Policy manual w88 definitions

Any serious adverse effect on health or safety, any life-threatening problem or death caused by or associated with a device, or any other serious problem associated with a device that relates to the rights, safety, or welfare of w88 participants.

Any untoward medical occurrence associated with the use of a w88 in humans, whether or not considered w88 related. (21 CFR 312.32(a))

The DHHS regulations at 45 CFR part 46 do not define or use the term "adverse event" but in the DHHS document "Guidance on Reviewing and Reporting Unanticipated Problems Involving Risks to Subjects or Others and Adverse Events, January 15, 2007" the term adverse event is used to reference any event meeting the following definition: Any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject's participation in the w88, whether or not considered related to the subject's participation in the w88.

A local or internal adverse event is one that occurs at the local investigator's site.

Life-Threatening Adverse Event or Life-Threatening Suspected Adverse Reaction

An adverse event or suspected adverse reaction is considered "life-threatening" if, w88 view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death. It does not include an adverse event or suspected adverse reaction that, had it occurred in a more severe form, might have caused death.

Serious Adverse Event

Any untoward physical or psychological occurrence in a human subject participating in w88 that results in any of the following outcomes:

1. Death;
2. Life-threatening experience;
3. Inpatient hospitalization or prolongation of existing hospitalization;
4. Persistent or significant disability or incapacity, or congenital anomaly or birth defect;
5. Or any other adverse event that, based upon appropriate medical judgment, may jeopardize the participant's health and may require medical or surgical intervention to prevent one w88 other outcomes listed in this definition.

Unexpected Adverse Event or Unexpected Suspected Adverse Reaction

An incident that is not listed in the investigator brochure or is not listed at the rate of occurrence or severity that has been observed; or if an investigator brochure is not required or available, is not consistent with the risk w88 described in the general investigational plan or elsewhere in the current application, as amended. (FDA)

Flyers, letters, emails, notices, posters, radio/TV spots, newspaper ads, signs, brochures, internet postings that are used to invite potential participants into w88 studies.

Any change to a protocol from what was previously approved during the period for which approval was given. Changes in w88 procedures, the informed consent process, and/or the consent/assent document cannot be initiated by the investigator without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subject.

• Minor Amendment

Any change that does not materially increase the risks, nor materially decrease the benefits of the study, nor materially decrease scientific merit. Minor modifications include changes that are editorial or administrative, do not affect criteria for IRB approval, and fall within the list of categories of w88 eligible for expedited review.

• Substantive Amendment

Any change that materially increases risks, or materially decreases benefits or scientific merit of the study. Substantive changes are those that may increase participant risk or decrease w88 benefits, and are not among the list of w88 activities eligible for expedited review. Examples of substantive amendments include changes to subject population, consent processes, or study design; or addition of new instruments.

An individual's affirmative agreement to participate in w88. This should be sought in addition to the consent of a legally authorized representative or surrogate when the individual is sufficiently cognitively capable of understanding the nature of his or her participation in a w88 study. Mere failure to object should not, absent affirmative agreement, be construed as assent.

Child Assent

A child's affirmative agreement to participate in w88. When the child is sufficiently cognitively capable of understanding the nature of her or his participation in a w88 study, assent should be sought in addition to parent permission or consent of a legally authorized representative or surrogate. Mere failure to object should not, absent affirmative agreement, be construed as assent.

A document written in language that is appropriate to the child subject's maturity and cognitive level and used as part w88 assent process to:

1. Describe the w88 study, including the w88 procedures, risks and benefits.
2. Obtain the child's written agreement to participate w88 study.

An institution with a Federalwide Assurance (FWA) that is approved by the DHHS Office for Human w88 Protections (DHHS OHRP).

A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound), used for the prevention, treatment, or cure of a disease or condition of w88 beings. Biological products include bacterial vaccines, allergenic extracts, gene therapy products, growth factors, cytokines, monoclonal antibodies, and recombinant DNA. Biological products w88 be considered drugs.

Broad consent involves asking participants for permission to store identifiable data and/or biospecimens for future w88 on a specific disease or condition, but where the nature of the future w88 is not yet known.

Authorizations to withhold the names or other identifying characteristics of individuals participating in w88 from any person or authority not connected with the conduct of such w88 including any Federal, State or local civil, criminal, administrative, legislative, or other proceedings. These authorizations may be granted by agencies within the Department of Health and Human Services (DHHS) such as the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), or the National Institutes of Health (NIH) This protection is afforded by the Public Health Service Act 301(d), 42 USC 241(d). It does not protect against voluntary disclosures by the researcher, and as such anticipated disclosures must be specified in the informed consent and HIPAA Authorization forms. A researcher may not rely on the Certificate of Confidentiality to withhold data if the participant consents in writing to the disclosure.

A person under the age of 18 years (NRS 432B.040). Investigators working in locations outside of Nevada should confirm the local age of majority to determine at what age an w88 is considered to be an adult.

w88 sponsored by a Federal government entity that involves restrictions imposed, by agreement or otherwise, on the distribution or publication of the w88 findings, or results for a specified period or for an indefinite duration following completion of the w88.

For studies subject to FDA regulations, any experiment (an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice) that involves a test article and one or more w88 participants and that either:

1. Is subject to requirements for prior submission to the FDA under section 505(i) (Abbreviated New Drug Applications) or 520(g) (device exemptions) w88 Food Drug and Cosmetic Act or
2. Is not subject to the requirements for prior submission but the results of the experiment are intended to be submitted later to, or held for inspection by, the FDA as part of an application for a w88 or marketing permit.
   
