Use LEFT and RIGHT arrow keys to navigate between flashcards;
Use UP and DOWN arrow keys to flip the card;
H to show hint;
A reads text to speech;
36 Cards in this Set
- Front
- Back
|
In order to approve a project the following must be met: -Risks to subjects are minimized -Risks are reasonable in relation to anticipated benefits -Selection of subjects is equitable -Informed consent is sought from each subject -Informed consent is appropriately documented a. IRB Approval b. IRB consist of: c. NIH/OLAW d. Full IRB review |
a. IRB Approval |
|
|
Should include a full discussion and disclosure of: -the nature of the research, -any risks and benefits, -subjects involvement is voluntary and they may withdraw from the study at any time, -risks should be explained in the context of recognizable experiences a. Animal Care and Use Guidance b. USDA Animal Care and Use c. Informed consent d. Substantive Informed Consent |
d. Substantive Informed Consent |
|
|
-Reviewed at full board -Must review annually or more frequently -Disapproval is only allowed at full board meetings a. IRB Approval b. Human Subject c. Full IRB review d. Expedited IRB review |
c. Full IRB review |
|
|
A living individual about whom an investigator conducting research obtains: -data through intervention or interaction with the individual, or -identifiable private information a. Human Subjects Oversight b. Full IRB review c. Human Subjects Exempt d. Human Subject |
d. Human Subject |
|
|
assurance + annual reports a. Noncompliance b. IRB Approval c. NIH/OLAW d. Human Subject |
c. NIH/OLAW |
|
|
-The research involves no more than minimal risk, -The waiver or alteration will not adversely affect the rights and welfare of the subject, -The research cannot practically be carried out without the waiver or alteration; AND -The subjects will be provided with additional pertinent information, if appropriate, after participation a. Research b. Human Subject c. NIH/OLAW d. Other Reserach |
d. Other Research |
|
|
-Reviews all research involving vertebrate animals, -Approves for up to 3 years with annual continuing reviews, -Reviews facilities and program every 6 months a. Institutional Animal Care and Use Committee members must be b. Institutional Animal Care and Use Committee consists of c. Institutional Animal Care and Use Committee type of Action d. Institutional Animal Care and Use Committee is responsible for and |
d. Institutional Animal Care and Use Committee is responsible for and |
|
|
at least 5 members of varying backgrounds who: •Are sufficiently qualified •Are not solely from one profession •Are diverse Additional IRB composition requirements: •At lease one non-scientist •At least one non-affiliated member •Expertise on vulnerable populations •Outside consultants when needed a. IRB Responsibilities b. NIH/OLAW c. IRB Approval d. IRB consist of : |
d. IRB consist of : |
|
|
Means that the IRB does not have to review (exempt under 45 CFR 46); does not mean that subjects shouldn't haveprotections Must be determined by someone other than the investigator a. Human Subjects Exempt b. Human Subject c. Human Subjects Oversight d. Subject recruitment |
a. Human Subjects Exempt |
|
|
Review and approve, require modifications, ordisapprove all covered research Review informed consent practices and ensurecompliance with regulations Notify investigators of concerns, questions, anddecisions Conduct yearly (or more frequent) review ofongoing covered research a. IRB Approval b. IRB consist of : c. IRB Responsibilities d. Federal Regulations |
c. IRB Responsibilities |
|
|
AAALAC - Association for the Accreditation and Assessment of Laboratory Animal Science International a. Animal Care and Use Guidance b. Animal Care and Use Policy c. Animal Care and Use Accreditation d. Animal Care and Use Law |
c. Animal Care and Use Accreditation |
|
|
21 CFR 50 - FDA Protection of Human Subjects a. Requirements for clinical investigations regulated by the FDA b. USDA Animal Care and Use c. Prior to starting work, investigators must d. Government Program Evaluations |
a. Requirements for clinical investigations regulated by the FDA |
|
|
