45 Code of Federal Regulations Part 46 (45 CFR 46)
The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research.
An undesirable and unintended, although not necessarily unexpected, experience associated with the research study.
Subjects’ identities are unknown to the investigator, not requested, and not given. It is a guarantee of privacy by virtue of recording data collected so that there is no way for anyone (including the investigator) to be able to identify participants by the data collected. If the only time the investigator asks for a name is for a signature on a consent form, the investigator should request IRB approval for implied consent (e.g., verbal consent), to preserve anonymity. The words “anonymous” and “confidential” do not have the same meaning and are not interchangeable.
Pre-existing data collected in the past, usually for a purpose other than research (i.e., motor vehicle records, medical records, criminal justice records). The complete data set must exist prior to the initiation of a research project using the data.
Affirmative agreement by an individual not competent to give legally valid informed consent (e.g., a child or cognitively impaired person) to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.
Assurance of Compliance
See: Federal Wide Assurance
Authorized Institutional Official
An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical or behavioral research.
Personal capacity to consider alternatives, make choices, and act without undue influences or interference of others.
A statement of basic ethical principles governing research involving human subjects issued by the National Commission for the Protection of Human Subjects in 1979. It identifies three fundamental ethical principles for all human subjects research: respect for persons, beneficence, and justice. These principles have been formally adopted by UTD through its Federalwide Assurance for all research involving human subjects.
One of the three ethical principles discussed in the Belmont Report that entails an obligation to protect persons from harm. The principle of beneficence can be expressed in two general rules: (1) do not harm; and (2) protect from harm by maximizing possible benefits and minimizing possible risks of harm.
A valued or desired outcome to the study that will be an advantage to the subjects participating. Monetary incentives are not considered as benefit.
Certificate of Confidentiality (CoC)
Issued by the National Institutes of Health (NIH) and other HHS agencies to protect identifiable research information from forced or compelled disclosure. The certificates allow researchers to refuse to disclose names, sensitive research information, or other identifying information on individual research participants in civil, criminal, administrative, legislative, or other proceedings, whether at the federal, state, or local level. They may be granted for studies collecting information that, if disclosed, could have adverse consequences for subjects, such as damage to their financial standing, employability, insurability, or reputation.
They protect subjects from compelled disclosure of identifying information but do not prevent the voluntary disclosure of identifying characteristics of research subjects. Researchers, therefore, are not prevented from voluntarily disclosing certain information about research subjects, such as evidence of child abuse or a subject’s threatened violence to self or others. However, if a researcher intends to make such voluntary disclosures, the consent form should clearly indicate this. Furthermore, they do not prevent other types of intentional or unintentional breaches of confidentiality.
People who have not attained the legal age for consent to treatment or procedures involved in research, as determined under the applicable law of the jurisdiction in which the research will be conducted. In Texas, where federal regulations and state law both apply, individuals under the age of 18 are considered to meet the definition of children. Some funding agencies may define children differently.
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.
Identifying information that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol or combination thereof and a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.
Compelling or forcing someone to participate in or perform an action that would not ordinarily be done of the individual’s own free choice.
Anyone who plays a part in the protocol and has access to study records.
Having either a psychiatric disorder (e.g., psychosis, neurosis, personality or behavior disorder, or dementia) or a development disorder (e.g., mental retardation) that affects cognitive or emotional functions to the extent that capacity for judgment and reasoning in significantly diminished. Others, including persons under the influence of or dependent on drugs or alcohol, those suffering from degenerative diseases affecting the brain, terminally ill patients, and persons with severely disabling physical handicaps, may also be compromised in their ability to make decisions in their best interests.
The “Federal Policy for the Protection of Human Research Subjects,” informally known as the “Common Rule.” The Common Rule outlines the criteria and mechanisms for IRB review of human subjects research.
Payment or medical care provided to subjects injured in research; does not refer to payment (remuneration) for participation in research.
Conflict of Interest
Any situation in which financial or personal obligations may compromise or present the appearance of compromising an individual or group’s professional judgment in conducting, reviewing, or reporting research.
Treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure. It exists to protect the information collected (including subject’s privacy). The words “anonymous” and “confidential” do not have the same meaning and are not interchangeable.