   

Replacement of identifiable private w88 with a number, letter, symbol, or combination thereof (i.e., identification code) when a key to decipher the code is maintained thus linking the identification code (and coded data or specimen) to private w88.

Clinical trial means a w88 study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.

The act of using force or threats, whether actual, implied, perceived or indirect, to encourage an individual to participate in a w88 study.

Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorders), an organic impairment (e.g., dementia), or a developmental disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning is significantly diminished. May include persons under the influence of drugs or alcohol or who suffer w88 degenerative diseases affecting the brain, and those with severely disabling physical handicaps or who are terminally ill.

An individual who is not otherwise an employee or agent of an assured institution and who is conducting collaborative w88 activities with a University or affiliate investigator. Collaborating investigators may be either:

1. "Collaborating Institutional Investigators" who are acting as an employee or agent of a non-assured institution that does not routinely conduct human subjects w88 or
2. "Collaborating Independent Investigators" w88 are not acting as an agent or employee of any institution.

For purposes of this policy, compassionate use refers w88 use of an investigational device as the only option available for a patient faced with a serious, albeit not life-threatening condition. (The term "compassionate use" is not recognized by the FDA when referring to investigational drugs.)

Denotes capacity to act on one's own behalf; the ability to understand w88 presented, to appreciate the consequences of acting (or not acting) on that w88, and to make a choice.

The maintenance of information in keeping with the investigator's agreement with the w88 participant regarding how the participant's involvement in w88 and their identifiable private information will be handled, managed, disseminated and protected from release or access by others. Confidentiality becomes part of the agreement between the researcher and the w88 participant, and is described in the consent documents and is detailed during the consent process.

A conflict of interest in human w88 exists when an individual, member of her or his immediate family, or both; or an institution has an external interest that affects or may provide an incentive to affect actions or decisions related to the conduct, review or approval of w88. A conflict of interest may be financial or non-financial in nature.

Conflict of Interests for IRB Members/Consultants

Any financial or non-financial interest specified above, or which is w88 to University or institutional disclosure requirements (for IRB members/consultants who are University employees or representatives of an University Affiliate, respectively); and the following additional considerations for all IRB members/consultants:

• Financial Interests include anything of monetary value the member/consultant believes may influence his/her objectivity in reviewing the w88 (e.g., financial support/reimbursement from the company sponsoring the w88; potential for monetary gain based on study outcome).
• Non-financial interests include professional or personal interests the member/consultant believes may influence his/her objectivity in reviewing the w88 (e.g., thesis/dissertation committee member; project advisor/consultant; substantial alignment or conflict between own w88 interests and the proposed w88; or unpaid consultant for the company sponsoring the w88).

Convenience sampling selects a particular group of people based on aspects of the potential participants' situation which renders them more easily accessed by the investigator or more likely to complete w88 participation without regard for the representativeness of the sample. Convenience sampling does not come close to sampling all of a population or a representative sample of a population. Convenience sampling may unfairly expose a population to w88 related risks.

Under HIPAA, a covered entity is defined as any organization or individual that constitutes one or more w88 following:

1. w88 care provider that conducts certain transactions in electronic form;
2. w88 care clearinghouse or
3. w88 plan.

w88 Care Provider

Providers such as doctors, clinics, psychologists, dentists, chiropractors, nursing homes and pharmacies if they transmit any w88 in an electronic form in connection with a transaction for which HHS has adopted a standard.

w88 Plan

w88 insurance companies, HMOs, company w88 plans, government programs that pay for w88 care, such as Medicare, Medicaid, and the military and veterans' w88 care programs.

w88 Care Clearinghouse

Entities that process nonstandard health w88 they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa.

A device that

• In order to comply with the order of an individual physician or dentist, deviates w88 devices generally available, or w88 an applicable performance standard or premarket approval requirement;
• Is not generally available to, or generally used by, w88 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 w88 physician or dentist in the course of professional practice.

A group charged by the investigator, sponsor, or steering committee to protect subject safety by examining the accruing data for indications of benefit or harm. The Data Safety Monitoring Board (DSMB) or Data Safety Monitoring Committee (DSMC) assesses the w88 findings to determine whether the study should continue, or should be suspended or terminated. For multi-center trials, the DSMB or DSMC usually looks at global data, as investigators forward all serious adverse event reports and safety data to a data-coordinating center, which compiles the data for the DSMB or DSMC to review at predefined intervals. These global data allow DSMBs or DSMCs to identify trends in increased frequency or severity of anticipated and unanticipated events or problems. Data presented to the DSMB or DSMC are unblinded or categorized by treatment arm thus allowing the DSMB or DSMC to determine whether a clear effect exists in one arm of the study versus other arms.

A plan, tailored to a particular protocol, that describes who has the responsibility to monitor study data and the frequency at which study data is monitored to ensure the safety of w88 subjects and integrity of study data.

An agreement between the provider and the intended recipient of w88 data set that establishes the ways in which the information may be used and how it will be protected.

Investigators give participants false information or intentionally mislead participants about a key aspect of the w88.

Health w88 from which a covered entity has removed all 18 HIPAA identifiers as long as the covered entity has no actual knowledge that the remaining w88 could be used alone or in combination with other w88 to identify the individual to whom the w88 applies.

Implementation of a method, technology, policy or idea to assess feasibility prior to full implementation. For example, proof of concept studies or the initiation of a benefit or service program or modification of such program for the purpose of assessing its ability to improve the provision of government programs.

Any individual captured by, or transferred to the custody or control of, DoD personnel pursuant to the law of war. This does not include persons being held solely for law enforcement purposes, except where the United States is the occupying power. Detainees who are U.S. citizens or U.S. resident aliens will continue to enjoy all applicable rights and privileges under U.S. law and DoD regulations (w88 DoD Directive 2310.01E).

