What is Needed for Your GCU Dissertation Proposal Defense?

Step 1: Reviewing the IRB Approval Requirement

Embarking on a research project, especially one involving human subjects, is a process that necessitates careful planning and adherence to ethical standards. One critical step in this journey is to review the Institutional Review Board (IRB) approval requirement. The IRB plays a pivotal role in ensuring that research involving humans is conducted ethically, safely, and with respect for the rights and welfare of participants. In this blog post, we will delve into the importance of reviewing the IRB approval requirement as Step 1 in your research endeavor.

Understanding the IRB

The Institutional Review Board is a regulatory body that oversees research involving human subjects. Its primary function is to evaluate and approve research protocols to ensure they meet ethical and legal standards. The IRB's role is to protect the rights, safety, and well-being of research participants. It acts as a safeguard against potential harm and ensures that research is conducted in an ethical and responsible manner.

Step 2: Getting Started with IRB and Video Tutorials

In the process of conducting research involving human subjects, once you've reviewed the Institutional Review Board (IRB) approval requirement, the next crucial step is to get started with the IRB application. Navigating the IRB process can be complex, but it's an essential part of ensuring ethical and legal compliance in your research. This blog post will guide you through Step 2: Getting Started with IRB and the benefits of using video tutorials to assist you in this process.

Understanding the Importance of IRB Approval

Before delving into the practical aspects of starting your IRB application, it's vital to understand why IRB approval is so important:

1. Ethical Compliance: IRB approval ensures that your research is conducted in an ethically sound manner, respecting the rights, privacy, and safety of research participants.

2. Legal Obligation: In many countries and institutions, obtaining IRB approval is a legal requirement for any research involving human subjects. Failure to comply can have serious consequences.

3. Research Credibility: IRB approval adds credibility to your research, making it more likely to be accepted by academic journals and institutions, ultimately enhancing the impact of your work.

Step 3: Completing CITI Training for Ethical Research

As you progress in your journey of conducting research involving human subjects, ethical considerations remain paramount. Step 3 in this process involves completing Collaborative Institutional Training Initiative (CITI) training, which is a critical component in ensuring that you understand and adhere to ethical standards in research. In this blog post, we will explore the significance of CITI training and how it contributes to ethical research practices.

Understanding the Role of CITI Training

CITI training is designed to educate researchers on ethical principles and regulatory requirements related to human research subjects. Collaborative Institutional Training Initiative offers comprehensive courses that cover various aspects of research ethics, including informed consent, confidentiality, data management, and the protection of vulnerable populations. Here's why CITI training is essential:

1. Compliance with Regulations:

   • Completing CITI training is often a requirement set by institutions and regulatory bodies overseeing research involving human subjects. It ensures that researchers comply with the ethical standards and legal obligations associated with their work.

2. Education on Ethical Principles:

   • CITI courses provide in-depth education on ethical principles, such as autonomy, beneficence, and justice, which are essential for conducting research that respects the rights and welfare of participants.

3. Protection of Participants:

   • Understanding the ethical guidelines taught in CITI training helps researchers safeguard the well-being of research participants by minimizing risks, ensuring informed consent, and protecting their privacy.

4. Enhanced Research Quality:

   • Researchers who have completed CITI training are better equipped to design and conduct studies that adhere to ethical standards. This ultimately leads to more robust and credible research.

Completing CITI Training

1. Determine CITI Requirements: Begin by identifying whether CITI training is required for your research project. Check with your institution, department, or the IRB to confirm the specific CITI training requirements that apply to your research.

2. Register for CITI Courses: Create an account on the CITI Program website (https://www.citiprogram.org/) and select the appropriate training modules based on your research area and role. CITI offers courses tailored to different disciplines and roles, including researchers, IRB members, and research staff.

3. Complete the Required Modules: Work through the CITI training modules at your own pace. These modules typically consist of readings, quizzes, and interactive elements that help reinforce your understanding of ethical principles and research regulations.

4. Pass the Quizzes: Successfully pass the quizzes associated with each module. Many institutions require researchers to achieve a passing score to  demonstrate their comprehension of the material.

5. Receive a Completion Certificate: Once you have completed the required modules and passed the quizzes, CITI will provide you with a completion certificate. Keep this certificate as proof of your training.

6. Maintain Ongoing Certification: Some institutions may require researchers to periodically renew their CITI certification to ensure that they stay up-to-date with evolving ethical guidelines and regulations.

Step 4: Obtaining Site Authorization from Your Selected Research Site

In the process of conducting research, especially in fields that involve data collection at specific sites or institutions, obtaining site authorization is a critical step. Step 4 involves securing the necessary permissions and approvals from the selected research site. This blog post explores the importance of site authorization and provides guidance on how to navigate this essential step in your research journey.

Understanding the Significance of Site Authorization

Site authorization, also known as institutional permission or site clearance, is the formal approval you need to conduct your research at a particular site or institution. This step is essential for several reasons:

1. Legal and Ethical Compliance:

   • Obtaining site authorization ensures that your research aligns with the policies and regulations of the institution or location where you plan to conduct your study.
   • It demonstrates your commitment to ethical research practices and compliance with any relevant laws or guidelines.

2. Access to Resources:

   • Site authorization grants you access to the facilities, data, participants, or resources required for your research. Without proper authorization, your research could be hindered or delayed.

3. Data Collection Permission:

   • In cases where your research involves data collection within a specific organization or institution, site authorization is necessary to gain access to participants and their data.

4. Collaboration Opportunities:

   • Some research projects involve collaboration with external organizations or institutions. Obtaining site authorization fosters partnerships and ensures a smooth research process.

