AAHRPP (Association for the Accreditation of Human Research Protection Programs, Inc.) - An organization that offers accreditation to research organizations that provide comprehensive protections to research participants.
Accrual - The number of subjects that have completed or are actively in the process of completing a research study. It is the number of subjects enrolled in a study. It does include drop outs.
Active Project - Is a research project that is considered "open" at The University of Iowa. The HawkIRB system currently recognizes the following stages in the life of a project:
Pending - A project has been submitted to the Human Subjects Office (HSO) and is currently under review by the HSO and/or the IRB. It has not received a formal IRB determination or IRB approval.
Withdrawn - A project that was withdrawn from the HawkIRB system prior to IRB approval.
Disapproved - A project which was reviewed by the IRB and not granted IRB approval.
Open - A project that has obtained IRB review and approval. Research related activities can begin or are underway.
Closed - A project status which indicates all research related activities have ended.
Adverse Event - An undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention (e.g., headache following spinal tap or intestinal bleeding associated with aspirin therapy; subject becomes emotionally upset after considering question on research survey, etc.).
Agent of the Organization - Agents include all individuals performing institutionally designated activities or exercising institutionally delegated authority or responsibility.
Assent - Agreement by an individual not able to give legally valid informed consent (i.e., a child or cognitively impaired person) to participate in research.
CBPR - Community-Based Participatory Research; The widely accepted definition of CBPR by the WK Kellogg Foundation defines CBPR as a, “...collaborative approach to research that equitably involves all partners in the research process and recognizes the unique strengths that each brings. CBPR begins with a research topic of importance to the community and has the aim of combining knowledge with action and achieving social change to improve health outcomes and eliminate health disparities.”
CBR - Community-Based Research; Research WITH the Community where the community members are participating to some degree in the research process.
CEnR - Community Engaged Research; Community-engaged research is a framework or approach for conducting research, characterized by specific principles that guide the research and the relationships between the communities and academic researchers. Community-engaged research requires partnership development, cooperation and negotiation, and commitment to addressing local health issues.
Chair - Chair or Vice-Chair, as designated on UI IRB roster submitted to OHRP, unless otherwise indicated.
*Children (Child) -
DHHS definition: 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.
FDA definition: persons who have not attained the legal age for consent to treatments or procedures involved in clinical investigations, under the applicable law of the jurisdiction in which the clinical investigation will be conducted.
*For purposes of research conducted in Iowa, the term “child” as used in both the DHHS and FDA regulations is analogous to “minor” under Iowa Code and is viewed as “an unmarried person under the age of eighteen years.” (Based on Iowa Code §600A.2 (12))
Clinical Investigation -
-any experiment that involves a test article and one or more human subjects and that is one of the following:
Subject to requirements for prior submission to the Food and Drug Administration under section 505(i)or 520(g) of the act, or
Is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act but the results of which are intended to be submitted later to , or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit.
The term does not include experiments that are subject to the provision of 21 CFR 58, regarding
Nonclinical laboratory studies. [21 CFR 50.3(c); 21 CFR 56.102(c)]
-any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects. For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice. [21 CFR 312.3(b)]
(Investigation): a clinical investigation or research involving one or more subjects to determine the safety or effectiveness of a device. [21 CFR 812.3(h)]
Coded Data - Identifying information (such as name or social security number) 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 (i.e., the code); and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.
Coercion - Occurs when an overt or implicit threat of harm is intentionally presented by one person to another in order to obtain compliance. For example, an investigator might tell a prospective subject that he or she will lose access to needed health services if he or she does not participate in the research.
Community Partner - The University of Iowa, Human Subjects Office (HSO) designated term for community-based organizations or independent individuals who work with University of Iowa Principal Investigators to conduct community-based research. Other terms used in the research world to describe this relationship include: research affiliate; community-partner; collaborating institution; collaborating independent individual; etc.
Confidentiality - The ethical or legal right that information is considered private and will be held secret unless consent is provided permitting disclosure.
Conflict of Interest - involves a situation in which faculty, staff, or student employees have a financial interest or other personal consideration that may compromise, or have the appearance of compromising, their professional judgment in performing their University duties (e.g. teaching; clinical care; designing, conducting, or reporting research; business decision-making; or performing other University obligations).
a. "Investigator" means the principal investigator or project director and any other person, whether faculty, staff, or student and regardless of title or position, who has the authority to make independent decisions related to the design, conduct, or reporting of University research. Also includes subgrantees, contractors, collaborators, or consultants of the University.
b. "Significant financial interest" means anything of monetary value or potential monetary value held by an investigator (and by the investigator's spouse and dependent children), and that reasonably appears to be related to the investigator's institutional responsibilities, as follows:
With regard to any publicly traded entity, remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. [For purposes of the definition of "significant financial interest," remuneration includes salary and any payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, paid authorship), equity interest includes any stock, stock option, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value.]