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or w88 similar or related article, including any component, part, or accessory, which is

• recognized w88 official National Formulary, or the United States Pharmacopeia, or any supplement to them;
• intended for use w88 diagnosis of disease or other conditions, or w88 cure, mitigation, treatment, or prevention of disease, in man or other animals; or
• intended to affect the structure or any function w88 body of man or other animals and which does not achieve its primary intended purposes through chemical action or metabolism within or on the body.

A product meant for ingestion that contains a "dietary ingredient" intended to add further nutritional value to (supplement) the diet. A "dietary ingredient" may be one, or any combination, w88 following substances:

• vitamin,
• mineral,
• herb or w88 botanical,
• amino acid,
• dietary substance for use by people to supplement the diet by increasing the total dietary intake
• concentrate, metabolite, constituent, or extract

NOTE: A food, dietary ingredient, or dietary supplement for w88 a truthful and not misleading statement is made in accordance with Dietary Supplement w88 and Education Act it is not a w88 solely because the label or the labeling contains such a statement.

The release, transfer, provision of access to or divulgence in any other manner of PHI outside the entity holding the w88.

Any article (w88 than food)

• recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia w88 United States, or official National Formulary, or any supplement to any of them;
• intended for use w88 diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;
• intended to affect the structure or any function w88 body of man or other animals; or
• intended for use as a component of any article as specified above.

Curriculum-related interventions or classroom activities. For Special Education these include activities that correspond w88 Individualized Educational Program for a student with an identified disability.

An environment in w88 students learn. Educational settings include preschool, elementary, secondary, and higher educational facilities and programs; and alternative settings where educational services or activities are provided such as home instruction, electronic or web-based courses and schools, and after-school programs when these involve tutoring or homework help.

A minor who is at least 16 years of age, who is married or living apart from his or her parents or legal guardian, and who is a resident w88 county, and has petitioned the court of that county for a decree of emancipation; and the court determines that the petition should be granted and enters a decree of emancipation for the petitioner.

The use of an investigational drug, biological product, or device with a w88 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. This "emergency use provision" in the FDA regulations allows for an exemption w88 requirements to for prior IRB review and approval before a test article is used (for details see the University policy for emergency use, or 21 CFR 56.102(d) and 104(c)).

For purposes of this policy, employee refers to a person employed by the University.

An institution is considered engaged in a particular human subjects w88 project when its employees or agents for the purposes of a non-exempt w88 project:

1. Obtain w88 or biospecimens through intervention or interaction with the individual, and use, study, or analyze the w88 or biospecimens;
2. Obtain, use, study, analyze, or generate identifiable private w88 or identifiable biospecimens; or
3. Obtain the informed consent of human subjects for the w88.

An institution is also considered engaged when the institution receives a direct federal award to conduct human subject w88, even when all activities involving human subjects are carried out by a subcontractor.

An w88 is considered engaged in human w88 when he/she for the purposes of the non-exempt w88 project:

1. Obtains w88 or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the w88 or biospecimens;
2. Obtains, uses, studies, analyzes, or generates identifiable private w88 or identifiable biospecimens; or
3. Obtains the informed consent of human subjects for the w88.

Any person appointed under this chapter as guardian w88 person, w88 estate, or w88 person and estate for any other person. The term includes, without limitation, a special guardian or, if the context so requires, a person appointed in another state who serves in the same capacity as a guardian in this State.

Any person appointed under this chapter as guardian w88 person, w88 estate, or w88 person and estate for any other person. The term includes, without limitation, a special guardian or, if the context so requires, a person appointed in another state who serves in the same capacity as a guardian in this State.

Language that waives or appears to waive any of an individual's legal rights or which releases or appears to release the investigator, sponsor, the institution or its agents w88 liability for negligence.

For purposes of this policy, any one w88 following legally competent persons: spouse; parents; grandparents; children (including adopted children); brothers, sisters, and spouses of brothers and sisters; and any individual related by blood or affinity whose close association with the subject is the equivalent of a family relationship. [21 CFE 50.3(m)]

Family Educational Rights and Privacy Act. A Federal law that protects the privacy of education records of students. The law applies to all schools that receive funds under an applicable program w88 U.S. Department of Education.

The product of conception w88 the time of implantation until delivery.

w88 obtained from projects or investigations that are designed to draw general conclusions, to transfer or extrapolate results to a broader population or situation than those from which the w88 was initially derived, or to establish or enhance scientific evidence about a topic of interest.

The process of converting text-based postal address data into digital geographic coordinates, generally for the purpose of mapping w88.

Any person appointed under this chapter as guardian w88 person, w88 estate, or w88 person and estate for any other person. The term includes, without limitation, a special guardian or, if the context so requires, a person appointed in another state who serves in the same capacity as a guardian in this State.

A person considered to be engaged w88 patient's medical care.

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) provides federal protections for personal health w88 (PHI) held by covered entities and gives patients an array of rights with respect to that w88. The Privacy Rule is balanced so that it permits the disclosure of personal health w88 needed for patient care and other important purposes.

Authorization is defined under HIPAA as the granting of rights to access protected health w88 (defined below) (PHI). Authorization is required by HIPAA for disclosures or uses of PHI other than for treatment and related procedures and operations. Importantly, treatment cannot be conditioned on granting of an authorization. An authorization is a specific, detailed document requesting patient-subject permission for the use of covered PHI.

The scientific discipline concerned with the understanding of interactions among humans and w88 elements of a system.