A structured, written description of relevant research project information in lay terms. The written consent document is not consent itself; it is the record of what has been communicated to a prospective subject. It is the document, based on a template provided by the IRB and approved by the IRB, to ensure that all regulatory elements are present and communicated to a potential subject. When signed by the potential subject, the consent document is a record of the receipt of research-related information by the subject. It also serves as reference material for the subject as the research project progresses. It is not legally binding, and the subject may choose to withdraw consent at any time.
Periodic review of research activities at intervals appropriate to the degree of risk. The criteria for approval are defined by federal regulations.
An agreement; as used here, an agreement that a specific research activity will be performed at the request, and under the direction, of the agency providing the funds. Research performed under contract is more closely controlled by the agency than research performed under a grant. (Compare: Grant.)
Control (Group/Subjects) or Controls
Subject(s) used for comparison who are not given a treatment under study or who do not have a given condition, background, or risk factor that is object of study. Control conditions may be concurrent (occurring more or less simultaneously with the condition under study) or historical (preceding the condition under study). When the present condition of subjects is compared with their own condition on a prior regimen or treatment, the study is considered historically controlled.
Cooperative Research Project
Research projects that involve more than one institution.
Co-Principal Investigator (Co-PI)
An Investigator who plays a key role in scientific development and conduct of the study. The Co-PI collaborates with the Principal Investigator who has overall responsibility for the conduct of the study.
A health care provider who electronically transmits any health information in connection with transactions for which HHS has adopted standards. Generally, these transactions concern billing and payment for services or insurance coverage. For example, hospitals, academic medical centers, physicians, and other health care providers who electronically transmit claims transaction information directly or through an intermediary to a health plan are covered entities. Covered entities can be institutions, organizations, or persons.
Data Use Agreement
An agreement into which a covered entity enters with the intended recipient of a limited data set that establishes the ways in which the information in the limited data set may be used and how it will be protected.
Process of informing subjects all the information related to the study that was previously undisclosed/withheld following completion of their participation in research. Debriefing is generally required when the study involves deception.
Intentionally providing false or misleading information to participants about some element of research project. (e.g., placebo, sham treatment group, deceptive study purpose, etc.)
Declaration of Helsinki
A code of ethics for clinical research approved by the World Medical Association in 1964 and widely adopted by medical associations in various countries. It was revised in 1975 and 1989
Information or data where direct identifiers such as name and address have been removed. In common use, the term refers to data where it may still be possible to identify individuals by inference or through codes held by the investigator or a third party. Therefore, data that is de-identified may not be anonymous because it may still permit at least probabilistic re-identification when analyzed in conjunction with other datasets.
Department of Health and Human Services. An agency of the federal government.
Early stages of a developing organism, broadly used to refer to stages immediately following fertilization of an egg through implantation and very early pregnancy (i.e., from conception to the eighth week of pregnancy). (See also: Fetus.)
Fair or just; used in the context of selection of subjects to indicate that the benefits and burdens of research are fairly distributed.
See: Minimal Review
Review of proposed research by the IRB chair or by one or more designated voting members rather than by the entire IRB. Federal rules permit expedited review for certain kinds of research involving no more than minimal risk and for minor changes in approved research.
Term often used to denote a therapy (drug, device, procedure) that is unproven or not yet scientifically validated with respect to safety and efficacy. A procedure may be considered “experimental” without necessarily being part of a formal study (research) to evaluate its usefulness. (See also: Research.)
A true experimental study is one in which subjects are randomly assigned to groups that experience carefully controlled interventions manipulated by the experimenter according to a strict logic allowing causal inference about the effects of the interventions under investigation.
When continuing review of the research does not occur prior to the end of the approval period specified by the IRB, IRB approval expires automatically. The study expires on the date specified on the approval letter and the consent document. No research activities described in the protocol (including data analysis) can occur after the expiration date until continuation of the study is approved by the IRB.
A faculty member who agrees to sponsor the research of a student, postdoctoral investigator, or external researcher/collaborator and shares in the responsibility for the ethical conduct of the research. The Faculty Sponsor is expected to discuss the general principle of research ethics prior to the initiation of any project involving human subjects and should be providing oversight and training to PI during the entire timeline of the research activity from planning, to IRB submission, to data collection and analysis. Just as the PI, the faculty sponsor is responsible for protection of the rights and welfare of the human subjects and adherence to UTD IRB’s requirements as well as applicable federal regulations and state statutes.
Food and Drug Administration. FDA is a federal agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.
