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What information should the protection of human subjects section of the proposal contain?
Applications must address the following elements on the Protection of Human Subjects section of the form: Risks to the subjects. Adequacy of protection against these risks. Potential benefits of the research to the subjects and others.
What is the protection of human subjects section of the NIH?
The HHS regulations for the protection of human subjects, in 45 CFR Part 46, implement Section 491(a) of the PHS Act and provide a framework, based on established, internationally recognized ethical principles, to safeguard the rights and welfare of individuals who participate as subjects in research activities
What is the common rule for protection of human subjects?
For all participating departments and agencies the Common Rule outlines the basic provisions for IRBs, informed consent, and Assurances of Compliance. Human subject research conducted or supported by each federal department/agency is governed by the regulations of that department/agency.
What are the requirements for human subjects?
The basic principle of human subjects protection is that people should not (in most cases) be involved in research without their informed consent, and that subjects should not incur an increased risk of harm from their involvement in research, beyond the normal risks inherent in everyday life.
What is NIH delayed onset study?
The NIH Grants and Funding. Glossary defines delayed onset as follows: Research is anticipated within the period of award but definite plans are not yet known and. cannot be described in the application. ()
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What is the protection of human research subjects?
Human Subjects Protections is a collective term for the federal, state, and university policies, procedures, and ethical considerations that protect the rights and welfare of human beings who participate in research as the subjects of that research.
Is there a page limit for protection of human subjects?
Note: There are no page limits for any attachments in the PHS Human Subjects and Clinical Trials Information form. Select Yes or No to indicate whether the proposed research involves human specimens and/or data. Select Yes or No to indicate whether the proposed research is exempt from Federal regulations.
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