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Regulations & Ethics for Human Research: Conflicts, Consent, Data Protection, Exams of Business Economics
An overview of the regulations and ethical considerations surrounding research with human subjects, focusing on individual and institutional conflicts of interest, informed consent, and data protection. Topics include examples of financial and institutional cois, the role of peer reviewers, fda disclosure requirements, and the application of the belmont report principles. The document also covers the importance of fair outcomes, respect for persons, and beneficence in research involving human subjects.
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| During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: | Disclose their potential COI and may answer questions, but recuse themselves from voting |
| An example of an institutional COI is: | An industry sponsor pays for the construction of a new research laboratory at the organization |
| What is the term for management controls that are built in to a research study (for example, independent data analysis)? | Inherent controls |
| A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. | No later than the time of proposal submission |
| 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. |
| The FDA regulations governing disclosure of individual COIs require: | Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies |
| The COI management plan aims to: | Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed |
| A researcher’s membership on an advisory board with an organization sponsoring research can create a COI because: | It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research’s success |
| The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: | There may be bias by the peer reviewer as to the area of research |
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| 1. | The COI management plan aims to: | Provide procedures or extras steps to be taken to minimize the risk of bias when a COI is disclosed | |
| 2. | During an Institutional Review Board (IRB) meeting, any IRB member who may have a potential COI with a study under review should: | Disclose their potential COI and may answer questions, but recuse themselves from voting | |
| 3. | 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. | |
| 4. | An example of an institutional COI is: | An industry sponsor pays for the construction of a new research laboratory at the organization | |
| 5. | The FDA regulations governing disclosure of individual COIs require: | Applicants submitting marketing applications to disclose financial COIs of researchers who conducted clinical studies | |
| 6. | The peer review process can create conflicts of interest because the choice of who reviews a potentially publishable project may show: | There may be bias by the peer reviewer as to the area of research | |
| 7. | A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. | No later than the time of proposal submission | |
| 8. | A researcher’s membership on an advisory board with an organization sponsoring research can create a COI because: | It may be difficult for the researcher to appear neutral, as the researcher may have an interest in the research’s success |
| 9. | What is the term for management controls that are built in to a research study (for example, independent data analysis)? | Inherent controls |
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Robert F. Kennedy Jr.’s campaign plans 'three-way debate' counter programming
Updated June 25, 2024 at 17:48 PM ET
Robert F. Kennedy Jr.'s longshot presidential bid has hit several roadblocks in recent days: after not hitting polling thresholds and not being on enough state ballots, he will not be on this week’s presidential debate stage .
The latest fundraising reports show the campaign does not have a lot of money in the bank, but Kennedy’s campaign manager and daughter-in-law Amaryllis Fox Kennedy is not worried about the prospects for the future of the campaign.
In an interview with NPR’s Morning Edition, she insists there will be a “three-way debate” Thursday, falsely claiming that the independent presidential candidate met the criteria published by CNN to appear on the debate stage alongside President Biden and former President Donald Trump.
Later Tuesday afternoon, the campaign announced "The Real Debate" counter programming, where Kennedy will "answer the same debate questions live" on a website and streaming on the X social media site.
"I'm going to be on that debate stage with or without their permission," RFK said in a video.
The media outlet’s qualifications included a requirement that a candidate have at least 15% support in four polls from certain high-quality pollsters and appear on enough state ballots to reach the 270 electoral vote threshold to actually win the presidency.
RFK Jr. met neither, and the campaign filed a complaint with the Federal Election Commission arguing that this week’s debate is illegal without his inclusion, even suggesting that CNN staffers could face prosecution if it were to happen.
Kennedy earned at least 15% in three qualifying polls according to CNN, but his support has dropped recently: the latest NPR/PBS News/Marist poll showed Kennedy at 11% and a recent Fox News poll had him at 10%.
According to the latest press release from the campaign, Kennedy is officially on the ballot in eight states: Utah (6), Michigan (15), California (54), Delaware (3), Oklahoma (7), Hawaii (4), Texas (40) and South Carolina (9), which only accounts for 138 electoral votes, well short of what is required.
