CITI
| 2. | Question 1 Question : What are some considerations for a U.S. researcher conducting a study in a non-U.S. setting when obtaining informed consent from subjects? Your answer : In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Correct Answer : In addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Comment : The points to consider when obtaining informed consent in non-U.S. settings include in addition to the consent of the research subjects, are there other individuals or groups whose permission must be sought? Sometimes, in non-U.S. communities, people other than the individual taking part in the research may be required to give permission before the potential subject may be asked to participate. These individuals may include a spouse, a head of household, or a group leader. However, another individual’s permission should not substitute for a subject’s voluntary informed consent unless an IRB or equivalent local review committee has waived that consent process. The witness signature line is an issue in documentation of informed consent; ensuring that consent process does not slow down recruitment is an issue in study design and not a non-U.S. setting specific issue, and maintaining confidentiality is a privacy/confidentiality issue. Points Earned : 1 Question 2 Question : Which of the following activities constitutes engagement in research? Your answer : Obtaining informed consent and conducting research interviews. Correct Answer : Obtaining informed consent and conducting research interviews. Comment : If an institution obtains informed consent and conducts research interviews it is engaged in research. Points Earned : 1 Question 3 Question : A professor at Big State University proposes to study attitudes about obesity in Chile by giving subjects in Chile surveys to complete. Which is a question that the Big State University IRB should ask the researcher in order to determine if this study should be reviewed by a local Chilean IRB or ethics committee as well as the Big State University IRB? Your answer : Does the potential subject population include children? Correct Answer : Will the researcher have collaborators at the research site abroad? Comment : There are several factors that determine what kinds of review are needed for international research, including if the researcher have collaborators at the research site abroad. If international research is carried out without the involvement of foreign collaborators the research may be reviewed by the researcher’s home institution. The need for local review will be determined by policies and regulations rather than by U.S. law. When U.S. researchers collaborate with researchers at foreign institutions, determining the appropriate review type and method depends on whether the collaborating institution is engaged in the research. The other responses are incorrect because they do not help the IRB determine where the research should be reviewed. Points Earned : 0 Question 4 Question : What procedures must be described in an agreement called an “assurance of compliance” with OHRP? Your answer : Procedures in place to outline how unanticipated problems will be reported to the local IRB. Correct 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. Comment : If research involves collaboration with an institution that is “engaged” in research in the foreign country (See below for a discussion of “engagement in research”), the collaborating institution will need to have 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. These procedures must be described in an agreement called an “assurance of compliance” with OHRP. The written procedures for reporting unanticipated problems are institutional policy, the procedures outlining randomization should be covered in the research plan/protocol, and the procedures in place to comply with ethical principles is the Federalwide Assurance (FWA), not “assurance of compliance.” Points Earned : 0 Question 5 Question : 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 at the foreign site? Your answer : If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted, but still require review by the institutional official at the local site. Correct Answer : If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. Comment : A great deal of research in the social and behavioral sciences may qualify for exemption, depending upon institutional policy. If a proposed study qualifies for exemption, federal regulations do not require review at the foreign site where it will be conducted. Federal regulations do not require exempt research to be reviewed by an institution’s IRB or an institutional official -t hose decisions are left to institutional policy. Question : A researcher proposes a study and wants to recruit subjects from health care clinics in Jamaica. The survey will be conducted by the U.S. researchers at the clinic. The nurses at the clinic will inform prospective subjects about the availably of the research, but will not consent the subjects nor perform any research procedures (even screening procedures). Are the nurses engaged in the research according to federal regulations? Your answer : Yes, they are engaged because the research is taking place at the clinic and they work there. Correct Answer : No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information. Comment : No, they are not engaged because they are only informing the subjects and not consenting or performing