*Likely to have to have a Federalwide Assurance (FWA) *The institution is responsible for reviewing all human subjects research through use of and support of anInstitutional Review Board (IRB). *Enuring compliance with all requirements in our FWA and the regulations and providing education a. Institutional Animal Care and Use Committee members must be b. Institutional Requirements if you accept federal funding: c. Institutional Animal Care and Use Committee Evaluates d. Institutional Animal Care and Use Committee type of Action |
b. Institutional Requirements if you accept federal funding: |
|
|
Types of review • Designated member reviews • Full board reviews a. Institutional Animal Care and Use Committee Evaluates b. Institutional Animal Care and Use Committee consists of c. Institutional Animal Care and Use Committee type of review d. Institutional Animal Care and Use Committee type of Action |
c. Institutional Animal Care and Use Committee type of review |
|
|
Qualified through experience & expertise to provide oversight for the animal programs, facilities & procedures a. Institutional Animal Care and Use Committee type of Action b. Institutional Animal Care and Use Committee consists of c. Institutional Animal Care and Use Committee members must be d. Institutional Animal Care and Use Committee Evaluates |
c. Institutional Animal Care and Use Committee members must be |
|
|
Meet the definitions of BOTH research and human subjects. a. IRB reviews projects that are b. IRB consist of : c. IRB Approval d. IRB Responsibilities |
a. IRB reviews projects that are |
|
|
Must complete training prior to initiation of that work before interacting with human or animal subjects a. Human Subjects Oversight b. What is informed consent? c. USDA Animal Care and Use d. Prior to starting work, investigators must |
d. Prior to starting work, investigators must |
|
|
•Reviewed by one or more IRB member outside of committee meeting. •Must fit in one of 9 categories a. Other Research b. IRB Approval c. Expedited IRB review d. Full IRB review |
c. Expedited IRB review |
|
|
Is evaluated in the context of risk to subjects. If there are serious unanticipated problems ornegligence/intentional harm the institution would need to report to the appropriate agency. Suspensions mustalso be reported a. IRB Approval b. NIH/OLAW c. Noncompliance d. Human Subject |
c. Noncompliance |
|
|
Research participant is legally and mentally able to give consent or has a representative,They are given sufficient time to consider participation and ask questions,Coercion/undue influence is minimized,The language is appropriate for the population and understandable to the individual subjectNo exculpatory language - language in which the subject is made to waive or appear to waive legal rights ORreleases or appears to release researchers from liability for negligence: http://www.hhs.gov/ohrp/policy/exculp.html a. Subject recruitment b. History of Human Subjects c. What is Research? d. What is informed consent? |
d. What is informed consent? |
|
|
Public Health Service (Office of Laboratory Animal Welfare - OLAW) - all species at institutions that accept PHSfunding a. Animal Care and Use Policy b. Animal Care and Use Law c. Animal Care and Use Guidance d. USDA Animal Care and Use |
a. Animal Care and Use Policy |
|
|
• Advertisements and other methods should beconsistent with protocol • Recruitment should not be coercive or makeunfounded claims • It should be clear from recruitment materials thatResearch is involved a. Human Subject b. Subject recruitment c. Full IRB review d. Federal Regulations |
b. Subject recruitment |
|
|
HHS - Department of Health and Human Services OHRP - Office of Human Research ProtectionFDA - Food and Drug Administration a. Human Subjects Oversight b. Human Subjects Exempt c. Human Subject d. Subject recruitment |
a. Human Subjects Oversight |
|
|
Subpart B: Additional Protections for PregnantWomen, Human Fetuses and Neonates involvedin Research Subpart C: Additional Protections Pertaining toBiomedical and Behavioral Research InvolvingPrisoners as Subjects Subpart D: Additional Protections for ChildrenInvolved as Subjects in Research a. Government Program Evaluations b. Federal Regulations c. Animal Care and Use Accreditation d. Special Protections for Vulnerable Populations |