With regard to any non-publicly traded entity, the value of any remuneration received from the entity in the calendar year preceding the disclosure, when aggregated, exceeds $5,000, or any equity interest (e.g., stock, stock option, or other ownership interest);
Intellectual property rights and interests (e.g., patents, copyrights), upon receipt of income related to such rights and interests; or
A position giving rise to a fiduciary duty, such as director, officer, partner, trustee, employee, or any position of management.
For investigators applying for or conducting research funded by the PHS, any reimbursed or sponsored travel related to the investigator's institutional responsibilities (i.e., travel is paid on behalf of the investigator and not reimbursed to the investigator so that the exact monetary value may not be readily available). Disclosure of this interest will include the purpose and duration of the trip, the identity of the sponsor/organizer, and the travel destination.
c. Prior to submission/initiation of research. Prior to the investigator's submission of a grant application or the University's execution of a cooperative agreement or sponsored research contract, or prior to initiation of any human subjects research, whether funded or not, each investigator is required to submit a disclosure form describing any financial interest held by the investigator, the investigator's spouse, or any dependent child of the investigator that the investigator determines to be reasonably related to the investigator's institutional responsibilities. In those cases where the University has determined that a financial conflict of interest exists, no research funds may be expended and no research may begin until the investigator has agreed in writing to any management plan required by the University for this research.
For UI IRB members only, the following indicate a conflict of interest with a protocol under review:
s/he serves as a co-investigator or other member of the research team or
a member of his/her immediate family serves as a co-investigator or other member of the research team
Continuing Noncompliance - Any noncompliance that occurs repeatedly to the point of suggesting a pattern or an underlying problem. Continuing noncompliance may occur due to lack of knowledge (unintentional) or due to deliberate choice to ignore regulations or determinations of the IRB (intentional).
Continuing Review - The PI must submit a Continuing Review form prior to 12:01 am on the date the approval for the study expires. The IRB is required to conduct a Continuing Review of all non-exempt research projects at intervals appropriate to the degree of risk, but not less than once a year.
Contribute - To be an important factor in.
Designed - Done with a purpose or intent.
Existing (Data, Documents, Records, Pathological or Diagnostic Specimens) - Existing with regards to these materials means the items must be “on the shelf” or in existence at the time the project is submitted to the IRB for review.
Expedited Review - Expedited review means that an individual IRB chair (or his/her IRB chair designee), are responsible for the review and approval of a research study and the HawkIRB application does not need to be reviewed by the full IRB Board. Under the regulations only those studies that are minimal risk qualify for this type of review. Expedited review does not mean that the review occurs quickly.
Federal Agency Other than DHHS that is subject to “The Common Rule”
Any one of the following:
- Agency for International Development (22 CFR 225)
- Central Intelligence Agency (Executive Order)
- Consumer Products Safety Commission (16 CFR 1028)
- Department of Agriculture (7 CFR 1c)
- Department of Commerce (15 CFR 27)
- Department of Defense (32 CFR 219)
- Department of Education (34 CFR 97)
- Department of Energy (10 CFR 745)
- Department of Homeland Security (Public law 108-458 Sec. 8306)
- Department of Justice (28 CFR 46)
- Department of Transportation (49 CFR 11)
- Department of Veteran’s Affairs (38 CFR 16)
- Environmental Protection Agency (40 CFR 26)
- Housing and Urban Development (24 CFR 60)
- National Aeronautics and Space Administration (14 CFR 1230)
- National Science Foundation (45 CFR 690)
- Office of Science and Technology Policy (Adoption of policy)
- Social Security Administration (Public law 7.5.26)
Federalwide Assurance (FWA) - Assurance of compliance with Department of Health and Human Services (DHHS) regulations pertaining to the protection of human subjects. The federal Office for Human Research Protections (OHRP) requires that an institution/organization have an OHRP-approved assurance of compliance with the DHHS regulations (45 CFR 46.103) if the institution/ organization is engaged in human subjects research that is conducted or supported by any agency of the DHHS. The University of Iowa, FWA#00003007.
