Term
Institutional Review Board (purpose & approval) |
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Definition
a committee that has been formally designated to approve, monitor, and review biomedical and behavioral research involving humans with the aim to protect the rights and welfare of the research subjects. IRB has these core ethical principles: Respect Beneficence (prevent or remove harms or to simply improve the situation of others) & Justice |
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Term
Informed Consent (& in spirit) |
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Definition
(a) competence in making a meaningful decision to participate; (b) knowledge of research, alternatives available, risks & benefits; (c) volition free from coercion, constraint, pressures, duress, absence of penalty, including withdrawing from research. (See University IRB for requirements of consent including language and rules for assent): Purpose of the research. Procedures involved in the research. Alternatives available should a subject decide not to participate in the research. All foreseeable risks and discomforts to the subject. *Note that these include not only physical injury but also possible psychological, social, or economic harm, discomfort, or inconvenience. Benefits of the research to society and possibly to the individual human subject. Length of time the subject is expected to participate. Payment for participation (if applicable). Person to contact for answers to questions or in the event of a research-related injury or emergency. Statement that participation is voluntary and that refusal to participate will not result in any consequences or any loss of benefits that the person is otherwise entitled to receive. Subjects' right to confidentiality |
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Term
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Definition
Generally, consent & assent are required. Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent (DHHS). Many complicated examples such as developmental characteristics; possible direct benefits of research to child great, not available outside research, assent may not be needed. IRB 7-17 but variations |
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Misrepresenting research, findings. Need for deception is justified by review of research; Participants are debriefed. |
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Conflict of Interest and Dual Relationship |
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Definition
Examples showing concern of impaired objectivity, possible harm or exploitation: personal, social, professional and administrative relations; professional relationship and judging research; financial interest in outcomes |
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Functional assessment, food safety & dietary issues |
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Federal regulations protecting research subjects (IRB) |
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Definition
RESPECT for persons involves a recognition of the personal dignity and autonomy of individuals, and special protection of those persons with diminished autonomy. BENEFICENCE entails an obligation to protect persons from harm by maximizing anticipated benefits and minimizing possible risks of harm. JUSTICE requires that the benefits and burdens of research be distributed fairly. |
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Term
Key sources for ethical practice and conflict resolution |
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Definition
IRB and other professional organizations (NASP, APA, ABA) have their own ethical guidelines to follow. |
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Definition
Is the intervention the "lease restrictive," the most effective procedure, is it an aversive or punishment procedure, can the intervention environment support the intervention? |
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Do you have explicit consent to share info? Is the pupose of sharing info clear? Are there protections for research (fictitious names and locations)? Follow specific laws for disclosing info and dispose of records appropriately. |
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Steps with concerns about unethical colleague |
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Definition
Report unethical behavior by following procedural or organizational guidelines. |
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Definition
Additional safeguards required for subjects likely to be vulnerable to coercion or undue influence.Check to see if safeguards are in place for vulnerable subjects, e.g., pregnant women, fetuses, socially- or economically-disadvantaged, decisionally-impaired. |
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Positive interventions preferred over ones that are aversive or punishment procedures |
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It is best to use evidence based treatments which will enhance the likelihood of getting positive results. RtI requires the use of evidence based treatments. |
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Least Restrictive Treatment |
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Definition
Use the most effective procedure in the least restrictive environment |
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Definition
withholding treatment is inappropriate whenever withholding an active (proven effective) treatment would increase the risk of more than minor harmful consequences or when minor or minimal harmful consequences due to withholding an active treatment are likely to be irreversible. |
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Definition
(a) Will personally-identifiable research data be protected to the extent possible from access or use? (b) Are any special privacy & confidentiality issues properly addressed |
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How IRB determines or judges "risk" |
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Definition
Risk to Benefit Assessment. Different categories of risk: No more than minimal risk, minor increase over minimal risk, more than a minor increase over minimal risk. |
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Term
Children who are wards of the State |
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Definition
Additional safeguards required for subjects likely to be vulnerable to coercion or undue influence. |
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