any research procedures, or receiving or sharing any private, identifiable information. An institution is not engaged if its only involvement is to provide space for the U.S. researchers to conduct their own research. Question 1 Question : The 1998 FDA regulations for requiring disclosure of significant financial interest reflect which threshold: Your answer : Any equity interest in a publicly held company that exceeds $50,000 Correct Answer : Any equity interest in a publicly held company that exceeds $50,000 Comment : In 1998, the FDA issued its final rule requiring disclosure of: Any equity interest in a publicly held company that exceeds $50,000 in value. These must be disclosed only for covered clinical studies that are ongoing on or after February 2, 1999. The requirement applies to interests held during the time the clinical investigator is carrying out the study and for 1 year following completion of the study and significant payments of other sorts, which are payments that have a cumulative monetary value of $25,000 or more made by the sponsor of a covered study to the investigator or the investigators’ institution to support activities of the investigator exclusive of the costs of conducting the clinical study or other clinical studies, (e.g., a grant to fund ongoing research, compensation in the form of equipment or retainers for ongoing consultation or honoraria) during the time the clinical investigator is carrying out the study and for 1 year following completion of the study. This requirement applies to payments made on or after February 2, 1999. Points Earned : 1 Question 2 Question : Significant financial interest, as defined by the 2011 final rule that amended Public Health Service (PHS) regulations on Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought (42 C.F.R. Part 50, Subpart F) and Responsible Prospective Contractors (45 C.F.R. Part 94), include(s) (Check all that apply): Your answers – Equity/stock interests (regardless of value) in a non-publicly traded company. – Intellectual property rights upon receipt of income related to such rights. – Consulting payments in excess of $5,000. – Salary from an outside institution of between $2,000-$3,000 in any twelve-month period. Correct Answer : – Equity/stock interests (regardless of value) in a non-publicly traded company. – Intellectual property rights upon receipt of income related to such rights. – Consulting payments in excess of $5,000. Comment : The PHS defines “significant financial interests” in terms of a monetary threshold (remuneration or equity interest of $5000) received from an entity within the last twelve months preceding the disclosure. For PHS, remuneration includes salary and any payment for services not otherwise identified as salary (for example, consulting fees, honoraria, paid authorship). Equity interest may be in form of stocks, stock options, or other ownership interest, as determined through reference to public prices or other reasonable measures of fair market value. An important distinction is made in the 2011 final rule with respect to non-publicly traded entities. It is now the case that a significant financial interest with respect to these organizations exists when there is remuneration received in the last twelve months that exceeds $5,000 or when an investigator (or the investigator’s spouse or dependent children) holds any equity interest. Notice that there is no threshold with respect to equity interest in non-publicly traded entities. Intellectual property rights upon receipt of income related to such rights also constitute a significant financial interest. Points Earned : 0 Question 3 Question : According to the HHS 2011 updated of the PHS federal regulations, the threshold amount for reporting a significant financial interest (investigator and his/her spouse and dependents) is: Your answer : Greater than $5,000 of ownership in any single public entity/public company. Correct Answer : Greater than $5,000 of ownership in any single public entity/public company. Comment : The federal rules for PHS define a threshold for reporting a significant financial interest as anything of monetary value. This includes equity interests (e.g., stocks, stock options, or other ownership interests) that exceed $5,000 in value either as remuneration or as ownership (stock/stock options/other ownership interests) interest in any single publicly traded company. For non-publicly traded any interest, regardless of value, must be disclosed. According to these rules, the equity interests of the investigator’s spouse and dependent children are aggregated to determine the threshold for disclosure. Points Earned : 1 Question 4 Question : A conflict of interest implies: Your answer : The potential for bias. Correct Answer : The potential for bias. Comment : A conflict of interest is a situation in which financial or other personal considerations have the potential to compromise or bias professional judgment and objectivity. A conflict of interest implies only the potential for bias. Points Earned : 1 Question 5 Question : A financial conflict of interest could involve: Your answer : Receiving stock in a company funding your research. Correct Answer : Receiving stock in a company funding your research. Comment : Tangible, or financial conflicts of interests, are those that involve direct financial relationships. Points Earned : 1 Question 1 |
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