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Get the free Federalwide Assurance (FWA) for the Protection of Human Subjects ... - azwestern

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Submission Number: 11674 11/6/2008 5:24:51 PM Institution Name: ARIZONA WESTERN COLLEGE OMB No. 0990-0278 Approved for use through 1/31/2008 U.S. Department of Health and Human Services (HHS) Federal
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How to fill out federalwide assurance fwa for

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How to fill out federalwide assurance fwa form:

01
Start by providing basic information: Fill out the name of the organization or institution for which the federalwide assurance is being filled out. Also, include the contact information of the responsible official who will oversee compliance with the assurance.
02
Identify the departments and agencies involved: Specify the federal departments and agencies that will be conducting or supporting research involving human subjects under the federalwide assurance. This could include government agencies such as the National Institutes of Health or the Department of Defense.
03
Describe the research activities: Provide a brief description of the types of research activities that will be conducted under the federalwide assurance. This could range from clinical trials to social science studies. Make sure to include any specific areas of focus or populations involved.
04
Outline the organizational structure: Describe the organizational structure that will oversee the protection of human subjects. This should include information about the Institutional Review Board (IRB) responsible for reviewing and approving research protocols involving human subjects.
05
Specify the policies and procedures in place: Detail the policies and procedures that the organization has in place to protect human subjects in research. This could include informed consent processes, data security measures, and procedures for reporting adverse events.
06
Provide documentation of IRB approval: Include documentation of IRB approval for the federalwide assurance. This could be in the form of IRB meeting minutes, approval letters, or other appropriate documentation.

Who needs federalwide assurance fwa for:

01
Institutions conducting federally funded research: Any institution or organization that receives federal funding for research involving human subjects is required to have a federalwide assurance. This ensures that the rights and welfare of human subjects are protected in accordance with federal regulations.
02
Researchers conducting specific types of research: Individual researchers who are conducting specific types of research that involve human subjects may also need a federalwide assurance. This is particularly true if their research is funded by a federal agency or if they collaborate with an institution or organization that has a federalwide assurance.
03
Institutions collaborating with federally funded research projects: Institutions that collaborate with federally funded research projects that involve human subjects may also need a federalwide assurance. This is to ensure that all institutions involved in the research uphold the same standards for protecting human subjects.
In summary, anyone conducting federally funded research involving human subjects or collaborating with such research should fill out a federalwide assurance fwa form. This ensures that adequate protections are in place to safeguard the rights and welfare of human subjects.
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Federalwide assurance (FWA) is a written assurance of compliance with the Department of Health and Human Services (HHS) regulations for the protection of human research subjects.
Institutions that conduct or support human subjects research funded by the HHS must file for federalwide assurance (FWA).
To fill out federalwide assurance (FWA), institutions must provide detailed information about their research programs and policies related to human subjects research.
The purpose of federalwide assurance (FWA) is to ensure that institutions conducting human subjects research comply with ethical and regulatory standards to protect the rights and welfare of research participants.
Information such as the institution's research programs, policies, procedures for obtaining informed consent, and mechanisms for monitoring and reporting on research activities involving human subjects must be reported on federalwide assurance (FWA).
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