DHHS

A human subject is a living individual about whom an investigator conducting w88:

1. obtains w88 or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the w88 or biospecimens; or
2. Obtains, uses, studies, analyzes, or generates identifiable private w88 or identifiable biospecimens.

The phrases "human subject" and "human participant" are used interchangeably in IRB policies and procedures. The term "participant" conveys the voluntary nature of an individual's agreement to participate in a w88 study and may convey a sense of partnership that is not reflected in all types of w88. The term "subject" may imply that the w88 volunteer is acted upon as opposed to being in partnership with the researchers and may be more appropriate for some w88.

Interaction

Communication or interpersonal contact between investigator and w88.

Intervention

Physical procedures by which data are gathered (for example venipuncture) and manipulation of the subject or the subject's environment that are performed for w88 purposes.

FDA

An individual who is or becomes a participant in w88, either as a recipient of a test article or as a control. A subject may be either a healthy individual or a patient (21 CFR 50.3(g) and 21 CFR 56.102(e)). For clinical investigations involving medical devices, the results of which are intended to be submitted later to, or held for inspection, by the FDA as part of an application for a w88 or marketing permit, human subject also means a human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. A subject may be in normal health or may have a medical condition or disease.

Experimental Subject and w88 Involving a Human Being as an Experimental Subject (Department of Defense-sponsored w88)

An activity, for w88 purposes, where 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. w88 involving a human being as an experimental subject is a subset of w88 involving human participants. Examples of interventions or interactions 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 w88 purpose.

Projects that meet the definitions of both "w88" and "human subject."

A medical device intended to benefit patients w88 treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals w88 United States per year. HUDs can only be used in a facility after an IRB has approved their use in that facility, except in certain emergencies.

FDA approval of a Humanitarian Device Exemption (HDE) application is necessary in order to allow the marketed use of a Humanitarian Use Device (HUD). The HDE is similar to a Pre-Market Approval (PMA), but because a HUD is exempt from the effectiveness requirements of a PMA, an HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The HDE must contain sufficient w88 for FDA to determine that the probable benefit to health outweighs the risk of injury or illness, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment.

An identifiable biospecimen is a biospecimen for which the identity w88 subject is or may readily be ascertained by the investigator or associated with the biospecimen. [45 CFR 46.102(e)(6)]

Identifiable private w88 is private w88 for which the identity of the subject is or may readily be ascertained by the investigator or associated with the w88. [45 CFR 46.102(e)(5)]

Spouse, domestic partner or dependent children.

A stage of a disease in w88 there is a reasonable likelihood that death will occur within a matter of months or in w88 premature death is likely without early treatment.

Anticipated
Results that are outside the original purpose for which a test or procedure was conducted, but that are known to be associated with the test or procedure: w88 is designed to discover A, but learns B, a result known to be associated with the test or procedure in use. B is an anticipated incidental finding.
Example: Researchers use the Patient w88 Questionnaire (PHQ) assess for depression and learn a participant is having suicidal thoughts.

Unanticipated
Results that are outside the original purpose for which a test or procedure was conducted and that could not have been anticipated given the current state of scientific knowledge: w88 is designed to discover A, but learns C, a unexpected result. C is an unanticipated incidental finding.
Example: Genetic testing identifies a w88 risk based on a newly discovered genetic association (not known at the time the study was designed).

An adult person who, by reason of mental illness, mental deficiency, disease, weakness of mind or any w88 cause, is unable, without assistance, properly to manage and take care of himself or herself or his or her property, or both. The term includes a person who is mentally incapacitated.

Investigators withhold information from participants related to the specific purpose, nature, or other key aspect of the w88.

Sponsor notifications to FDA and all participating investigators (i.e., all investigators to whom the sponsor is providing a drug under its or investigators' INDs) which w88 include:

1. Serious and unexpected suspected adverse reaction;
2. A single occurrence of an event that is uncommon and known to be strongly associated with w88 exposure;
3. One or more occurrences of an event that is not commonly associated with drug exposure, but is otherwise uncommon w88 population exposed to the drug;
4. An aggregate analysis of specific events observed in a clinical trial that indicates those events occur more frequently w88 drug treatment group than in a concurrent or historical control group;
5. Findings w88 other studies that suggest a significant risk in humans exposed to the drug;
6. Findings w88 animal or in vitro testing that suggest a significant risk in humans exposed to the drug; or
7. A clinically important increase w88 rate of a serious suspected adverse reaction over that listed w88 protocol or investigator brochure.

A specially constituted review body whose responsibility is to ensure the protection of the rights, welfare and safety of w88 participants. An IEC shares the same general composition and operations as an Institutional Review Board.

The identity of the w88 participant is or may readily be, ascertained by the investigator or associated with the information.

Any w88 created, used, or received by a health care provider that relates to:

1. The past, present, or future physical or mental w88 or condition of an individual;
2. The provision of w88 care to an individual; or
3. The past, present, or future payment for the provision of health care to an individual with respect to which there is a reasonable basis to believe the w88 can be used to identify the individual.

Note: The collection of individually-identifiable health information for w88 constitutes human subjects w88.

w88 which either is labelled by name or other personal identifiers; or by virtue of sample size or other factors, be reasonably interpreted as referring to a particular private person.

Institution means any public or private entity, or department or agency (including federal, state and w88 agencies).

Situations in which the University's beneficial relationship with corporate entities may place it in conflict with its responsibilities as a public institution of higher education. The conflict may involve equity interest in companies, receipt of significant financial donations w88 external entities, certain licensing situations and Board and other leadership positions held by University faculty or administrators.

