of NIH research is to acquire new knowledge to help prevent, detect, diagnose, and treat disease and disability, from the rarest genetic disorder to the common cold. The NIH mission is to uncover new knowledge that will lead to better health for everyone. NIH works toward that mission by: conducting research in its own laboratories; supporting the research of non-Federal scientists in universities, medical schools, hospitals, and research institutions throughout the country and abroad; helping in the training of research investigators; and fostering communication of medical and health sciences information.

National Science Foundation (NSF): The National Science Foundation (NSF) is an independent federal agency created by Congress in 1950 "to promote the progress of science; to advance the national health, prosperity, and welfare; to secure the national defense…" With an annual budget of about $5.58 billion, the NSF is the funding source for approximately 20 percent of all federally supported basic research conducted by America's colleges and universities. In many fields such as mathematics, computer science and the social sciences, NSF is the major source of federal backing.

Neonate: A newborn.

Non-Affiliated Member: Any IRB member who is not a current or former employee or student of Mayo Clinic and who does not have an immediate family who is a current or former employee or student of Mayo Clinic.

Non-Compliance: Failure to comply with Federal regulations, Mayo Clinic's Office for Human Research Protection – IRB – Policy, or the determinations or requirements of the Mayo Clinic IRB.

Non-Scientific Member: Any IRB member who does not have a terminal degree in a medical or scientific field.

Non-Significant 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-Unanticipated Problem Involving Risk to Subjects or Others (Non-UPIRTSO): A problem/event that does not meet Mayo Clinic's IRB definition of a UPRITSO. Non-UPIRTSOs may result from the action of the subject, Investigator, or staff.

Nonviable Neonate: A neonate after delivery that, although living, is not viable.

Not Less Than Once Per Year: All research proposals, with the exception of exempt proposals, must receive IRB continuing review at a minimum of once every 365 days, per Federal regulations. There are no exceptions or grace periods allowed.

Office for Human Research Protection (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.

Parent: A child's biological or adoptive parent.

Performance Site(s) Engaged in Research: A performance site becomes "engaged" in human subjects research when its employees or agents 1) intervene or interact with living individuals for research purposes, or 2) obtain individually identifiable private information for research purposes. Further, a performance site is considered to be "engaged" in human subjects research when it receives a direct Federal award to support the research.

Periodic Quality Review: Random assessments of the internal IRB department and external departments or sites involved in the conduct of human subjects research at Mayo Clinic conducted by the IRB Quality Team. These reviews are used to evaluate proper execution and accurate documentation of an IRB approved research project, internal and external quality reviews monitor the adherence to federal regulations, state and local law, Mayo Clinic IRB policies and procedures, adherence to the study protocol, accurate documentation and reporting of study related activities, and evaluation / observation of the consent process.

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, querying of databases for any type of individually identifiable health information, or any activity where PHI is accessed to prepare a research protocol.

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 which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.

Protected Health Information (PHI): Individually identifiable health information that is or has been collected or maintained by the covered entity in the course of providing healthcare that can be linked back to the individual participant.

Related: A problem/event is "related" if it is possibly, probably or definitely related to the research study.

Request for Modification: Investigators must obtain prior approval from the IRB for any modifications of the previously approved research, including modifications to the informed consent process and document, except those necessary to eliminate apparent immediate hazards to subjects as set forth in Federal regulations.

Research: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Serious: Serious problems/events can be well defined and include death; life threatening adverse experience; hospitalization: inpatient, new, or prolonged; disability/incapacity: persistent or significant; birth defect/anomaly; and/or per protocol OR may be problems/events that in the opinion of the local Investigator may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data.

Serious Non-Compliance: An action or omission taken by an Investigator that any other reasonable Investigator would have foreseen as compromising the rights and welfare of a participant. The following events will in most cases be considered Serious Non-compliance: (i) the conduct of any non-exempt research involving human subjects without IRB review and approval; (ii) enrollment of any human subject in a research study involving greater than minimal risk without informed consent; or (iii) implementation of substantive modifications involving possible risks to human subjects or others without IRB review and approval.

Scientific Member: Any IRB member who has a terminal degree in a medical or scientific field.

Short Form Consent: A written consent document stating that the elements of informed consent required by Federal regulations have been presented orally to the subject or the subject's legally authorized representative.

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-Imposed Hold: A determination from the sponsor of the study to place specific research activities on hold. This determination may be made for interim data analysis; inadequate drug availability; response to a DSMB report/recommendation; or a pre-planned stopping point.

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 has occurred.

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 his/her study personnel.

Termination for Cause: An action initiated by the IRB to stop permanently some or all research procedures.

Treatment 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 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: (unexpected) problems/events are those that are not already described as potential risks in the consent form, not listed in the Investigator's Brochure, or not part of an underlying disease. A problem/event is "unanticipated" when it was unforeseeable at the time of its occurrence. A problem/event is "unanticipated" when it occurs at an increased frequency or at an increased severity than expected.

Unanticipated Adverse Device Effect: any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem to participants or others associated with a device that relates to the rights, safety, or welfare of participants.

Unanticipated Problem Involving Risk to Subjects or Others (UPIRTSO): Mayo Clinic's IRB defines unanticipated problem/event involving risk to subjects or others (UPIRTSO) as any problem or event that was 1) Serious: Serious problems/events can be well defined and include death; life threatening adverse experience; hospitalization: inpatient, new, or prolonged; disability/incapacity: persistent or significant; birth defect/anomaly; and/or per protocol OR may be problems/events that in the opinion of the local Investigator may have adversely affected the rights, safety, or welfare of the subjects or others, or substantially compromised the research data 2) Unanticipated: (unexpected) problems/events are those that are not already described as potential risks in the consent form, not listed in the Investigator’s Brochure, or not part of an underlying disease. A problem/event is "unanticipated" when it was unforeseeable at the time of its occurrence. A problem/event is "unanticipated" when it occurs at a increased frequency or at a increased severity than expected AND 3) at least possibly Related: A problem/event is "related" if it is possibly 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 heartbeat and respiration.

Written Consent Form: A written consent document that includes the elements of informed consent required by Federal regulations.