The investigation phase occurs after the inquiry if there is sufficient evidence to indicate that research misconduct may have taken place. The inquiry is generally the first main phase in response to a research misconduct allegation.

1 Answer. The organization that receives federal funding for a project. The organization that receives a federally-funded grant can typically claim ownership of the data from the project.

Question : Which of the following is most likely to create a poor relationship between a mentor and a trainee? Your answer : The trainee has an interest in learning more about the mentor’s field of study.

Which of the following is most likely to help the journal publication process mitigate reproducibility problems? Moving away from a review process that favors the publication of positive results.

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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 of following is true about the management of conflicts of interest? Management plans are often created to reduce the impact of conflicts of interest.

What is the primary purpose of the “3 R’s” concept? The primary purpose of the “3 Rs” is to urge investigators to minimize use of animals and minimize pain and distress caused by animal research.

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects? Determining that the study has a maximization of benefits and a minimization of risks. Ensuring that risks are reasonable in relationship to anticipated benefits.

The principle of beneficence can be applied to a study employing human subjects by determining that the study has a maximization of benefits and a minimization of risks.

Beneficence in Nursing

1. Resuscitating a drowning victim.
2. Providing pain medication as soon as possible to an injured patient in the emergency room.
3. Lifting side rails on a patient’s hospital bed to prevent falls.
4. Providing vaccinations.
5. Performing daily tasks for patients who are unable to carry them out alone.

“Exempt” human subjects research is a sub-set of research involving human subjects that does not require comprehensive IRB review and approval because the only research activity involving the human subjects falls into one or more specific exemption categories as defined by the Common Rule.

There are three major types of review: Exempt, Expedited, and Full.

FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR Part 56).

No institutional official may overrule IRB disapproval, but institutions may choose not to support or permit research that the IRB has approved.

Institutional priorities take precedence over all IRB determinations. Department chairs can overturn an IRB disapproval. Officials of the institution may overturn an IRB disapproval. Officials of the institution may overrule an IRB approval.

What statement about risks in social and behavioral sciences research is most accurate: Risks are specific to time, situation, and culture. The primary purpose of a Certificate of Confidentiality is to: Protect identifiable research information from compelled disclosure.

Investigators may appeal an IRB decision. A principal investigator may appeal the decision by writing a letter to the IRB requesting reconsideration. The IRB retains the final authority for approval of proposed research with human subjects.

Which of the following activities constitutes engagement in research? Obtaining informed consent and conducting research interviews. Laws, customs, and norms in the area in which the research will be conducted.

Which of the following is considered a SBR data collection method? Hearing screenings, blood draws, and other physical exams are usually designed to collect physiological data, not information about attitudes and beliefs.

1 Answer. To evaluate the association between individual genotypes and the safety and efficacy of a particular drug or class of drugs.

Can Investigator B use the specimens for cancer research without re-consent if the specimens are de-identified? Yes, if the biospecimens are de-identified then the research is no longer considered human subjects research.

GINA prohibits the use of genetic information in making employment decisions, such as hiring, firing, advancement, compensation, and other terms, conditions, and privileges of employment.

Genetic determinism is the notion that genes have a controlling influence on human health, behavior and disease. However, current thinking is that genes function in a complex relationship with environmental influences, meaning that genes alone are not determinative.