d. Special Protections for Vulnerable |
|
|
registration + annual reports a. Animal Care and Use Guidance b. Animal Care and Use Policy c. USDA Animal Care and Use d. Animal Care and Use Law |
c. USDA Animal Care and Use |
|
|
*Copies of all protocols, evaluations, consent documents (HS), continuing reviews, progress reports, andunanticipated problems reported*Meeting minutes *IRB/IACUC-PI Correspondence Committee membership & credentials Written procedures a. Prior to starting work, investigators must b. USDA Animal Care and Use c. The following standards are common to both IRBs and IACUCs d. Substantive Informed Consent should include |
c. The following standards are common to both IRBs and IACUCs |
|
|
Minimum of 5 members • Veterinarian • Practicing scientist experienced in animal research • Non-affiliated member • Non-scientist a. Institutional Animal Care and Use Committee consists of b. Institutional Animal Care and Use Committee Evaluates c. Institutional Animal Care and Use Committee type of Action d. Institutional Animal Care and Use Committee members must be |
a. Institutional Animal Care and Use Committee consists of |
|
|
A systematic investigation designed to develop or contribute to generalizable knowledge (includes researchdevelopment, testing, and evaluation). This include biomedical, social, and behavioral research a. Human Subject b. Full IRB review c. What is Research? d. Other Research |
c. What is Research? |
|
|
•Respect for persons •Beneficence •Justice a. Belmont Report (1979) b. Full IRB review c. Subject recruitment d. Federal Regulations |
a. Belmont Report (1979) |
|
|
USDA - Animal Welfare Act (certain species) a. USDA Animal Care and Use b. Animal Care and Use Policy c. Animal Care and Use Guidance d. Animal Care and Use Law |
d. Animal Care and Use Law |
|
|
• Approve • Find acceptable following revisions • Disapprove (only at full board) a. Institutional Animal Care and Use Committee type of review b. Institutional Animal Care and Use Committee type of Action c. Institutional Animal Care and Use Committee consists of d. Institutional Animal Care and Use Committee Evaluates |
b. Institutional Animal Care and Use Committee type of Action |
|
|
Guide for the Care and Use of Laboratory Animals (not really guidance because it is adopted by both USDA &OLAW). Similar to the rDNA "guide" a. Animal Care and Use Accreditation b. Animal Care and Use Policy c. Animal Care and Use Law d. Animal Care and Use Guidance |
d. Animal Care and Use Guidance |
|
|
*Nuremberg Code (1946) *Declaration of Helsinki (1964) *National Commission for the Protection of Research Subjects in Biomedical and Social Behavioral Research (1974) *Belmont Report (1979) a. Human Subjects Exempt b. History of Human Subjects c. IRB Responsibilities d. Human Subject |
b. History of Human Subjects |
|
|
•45 CFR 46 - DHHS Policy for Protection of Human Subjects - Subpart A = the "Common Rule" •Heavily influenced by the Belmont Report•Adopted by 15 Federal departments and agenciesSubpart B - D = Additional protections for vulnerable populations a. Subject recruitment b. Full IRB review c. Other Research d. Federal Regulations |
d. Federal Regulations |
|
|
Justification of need for the research, numbers and types of animals Procedures to ensure appropriate speciesDegree of discomfort or distress and if they are justified Appropriate use of analgesia and anesthetics Permits &licenses Euthanasia and disposal practices a. Institutional Animal Care and Use Committee type of review b. Institutional Animal Care and Use Committee Evaluates c. Institutional Animal Care and Use Committee consists of d. Institutional Animal Care and Use Committee type of Action |
b. Institutional Animal Care and Use Committee Evaluates |
|
|
•The study is an evaluation of a public program of services, is subject to governmental approval, and is evaluatingprocedures for obtaining benefits, changes in the program, or methods or levels of payment to be made under theprogram, AND •The research cannot practicably be carried out without the waiver or alteration a. Federal Regulations b. Subject recruitment c. IRB Responsibilities d. Government Program Evaluations |
d. Government Program Evaluations |