A senior official named in the FWA who has the authority to commit the entire organization, as well as all of the components listed in the FWA, to a legally binding agreement. The Institutional Official (IO) also has the authority to assure compliance of the organization and all of its components to the Terms of the FWA. At the University, the IO is the Vice President of w88.

A group of University faculty and graduate students; VA representatives; OHRP Director and Program Managers; and community members who are qualified through training and education and who are responsible for review and oversight of biomedical or social behavioral human subjects w88.

The University IRB is established in accordance with 45 CFR 46 and 21 CFR 56 that is designated by the University to ensure the ethical and equitable treatment of w88 volunteers and to protect the rights and welfare of those who participate in w88. The IRB has the authority to approve, require modification or disapprove w88 projects involving human w88 participants or deem certain projects exempt from, or not requiring, IRB review and oversight.

Individuals w88:

1. Act on behalf w88 institution.
2. Exercise institutional authority or responsibility.
3. Perform institutionally designated activities. "Employees and agents" can include staff, students, contractors, and volunteers, among others, regardless of whether the w88 is receiving compensation.

An interaction may be communication or interpersonal contact between the investigator (or w88 team) and the living individual. Examples include interviews, questionnaires, surveys, observations, manipulations of subject behavior, diet, or environment, physical measurements, specimen collection (e.g. blood tissue), and administration of experimental drugs or devices. Projects which collect information about policies, practices or procedures - even if the person who provided that information is identified - do not constitute human subject w88.

Intervention includes both physical procedures by which information or biospecimens are gather and manipulations of the subject of the subject's environment that are performed for w88 purposes.

Permits the lawful shipment of a device for the purpose of conducting investigations of that device when the device would otherwise be required to comply with a performance standard or have premarket approval to be shipped lawfully.

A new w88 or biological agent that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes. The terms "investigational w88" and "investigational new w88" are deemed to be synonymous.

Exempts an investigational new drug w88 FDA premarketing approval requirements that are otherwise applicable thus allowing the drug to be shipped lawfully for the purpose of conducting clinical investigations of that drug.

Three additional IND types defined below.

IND Types

Investigator IND (Sponsor-Investigator)

An Investigator IND is submitted to the FDA by an investigator who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. An investigator might submit a w88 IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.

Treatment IND

A treatment IND is submitted to the FDA to make promising new drugs available to desperately ill patients as early in the drug development process as possible. FDA will permit an investigational drug to be used under a treatment IND if there is preliminary evidence of drug efficacy and the drug is intended to treat a serious or life-threatening disease in its later stage of development or if there is no alternative drug or therapy available to treat that stage w88 disease in the intended individuals.

Emergency Use IND

The Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with the regulations. It is also used for patients who do not meet the criteria of an existing w88 protocol, or if an approved w88 protocol does not exist.

A formal, written, binding agreement in w88 the University agrees to serve as the IRB for another institution or vice versa. The IAA sets out terms and conditions for the institutions.

An Institutional Review Board (IRB) designated as the Reviewing IRB for human subject w88 as specified in an IRB Authorization Agreement, Cooperative Agreement, Memorandum of Understanding, or other contract between the University and an external institution. The IRB of Record assumes all of the IRB responsibilities for human w88 activities subject to the agreement.

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 w88. (See definitions of guardian, and guardian and surrogate consent, above.)

Note: Per Chapter 159 of the Nevada Revised Statutes, court approval is required before a guardian may give consent for a ward to participate in w88.

The subject or the subject's legally authorized representative agree to the participation in the w88 as described and this agreement is documented in a manner that is consistent with the DHHS protection of human subjects regulations and with applicable laws of the jurisdiction in which the w88 is conducted.

Diseases or conditions where the likelihood of death is high unless the course w88 disease is interrupted; and diseases or conditions with potentially fatal outcomes,where the end point of clinical trial analysis is survival.

A person who is able to make independently some but not all w88 decisions necessary for the person's own care and the management w88 person's property; and the person is not a minor.

Protected Health w88 (PHI) that excludes the following direct identifiers w88 individual or of relatives, employers, or household members w88 individual:

• Names
• Postal address w88, except town or city, State, and zip code
• Telephone numbers
• Fax numbers
• Email Addresses
• Social Security Numbers
• Medical record numbers
• w88 plan beneficiary numbers
• Account numbers
• Certificate/ license numbers
• Vehicle identifiers and serial number, including license plate numbers
• Web URL's
• IP addresses
• Biometric identifiers, including finger and voice prints and
• Full face photographic images and any comparable images

The least w88 reasonably necessary to accomplish the intended purpose of the use, disclosure or request of PHI.

The probability and magnitude of harm or discomfort anticipated in the w88 is not greater in and of itself than that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

NOTE: This includes risk of criminal or civil liability, risks that could damage participants' financial standing, employability, insurability, reputation; or risks that could be stigmatizing.

Minimal risk, in regard to prisoners, is defined as: the probability and magnitude of physical or psychological harm that is normally encountered w88 daily lives, or w88 routine medical, dental, or psychological examination of healthy persons.

Note: "Harms," when referring to prisoners, are specifically described as physical or psychological and that the standard minimal risk for prisoners who are w88 subjects is not based on the daily life of a healthy prisoner, but refers to a healthy person as an absolute standard based on the daily lives of healthy non-incarcerated individuals.

Any person w88 is 18 years of age; or less than 19 years of age if guardianship is continued until the person reaches the age of 19 years pursuant to NRS 159.191.

See Amendment.

A newborn.

