Profbarr

Within how many days of acquiring or discovering a significant financial interest is the investigator required to submit an updated disclosure to the institution? - Correct Answer- 30 days. Which of the following is true regarding the U.S. Public Health Service and its approach to the disclosure of significant financial interests? - Correct Answer- Any equity interest in a non-publicly traded company must be disclosed. According to the U.S. Public Health Service regulations, investigat...

Your informed consent form must describe _______. - Answer- All foreseeable risks and discomforts. Under the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) regulations, what is the Institutional Review Board (IRB) charged with? Select all that apply. - Answer- - Protecting the rights and welfare of human subjects - Assuring that researchers follow all applicable institutional policies and federal regulations related to research with human s...

You overhear someone say the following about Good Clinical Practice (GCP) in the hallway: "GCP is mostly just meant to curb abuses by unscrupulous researchers who make bad decisions in response to pressure to discover the next big thing." What could you say in response to this? - a. That's right; GCP are very rigorous rules that every researcher must follow - b. That's not quite right, because GCP is really more about the behavior of participants...NOT about the behavior of researchers...

What procedures must be described in an agreement called an "assurance of compliance" with OHRP? - Answer- Procedures in place that ensure that subjects will be protected in a manner commensurate with the Common Rule, including review by an independent committee comparable to an IRB. A researcher proposes to conduct a study at a foreign site that has been determined to be exempt from the federal regulations by institutional policy. According to federal regulations, is review required a...

Good Clinical Practice (GCP) - Answer- international ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the participation of human subjects Clinical Trial (NIH Def) - Answer- Beyond just biomedical studies, Social and Behavioral interventions are now defined as clinical trials. Why implement GCP? - Answer- - Protect participants - Prevent non-compliance issues - Yield quality data for reproducible findings Sponsor - Answe...

Which of the following are the three principles discussed in the Belmont Report? A. Respect for Persons, Beneficence, Justice B. Informed Consent, Institutional Assurance, Researcher Responsibility C. Privacy, Confidentiality, Equitable Selection of Subjects D. IRB Review, Federal Regulations, Declaration of Helsinki - Answer- A. Respect for Persons, Beneficence, Justice The Belmont Report's principle of respect for persons incorporates at least two ethical convictions: first, ...

Which type of inappropriate practice most likely occurred if a researcher takes credit for someone else's idea and does not acknowledge the original source? - Answer- Plagiarism According to U.S. Federal Research Misconduct Policy, which of the following is considered to be research misconduct? - Answer- Plagiarism Which of the following is true regarding research misconduct? - Answer- Federal funding agencies typically rely on an institution to make the initial response to an allegati...

A researcher is conducting a written survey about people's attitudes toward walking as an exercise option at the local shopping mall that supports a walking program. The survey is anonymous (without codes, names or other information) and volunteers may complete the survey and place it in a box at the shopping mall exits. Which of the following is the most important issue that the researcher addressed in planning the research? - Answer- Confidentiality of the individual subject's respons...

Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? - Answer- Determining that the study has a maximization of benefits and a minimization of risks. 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: - Answer- Persons with diminished autonomy are entitled to protection. Which of the ...

Belmont Report - Answer- provides the ethical framework for the federal regulations designed to protect human research subjects. Belmont Report and Its Principles - Answer- 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: - Answer- Persons with diminished autonomy are entitled to protection. The Belmont Report's principle of respect for persons incor...