Obtaining Site Authorization

1. Identify the Site Contact: Determine who the appropriate contact person is at the selected research site. This may be an institutional review board (IRB), a research administrator, a department head, or a designated representative.

2. Review Site Requirements: Understand the specific requirements and procedures for obtaining site authorization at the chosen location. Different institutions may have varying processes and documentation needs.

3. Prepare Your Documentation: Gather all necessary documentation, including your research proposal, IRB approval, informed consent forms, and any other materials required by the site. Ensure that your documentation is complete and in compliance with site-specific guidelines.

4. Contact the Site Representative: Reach out to the site contact and initiate communication regarding your research project. Clearly explain your intentions, objectives, and the scope of your research.

5. Submit Your Request: Follow the site's designated process for requesting authorization. This typically involves submitting your documentation and application for review.

6. Address Feedback and Questions: Be prepared to address any questions or concerns raised by the site representative during the authorization process. Timely and clear communication is key to a smooth approval process.

7. Await Authorization: Once you have submitted your request, patiently await site authorization. The time it takes to receive approval may vary depending on the institution's internal processes.

8. Maintain Records: Keep meticulous records of all correspondence and documentation related to site authorization. This documentation may be needed for future reference or to address any issues that arise during your research.

    

Step 5 Working with IRB Forms and Templates

1. Obtain the Required IRB Forms:

   • Contact your institution's IRB office to access the specific forms required for your research submission.

   • Ensure you have the most up-to-date versions of the forms to avoid potential delays in the review process.

2. Understand IRB Guidelines:

   • Familiarize yourself with the guidelines provided by your institution's IRB regarding the completion of these forms.
   • Pay attention to any specific instructions, formatting requirements, or documentation needed for your submission.

3. Complete the Forms:

   • Start by filling out the IRB forms, providing accurate and comprehensive information about your research project.
   • Be sure to include details about your research objectives, methodology, participant recruitment, informed consent process, and data management plan.

4. Utilize Templates:

   • Many institutions offer templates for creating informed consent forms, recruitment materials, and other documents required for IRB approval.
   • Use these templates as a starting point to ensure that your documents are well-structured and include all necessary elements.

5. Seek Feedback:

   • Before finalizing your IRB submission, seek feedback from colleagues, mentors, or advisors who have experience with the IRB process.
   • Reviewers can help you identify any gaps or areas that require clarification in your documents.

6. Submit Your IRB Application:

   • Once your IRB forms and documents are complete, submit your application to the IRB office for review.
   • Be prepared to address any questions or requests for revisions that may arise during the review process.

     Step 6 Submitting Your Research Application in IRIS

     In the research journey, Step 8 is a crucial milestone: submitting your research application in the Institutional Review Board Information System (IRIS). This step represents the culmination of your efforts to ensure that your research project adheres to ethical and regulatory standards. In this blog post, we will delve into the significance of submitting your application in IRIS and guide you through this essential process.

     Understanding the Role of IRIS in Research Approval

     IRIS, or the Institutional Review Board Information System, is a centralized platform used by many institutions to manage the submission, review, and tracking of research applications involving human subjects. Its primary functions include:

     1. Streamlining the Review Process: IRIS simplifies the submission process for researchers by providing a digital platform to submit all required documentation and forms.

     2. Enhancing Communication: IRIS facilitates communication between researchers and the Institutional Review Board (IRB) by enabling document sharing, feedback, and status tracking.

     3. Maintaining Compliance: It helps ensure that research projects meet ethical and regulatory standards, such as those outlined in the Common Rule or other institutional policies.

     Step 8: Submitting Your Research Application in IRIS

     1. Prepare Your Documents: Before initiating the submission process in IRIS, ensure that you have all the required documents and forms ready. This typically includes your research protocol, informed consent forms, recruitment materials, and any supporting documentation.

     2. Access IRIS: Log in to your institution's IRIS platform using your credentials. If you're unfamiliar with the platform, reach out to your institution's IRB office for training or guidance.

     3. Start a New Submission: Within IRIS, locate the option to start a new research submission. This will typically involve selecting the type of research, providing project details, and uploading the necessary documents.

     4. Upload Documents: Follow the prompts to upload all required documents and forms. Ensure that each document is correctly labeled and attached in the appropriate sections.

     5. Complete Application Forms: Many IRIS platforms include built-in application forms that guide you through the submission process. Complete these forms accurately, providing detailed information about your research.

     6. Review and Edit: Carefully review all the information you've provided before finalizing your submission. Make any necessary edits or revisions to ensure accuracy and completeness.

     7. Submit Your Application: Once you're confident that your application is complete, submit it through the IRIS platform. Be aware of submission deadlines and ensure that you meet them to avoid delays.

     8. Await IRB Review: After submitting your application, the IRB will review your research proposal, documents, and forms. Be prepared to address any questions or requests for revisions that may arise during this review process.

     9. Track Progress: IRIS often includes features for tracking the progress of your submission, from initial review to approval. Monitor your submission's status regularly and respond promptly to any requests from the IRB.

     10. Maintain Documentation: Keep records of all communication, revisions, and approvals related to your research project within the IRIS platform. This documentation may be needed for future reference or audits.

     Conclusion

     Submitting your research application in IRIS is a pivotal step in the ethical and regulatory approval process. By leveraging this digital platform, you streamline the submission process, enhance communication with the IRB, and ensure that your research project complies with ethical and regulatory standards. Step 8 reflects your commitment to conducting responsible and ethical research, ultimately contributing to the advancement of knowledge in your field.