Which of the following studies need irb approval. Which of the following studies would need IRB approval quizlet? [Solved] (2022) 2022-10-22
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Institutional Review Board (IRB) approval is an important part of the research process that ensures the ethical treatment of human subjects involved in a study. The IRB is responsible for reviewing and approving research protocols to ensure that they meet ethical standards and regulations.
There are several types of studies that generally need IRB approval. These include:
Clinical trials: Clinical trials are research studies that involve human subjects and are designed to test the safety and effectiveness of new medical treatments, such as drugs or medical devices. These studies often need IRB approval to ensure that the rights and welfare of the subjects are protected.
Social and behavioral research: Studies that involve human subjects and involve social or behavioral interventions, such as surveys or experiments, also often require IRB approval. This is to ensure that the subjects are treated ethically and that their privacy is protected.
Genetic research: Studies that involve the collection and analysis of genetic information from human subjects may also need IRB approval. This is to ensure that the subjects' genetic privacy is protected and that any potential risks are minimized.
Education research: Studies that involve human subjects and are conducted in educational settings, such as schools or universities, may also need IRB approval. This is to ensure that the rights and welfare of the subjects are protected and that any potential risks are minimized.
In conclusion, it is important to obtain IRB approval for studies that involve human subjects to ensure that the rights and welfare of the subjects are protected and that the study is conducted ethically. This may include clinical trials, social and behavioral research, genetic research, and education research.
CITI Flashcards
Asking a subject in a wheelchair to complete surveys verbally because the tables in the science room are too tall for the subject to easily complete a written form. Which of the following statements best characterizes what occurred? Epidemiological Studies such as investigations on health outcomes, interventions, disease states and conclusions about cost-effectiveness, efficacy, efficiency, interventions, or delivery of services to affected populations. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in to secure approval , or disapprove research. Studies may also be modifying study procedures to move from in-person visits to remote visits or revising study inclusion criteria to decrease the risks for some vulnerable populations. Studies collecting identifiable information about living individuals. Which of the following statements about parental permission is correct? Based on HHS regulations, should the researcher report this event to the IRB? Clinical Investigations including research to increase scientific understanding about normal or abnormal physiology, disease states or development, and research to evaluate the safety, effectiveness or usefulness of a medical product, procedure, or intervention. Ensuring that the selection of subjects includes people from all segments of the population.
All research must be reviewed by the IRB. The value of stock is not calculated when determining significant financial interests. The researcher wants to add an adolescent population aged 12 to 17 to the study and has designed a parental permission and assent process. The only record linking the subject and the research is the consent document and the principal risk is a breach of confidentiality. The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that: Persons with diminished autonomy are entitled to protection. What is IRB approval in research? Which of the following statements is true regarding the reporting of outside interests and the management of conflicts? Studies that involve cadavers.
What DOES and DOES NOT require IRB Review and Approval?
No, this does not need to be reported because it is unrelated to participation in the study. Persons who are under 18 years of age. Research is subject to the IDE regulations when it involves any use of a medical device to determine safety or effectiveness of that device. After they receive funding but before they start their research. Which of the following most directly contributed to the establishment of the National Research Act and the creation of the Belmont Report quizlet? Studies collecting data about living individuals. The investigator and the treating physician enter into an agreement prohibiting the release of the key to decipher the code to the investigator under any circumstances, until the individuals are deceased. A therapist at a free university clinic treats elementary school children with behavior problems who are referred by a social service agency.
Which of the following studies would need IRB approval quizlet? [Solved] (2022)
The students must be offered an optional classroom activity. Individuals may post private identifiable information about themselves on-line without intending it to be public and available to researchers. Public Health Service to do which of the following: Update their financial conflict of interest policy every four years. Mobility and access to transportation can be impedances to research participation. Which of the following financial conflict of interest information must be made available by institutions on a public website or within five business days upon request? Potential subjects might find some of the research questions embarrassing, personal, or intrusive.
Repository Research, Tissue Banking, and Databases utilizing stored data or materials cells, tissues, fluids, and body parts. The survey asks subjects about their highest level of education, political affiliation, and views on various social issues. Studies that use data collected for internal department use only and the aim of the study is quality improvement for the department only. Individuals who have physical disabilities and are employed should not be asked to participate in research. Convened Review Determination for Exemption Not Human Subjects Expedited Review Identify one way faculty researchers can possibly avoid undue influence of student subjects? No later than the time of applying for funding. Obtain a Certificate of Confidentiality.
Which of the following studies would need IRB approval?
For example, all Harvard research studies that involved direct contact with study subjects have been paused. The most likely additional risk is that some subjects may: Feel that their privacy has been invaded. Select all that apply. If you plan to publish your research in a traditional peer-reviewed journal, you will usually need an IRB review. Department of Education requirements for research involving individuals with mental disabilities. In the event of any distress you may have related to this research, you will be given access to appropriate resources.
The subjects are literate in their own language; however, they do not read, write, or speak English. . Providing a thorough debriefing at the end of the study. In this example, the student is not conducting research involving human subjects because the data was not collected for the purpose of her research, it was collected for the purposes of the individual agencies, and she cannot readily ascertain the identity of the individuals. Provide a list of the IRB members who reviewed the protocol. Is this an example of an unanticipated problem that requires reporting to the IRB? A researcher proposes to join a moderated support group for cancer survivors posing as a survivor.
Which of the following studies would need IRB approval? Studies that involve cadavers. Studies that
A student plans on interviewing 15 principals in neighboring high schools. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Which of the following on-line research strategies raises the most concerns regarding the ethical principle of respecting the autonomy of research subjects and the corresponding federal regulations requiring informed consent? Department of Education ED that involves children with mental disabilities, an IRB must: Apply only the subpart of 45 CFR 46 that calls for additional protections of children participating in research. Within 90 days of discovering or acquiring a new significant financial interest. Professor Q has retained the key to identifiers in case she decides to do a follow-up study at a later date. This study might be determined to be violating which principle of the Belmont Report? This situation most likely involves falsification.
Which of the following statements is true? Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? Human Genetic Research such as pedigree studies, positional cloning studies, gene transfer research, longitudinal studies to associate genetic conditions with health, health care, or social outcomes, and gene frequency studies. Persons who are under 21 years of age. What is the most appropriate process for research collaborators? Which of the following statements most accurately describes a mitigation report? An investigator uses his Facebook wall to post a URL link to a survey he is hosting on SurveyMonkey. The parents of the children might feel pressure to give permission to the therapist to use their children's data so that she will continue to provide services to their children. Any level of risk, but all the subjects are adults. You assert that it is in the best interest of the subject to remain in the study while incarcerated.
This is an unanticipated problem that must be reported because the incident was a unexpected in other words, the researchers did not anticipate the theft ; b related to participation in the research; and c placed the subjects at a greater risk of psychological and social harm from the breach in confidentiality of the study data than was previously known or recognized. Parents must approve written documentation. All of the above None of the above. A researcher posts a notice on an open on-line support group for interracial adoptees asking anyone who would be interested in being interviewed for her study to contact her. All the subjects are adults and the risk is minimal. The lieutenant in charge of a dorm of long-term prisoners offers to gather volunteers to speak to the researcher and also offers to vouch for the integrity of the researcher.
