Term
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Definition
| The probability of harm or discomfort...not greater...than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations. |
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Term
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Definition
| Respect for persons, benficence, and justice |
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Term
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Definition
| An administrative body composed of scientists and nonscientists established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. |
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Term
| Institutional Official (IO) |
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Definition
| The person who signs the OHRP Federalwide Assurance and has the legal authority to act and speak for the institution, and should be somone who can ensure that the institution will effectively fulfill its research oversight function |
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Term
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Definition
| Charged with monitoring and promoting compliance with DHHS regulations that relate to the ethical standards of human-subject resarch. They have the final word on when an institution is not complying with DHHS regulations and what the institution must do to correct the problem |
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Term
| Federalwide Assurance (FWA) |
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Definition
| A type of contract established by OHRP that specifies when and how the institution will comply with DHHS research regulations |
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Term
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Definition
| References required by federal regulations that are used to instruct and remind the IRB of step-by-step tactics about how to implement policy |
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Term
| Institutional Handbook/Manual |
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Definition
| Informs researchers about the application process, researcher responsibilities, and specific techniques such as obtaining a child's assent |
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Term
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Definition
| Regulations require sufficient docuemntation about the number of memebrs present at the review of each submission, teh vote, and a description of any controverted issues |
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Term
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Definition
| Proactive, non-punitive, and focused on educating investigators about their ethical and regulatory responsibilities in the conduct of research |
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Term
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Definition
| Primary person responsible for managing the IRB office and many of the administrative aspects of IRB meetings |
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Term
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Definition
| Must consist of at least five members and include at least one scientist, one nonscientist and one person not affiliated with the institution |
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Term
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Definition
| Refers to the number of voting member positions on the IRB |
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Term
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Definition
| When there is more than one member for an IRB roster position |
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Term
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Definition
| Committee consisting of one or more experienced reviewers organized for the purpose of managining a specific task or making a specific type of decision |
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Term
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Definition
| Decreases in quality of life that result from information being created or used in a way that is damaging to the individual in question-- A result of the creation or transfer of information in a way that may negatively affect the research subject |
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Term
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Definition
| A type of review that can be conducted by the Chair, designated IRB members, or a subcommittee of the IRB |
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Term
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Definition
| A systematic investigation including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge |
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Term
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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 |
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Term
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Definition
| A life-threatening situation in which no standard acceptable treatment is available and there is insufficient time to convene a quorum for full board IRB approval |
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Term
| The National Commission for the Protection of Human Subjects |
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Definition
| Created to identify the basic ethical principles that should be followed in conducting human subjects research. This organization also developed The Belmont Report |
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Term
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Definition
| Magnitude of the potential harm or discomfort and the probability of the harm or discomfort occuring. |
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Term
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Definition
| Can be defined in terms of having control over the extent, timing, and circumstances of sharing onself (physically, behaviorally, or intellectually) with others |
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Term
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Definition
| 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 in ways that are inconsistent with the understanding of the original disclosure without permission |
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Term
| Criteria for waiver or alteration of consent |
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Definition
| The research involves no more than minimal risk, the waiver or alteration will not adversely affect the rights and welfare of the subjects, the research could not practicably be carried out without the waiver or alteration, and whenever appropriate, the subjects will be provided with additional pertinent information after participation. |
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Term
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Definition
| Ongoing process and an opportunity to retain subjects in trials. |
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Term
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Definition
| The first step in the consent process |
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Term
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Definition
| A committee that is established specifically to monitor data throughout the life of a study to determine whether it is appropriate, from both scientific and ethical standpoints, to continue the study as planned |
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Term
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Definition
| General term for specific and predetermined parameters that guide the data monitoring process |
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Term
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Definition
| Language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence |
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Term
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Definition
| Principle underlying the doctrine of informed consent. Requires recognition of the individual as an autonomous agent and protection of the individual with diminished autonomy. |
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Term
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Definition
| The doing of good, obligates the researcher to secure the individual’s well-being by maximizing benefits and minimizing harms to the individual research subject. Requires that the researcher perform a risk/benefit analysis, examining the probability and magnitude of possible harms and anticipated benefits to the individual |
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Term
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Definition
| The specificity or severity of the AE is not consistent with the current investigator's brochure or with other current risk information |
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Term
| Related or Possibly Related |
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Definition
| There is a reasonable possibility the AE may have been caused by the drug or intervention or it is possible that the AE may have been cused by the drug or intervention, but there is insufficient information to determine the likelihood of this possibility |
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Term
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Definition
| Results in death, OR is life threatening, OR requires inpatient hospitalization, OR results in serious, persistent, or significantly disability or incapacity, OR results in congenital anomaly or birth defect, OR causes cancer, OR is an overdose, OR is any medical event which requires treatment to prevent one of the medical outcomes listed previously |
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Term
| Factors that may determine when a DSMB is necessary |
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Definition
| a large study population, multiple study sites, highly toxic therapies or dangerous procedures, high expected rates of morbidity or mortality in the study population, high chance of early termination |
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Term
| Reasons a DSMB may stop a study |
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Definition
