Institutional Review Board Review of Human Subjects Research by 2J2xe89X

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									IRBNet Assistance
CONTENTS:


GENERAL INSTRUCTIONS AND GUIDANCE
     Learn about IRBNet
     Locate forms
     Sign the application
     Share with other team members or collaborators
     Assure that an application is complete
     Update documents or revise applications.
     Save file versions

NEW STUDY
      IRBNet application
      IRB Checklist
      Required training

CONTINUING REVIEW
      IRBNet application
      IRB Checklist
      Required training

AMENDMENT OR MODIFICATION TO AN APPROVED STUDY
     IRBNet application
     IRB Checklist
     Required training

OTHER APPLICATIONS
     Reports
     Closure
     Determination of whether a project is human subject research


GENERAL INSTRUCTIONS AND GUIDANCE

LEARN ABOUT IRBNET
      Click on the following link to located IRBNet training resources and contact information on the
      NOHSP webpage: http://www.nemours.org/research/nohsp/submission/irbnet-training.html
      And/or:
      Attend a Nemours IRBNet Boot Camp. Netmeeting sessions will be offered twice a month. Contact
      the NOHSP office for specific times and log-in information..

LOCATE FORMS, TEMPLATES AND OTHER DOCUMENTS ON IRBNET
     The current approved Nemours application forms and templates are located on IRBNet.
     From the STUDY DESIGNER page, either:
      Select a document from the drop down list for the Forms and Reference Library
                 o Select the form or template that you need and save it to your computer to
                    complete.
                 o If you do not see an application, it may be available as an electronic form. Check
                    out: Add New Document.
      Click on Add New Document to:
                 o Upload a document from your computer
                 o Access an electronic ‘smart form’. Currently, the only form here is the Initial
                    Application Form.


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SIGNATURES
      Signatures within IRBNet are compliant with FDA electronic signature regulations and the HSP
      signature policy (HSP#001) has been revised accordingly.
      The signature requirement depends on the type of application submitted:
       PI signature is required for:
                  o New studies
                  o Investigator Agreement and Conflict of Interest disclosures.
                  o Continuing review (except for the very limited circumstances described below).
                  o Serious adverse event reports.
                  o Amendments that require review by the convened IRB.
                  o Any submission that affects the risk to benefit assessment of a study.
       The PI may delegate signature authority for:
                  o Submissions that do not affect the risk to benefit assessment of a study. For
                       example, an external safety report.
                  o Amendments that are minor and are eligible for expedited review.
                  o Continuing review applications when the criteria for expedited Category 8a are met.
       A signature ‘on behalf of’ the PI should be used only in the rare event when the PI cannot
         access IRBNet.

           Members of the research team must sign when they:
                 o Are listed in the Initial Application
                 o Are included in the Investigator Agreement and Disclosure Statement. (This includes
                     all members listed in the Application or added in an amendment)

SHARING WITH THE RESEARCH TEAM OR COLLABORATORS
You can share, or give access to, your IRBNet study with any person who has Internet access. This
includes:
         Nemours investigators, coordinators
         Non-Nemours investigators
         Sponsors
         Collaborators anywhere

Before you can share the study, the person must:
 Register with IRBNet (IRBNet.org) following the instructions in the upper right hand corner.
 Complete the User Profile, and
 Affiliate with a site. Nemours associates should affiliate with their main Nemours location. It is possible
  to affiliate with more than one site. (E.g., Sacred Heart Hospital and Nemours)
 Reply to the IRBNet email to complete your registration.

ASSURE THAT THE APPLICATION IS COMPLETE
The Principle Investigator is responsible for ensuring that submissions to the IRB are complete. Whether or
not the PI, or a designated member of the research team ‘submits’ the application, the application is not
complete until all required elements are received by the IRB. Incomplete submissions will not be
scheduled for IRB review.

                 (Read the instructions for the type of application you are submitting.)

UPDATE / REVISE / ADD to a SUBMISSION
Once a study has been submitted, it is locked against further changes. Unless the IRB Coordinator unlocks a
study, any changes will be submitted as a new packet.

To submit only the new or updated version of a previously submitted document:
    1. In Study Designer, click Add New Document
    2. Click: Create New Package. This will bring you to the Study History page.
    3. Open the new package with the status Work in Progress.


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    4. In Study Designer, you will be able to choose the document you wish to revise/update, or add a new
       document.
    5. Delete any document that you do not want to resubmit. This is important. Otherwise, you are
       constantly resubmitting documents and your study history will be a mess! Remember, these are only
       copies, cloned for your convenience. Previous submissions are not changed.

SAVE FILE VERSIONS
      WARNING: DO NOT SAVE DOCUMENT DRAFTS ON IRBNET BY CLICKING ON THE MS WORD
      SAVE ICON. YOU WILL LOSE THEM.
       If you are sharing or preparing a draft, save it to your computer (choose save as) before
        uploading it to IRBNet.
       Assign a descriptive title. For example: GROUP 1 PPF, or GROUP 2 PPF.
       If you are replacing a document that has already been uploaded to IRBNet, choose the UPDATE
        option to replace the current file. Otherwise, you will have multiple versions in a packet.