Federal Policy (The)
The federal policy that provides regulations for the involvement of human subjects in research. The Policy applies to all research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency that takes appropriate administrative action to make the Policy applicable to such research. Currently, sixteen federal agencies have adopted the Federal Policy. (Also known as the “Common Rule.”)
Federal Wide Assurance (FWA)
The only type of assurance of compliance accepted and approved by the Office for Protection from Research Risks for institutions engaged in non-exempt human subjects research conducted or supported by the Department of Health and Human Services (HHS). Through the FWA, an institution commits to HHS that it will comply with the requirements in the HHS Protection of Human Subjects regulations at 45 CFR part 46. The University of Texas at Dallas has an approved Federal Wide Assurance number with HHS: 00005412
The placenta, amniotic fluid, fetal membranes, and umbilical cord.
The product of conception from the time of implantation until delivery. If the delivered or expelled fetus is viable, it is designated an infant. The term “fetus” generally refers to later phases of development; the term “embryo” is usually used for earlier phases of development. (See also: Embryo.)
A report the principal investigator may elect to submit to the IRB to serve as a final record of any pertinent activity since the last continuing review report and to record research project completion. The Final Report will trigger close out of the protocol in the IRB office.
Financial Interest (in or related to the research)
Financial interest of any amount in the sponsor, product or service being provided, or a competitor of the sponsor. This can also be referred to as Financial Conflict of Interest.
Full Board Review
Projects that do not fall into either the exempt or expedited review categories must undergo a review by the full IRB. Such research typically involves vulnerable populations (such as children, pregnant women or fetuses, prisoners, ethnic minority, people with mental impairment, etc.); projects that may involve coercion or undue influence; those that include sensitive data; involves some sort of deception in recruitment; and those which include more than minimal risk to subjects. For the research to be approved, it must receive the approval of a majority of the IRB members. The IRB Chair makes the final determination as to which protocols classify as needing Full Board Review.
In most cases, research studies are intended to be shared, published, and presented to colleagues and to draw general conclusion and to have an impact on others. Activities that are disseminated with the intent to influence behavior, practice, theory, future research designs, etc. are contributing to generalizable knowledge even if the research results do not generate publications or reports.
Good Clinical Practice
An international quality standard for clinical care, including but not limited to clinical trials involving human subjects. The standard is provided by International Conference on Harmonisation (ICH/GCP).
Financial support provided for research study designed and proposed by the Principal Investigator(s). The granting agency exercises no direct control over the conduct of approved research supported by a grant. (Compare: Contract.)
Greater than Minimal Risk
The research involves the probability or magnitude of risk is greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
A person appointed by a court to have full authority to make decisions for and act on behalf of a child or decisionally impaired adult, except as otherwise provided for by law. For research conducted outside Texas, children are defined under the applicable law of the jurisdiction in which the research or clinical investigations will occur.
The acronym for the Health Insurance Portability and Accountability Act of 1996, intended to provide standards for protecting the privacy of personally identifiable health information (PHI).
A customized document or form that gives permission to use specified protected health information (PHI) for a specific purpose, or to disclose PHI to a third party specified by the investigator other than for treatment, payment or health care operations.
Human In-Vitro Fertilization
Any fertilization involving human sperm and ova that occurs outside the human body.
Human Subject (also known as Human Participant)
A living individual about whom an investigator (whether professional or student) conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information.
*Note: Research on autopsy materials or specimens from deceased individuals is not considered to be human subjects research. However, some research, such as genetic studies providing private medical information about living relatives may need IRB review.
Refers to a person’s mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Often used as a synonym for incompetence. (See also: Incompetence.)
Researchers intentionally withholding information about the true purpose or nature of the research study.
Individually Identifiable Information
Any information about a living individual that is linked, associated with, or contains the name or any details of the individual that would allow someone to be able to directly or indirectly identify a subject from the information collected.
Individually identifiable health information
Any information collected from an individual (including demographics) that is created or received by a health care provider, health plan, employer, and or health care clearinghouse that relates to the past, present or future physical or mental health or condition of an individual, or the provision of health care to an individual or the past, present or future payment for the provision of health care to an individual and identifies the individual and or to which there is reasonable basis to believe that the information can be used to identify the individual.
A person’s voluntary agreement, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress, or other form of constraint or coercion, based upon adequate knowledge and understanding of relevant information in order to participate in research or to undergo a clinical procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence.
