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RHIA exam prep #31
Chapter 20
| Question | Answer |
|---|---|
| What does OHRP stand for? | Office for human research protections (OHRP) |
| is minimizing harms and maximizing benefits. ____ requires the best possible research design to achieve its goals. It also requires that researchers be able to perform the research and handle the risks. | Beneficence |
| In this clinical trial phase, participants increased to 100-200 people | Phase 2 |
| In giving ___ ___, subjects do not waive any of their legal rights nor do they release the investigator, sponsor or institution from liability for negligence. | informed consent |
| ___ studies are used to generate hypotheses for later experimental studies. | Observational |
| ____ events can be checked as they occur; many ____ can be studied including those that were not anticipated at the start of the study. | Outcome |
| The advantage of an ___ ___ is that they are easy to conduct and cost effective with minimal risk to the subjects. Also existing records may be used to conduct the studies. | Odd ratio |
| Objectives of ____ _ drug trials are to determine the metabolic and pharmacological actions of the drug in humans to determine the side effects associated with increasing dosages and to gain early evidence of effective ness. | phase 1 |
| Relative risk ___ than 1.0 indicates an increased risk for the exposed group | greater |
| Phase _ may include studying different doses or schedules of administration than what was used in phase 2 studies, the use of the drug in other patient populations or other stages of the disease or the use of the drug over a longer period | Phase 4 |
| Has established a patient centered care improvement guide. It provides best practices to assist hospitals in moving toward patient centered care. | AHRQ |
| Sometimes during the course of the research study, ___ ___ events occur. When this happens, the investigator must notify the IRB and complete an unanticipated problem involving risk to human subject’s report. | protocol reportable |
| An informed consent for must include a description of foreseeable ___. | risks |
| Odds ration of ___ ___ indicates that the cases were twice as likely to be exposed as the controls. This implies that the exposure is associated with twice the risk of the disease. | 2.0 |
| In this clinical trial phase, it is designed to collect more information on drug effectiveness and safety for evaluating the drugs overall risk benefit. | Phase 3 |
| An ___ ___ review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth | expedited research |
| in the ___ ___ study, the subject are individuals who have been exposed or not exposed to the disease and the focus is exposure status. | case control |
| Advantages of the ____ study is that the researcher can control the data collection process throughout the study | Case-Control Studies |
| A description of benefits to the subject must be included in an ___ ___ form | Informed consent |
| Research that is ____ does not mean that the researchers have no ethical obligations to the participants. However, regulatory requirements such as informed consent and yearly renewal from IRB does not apply to this type of research. | exempt |
| Odds ratio of _._ indicates that the evidence of disease is equal in each group thus the exposure may not be a risk factor for the disease of interest. | 1.0 |
| In this clinical trial phase, it involves the administration of a new drug to a larger number of patients in different clinical settings to determine its safety, effectiveness and appropriate dosage. | Phase 3 |
| Another different is that in a ___ study the subjects are individuals with or without the disease and focus is disease status | cohort |
| May also be referred to as a prevalence study because it describes characteristic and health outcomes at a particular point. | Cross Sectional Studies |
| Federal regulation requires an informed consent form must include a disclosure of the appropriate ___ ___ or courses of treatment if any that may be advantageous to the subject. | alternative procedure |
| Education settings, Use of educational tests, surveys, interviews or observation, Use of educational tests, surveys, interviews or observation | Examples of Exempt research activities |
| An IRB must review all research activities covered by the HHS regulations and either: | Full Approval, Approval subject to modifications, Reconsideration and Disapproval |
| Taste and food quality evaluation and consumer acceptance studies, Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens | Examples of Exempt research activities |
| The IRB must first determine if research is being conducted and then determine if human subjects are being ____. | protected |
| HHS will support nonexempt research covered by the regulations only if the organization has an _ _ _ _ approved assurance on file | OHRP |
| The broad objective of ___ and ___ ___ ___ studies is to establish reproducible facts and theory that help solve problems. | Clinical and biomedical research studies |
| A ___ may be specific to the individual subject in that it provides a good therapeutic outcome or it may be a direct advantage to society as a whole rather than the individual subject. | benefit |
| A summary of the changes include: broadening protections for research subjects, such as more focused informed consent documents that are shorter & clearer, a focus on more oversight for those studies that hold more risk for the research subject and less o | Revisions to the Common Rule that were made in the Notice of Proposed Rulemaking |
| An _ _ _ must perform continuing reviews of ongoing research as often as necessary per degree of risk, but do not less than one year. | IRB |
| In this phase of clinical trials, they are considered the safest and usually involve administering a single dose to healthy volunteers | Phase 1 |
| Relative risk of ___ than 1.0 indicates a decreased risk for the exposed group | less |
| The objective is to determine the frequency of the risk factor among the cases and the frequency of the risk factor among the controls in order to determine possible causes of the disease. | Case control studies |
| An informed consent form requires an ____ of who to contact for answers to pertinent questions. | explanation |
| Research and demonstration projects that are conducted by or subject to the approval of department or agency heads and are design to study, evaluate or otherwise examine. | Examples of Exempt research activities |
| __ ___ includes those activities that 1) present no more than the minimal risk to human subject and 2) involve only procedures listed in one or more of the following categories: collection of data, collection of blood | Expediated research |
| A major advantage of the ___ ___ study is that it is relatively easy to conduct and may produce results in a short period of time. | cross sectional |
| In this phase of clinical trials, the purposes of this trial are to evaluate the drugs effectiveness for a certain indication in patients with the condition under study and to determine the short term side effects and risks associated with the drug. | Phase 2 |
| Requires that people be treated fairly and that benefits and risks be shared equitably among the population ____ requires that subjects be selected equitably and that vulnerable population or populations of convenience not be exploited. | Justice |
| An informed consent form federally requires a statement that participation is ___ and that the subject may discontinue participation at any time without penalty or loss of benefits to which they are entitled to. | voluntary |
| Prospective collection of biological specimens for research purposes by noninvasive means, Collection of data through noninvasive procedures not including general anesthesia or sedation. Ex: MRI | Examples of Exempt research activites |
| In a ___ ___study, if there is an association between exposure and disease, the prevalence of history of exposure will be higher in persons with the disease (cases) than in those without it (controls) | case control |
| In this phase of clinical trials, can pose a high level of unknown risk because this is the first administration of a drug to a human | Phase 1 |
| The purpose of the measures developed by the NCQA is to provide purchasers of healthcare, primarily employers with information about cost and effectiveness of organizations with which they contract for services | NCQA |
| is conducted by reviewing records from the past | retrospective |
| ___ research activities may include the involvement of human subjects in one or more specific categories | Exempt |
| Risk for exposed group or the incidence rate of the exposed group/risk for unexposed group or incident rate of the unexposed group | Risk ratio equation |
| is designed to observe events that occur after the subjects have been identified. Is considered a Cohort study | Prospective |
Created by:
Kristinama021