| efficacy, futility, or safety |
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Term
| Non-serious, non-continuing |
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Definition
| A problem that appears to be isolated or is a misunderstanding of that is not serious or continuing. This incident remains internal. A letter from the IRB office to the PI describing a summary of the audit will be written. A response from The PI describing correction actions is also required. |
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Term
| Serious or Continuing Problem |
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Definition
| A problem that indicates noncompliance that is serious or continuing, OHRP will be notified within 48 hours, regardless of the funding source. If applicable the FDA will be notified |
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Term
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Definition
| No less than one year and is determined by the risk to subjects |
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Term
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Definition
| Language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights |
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Term
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Definition
| To make health insurance portable and increase accountability in Medicare billing |
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Term
| Protected Health Information (PHI) |
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Definition
| Individually identifiable health information held by a covered entity |
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Term
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Definition
| Written permission from an individual allowing a CE to use or disclose specified PHI for a particular purpose |
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Term
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Definition
| The part of medical records that must be disclosed to the individual--research information that is specifcally for research is not typically part of this |
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Term
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Definition
| An agreement in which the data recipient promises not to attempt to re-identify or contact the individuals |
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Term
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Definition
| Allows more identifiers than a de-identified data set--in particular allows all dates and additional ZIP codes are allowed, but street addresses are not allowed--this set is still considered PHI and is subject to the minimum necessary requirements of the Privacy Rule |
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Term
| Business Associate Contracts (BACs) |
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Definition
| For activities related to treatment, payment, or operations--the only research activities for which this might be pertient are obtaining authorizations and creating a limited or de-identified data set |
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Term
| Federalwide Assurance (FWA) |
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Definition
| Written documentation of an institution's commitment to comply with federal regulations governing human subjects research--covers all federally supported or conducted research involving human subjects |
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Term
| Human Protections Administrator |
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Definition
| An employee or agent of the FWA institution who exercises day-to-day operational responsibility for the institution's program for protecting human subjects |
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Term
| International Conference on Harmonization (ICH) |
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Definition
| Designed to streamline the process for developing and marketing new drugs internationally, composed of representatives from the pharmaceutical industry and the regulatory bodies of the US, Japan, and the EU, and has established several international standards of good clinical practice (GCP) for the development of pharmaceutical products |
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Term
| Differences Between ICH guidelines and US Regulations |
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Definition
| Definition of vulnerable subject, Confidentiality of Medical Records, Signature by Person Conducting the Consent Discussion, Subject Receipt of a Signed and Dated Copy of the Consent Form, Assent for Children and Mentally Incapacitated Adults, Impartial Witness for Illiterate Subjects, and Prior Approval for Minor Amendments |
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Term
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Definition
| A treating physician administers a drug for an indication other than the approved ones |
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Term
| Three main situations where the DHHS and FDA regulations differ |
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Definition
| Emergency use of a test article, management of AE reports, and the explanation of access to study records in the consent form |
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Term
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Definition
| The primary source of guidance concerning VA interpretation of the Common Rule for the protection of human subjects |
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Term
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Definition
| Responsible for the overall policy, planning, coordination, and direction of research activities within VHA and oversees all VA R&D committees that are located within VA facilities |
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Term
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Definition
| A specialized program within ORD responsible for training, education, policy, development, and guidance related to human subject protection throughout the VA |
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Term
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Definition
| Advises the VA's Under Secretary for Health on all matters regarding compliance and assurance for human subjects protections, as well as animal welfare, research safety, physical security, and research misconduct |
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Term
| Certificates of Confidentiality |
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Definition
| Permits researchers to protect the privacy of subjects by refusing to disclose their names and other identifying characteristics, even if asked to do so by courts or governmental agencies--can be obtained only if a determination is made that the research is of sensitive nature and protection is necessary to reach the objectives of the research--does not apply to voluntary disclosure of identifying informaiton by either a subjet or an investigator |
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Term
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Definition
| Requires that competent investigators design ethical research, protect human subjects from risk, and make continuing assessments of the risk/benefit ratio |
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Term
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Definition
| Requires that researchers carry out the process of informed consent and protect subject privacy |
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Term
| Form 483 "Statement of Findings" |
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Definition
| Essentially a blank page that the deficiencies found during an FDA audit are written on |
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Term
| Establishment Inspection Report (EIR) |
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Definition
| A report which contains positive and negative observations from the FDAs audit of an IRB |
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Term
| Voluntary Action Indicated (VAI) Letter |
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Definition
| Letters taht simply ask for a correction of minor deficiencies found during an FDA audit |
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Term
| Official Action Indicated (OAI) Letter |
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Definition
| Letter that demands correction for what the FDA believes to be serious deficiencies and/or violations of the regulations--these are called warning letters and often carry some type of sanction for the instituion and its investigators |
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Term
| Study-oriented Inspections |
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Definition
| Inspections that are done at study sites that have participated in pivotal clinical trials (trials that the FDA uses to approve drugs and devices for marketing) |
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Term
| Investigator-oriented Inspections |
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Definition
| Inspections that are usually the result of one or more reports of questionable behavior or of questions that have been raised |
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Term
| The 3 Statutory Responsibilities of OHRP |
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Definition
| Administration of assurances, education, and compliance oversight |
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Term
| Five Basic Categories of Harm as noted in The Belmont Report |
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Definition
| social harm, economic harm, legal harm, psychological harm, and physical harm |
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Term
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Definition
| Persons who are relatively (or absolutely) in capable of protecting their own interest |
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Term
| Criteria for Waivers of any or all of the elements of informed consent |
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Definition
1. The research involves no more than minimal risk.
2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.