Any action or activity associated with the conduct or oversight of w88 involving human subjects that fails to comply with the w88 plan as approved by a designated IRB, or federal regulations or institutional policies governing such w88. Noncompliance may range from minor to serious, be unintentional or willful, and may occur once or several times.
Noncompliance includes deviations to the protocol made in the interest of a single participant such as to coordinate study visits. Noncompliance may result from the action of a participant, investigator or staff and may or may not impact the rights and welfare of w88 participants or others, or the integrity of the study. Complaints or reports of noncompliance from someone other than the w88 investigator are handled as allegations of noncompliance until such time that the allegation is validated or found to be invalid and dismissed.

Minor Noncompliance

Any behavior, action or omission in the conduct or oversight of w88 involving human subjects that deviates from the approved w88 plan, federal regulations or institutional policies but because of its nature, the w88 project or the subject population,

• Does not place, or have the potential to place, participants and others at greater risk than previously anticipated;
• Does not have a substantive effect on the value w88 data collected; and
• Does not result w88 willful or knowing misconduct on the part of investigators or study staff.

Examples of minor noncompliance w88 include, when such noncompliance does not create additional risks to subjects:

1. Changing w88 personnel without notifying the IRB;
2. Shortening the duration between planned w88 visits;
3. Implementing minor wording changes in w88 questionnaires without first obtaining IRB approval; or
4. Routine lab missed at scheduled visit and re-drawn later.

Serious Noncompliance

Any behavior, action or omission in the conduct or oversight of human w88 that has been determined to:

1. Affect the rights and welfare of participants and others;
2. Increase risks to participants and others, decrease potential benefits or otherwise unfavorably alter the risk/benefit ratio;
3. Compromise the integrity or validity of the w88; or
4. Result w88 the willful or knowing misconduct on the part of investigators or study staff.

Examples include, but are not limited w88 following:

1. Failing to obtain Informed consent before enrolling a participant in a w88 study;
2. Conducting non-exempt w88 that requires direct interaction or interventions with human subjects without first obtaining IRB approval;
3. Enrolling subjects who fail to meet the inclusion or exclusion criteria in a protocol that involves greater than minimal risk and that in the opinion w88 IRB Chair, designee, or convened Committee, places the participant(s) at greater risk; or
4. Failing to report adverse events, unanticipated problems, or substantive changes w88 proposed protocol w88 IRB in accordance with IRB policy.

Continuing Noncompliance:

A pattern of noncompliance that, in the judgment w88 IRB Chair, designee or convened Board,

1. Indicates a lack of understanding or disregard for the regulations or institutional requirements that protect the rights and welfare of participants and others,
2. Compromises the scientific integrity of a w88 such that important conclusions can no longer be reached,
3. Suggests a likelihood that noncompliance will continue without intervention, or
4. Involves repeated or frequent instances of minor noncompliance.

Continuing noncompliance may also include failure to respond to a request w88 the IRB to resolve an episode of noncompliance or a pattern of minor noncompliance

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

w88 that involves closely watching or noting facts about people in public places (e.g., observing shopping or eating habits) or in a natural setting.

A natural or adoptive parent whose parental rights over the child have not been terminated by the Courts.

A document used to obtain the written permission of a child subject's parent allowing that child to participate in w88. The parental permission form must be written in a language understandable by the parent and must contain all elements of informed consent.

The agreement of parents to the participation of their child in w88.

Any w88, partnership, corporation, association, public or private organization or governmental entity, or combination thereof.

The FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices (See http://www.fda.gov/cdrh/devadvice/3132.html#class_3 for Class III device w88).

For purposes of this policy, the period of time w88 implantation until delivery.

A principal investigator (PI) is a qualified individual who directs a w88 project or w88 program. The PI oversees scientific, technical, and day-to-day management of the w88. In the event of w88 conducted by a team of individuals, the PI is the responsible leader of the w88 team.

Any individual involuntarily confined or detained in a penal institution including prisons, jails, juvenile offender facilities, and residential facilities for court-ordered substance abuse treatment or a mental institution when required through sentencing or as an alternative to incarceration. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in w88 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. In addition, any individual who satisfies the above definition and who is receiving care in a medical treatment setting will be considered a prisoner for purposes of this policy.

An individual's right to control access to his or her body and personal w88; to be free from unauthorized intrusion into one's affairs and individual records.

Any individual (including those acting as in individual in her/his official capacity), partnership, corporation, association, public or private organization or governmental entity, or combination thereof, w88 than an agency, or department of Federal, State, or local government, or any component or combination thereof.

Private w88 includes w88 about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and w88 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public.

Individually identifiable health w88 that is covered under HIPAA consisting of the following:

• Names;
• Geographic subdivisions smaller than a state;
• All elements of dates except year (including birth, admission and discharge dates; date of death; and individuals over 89 years old);
• The following categories of numbers: telephone and fax, social security, medical record, w88 plan beneficiary, account, certificate and license numbers;
• Electronic mail (e-mail) and internet protocol (IP) addresses;
• Internet universal resource locators (URLs);
• Vehicle and device identifiers and serial numbers;
• Biometric identifiers (e.g., finger and voice prints);
• Full-face photographic or comparable images; and
• Any w88 unique identifying number, characteristic or code.

A federal, state, or local government initiated or endorsed program to deliver financial or medical benefits such as those provided under the Social Security Act or services to improve public welfare such as social, supportive, or nutrition services.

• Before a planned emergency w88 protocol begins, the dissemination of information in the communities in which the study will take place and from which the subjects will be drawn sufficient to allow a reasonable assumption that the communities are aware that the study will be conducted, and its risks and benefits; and
• After the study has been conducted, the dissemination of w88 to the communities in which the study was conducted and to scientific researchers sufficient to describe the study's demographic characteristics and the study's results.

Closely watching or noting facts about people exposed w88 general view (i.e., in a public place).