Informed consent is a continual process by which a subject voluntarily confirms his/her willingness to participate in a research study, after having been informed and can demonstrate understanding of all aspects of the research study that are relevant to the his/her decision to participate. It is documented by means of a written, signed and dated informed consent form; however, it is not just a form to be signed, rather an educational process that takes place between the investigator and the prospective participant about the study throughout the study. It is required unless the IRB waives the requirement for the signed consent. (See: Waiver of Signed Consent)
(1) Any public or private entity or agency (including federal, state, and local agencies).
(2) A residential facility that provides food, shelter, and professional services (including treatment, skilled nursing, intermediate or long-term care, and custodial or residential care). Examples include general, mental, or chronic disease hospitals; inpatient community mental health centers; halfway houses and nursing homes; alcohol and drug addiction treatment centers; homes for the aged or dependent, residential schools for the mentally or physically handicapped; and homes for dependent and neglected children.
An officer of an institution with the authority to speak for and legally commit the institution to adherence to the requirements of the federal regulations regarding the involvement of human subjects in biomedical and social/behavioral research. At The University of Texas at Dallas, the Assistant Vice President for Research Compliance is the institutional official.
Institutional Review Board (IRB)
A specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in biomedical or behavioral research. It is a university-wide standing committee whose members are appointed annually by UTD’s President.
Confined, either voluntarily or involuntarily (e.g., a hospital, prison, or nursing home).
Institutionalized Cognitively Impaired
Persons who are confined, either voluntarily or involuntarily, in a facility for the care of the mentally or otherwise disabled (e.g., a psychiatric hospital, home, or school for the mentally retarded).
Includes communication or interpersonal contact with a subject or his/her private identifiable information.
Includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subjects’ environment that are performed for research purposes.
Investigational New Drug or Device
A drug or device permitted by FDA to be tested in humans but not yet determined to be safe and effective for a particular use in the general population and not yet licensed for marketing.
Considered to be an individual performing various tasks related to the conduct of human subjects research activities such as:
- Obtaining information about living individuals by intervening or interacting with them for research purposes.
- Obtaining identifiable private information about living individuals for research purposes.
- Obtaining voluntary informed consent of individuals to be subjects in research.
- Studying, interpreting or analyzing identifiable private information or data for research purposes.
Literally, “in glass” or “test tube;” used to refer to processes that are carried out outside the living body, usually in the laboratory, as distinguished from in vivo.
The determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.
IRB of Record
See: Primary Reviewing Institution
An ethical principle discussed in the Belmont Report requiring fairness in distribution of burdens and benefits; often expressed in terms of treating persons of similar circumstances or characteristics similarly.
Legally Authorized Representative
An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research activity.
Limited Data Set
PHI that may be used or disclosed, for purposes of research, public health, or health care operations, without obtaining either an individual’s Authorization or a waiver or an alteration of Authorization for its use and disclosure, with a data use agreement.
A study designed to follow subjects forward through time.
See: Cognitively Impaired.
Exempt research is research involving less than minimal risk. To qualify as exempt, research must fall into one of six federally-defined categories which present the lowest degree of risk to potential subjects; however, that designation can only be made by the IRB office, and therefore still requires submission of application materials.
A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed 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. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.
The definition of minimal risk for research involving prisoners differs somewhat from that given for noninstitutionalized adults.
The collection and analysis of data as the project progresses to assure the appropriateness of the research, its design and subject protections.
National Institutes of Health: a federal agency within the Public Health Service, DHHS, comprising 21 institutes and centers. It is responsible for carrying out and supporting biomedical and behavioral research.
Researchers or individuals other than researchers, such as research staff, Institutional Review Board (IRB) staff, or IRB members, did not adhere to Federal Regulations and/or The University of Texas at Dallas policies, procedures, requirements, or IRB determinations for conducting research involving human subjects.
An expelled or delivered fetus which, although it is living, cannot possibly survive to the point of sustaining life independently, even with the support of available medical therapy. Although it may be presumed that an expelled or delivered fetus is nonviable at a gestational age less than 20 weeks and weight less than 500 grams, a specific determination as to viability must be made by a physician in each instance. (See also: Viable Infant.)
A code of research ethics developed during the trials of Nazi war criminals following World War II and widely adopted as a standard during the 1950s and 1960s for protecting human subjects.