3. The research could not practicably be carried out without the waiver or alteration. Inconvenience and expense are not acceptable factors in approving waivers.
4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation. |
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Term
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Definition
| May be caused by grouping high-risk adolescents for behavioral interventions in which negative behaviors are enforced. This is of particular risk in school-based research. |
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Term
| Activities with schoolchildren that DO NOT qualify for exemption under Subpart D |
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Definition
1. Research involving surveys
2. Research involving interviews
3. Observation of public behavior when the researcher participates in the activities being observed |
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Term
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Definition
| The primary source of information used to design Phase I “first in human” research studies. |
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Term
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Definition
| A study that’s primary purpose is to assess safety. Participants in these studies stand to gain nothing therapeutically and there is not personal benefit to them |
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Term
| Reasons the majority of Phase I clinical trial participants must be confined to a research unit |
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Definition
| To monitor participant health and to allow PK and PD sampling to be collected at protocol driven specific time points |
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Term
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Definition
| The product of conception from the time of implantation until delivery. |
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Term
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Definition
| Encompassing the period of time from confirmation of implantation until expulsion or extraction of the fetus. |
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Term
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Definition
| Able to survive if given the benefit of available medical therapy to the point of independently maintaining heartbeat and respiration |
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Term
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Definition
| A fetus that has not attained a gestational age of 20 weeks and does not exceed 400 grams in weight |
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Term
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Definition
| Cells that are self-replicating, are derived from human embryos or fetal tissue and are known to develop into cells and tissues of the three primary germ layers.” Research on such cells may be conducted only if the cells were derived from human embryos that were created for the purposes of fertility treatment and were in excess of the clinical need of the individuals seeking such treatment |
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Term
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Definition
| The state in which genuine uncertainty exists regarding which intervention—experimental or control—is better. Neither the experimental or control intervention is preferred |
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Term
| Minor increase over minimal risk |
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Definition
| A slight increase in the potential for harms or discomforts beyond minimal risk |
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Term
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Definition
| A child’s biological or adoptive parent |
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Term
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Definition
| An individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care |
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Term
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Definition
| A child’s affirmative agreement to participate in research. The regulations do not indicate an age at which this ought to be possible |
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Term
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Definition
| Any individual involuntarily confined or detained in a penal institution, including situations where a human subject becomes one after the research has commenced |
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Term
| Minimal Risk as Defined in Subpart C |
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Definition
| 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. In non-prisoner research, IRBs consider a wide range of risks, representing the possibility of physical, psychological, social, economic, or legal harms. In Subpart C, however, only physical or psychological harm is mentioned |
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Term
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Definition
| An ethical analysis of risks and benefits built on the recognition that clinical research often contains a mixture of therapeutic and non-therapeutic procedures and that separate moral standards are required for each |
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Term
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Definition
| Individuals’ right to have control over access to themselves and their information |
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Term
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Definition
| How information that is obtained from individuals is protected |
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Term
| Human Protections Administrator |
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Definition
| An employee or agent of teh FWA institution who exercises day-to-day responsibility for teh institution's program for protecting human subjects |
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Term
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Definition
| A special category of drugs allowed to be used for treatment while Phase II studies are still underway. After initial enthusiasm, use of these has declined |
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Term
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Definition
| A special category of drugs for studies invoking the special waiver of consent for treatment studies in an emergency setting. A set of rules under which therapeutic trials in an emergency setting can be done. These rules provide for a community consultation in lieu of individualized consent and restrict the research to a very serious condition under circumstances that preclude getting surrogate consent in a timely manner |
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Term
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Definition
| Samples colelcted without direct identifiers adn invovle the lowest level of risk. |
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Term
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Definition
| Samples that were originally collected with a direct identifier and from which the identifier has been irretrievably stripped from the sample and replaced with a random code |
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Term
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Definition
| Samples in which the identity can be readily ascertained |
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Term
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Definition
| Samples where the direct identifier is replaced with a code and a key to the code exists. These samples are the most used in research |
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Term
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Definition
| Any medical treatment that is inactive for the condition being evaluated other than the effect may result from a person’s thinking that he or she may be receiving an active treatment |
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Term
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Definition
| A control group that is chosen from studies that were completed in the past |
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Term
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Definition
| A trial that uses active treatment control where the goal is to show that the study drug is not less effective than the control by more than a defined amount |
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Term
| Intrapatient Dose Escalation |
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Definition
| A dosing scheme that allows patients to be given successively higher doses of an experimental drug if the initial dose administered proves to be well tolerated but unable to shrink the tumor |
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