FERPA (Family Education Rights and Privacy Act) - A federal law of 1974 that protects the privacy of student education records.
Full Board - Comprised of a chair and sufficient number of board members who review and vote on all new studies, continuing reviews and modifications that are considered to be greater than minimal risk or contain a new or novel component proposed as part of the research study.
Full Board Group - Team of HSO staff specializing in the processing of IRB applications that require full board biomedical (01 or 03) review.
Guardian - A person who is not the parent of a child, but who has been appointed by a court or juvenile court having jurisdiction over the child, to have a permanent self-sustaining relationship with the child and to make important decisions which have a permanent effect on the life and development of that child and to promote the general welfare of that child. A guardian may be a court or a juvenile court. Unless otherwise enlarged or circumscribed by a court or juvenile court having jurisdiction over the child or by operation of law, the rights and duties of a guardian with respect to a child shall be as follows:
To consent to marriage, enlistment in the armed forces of the United States, or medical, psychiatric, or surgical treatment.
To serve as a guardian ad litem, unless the interests of the guardian conflict with the interests of the child or unless another person has been appointed guardian ad litem.
To serve as custodian, unless another person has been appointed custodian.
To make periodic visitations if the guardian does not have physical possession or custody of the child.
To consent to adoption and to make any other decision that the parents could have made when the parent-child relationship existed.
To make other decisions involving protection, education, and care and control of the child.
[Iowa Code 232.2(21)]
Generalizable - Intent to draw conclusions from research which will develop or contribute to a general body of knowledge.
HawkIRB - HawkIRB is The University of Iowa’s electronic application system for human subject researchers and the IRB. The goal of HawkIRB is to provide a nearly-paperless system that provides information to the investigator about the IRB review and approval process as it occurs.
HIPAA (Health Insurance Portability and Accountability Act) - A federal law of 1996, the HIPAA Privacy Rule provides federal protections for personal health information held by covered entities and gives patients an array of rights with respect to that information.
HIPAA Letter - A letter used by non-UI “covered entities” to document compliance with the HIPAA Privacy Rule. The UI IRB requires this letter, or similar documentation, from the covered entity in instances when a covered entity, for research purposes, gives UI researchers access to protected health information maintained by that entity without the patient’s explicit authorization.
HSRD form (Human Subjects Research Determination Form) - An electronic tool in HawkIRB that uses a short series of questions to assess whether or not a research proposal constitutes as "human subjects research."
Human Subject -
DHHS definition: a living individual about whom an investigator (whether professional or student) conducting research obtains a) data through intervention or interaction with the individual, or b) identifiable private information. [45 CFR 46.102.(d)]
FDA definitions (Human Participant): an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A participant may be either a healthy human or a patient. [21 CFR 50.3(g)]
Also (Subject): 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. [21 CFR 812.3(p)]
OHRP definition: a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information. [45 CFR 46.102.(d)]
Human Subjects Office (HSO) - The University of Iowa, Human Subjects Office (HSO) was established by the Vice President for Research to provide administrative support for the University of Iowa Institutional Review Boards.
Human Subjects Protection Training (CITI) - All members of a research team conducting human subjects research at the University of Iowa or at the Iowa City VAMC are required to complete an education program and become "certified" in human subject protections through the Collaborative Institutional Training Initiative program (CITI).
ICVAHCS - Iowa City VA Healthcare System (formerly known as VA or VAMC).
IDE - Investigational device exemption
Identifiable - The identity of the subject is or may readily be ascertained by the investigator or associated with the information.
Identifiable Private Information - Private information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g, a medical record). This information is considered individually identifiable if the identity of the subject is or may readily be ascertained by the investigator or associated with the information. [45 CFR 46.102(f)(2)] If information includes Protected Health Information (as defined later under Protected Health Information), identifiable information includes any of the following information for the individual, relative, employer, or household member of the individual:
Name, street address, city, county, precinct, zip code, geocodes smaller than state
Date of birth, ages > 89 years of age; or other dates such as diagnosis dates, procedure dates, admission or discharge dates
Telephone numbers, fax numbers, e-mail addresses, social security numbers, medical record number
Health plan beneficiary numbers, account numbers, certificate/license numbers
Vehicle identifiers and serial numbers or license numbers, device identifiers and serial numbers
Web URLs, Internet Protocol (IP) address numbers, biometric identifiers including finger/voice prints
Full face photographic images and any comparable images
IND - An investigational new drug application.