Office for Human Research Protections (OHRP)
The agency that 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 is part of the Office of the Assistant Secretary for Health (OASH) in the Office of the Secretary (OS), U.S. Department of Health and Human Services.
OHRP provides clarification and guidance, develops educational programs and materials, maintains regulatory oversight, and provides advice on ethical and regulatory issues in biomedical and behavioral research. OHRP also supports the Secretary’s Advisory Committee on Human Research Protections (SACHRP) which advises the HHS Secretary on issues of human subject protections.
A child’s biological or adoptive parent.
The agreement of parent(s) or guardian to the participation of their child or ward in research.
Something (e.g., cash, gift cards, toys, drawings, research credits, other gifts, etc.) provided to participants for participation in research. (NOTE: It is wise to confine use of the term “compensation” to payment or provision of care for research-related injuries.) (Compare: Compensation.)
The UTD IRB is responsible for reviewing the method, rate, and schedules of payment to subjects. It is the IRB’s charge to ensure that the amount of payment and the proposed method and timing of disbursement do not present undue influence to subjects.
Public Health Service. Part of the U.S. Department of Health and Human Services, it includes FDA, NIH, CDC, SAMHSA, and HRSA.
A chemically inert substance given in the guise of medicine for its psychologically suggestive effect; used in controlled clinical trials to determine whether improvement and side effects may reflect imagination or anticipation rather than actual power of a drug.
The period of time from confirmation of implantation of a fertilized egg within the uterus until the fetus has entirely left the uterus (i.e., has been delivered). Implantation is confirmed through a presumptive sign of pregnancy such as missed menses or a positive pregnancy test. This “confirmation” may be in error, but, for research purposes, investigators would presume that a living fetus was present until evidence to the contrary was clear. Although fertilization occurs a week or more before implantation, the current inability to detect the fertilization event or the presence of a newly fertilized egg makes a definition of pregnancy based on implantation necessary.
Primary Reviewing Institution (IRB of record)
An institution that agrees to be responsible for the review of cooperative research project (multi-site research).
The scientist, researcher, or scholar with primary responsibility for the design and conduct of a research project.
An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism; individuals with psychiatric illnesses) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution.
An individual representing the interests of incarcerated persons who may be approached and enrolled as research subjects.
Control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others.
Includes information about behavior that occurs in a setting in which an individual can reasonably expect that no observation or recording is taking place. It includes information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (such as a medical record). Private information must be individually identifiable in order to be considered information to constitute research involving human subjects. This may include identifiable private information obtained from a primary subject about a third party.
Protected Health Information (PHI)
Personal and/or individually identifiable health information about a research participant that is transmitted or maintained in any form or medium by a covered entity (including a health plan, healthcare clearinghouse, health care provider), or its business associates. Such information may be contained in medical records including but not limited to name, address, telephone numbers, fax numbers, social security number, medical record number, health insurance number, certificate/license numbers, vehicle and serial numbers, biometric identifiers (voice and fingerprints), full face photographs and any unique identifying numbers or characteristics or codes.
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.
Accidental or unintentional changes to, or non-compliance with the research protocol that does not increase risk or decrease benefit or; does not have a significant effect on the subject’s rights, safety or welfare; and/or on the integrity of the data. Deviations may result from the action of the subject, researcher, or research staff
An incident or non-compliance with the research protocol that has serious effect on subject’s rights, safety, welfare, and/or on the integrity of the data.
Random, Random Assignment, Randomization, Randomized
Assignment of subjects to different treatments, interventions, or conditions according to chance rather than systematically (e.g., as dictated by the standard or usual response to their condition, history, or prognosis, or according to demographic characteristics). Random assignment of subjects to conditions is an essential element of experimental research because it makes more likely the probability that differences observed between subject groups are the result of the experimental intervention.
A component of the consent process, is the process of distributing or presenting information that describes the research project and eligibility criteria so that a prospective subject may consider enrollment.
Providing compensation to a research participant for out-of-pocket expenses the participant incurred that are directly attributed to participation in the research study. Examples of reimbursable expenses are parking or transportation to the study site.
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Respect for Persons
An ethical principle discussed in the Belmont Report requiring that individual autonomy be respected and that persons with diminished autonomy be protected.
