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This document is an application form for researchers at the University of the District of Columbia seeking approval to conduct research involving human participants. It requires details about the
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How to fill out UDC Institutional Review Board Application for Approval to Use Human Participants

01
Gather all necessary documents and information regarding your research project.
02
Access the UDC Institutional Review Board (IRB) application form online or obtain a physical copy.
03
Fill out the application form with detailed information about your study, including objectives, methodology, and participant involvement.
04
Clearly explain how you will obtain informed consent from participants.
05
Include details about data confidentiality and how participant data will be protected.
06
Review the application for completeness and clarity before submission.
07
Submit the application along with any required supporting documents to the UDC IRB.

Who needs UDC Institutional Review Board Application for Approval to Use Human Participants?

01
Researchers planning to conduct studies involving human participants.
02
Faculty members and students at UDC seeking approval for their research involving human subjects.
03
Any individual or group requiring ethical review for research projects involving human data.
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People Also Ask about

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.
Important Note: Under this type of administrative approval no human participants may be involved in any activities defined as research until the entire project, including data collection procedures and study instruments, recruitment materials and informed consent documents have been reviewed and approved by the IRB.
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.
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.
The regulations do outline the criteria for IRB approval of research. 21 CFR 56.111(a)(1) requires the IRB to assure that risks to the subjects are minimized. 21 CFR 56.111(a)(2) requires the IRB to assure that the risks to subjects are reasonable in relation to the anticipated benefits.
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.
An IRB Authorization Agreement (IAA) is a special agreement between two institutions who are engaged in human subjects research to establish the Single IRB reviewing. An IAA allows an institution with a Federalwide Assurance (FWA) to extend the applicability of its FWA to cover another institution.

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The UDC Institutional Review Board Application for Approval to Use Human Participants is a formal request that researchers must submit to the Institutional Review Board (IRB) in order to obtain permission to conduct research involving human subjects. This application ensures that the rights, welfare, and safety of participants are protected.
Anyone conducting research involving human participants at the University of the District of Columbia (UDC), including faculty, students, and staff, is required to file the application. This applies to all research activities that include interaction with or data collection from individuals.
To fill out the application, researchers must provide detailed information about their study, including the research objectives, methodologies, participant recruitment strategies, informed consent procedures, and measures to protect participant confidentiality. The application should be completed using the designated format and submitted for review to the IRB.
The purpose of the application is to ensure ethical standards are maintained in research involving human subjects. It assesses potential risks to participants, evaluates the study's benefits, and ensures compliance with federal and institutional regulations regarding human research.
The application must report various information, including the research title, principal investigator's details, research objectives, methodologies, participant demographics, consent processes, potential risks and benefits, and plans for data security and confidentiality.
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