Manual Responsible Research: A Systems Approach to Protecting Research Participants

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Log out of ReadCube. Purpose : To provide a primer for novice nurse scientists about the increasingly regulated human research environment. Organizing Constructs : Federal regulations and international guidelines about protection of human research participants are discussed, with particular attention to institutional review boards for human research.


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Conclusion : Understanding the processes used by institutional review boards to foster ethical human research promotes collaborative interactions and supports compliant research work. Volume 36 , Issue 3.

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Summary: Protecting Research Participants (Research Involving Human Participants V1)

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Volume I - Report and Recommendations

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  • Ethics in Public Health Research.
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  • Oversight of Human Participants Research: Identifying Problems To Evaluate Reform Proposals.

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Abstract Purpose : To provide a primer for novice nurse scientists about the increasingly regulated human research environment. In its work, the committee suggests a systems approach to providing protection, offers several broad recommendations for reform, and proposes practical suggestions to improve the oversight of human research at the institutional level. In the committee's framework, the HRPPP is a system composed of interdependent elements that come together to implement policies and practices that ensure appropriate protection of research participants.

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The exact structure of an HRPPP will vary among research organizations and protocols according to the protection needs intrinsic to a particular study. Despite this flexibility, however, there are basic protection functions necessary to ensure the safety of participants and it is essential that all be met. These functions include: comprehensive review of protocols including scientific, financial conflict of interest, and ethical reviews ; ethically sound participant-investigator interactions; on-going and risk-appropriate safety monitoring; and quality improvement and compliance activities.