NEW STUDY (INITIAL APPLICATION)

    1. Create a new study.
    2. Prepare the documents you will submit.
           a. Use the IRB forms and templates located on IRBNet. (Refer to the General Information
                provided above.)
           b. Upload electronic versions of external study documents (protocols, Investigator Brochures).
                For example:
                    PDF protocols and Investigator Brochures from a Sponsor
                    CRRC reviews and approval letter, if applicable. (Review CRRC Guidelines on
                     Biomedical Research site on the Nemours Intranet.)
                    Scanned copies of signed letters.
    3. Share with the research team, especially those who will need to sign the application. (Refer to the
       General Information provided above.)
    4. Have applicable investigators and coordinators review and sign the application.
    5. Verify that the research team has completed the required training for human subjects research.
    6. Use this checklist to make sure that the application is complete.
        Do not submit the checklist with your application.

           A Nemours Application for Initial IRB Review.
             Use the Application in the IRBNet Reference Library.
             Make sure that the information throughout the submission (application form, protocol,
                 parental permission forms, are consistent.)
            Complete protocol, including any associated surveys, questionnaires, case report forms, and
        other related items.
            Proposed Parental Permission Form (or waiver request, if appropriate) for research involving
        subjects less than 18 years old.
             Use the Template located in the IRBNet Reference Library.
           Proposed Child (7-11 years) and/or Adolescent (12 – 17 years) Assent Forms.
             Use the Template located in the IRBNet Reference Library.
           Propose Informed Consent Form (or waiver request, if appropriate) for research involving adult
        subjects 18 years old and older.
             Use the Template located in the IRBNet Reference Library.
           Investigator’s Brochure or package insert, if available, (for industry sponsored drug, biologic, and
        device trials)
           All subject recruitment material
             Including: advertisements, brochures, scripts, internet site content and URL, any other
                 recruitment item
           Evidence of scientific merit review, if applicable
           DHHS-approve protocol and sample consent, if applicable.

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          Every member of the research team that is listed on the initial application must:
                  o Be included in the Investigator Agreement and Disclosure Statement.
                  o Must disclose any financial conflict of interest.
          Documentation of required training must be on file with the IRB. Reference the Checklist for HSP
       Training.
    7. Submit.


CONTINUING REVIEW

    1. Create a new packet.
    2. Prepare the documents you will submit.
          a. Use the Continuing Review Application and consent templates located on IRBNet.
          b. Upload electronic versions of external study documents (protocols, Investigator Brochures).
               For example:
                   Progress reports
                   DSMB reports
                   Publications
    3. Use this checklist to make sure that the application is complete.
        Do not submit the checklist with your application.

         Nemours Application for Continuing Review.
            Use the Application in the IRBNet Reference Library.
            Make sure that the information, for example, the study description and the numbers of
               participants, is consistent with the initial application and any prior continuing review
               application.
         Updated Parental Permission, Assent, or Informed Consents, as applicable.
            Use the Templates located in the IRBNet Reference Library.
          Copies of publication or reports.
          Documentation of required training must be on file with the IRB. This does not need to be
       submitted.
            HSP training is renewed every 2 years by taking the applicable CITI Refresher course.
    4. The Principal Investigator reviews and signs the application.
    5. Submit.


AMENDMENT/MODIFICATION TO APPROVED STUDY

    1. Create a new packet.
    2. Prepare the documents you will submit.
          c. Use the Application for Amendment to Approved Protocol located on IRBNet.
          d. Upload electronic versions of external study documents (protocols, Investigator Brochures).
               For example:
                   Revised Protocol
                   Summary of changes
    3. Use this checklist to make sure that the application is complete.
        Do not submit the checklist with your application.

           Nemours Application for Continuing Review.
             Use the Application in the IRBNet Reference Library.
           Updated Parental Permission, Assent, or Informed Consents, as applicable.
             Use the Templates located in the IRBNet Reference Library.
           Documentation of required training must be on file with the IRB for new investigators, or staff that
       will obtain informed consent. This does not need to be submitted.
    4. Sign. (see Sign the Study in the General Information section, above)
    5. Submit.


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OTHER APPLICATIONS
Any application to the IRB can be done (must be done) through IRBNet.
The reference library in IRBNet has forms for:
             Reports: SAEs, Unanticipated Problems, Deviations
             Closure Of A Study

There is no application form for requests for a determination of human subject research (see HSP-050 Is it
Research?)
To make sure that the IRB has the information needed to make this determination, Investigators, or project
leaders, should use the following checklist:

       A written plan or proposal with sufficient detail to convey the nature of the issue to be
       studied, including, if applicable:
              Rationale or purpose of the project
              Design or methods
              Assessment methods
              Whether or not there will be interaction or intervention with individuals.
              Health information use and protections. This should include information about any the
              source and identifiers that may be link information to an individual.
              All potential uses of the study findings, including publication or other intent to
              generalize the results.
       An assessment or justification of why this project does not meet the definition of human
       subjects research as defined by DHHS and/or the FDA.


To submit information or a request for review to the IRB when there is not a specific Nemours form:
    1. Create a new packet.
    2. Prepare the documents you will submit. (If not electronic, scan the document, if brief, or obtain a
       PDF version, if lengthy.)
    3. Add the prepared document.
    6. Sign. (see Sign the Study in the General Information section, above)
    7. Submit.




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