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Webinar SeriesWorking with Outsourced IRS: Where to Draw the Line June 25, 2014Presented by: Karen Christian son, Consultant, HIP Consulting Group Bette Wayne, Director of Institutional & Phase I

How to fill out working with outsourced irbs

How to Fill Out Working with Outsourced IRBs:

1. Understand the Purpose: Before filling out any forms or paperwork related to working with outsourced Institutional Review Boards (IRBs), it is essential to have a clear understanding of the purpose behind it. Familiarize yourself with the regulations and guidelines that govern IRB activities.
2. Gather Required Information: Collect all the necessary information and documents that are required to complete the IRB forms. This may include study protocols, consent forms, participant recruitment materials, and any other relevant documentation.
3. Complete the Application: Begin by carefully filling out the application form provided by the outsourced IRB. Make sure to provide accurate and detailed information regarding the study, its design, objectives, methods, risks, and benefits. Follow the instructions provided and be sure to include all the requested information.
4. Seek Clarification, if needed: If there are any questions or uncertainties about certain sections of the application form, don't hesitate to reach out to the outsourced IRB for clarification. It is crucial to have a clear understanding of what is being asked before submitting the application.
5. Consent Form Review: If your study involves obtaining informed consent from participants, carefully review the consent form templates provided by the outsourced IRB. Ensure that all the necessary elements and information required for obtaining informed consent are included.
6. Submit the Application: Once you have completed all the necessary sections of the application form and reviewed it for accuracy, submit it to the outsourced IRB according to their specified submission process. This can typically be done online or by mailing a physical copy.

Who Needs Working with Outsourced IRBs:

1. Researchers: Researchers, particularly those involved in conducting human subjects research, may need to work with outsourced IRBs. This applies to both academic and industry researchers who require ethical approval for their studies involving human participants.
2. Institutions: Universities, research institutions, and organizations that conduct research involving human subjects often collaborate with outsourced IRBs to ensure compliance with ethical guidelines and regulations. Working with an outsourced IRB can provide expertise and oversight in the review and approval process.
3. Sponsors and Funding Agencies: Sponsors and funding agencies supporting research projects that involve human subjects may require oversight from outsourced IRBs. This ensures that the research is conducted ethically, following established guidelines, and protects the rights and welfare of the participants.
4. Participants: Ultimately, participants who volunteer to be a part of research studies are also beneficiaries of outsourced IRBs. These boards protect the rights, safety, and confidentiality of the participants by reviewing and approving research protocols. Working with outsourced IRBs helps ensure that participants are informed, protected, and treated ethically throughout the study.

Remember, it is crucial to follow the specific requirements and guidelines provided by the outsourced IRB while working with them to ensure compliance and ethical conduct in research involving human subjects.

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