Individual Investigator Agreement (IIA) - Document to be completed by an individual community Investigator who is collaborating with an UI Principal Investigator on a CBR study but is not serving as a representative of a community organization, rather is participating as an individual independent investigator and is requesting UI IRB oversight for their activities.
Informed Consent - A person's voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, a subject may not waive or appear to waive any of his/her legal rights, or release or appear to release the investigator, the sponsor, the institution or agents of the institution from liability for negligence. [21 CFR 50.20 and 50.25].
Informed Consent Document - A written description in lay terms of relevant study information. It is the document of study information that is communicated to the potential subject. When signed by the potential subject, it records the receipt of study related information by the subject and the subjects agreement to participate in the research study.
Institutional Official - The Institutional Official (IO) who is the signatory on the FWA filed with OHRP to assure compliance with regulations governing protection of human subjects. OHRP requires the Institutional Official to be a high-level official who has the authority to represent the institution named in the FWA.
Institutional Review Board (IRB) - An Institutional Review Board is a group of individuals charged with reviewing proposed research involving human subjects to ensure the protection of those subjects and compliance with federal human subjects regulations. The University of Iowa has three such review boards, each consisting of faculty, staff, and representatives from the Iowa City community.
Interaction - Includes communication or interpersonal contact between investigator and participant (for example, survey or interview procedures).
Intervention - Includes both physical procedures by which data are gathered (for example, venipuncture, exercise, use of a computer mouse) and manipulations of the subject or the subject's environment that are performed for research purposes.
Investigation - A searching inquiry for ascertaining facts; detailed or careful examination.
IRB Authorization Agreement (IAA) - A formal, written, agreement in which the reviewing IRB agrees to serve as the IRB of Record for another organization.
IRB Chair - The individual designated on an UI Institutional Review Board roster submitted to OHRP as the person assigned with leading the IRB.
IRB Deferment Agreement (see also IRB Reliance Agreement) - A reliance agreement may be requested when you are conducting human subjects research under oversight of an IRB outside of the University of Iowa’s IRB.
IRB of Record - A reviewing IRB that assumes IRB oversight for another organization that meets the regularity definition of engaged in human subjects research. If federal funds are supporting this research, the organization is designated to do so through an approved Federalwide Assurance (FWA) on file with the Federal Office of Human Research Protection (OHRP).
IRB Reliance Agreement (see also IRB Deferment Agreement) - A reliance agreement may be requested when you are conducting human subjects research under oversight of an IRB outside of the University of Iowa’s IRB.
Legally Authorized Representative (LAR) - An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.
In studies involving children in the State of Iowa, the LAR is:
the parent, OR
the court-appointed guardian.
In non-VA studies involving cognitively impaired adults in the state of Iowa, the LAR is:
the designated proxy (such as a Durable Power of Attorney for Health Care)
the court-appointed guardian
In VA studies involving cognitively impaired adults, the LAR is:
Legal guardian or special guardian
Next-of-kin: a close relative of the subject 18 years of age or older, in the following priority:
In studies that involve cognitively impaired adults, permission must be sought from the first existing person in the above lists, even if another relative is more conveniently available.
Letter of Agreement – A document submitted with a HawkIRB application granting permission to conduct the research in a facility or with an organization outside the University, and/or to use data from an outside entity.
Medical Device - A device is: "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
Intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
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. [45 CFR 46.102(i) and 21 CFR 50.3(k)]
In research involving prisoners – The probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons. [45 CFR 46.303(d)]
Minor Modifications - Modifications to a research project and/or consent documents that pose no additional risk to subjects (i.e., changes in title, co-investigator(s), funding sources). If the modification is an addition or modification of procedures they must fall into one of the categories eligible for expedited review. To be considered a minor modification, it must also maintain similar or increased safeguards to protect the subject.
Modification - The PI must submit a Modification form in HawkIRB for any changes to the conduct or procedures of a study.
NIH (National Institutes of Health) - The National Institutes of Health 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.
Noncompliance - Failure to follow the federal regulations with respect to protection of human subjects in research or failure to follow the determinations of the IRB with respect to conduct of the research as approved by the IRB. For VA studies, this includes failure to follow the requirements of VHA Handbook 1200.5
Nonscientist - An individual who has little or no formal scientific or medical training or experience.
Nonsignificant Risk (NSR) Device Investigation - One that does not meet the FDA definition for a Significant Risk study.
OHRP (Office of Human Research Protections) - The Office for Human Research Protections (OHRP), an office of the U.S. Department of Health & Human Services, provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS). OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight, and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.
