Irb.ucdavis.edu

Risks and Benefits of Research

WebThe IRB will: Identify and compare the risks associated with the research from the risks of therapies or alternatives to participation in research. Determine that the risks will be minimized. Identify the anticipated benefits to be derived from the research. Determine that the risks are reasonable in relation to be benefits to subjects, if any

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URL: https://irb.ucdavis.edu/project-guidance/risks-and-benefits/

Does My Project Need Review

WebIf the answer to both questions is “yes”, then the project is human subjects research and you must submit an application for initial review to the IRB. Some human subjects research qualifies for an exemption determination. The U.S. Department of Health and Human Services provides decision charts to guide human subject research determinations.

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IRB Standard Operating Procedures

WebFinancial Conflicts of Interests. HRP-056. PPM 230-05 Public Health Service Regulations on Objectivity in Research. HRP-057. University of California Policy on Financial Conflicts of Interest. HRP-058. IRB Reliance When UC Davis Relies on an External IRB. HRP-059. IRB Reliance When UC Davis is the IRB of Record.

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Reporting to the IRB

WebAn Unanticipated Adverse Device Effect (UADE) is any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death, was not previously identified in a nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or …

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Ancillary Reviews

WebAt the IRB, we refer to these as ancillary reviews. Some ancillary reviews affect subject safety and therefore the IRB cannot approve a project until the ancillary review is complete. In most cases the research team is responsible for applying to the ancillary committee or reviewing applicable policies to ensure compliance with requirements.

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IRB Determinations

WebThis notice is documentation of the IRB’s determination related to the disclosure or use of protected health information. The type of waiver and the requirements for compliance with HIPAA are described in the letter. The investigator must ensure compliance with the conditions described in the letter.

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Subject Selection and Recruitment

WebCoercion will generally involve physical force. No relationship between the two individuals need exist for coercion to occur. Subject selection means the process of identifying potential research subjects based on specific inclusion or exclusion criteria. Recruitment is a component of the consent process.

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Required Education

WebEnter your personal information and click “Continue to Step 3.”. Enter a Username and Password and click “Continue to Step 4.”. Enter your country of residence and click “Continue to Step 5.”. Answer the required questions and click “Continue to Step 6.”. Provide the required information and click “Continue to Step 7.”.

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Consent Documentation

Web45 CFR 46.117 (a) Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A written copy shall be given to the person signing the

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Vulnerable Populations

WebVulnerable Populations. 45 CFR 46.111(b): “When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards should be included in the study to protect the rights and welfare of …

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