Even then, the campaign appears to overstate its current access: For example, Texas elections officials have not yet certified the petitions submitted earlier this year. In Mississippi , where the campaign previously said it had ballot access, elections officials there said that the “We the People” Party that would nominate Kennedy did not file the proper paperwork and is not on the ballot — for now.
Each state has different rules and thresholds for third-party ballot access, with different deadlines and different requirements for a candidate as opposed to creating a new political party. In all, the RFK campaign says it has collected signatures for another 17 states, though some of those are not submitted to state elections officials while others have not been verified yet.
Both Democrats and Republicans have ballot access in all 50 states, and will formally nominate Biden and Trump at conventions later this summer.
Democrats are currently suing in at least four states, including Nevada and North Carolina, to keep Kennedy off the ballot. They allege the campaign misled voters who signed petitions and made errors with the petitioning process.
Compounding the debate denial and the ballot access barriers, the campaign has been crunched for cash.
In total, the campaign has raised more than $46 million, including $10 million in self-funding from vice presidential nominee Nicole Shanahan, and spent over $40 million, with roughly a quarter of that going towards security services and campaign consulting, according to campaign finance reports.
In May, the campaign brought in roughly $2.6 million and spent more than $6 million, mostly on ballot access efforts. RFK Jr. has almost $6.5 million in the bank.
Kennedy’s campaign manager attributed the decline to the state of the economy and said there are actually more donors to the campaign than ever.
“We've added more donors and supporters, for example, in the first four days of June than in all of the month of May, and likewise in May compared with the previous month,” she said. “And I believe that that's a really exciting and telling sign of the growth of the movement. What we've seen is individual contributions — the actual total amount of individual donations go down rather than the total number.”
When asked what Kennedy would be doing on Thursday instead of attending the debate, his campaign manager teased the debate counter programming announced Tuesday.
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Study with Quizlet and memorize flashcards containing terms like A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation., The peer review process can create conflicts of interest because the choice of who reviews a ...
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. No later than the time of proposal submission.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. No later than the time of proposal submission.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. - Correct Answer: No later than the time of proposal submission The PHS regulations about financial conflict of ...
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he, and his ...
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. Jm. Submitted by Marcus M. Dec. 22, 2023 10:22 a.m. Instant Answer ...
Question: A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. Not until a notice of award is received Never -- the PHS regulation does not require researchers ...
Our expert help has broken down your problem into an easy-to-learn solution you can count on. See Answer. Question: A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. No later than the time of proposal submission. An example of an individual financial COI is:
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. No later than the time of proposal submission.
A researcher calls you stating that he plans to submit a proposal to the nih for a human subjects research study. He wants to know at what point he and his study team must submit coi disclosures to comply with the phs regulation. No later than the time of proposal submission never -- the phs regulation does not require researchers to submit coi ...
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. No later than the time of proposal submission: 8. A researcher's membership on an advisory board with an ...
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. A. Researchers must only submit COI disclosures if they have a significant financial interest related to the research.
Question 1 Question A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. No later than the time of proposal submission.
Question 1 Question A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation.
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. No later than the time of proposal submission
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. A. Researchers must only submit COI disclosures if they have a significant financial interest related to the research B.
Inherent controls may include independent data analysis, randomization, blinding, or low subject enrollment percentage at a local site for a large multi-center trial., A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study.
It calls for installing senior State Department leaders in "acting" roles that do not require Senate confirmation. Kiron Skinner, who wrote the State Department chapter of Project 2025, ran the department's office of policy planning for less than a year during the Trump administration, before she was forced out of the department. She considers ...
A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study team must submit COI disclosures to comply with the PHS regulation. A. Researchers must only submit COI disclosures if they have a significant financial interest related to the research.
Study with Quizlet and memorize flashcards containing terms like The COI management plan aims to:, The PHS regulations about financial conflict of interests require which party to disclose significant financial conflicts of interest?, A researcher calls you stating that he plans to submit a proposal to the NIH for a human subjects research study. He wants to know at what point he and his study ...
Updated June 25, 2024 at 17:48 PM ET. Robert F. Kennedy Jr.'s longshot presidential bid has hit several roadblocks in recent days: after not hitting polling thresholds and not being on enough state ballots, he will not be on this week's presidential debate stage.. The latest fundraising reports show the campaign does not have a lot of money in the bank, but Kennedy's campaign manager and ...