Top Ten Questions About IRBNet.org

Transcription

1 Top Ten Questions About IRBNet.org

2 1. How do I register? Registration is easy. To register, simply navigate your web browser The login area for IRBNet is in the upper right corner of the page. Click the New User Registration icon and navigate through the prompts entering providing your information. It is recommended that if you are a Genesis employee, that you use your Genesis . If you are not affiliated with Genesis, use an address that you check frequently. IRBNet will send you notices via prompting you to check IRBNet and notifying you of changes in status to your package. Also when registering, you ll be asked to choose an affiliation. Please select Genesis Health System, Davenport, IA. To finalize your registration, IRBNet will send an to the address you provided. Open the and click the link inside to finalize the registration process. 2. Is there any special IRBNet jargon I should know about before I begin? Of course, but there is one particular area that has proven over time to be most confusing. There is a difference between a New Project and a New Package. Think of creating a New Project as creating an empty filing cabinet for your study. The only information that can go into this cabinet is information pertaining to this study. To start a new study, create a New Project to create a new cabinet. New Project Package 1 New Package Package 2 New Package Package 3 New Package Package 4 New Package Package 5 After your initial submission is reviewed, eventually you are going to need to add more information to keep the IRB up to date. This is called Creating a New Package. It is the equivalent to adding a folder to your filing cabinet. 2

3 3. How Do I Create A New Project? Top Ten Questions About IRBNet.org To Create A New Project, click the Create New Project button. IRBNet will ask you for your project title, name of your principal investigator (PI), etc. You must provide information in all fields marked with a red asterisk. Also, note that the information you provide for your study and PI will be exactly what is printed in on IRB agenda, minutes and letters provided to you by the IRB. Now that you have built your cabinet, it s time to start adding documents that can be submitted to the IRB. 4. How Do I Upload Documents To IRBNet? IRBNet is simply a receptacle to store completed documents. Once your document(s) are completed it is very simple to upload documents from your C:, H:, or P: Drives. To upload documents open IRBNet and then open the project you wish to add documents. Please note IRBNet will not be able to pull documents out of GHS Connect via Citrix. By default, IRBNet will take you to a page it calls Project Overview. To add documents you ll need to navigate to a page called Designer. IRBNet gives you multiple ways to access this page. I recommend clicking the Designer button within the blue bar on the left side of the page. Once you arrive on the designer page, you ll see that the page is split into two steps. Step 1, provides access to our GHS-IRB s Forms Library. Here you can download the IRB forms and complete them, save them to your computer or network drive and then upload them back to IRBNet. Note: In the example below the library is not shown. However, this is where it can be found. 3

4 Under step 2, there is a button called Add New Document, click this button to begin the process of uploading a document. A page called Attach Document will appear. Using the dropdown menu select a document type that best suits your submission. Type a brief description of the document in the middle field, before clicking the browse button. Once you locate the document you wish to upload, highlight it and click Open. The file name will appear in the File Name field within the IRBNET Attach Document page. Click Attach to save. Keep repeating the process until all documents are uploaded. 4

5 5. How do other members of my research team see these documents? It is now required by GHS- IRB that all members of the research team have access to all documentation in IRBNet for a given study. This means that all research team members must have a registered IRBNet account and be granted access to the project by the person whom initially created the project in IRBNet. To share the project, click the Share this Project button. A Share Project page will pop up, click the blue word Share. You will then be asked to select an organization. Select Genesis and click the Select Organization button. A list similar to the one above will appear that will allow you to grant each team member access to the project. We recommend that Read access be given to most team members. Once access has been given, click the Save button. 5

6 6. Now that I uploaded and shared, am I done? No. The final step in the submission process is to sign and submit the package. First, to sign the package, click the sign this package button. A Sign Package page will appear. There are two ways to sign, for yourself or on behalf of the PI. If you are signing for yourself, simply select the appropriate title from the drop down menu and click the sign button. If you are signing for someone else, click the blue words designee signer mode. Then select the appropriate tile of the person you are signing for and type their name in the box provided and then click the sign button. The last step is to submit the package. To submit, click the Submit this Package button. Search for Genesis, highlight Genesis Heath System IRB, Davenport, IA and click Continue. Select an appropriate Submission Type from the drop down menu, and click the Submit button. The package has now been submitted. 7. How do I create a New Package on an existing Project? This is a great question. With the project you want to add to open, click the Designer button. Then under Step 2 on the Designer page, click the Add New Document button. You ll receive a message like the one above that basically says Are you sure that you want to create a new package? and if action has already been taken on your previous submission then the answer is definitely yes. We ll assume that this is the case here. Click the Create New Package button. A new Project History page will appear. Click the blue words New Document Package to access the Designer for this new package. You should now upload documents and then sign and submit the package to the IRB when you are ready. 6

7 8. I received a notice from IRBNet that my project was approved. How can I access my approval letter and other documents? Once you are logged into IRBNet and have the project open that you wish to review, these documents can best be viewed by using the Reviews button located within the blue bar of the left side of the screen. The Reviews page will show every letter and board document prepared by the IRB over the entire life cycle of the project. 9. Is there any way I can quickly review my project s history? Yes, via the Project History button. Not only can you view the entire life cycle of the project quickly, but by clicking the blue words pertaining to each package you can open individual packages and see what documents were submitted for review, the IRB s action and any documents and letters the IRB prepared in response. 7

8 10. I still have questions. Where do I go for help? It s normal to have questions. Please contact us for any of your IRB or IRBNet related concerns. Our contact information is given below: Sarah Castro castros@genesishealth.com Joy Lemmon lemmonjoy@genesishealth.com RGA Mainline Research@genesishealth.com 8