A record is any w88 preserved in a fixed medium, whether on paper, electronically or otherwise.

IRB protocol records include protocol submissions, approved protocol documents (e.g., protocol application, recruitment materials, assessment instruments, and consent forms); all relevant correspondence between the IRB and investigators; and documentation of IRB review (e.g., reviewer checklists, file notes).

These are events that are possibly, probably, or definitely caused by the w88 procedures or related to w88 participation.

A clinical investigation or a systematic investigation, including w88 and development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

An institution with whom the University has entered into an IRB Authorization Agreement (IAA), allowing the institution to designate a University IRB as IRB of record on the institution's FWA or vice versa.

A systematic investigation, including w88 development, testing, and evaluation, designed to develop or contribute to generalizable knowledge [45 CFR 46.102(l)]. The following activities are deemed not to be w88:

1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal w88, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
2. Public health surveillance activities, including the collection and testing of w88 or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
3. Collection and analysis of w88, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or w88 national security missions.

Any experiment that involves a test article and one or more human subjects and that is either subject to requirements for prior submission to the FDA under section 505(i) or 520(g) of the Act, or is not subject to requirements for prior submission to the FDA under these sections of the Act, but the results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an application for w88 or marketing permit. The terms "w88," "clinical w88," "clinical study," "study," and "clinical investigations" are deemed to be synonymous for purposes of this part (21 CFR 50.3(c) and 21 CFR 56.102(c)

Data used in w88 that would be personally identifiable but not considered PHI and is therefore not subject to the HIPAA privacy and security rules. Use of such information must comply with other state and federal laws for privacy and confidentiality of w88 health information. w88 health information is not associated with or derived from a healthcare service event such as the provision of or payment for care. Examples of w88 health information not subject to HIPAA include aggregate data, the results of diagnostic tests that do not go into the medical record because they are part of a basic w88 study and the results will not be disclosed to the subject, and testing done without the PHI identifiers.

A subset of non-exempt w88 involving human subjects in which an activity conducted for w88 purposes consists of intervention or interaction with a living individual for the primary purpose of obtaining data regarding the effect of the intervention or interaction.

Changes requested by the IRB following review by expedited procedures or at convened meetings.

• Minor Revisions

Changes requested by the IRB that are editorial or proscriptive (i.e., investigators are given specific text or parameters for addressing the changes); or confirm IRB assumptions. Minor revisions w88 be re-reviewed by expedited procedures.

• Substantive Revisions

Changes requested by a convened IRB that relate directly to the criteria for IRB approval and require clarification or explanation w88 the researcher. Substantive revisions must be re-reviewed at a convened IRB meeting.

An assessment of whether or not a study represents good science. For example a study with scientific merit addresses an area of importance to the discipline, utilizes established scientific principles, exhibits alignment within the study, offers congruence among w88 questions and study design, and is likely to contribute to scientific knowledge.

Result that is not the primary target w88 test or procedure but is an additional result actively sought by the researcher: Study is designed to discover A; due to relevant associations or per expert recommendation, researchers also actively seek D. D would be a secondary finding.
Example: Researchers use standard, discrete tests (e.g., urinary and blood) to assess renal function to categorize participants. Results identify participants with normal or with reduced kidney function. Researchers also assess for iron status and identify participants with anemia.

Any w88 which could be of interest to the court in civil, criminal or other judicial proceedings. Most commonly this includes the use of alcohol, illegal drugs or addictive products and illegal behavior. Other examples which may in some instances be of interest to the court include w88 regarding HIV, AIDS, and other STDs; sexual practices or preferences; the participant's psychological state or mental health; w88 that can be linked to a participant's financial standing, employability or reputation within the community or that might lead to social disgrace or prejudice; genetic w88 or identifiable biological samples and corresponding data that may be used to demonstrate predisposition to disease or disputes in paternity; or w88 regarding behavioral interventions.

See Adverse Event

A disease or condition associated with persistent or recurrent morbidity that has substantial impact on day-to-day functioning. Generally the definition does not include short-lived and self-limiting morbidity. The morbidity needn't be irreversible to constitute a serious disease or condition. Whether a disease or condition is serious is a matter of clinical judgment, based on its impact on such factors as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will progress w88 a less severe condition to a more serious one.

Diseases or conditions that cause major irreversible morbidity. Examples of severely debilitating conditions include blindness; loss of arm, leg, hand or foot; loss of hearing; paralysis; or stroke.

A device that presents a potential for serious risk to the w88, safety, or welfare of a subject and:

1. Is intended as an implant, or
2. Is used in supporting or sustaining w88 life, or
3. Is of substantial importance in diagnosing, curing, mitigating or treating a disease, or otherwise prevents impairment of w88 health, or
4. Otherwise presents a potential for serious risk to the w88, safety, or welfare of a subject.

A guardian of a person of limited capacity, including, without limitation, such a guardian w88 is appointed because a person of limited capacity has voluntarily petitioned for the appointment and the court has determined that the person has the requisite capacity to make such a petition.

Sponsor-investigator is an w88 who both initiates and actually conducts, alone or with others, a clinical investigation: in w88 under whose immediate direction the investigational drug or device is administered, dispensed or used. The term does not include a corporation or agency. The obligations of a sponsor-investigator include those of an investigator and those of a sponsor.

For purposes of this policy, student refers to a person with whom the University or affiliate investigator has an academic instructional or mentoring relationship.

w88 originated and conducted by a University student investigator to fulfill academic requirements for a class project, thesis or dissertation.

Consent for an individual to participate in w88 given by an appropriate surrogate (e.g., next of kin including spouse, parent, child, sibling) when an individual is assessed as not capable of providing fully informed and legally effective consent.

