What procedures must be described in an agreement called an “assurance of compliance” with OHRP? 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.
What are management controls that are built into a research study?
The procedures or protections put into place to minimize the risk of bias are often called controls. Management plans are typically tailored to the study and the researcher’s financial interests.
What is an example of an institutional COI?
Covered Official relationships where an institutional official receives payments, honoraria, royalties (including those from U-M), equity, options and warrants, company positions (e.g., board directorships and/or management), or gifts.
What is the term for management controls that are built in to a research study for example independent?
Match. What is the term for management controls that are built in to a research study (for example, independent data analysis)? Inherent controls. An example of an individual financial COI is: A researcher’s wife holds equity in a publicly traded pharmaceutical company that is also the sponsor of the researcher’s study
Which of the following studies would need IRB approval?
Which of the following studies need IRB approval? Studies collecting data about living individuals. Per federal regulations, which of the following elements must be included in an informed consent document? All foreseeable risks and discomforts.
What is an assurance of compliance agreement?
An assurance of compliance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by HHS.
Which of the following is the most effective strategy for preventing research misconduct?
Among the options mentioned, good mentoring is the most effective strategy for preventing research misconduct.
Which of the following most accurately describes a conflict of commitment?
Which of the following most accurately describes a conflict of commitment? It occurs when outside activities interfere with obligations to one’s primary employer.
Which if the following is an example of how the principle of beneficence is applied to a study involving human subjects?
Which of the following is an example of how the principle of beneficence is applied to a study involving human subjects? Ensuring that risks are reasonable in relationship to anticipated benefits.
Which of the following is most likely to own the data resulting from a research project?
Which of the following is most likely to own the data resulting from a research project? The organization that receives federal funding for a project.
Which of the following is an example of a mobile app used in research that is a medical device quizlet?
Which of the following is an example of a mobile app used in research that is a medical device? A daily calorie tracking app intended to determine and adjust insulin dosage levels.
Which of the following are the three principles included in the Belmont Report?
The three principles discussed in the Belmont Report are Respect for Persons, Beneficence, Justice.
Which of the following most accurately describes the main goal of RCR education and training?
Which of the following most accurately describes the main goal of RCR education and training? To promote greater awareness of proper research practice and research ethics.
Which of the following statements most accurately describes a mitigation report quizlet?
Which of the following statements most accurately describes a mitigation report? A report to PHS of efforts that will be taken by the institution to deal with any bias that was found in research conducted while there was an unreported financial conflict of interest.
Which of the following brought increased public attention to the problems with the IRB system?
Which of the following brought increased public attention to the problems with the IRB system? Death of Jesse Gelsinger (Although all of these are related to the problems with the IRB system, the death of Jesse Gelsinger was what received public attention.)
What is IRB approval in research?
Under FDA regulations, an Institutional Review Board is group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research.
Does Action research require IRB approval?
Action Research proposals need to be approved by the Institutional Review Board (IRB). Since Action Research falls under the purview of research involving human subjects, graduate students need to use IRB Form A, Form B, and Informed Consent (see template) (or Waiver of Informed Consent [Form I]) for the proposal.
Which of the following elements must be in an informed consent?
A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