Research conducted by reviewing records from the past (e.g., birth and death certificates, medical records, school records, or employment records) or by obtaining information about past events elicited through interviews or surveys. Case control studies are an example of this type of research.
Review (Of Research)
The concurrent oversight of research on a periodic basis by an IRB. In addition to the at least annual reviews mandated by the federal regulations, reviews may, if deemed appropriate, also be conducted on a continuous or periodic basis.
The probability of harm, injury, or loss (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Physical risks may arise from the use of test agents such as chemicals, therapeutic drugs, devices, physical agents (including radiation), and clinical procedures. Psychological risks may arise from the utilization of behavioral questionnaires or surveys, interview interactions, the collection of sensitive data, or the emotional stress of study participation. Social risks may arise from actual or potential breaches of confidentiality or anonymity such as harm to interpersonal relationships, damage to reputation or social standing, or exposure to legal sanctions. Economic risks may affect an individual’s financial status, employability or insurability.
A visit by agency officials, representatives, or consultants to the location of a research activity to assess the adequacy of IRB protection of human subjects or the capability of personnel to conduct the research.
Any person or entity that takes responsibility for, initiates or funds a study. The sponsor may be an individual, pharmaceutical company, device manufacturer, governmental agency, academic institution, private organization or other organization.
Any individual who is enrolled as a student at The University of Texas at Dallas.
All employees of The University of Texas at Dallas.
Studies designed to obtain information from a large number of respondents through written questionnaires, telephone interviews, door-to-door canvassing, or similar procedures.
A planned activity involving qualitative or quantitative data collection and data analysis that sets forth an objective(s) and a set of procedures intended to reach the objective(s), i.e., to acquire knowledge, develop a theory, or answer a question.
A person who is sick and is diagnosed with a disease that will take their life.
The misunderstanding held by participants enrolled in the research that the research project/trial they are participating in would be beneficial to them personally when the purpose of a project/clinical trial was actually to evaluate an experimental therapy or intervention, not to provide therapy.
This failure to distinguish between research and usual clinical care may result in an underestimation of the risks or overestimation of the benefits of research participation.
Treatment intended and expected to alleviate a disease or disorder.
An unanticipated problem involving risks to participant or others. Any event or information that: (1) was unforeseen; and (2) indicates that the research procedure caused harm to participants or others or indicates that the participants or others are at increased risk of harm. Unexpected Events may occur in non-clinical (behavioral or social science) as well as clinical research studies.
Use of any act of persuasion and influence (either real or perceived) including the offer of an excessive or inappropriate reward or other overture that could induce the forceful participation in research.
When referring to a delivered or expelled fetus, the term “viable infant” means likely to survive to the point of sustaining life independently, given the benefit of available medical therapy. This judgment is made by a physician. In accordance with DHHS regulations, the Secretary, HHS, may publish guidelines to assist in the determination of viability. Such guidelines were published in 1975, and specify an estimated gestational age of 20 weeks or more and a body weight of 500 grams or more as indices of fetal viability. These indices depend on the state of present technology and may be revised periodically. (See also: Nonviable Fetus.)
Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject’s decision to participate (or to continue to participate) in a research activity.
The regulations recognize certain populations to be given additional protections and special consideration when used in research. These subjects include pregnant women, human fetuses and neonates, prisoners, and children. The Code of Federal Regulations does not provide the exhaustive list of vulnerable populations, but the vulnerability is based on the ability to consent, potential for undue influence/coercion, risk and benefit in the study, and choice of subjects. In fact, depending on the circumstances, the vulnerable populations may include students; employees; individuals who are decisionally impaired due to illness, injury or other conditions; and non-English speakers or English as a second language speakers.
Waiver of Signed Consent
Federal regulations require a researcher to document that the research participants have provided informed consent. This is typically accomplished by signing a consent form. However, the requirement for documentation of consent may be waived by the IRB if the following four conditions are met: 1) the risk to the subject is not more than minimal 2) the waiver will not adversely affect the rights and welfare of the research participants 3) the research could not practicably be carried out without the waiver, and 4) the subjects will be provided with additional pertinent information after participation when appropriate.
Subject’s discontinuation from the research study prior to the completion of the study.
A person, who cannot be unfairly influenced by people involved with the research, who does not have a coercive relationship with the participant, who attends the informed consent process when the participant or the participant’s legally authorized representative is illiterate or legally blind.