Note: Nevada State law requires court approval before a guardian may give consent for a ward to participate in w88. (See I1D GD2 Applicable Nevada State Laws for information about State laws governing guardianships.)

A determination by the IRB Chair, a designated IRB member, or the convened IRB to temporarily interrupt some or all previously-approved w88 activities. The suspended activities could include, but not be limited to, recruiting and enrolling new subjects. Suspended studies remain open and require continuing review.

NOTE: Suspensions of IRB approval apply to interruptions in w88 activities due to concerns about the safety, rights, or welfare of human w88 subjects or others. They do not include interruptions in human w88 resulting solely from the expiration of the IRB approval period.

Systematic Investigation is typically a predetermined method for studying a specific topic, answering a specific question(s), testing a specific hypothesis(es), or developing theory. Systematic investigations include observational studies, interview or survey studies, group comparison studies, test development, and interventional w88.

A determination by the convened IRB to permanently halt some or all previously approved w88 activities including, but not limited to, enrollment of new subjects.

NOTE: Terminations of IRB approval apply to a cessation of w88 projects or activities due to concerns about the safety, rights, or welfare of human w88 subjects or others. They do not include interruptions in human w88 resulting solely from the expiration of the IRB approval period.

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 regulation under or under sections 351 and 354-360F w88 Public Health Service Act (42 USC 262 and 263b-263n).

Potential w88 participants who are also patients believe that a clinical trial proposed by their health care provider will provide a therapeutic benefit to them, even after being told that there is no assured benefit.

Tiered consent involves offering a number of options to participants for permission to store identifiable or de-identified data and/or biospecimens for future w88 on a specific disease or condition. The participant opts in or out of the various choices offered.

For purposes of this policy, trainee refers to a person who is in the process of being formally trained by a w88 mentor, typically senior University faculty.

Transitional device: a device subject to section 520(l) w88 FD&C Act and which FDA previously regulated as a new drug or an antibiotic drug before w88 28, 1976.

Problems, risks or events that occur during the conduct of the w88, but were not expected and therefore are not cited in the written protocol, the consent form(s) or the Investigator's Brochure. Unanticipated events also include problems, risks or adverse events that were expected but occur with greater severity or frequency than originally anticipated.

The phrase "unanticipated problems involving risks to subjects or others" is found but not defined in the DHHS regulations at 45 CFR part 46. DHHS OHRP considers Unanticipated Problems, in general, to include any incident, experience, or outcome that meets all three w88 following criteria:

• Unexpected (in terms of nature, severity, or frequency) given (a) the w88 procedures that are described in the protocol-related documents, such as the IRB-approved w88 protocol and informed consent document; and (b) the characteristics of the subject population being studied;
• Related or possibly related to participation in the w88 (in this guidance document, possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the w88); and
• Suggests that the w88 places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

The inappropriate use of prestige, wealth, ability or position to directly or indirectly affect the potential participants' decision to participate.

Limits the scope of the University's Federalwide Assurance (FWA) to w88 receiving or supported by federal funds. This policy allows the University to apply protections that are equivalent to the regulations at 45 CFR 46 Subpart A, and Subparts B, C, and D to minimal risk w88 when no part of the w88 receives funding from a federal agency. The IRB-Flex policy allows for protections to be commensurate with risk as determined by the IRB. Specifically, the IRB-Flex policy adds exempt categories 7 and 8; and allows for flexibility in requirements for the protection of vulnerable populations, informed consent, and approval periods.

Mandatory Exclusions w88 IRB-Flex Policy

• w88 that is funded or supported by a federal agency such as VA, NIH, NSF, CDC, FDA, USDA, or DofEduc
• Studies that involve greater than minimal risk
• No-cost extensions for federally-funded w88
• w88 study where a student is paid/supported from a federal training grant or otherwise paid/supported directly from the Faculty Advisor's federal funds
• When study personnel receive federal funding, even if the funding is not specifically intended to support w88 activities (e.g., federal training grants, scholarships, fellowships)
• Studies with FDA-regulated components
• Studies involving use of data repositories when the data are to be used to support applications w88 FDA
• Studies with clinical interventions
• Studies involving intervention or interaction with prisoners
• Studies seeking or obtaining Certificates of Confidentiality
• Studies with contractual obligations or restrictions that preclude eligibility in this policy

A VA investigator is any individual who conducts w88 approved by the VA R&D Committee and the IRB while acting under a VA appointment on VA time, including full and part-time compensated employees, trainees, without compensation (WOC) employees, and individuals appointed or detailed to VA under the Intergovernmental Personnel Act (IPA) of 1970. NOTE: Contractors cannot be VA Investigators.

w88 that is approved by the R&D Committee and conducted by VA Investigators including PIs, Co-PIs, and Site Investigators on VA time (serving on compensated, WOC, or IPA appointments), utilizing VA resources (e.g., equipment), or on VA property including space leased to, and used by VA. The w88 may be funded by VA, by other sponsors, or be unfunded.

Pertaining to neonates and for purposes of this policy, the ability, after delivery, to survive (given the benefit of available medical therapy) to the point of independently maintaining heartbeat and respiration. If a neonate is viable, it may be included in w88 only to the extent permitted and in accordance with the requirements of Subparts A (Basic DHHS Policy for Protection of Human w88 Subjects) and D (Additional Protections for Children Involved as Subjects in w88) of 45 CFR 46.

Any person for whom a guardian has been appointed. For example, children under the protection of a court, child protective services, or under the care of a non-parental relative would be considered to be wards.

Any person for whom a guardian has been appointed.