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This document outlines the policies and procedures for obtaining informed consent from research subjects participating in studies conducted at Rex Healthcare, emphasizing the ethical treatment and
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How to fill out REX HEALTHCARE INSTITUTIONAL REVIEW BOARD (IRB) STATEMENT OF POLICY

01
Obtain the REX Healthcare IRB Statement of Policy document.
02
Read through the entire document to understand the requirements and guidelines.
03
Complete the identification section by providing your name, position, and contact information.
04
Indicate the title and purpose of your research study in the designated section.
05
Provide a detailed description of the research methodology, including participant selection and data collection methods.
06
Outline the potential risks and benefits of the study for participants.
07
Include information about how participant confidentiality and data security will be maintained.
08
Submit the completed document to the IRB for review, making sure to follow any submission procedures.

Who needs REX HEALTHCARE INSTITUTIONAL REVIEW BOARD (IRB) STATEMENT OF POLICY?

01
Researchers conducting studies involving human subjects at REX Healthcare.
02
Institutional staff who are responsible for overseeing research compliance.
03
Any affiliate institutions or partners involved in collaborative research projects.
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The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research.
What is the Institutional Review Board (IRB)? The Institutional Review Board (IRB) is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated.
An IRB, or Institutional Review Board, is responsible for reviewing and approving research to ensure that the rights and welfare of human participants are protected.
Once your IRB protocol has been approved, you can view or save the approval letter by opening the protocol in Streamlyne. 1) Login to Streamlyne. 2) Search under: Main Menu > IRB > and click All My Protocols a. You can also search using the IRB Protocol lookup feature by clicking the word IRB Protocol.
Under 45 CFR 46.103, the IRB must review and approve all non-exempt human subject research. Failure to obtain IRB approval before conducting research could result in the researcher being unable to use data and other information collected through the research process.
The IRB approval letter lists the consent document(s) and other study documents that were approved with the submission. Please note, it does not list the study application. Investigators can obtain a list of these items by following the instructions listed below.
IRB Application Consent documents (Consent Document(s), Assent Document(s), PHI documents (if applicable), Debriefing Statements (if applicable), etc.) Recruiting documents (e.g. advertisements/poster/flyers, scripts, emails, social media posts, letters, etc.)
The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, exempt, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy.
One (1) visitor per patient (ages 18 and older). Visitors may switch out. Upon arrival, and upon every return, all visitors must pass through a security check and check in at the desk located in the emergency department main entrance.
The U.S. Federal policy requires that an IRB have at least 5 members of varying backgrounds including a chair person, a scientific member, a non‐scientific member, a representative of the community not affiliated with the institution, and a member of the institution.

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The REX Healthcare Institutional Review Board (IRB) Statement of Policy outlines the procedures and guidelines for the review of research involving human subjects conducted within the institution, ensuring compliance with ethical standards and federal regulations.
All researchers, including faculty, staff, and students conducting research involving human subjects at REX Healthcare are required to file the IRB Statement of Policy.
To fill out the IRB Statement of Policy, researchers must complete the designated application form, providing detailed information about the research project, including objectives, methodology, participant recruitment, and informed consent processes.
The purpose of the IRB Statement of Policy is to protect the rights and welfare of human subjects participating in research, ensuring that all research is conducted ethically and in accordance with regulatory requirements.
The information that must be reported includes the research title, principal investigator's details, a description of the research, potential risks, benefits, confidentiality measures, and the informed consent process.
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