Principal Investigator - (PI) is responsible for the content of the HawkIRB application and the conduct of the study. Even when responsibilities are delegated to members of the research team, the PI is ultimately responsible for the study.
Privacy - Freedom from unauthorized intrusion or the state of being let alone and able to keep certain personal information to oneself.
Private Information - Includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable in order for obtaining the information to constitute research involving human subjects.
Protected Health Information (PHI) - Information that:
Is transmitted or maintained in any form (electronic, oral, paper) by a covered entity, and
Identifies the individual or could reasonably be used to identify the individual; and
Relates to the past, present or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present or future payment for the provision of healthcare to an individual
[45 CFR 160.103]
Protocol - The formal design or plan of an experiment or research activity, specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data.
Quorum - A majority of voting members of an IRB, including at least one member whose primary expertise is in a nonscientific area.
Research - A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. [From 45 CFR 46.102(d)] The FDA defines research as a clinical investigation.
Clinical Investigation means any experiment that involves a test article and one or more human subjects and that either is subject to requirements for prior submission to the Food and Drug Administration under section 505(i) or 520(g) of the act, or is not subject to requirements for prior submission to the Food and Drug Administration under these sections of the act, but the results of which are intended to be submitted later to, or held for inspection by, the Food and Drug Administration as part of an application for a research or marketing permit. [21 CFR 50.3]
Research Misconduct - Fabrication, falsification, plagiarism, or other practices that seriously deviate from those that are commonly accepted within the research community for proposing, conducting, or reporting research. It does not include honest error or honest differences in interpretations or judgments of data or creative innovations that are nonetheless ethical, legal and meet professional standards.
Risk - The probability of harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude may vary from minimal to significant.
Serious adverse drug experience - Any adverse drug experience (associated with the use of the drug) occurring at any dose that results in any of the following outcomes: death, a life-threatening adverse drug experience, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered a serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed above. [21 CFR 312.32(a)]
Serious Noncompliance - Noncompliance that materially increases risks or that results in unexpected substantial harm to subjects or others. In addition the following instance(s) of noncompliance, as defined by OHRP, will always be determined as serious noncompliance:
Non-Exempt human subjects research being carried out without IRB review and approval or without appropriate informed consent.
Substantive modifications to IRB-approved research without IRB approval.
Significant Risk (SR) device study - One that presents a potential for serious risk to the health, safety, or welfare of a subject and (1) is intended as an implant; or (2) is used in supporting or sustaining human life; or (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 subject. [21 CFR 812.3(m)]
Statement of Work - The statement of work is the portion of a contract which describes the actual work to be done by the contractors, including precise specifications, performance dates, and quality requirements.
Suspension - By requirement of the convened IRB or an IRB Chair, a temporary halt to a selection of research activities being conducted under an IRB-approved project or a temporary halt to the IRB-approved project as a whole.
Systematic Investigation - Research development, testing and evaluation and subsequent gathering and analysis of information.
Termination - By requirement of the convened IRB, a permanent halt to some or all research activities in a previously approved IRB project.
Test Article - Means 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 the Federal Food Drug and Cosmetic Act, or under sections 351 or 354-360F of the Public Health Service Act. [From 21 CFR 50.3(j) and 21 CFR 56.102(l)]
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 the frequency, specificity or severity of which has not previously been identified in the investigational plan or application, or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects. [21 CFR 812.3(s)]
Unanticipated problem involving risk to subjects or others - Any problem or event that:
Was not expected given the nature of the research, the population under study and the approved procedures or protocol for conduct of the study,
Impacts the rights, safety, or welfare of subjects or others (i.e., those not directly involved in the research such as research staff or family members),
and is related to the research intervention, research procedures, and/or conduct of the research study.
Unexpected adverse drug experience - Any adverse drug experience (associated with the use of the drug), the frequency, specificity or severity of which is not consistent with the current investigator brochure; or, if an investigator brochure is not required or available, the specificity or severity of which is not consistent with the risk information provided to subjects and the IRB. [21 CFR 312.32(a)]
Undue Influence - Often occurs through an offer of an excessive or inappropriate reward or other overture in order to obtain compliance. For example, an investigator might promise psychology students extra credit if they participate in the research. If that is the only way a student can earn extra credit, then the investigator is unduly influencing potential subjects. If, however, she offers comparable non-research alternatives for earning extra credit, the possibility of undue influence is minimized.
VA Research - Research performed at the VAMC and/or utilizing VAMC resources, or performed by VAMC employees or agents on VAMC time.