Research Integrity and Assurance

Protocol Submission

IRB Wizard Pilot Program

The ASU IRB has chosen to participate in a test of an electronic “wizard” that, if successful, would provide investigators with a tool to self-determine if their project requires review by an IRB or if it meets the federal definition of exempt.  The testing phase will begin August 7, 2018. During our testing phase, all new protocols submitted to the ASU IRB through the ERA system will also need to be put through the wizard.  You will need the IRB Protocol Number that is provided when you submit your study through the ERA to complete the wizard. The determination made by the wizard will be compared to the ASU IRB determination for the corresponding study to confirm they are consistent.

We realize that this is extra work for you and we appreciate your efforts.  If this project succeeds, it will reduce administrative burden for investigators and IRB staff reviewing projects that do not require IRB oversight based on changes to Federal Regulations. Your information will be kept confidential; only a limited number of IRB personnel will have access to your answers and they will only be reviewed to assess any discrepancy between the IRB decision and corresponding wizard decision.

If you have questions, or wish to provide feedback/comments please submit these to the IRB at research.integrity@asu.edu and include “Wizard Demonstration” in the subject line.  All comments and feedback will be reviewed for potential improvements to the wizard.

 

Protocol submission

The majority of studies submitted at ASU do not need to be reviewed by the full IRB.  Studies that may require full committee review are generally those that may have greater than minimal risk or are working with vulnerable populations.  When working with these types of studies, it is important to keep in mind the submission deadlines if there is a time constraint in carrying out the study:

Bioscience IRB Social Behavioral IRB
Meeting date Submission deadline Meeting date Submission deadline
April 17, 2019 April 1, 2019 April 19, 2019 April 3, 2019
May 15, 2019 April 29, 2019 May 17, 2019 May 1, 2019
June 19, 2019 June 3, 2019 June 21, 2019 June 5, 2019
July 24, 2019 July 8, 2019 July 12, 2019 June 26, 2019
August 21, 2019 August 5, 2019 August 23, 2019 August 7, 2019
September 18, 2019 September 2, 2019 September 20, 2019 September 4, 2019
October 16, 2019 September 30, 2019 October 25, 2019 October 9, 2019
November 20, 2019 November 4, 2019 November 15, 2019 October 30, 3019
December 11, 2019 November 25, 2019 December 13, 2019 November 27, 2019
January 15, 2020 December 30, 2019 January 17, 2020 January 1, 2020
February 12, 2020 January 27, 2020 February 21, 2020 February 5, 2020
March 4, 2020 February 17, 2020 March 20, 2020 March 4, 2020
April 15, 2020 March 30, 2020 April 17, 2020 April 1, 2020
    May 15, 2020 April 29, 2020
    June 19, 2020 June 3, 2020
Prepare materials 

Before beginning a study in ASU's electronic submission system (ERA), confirm the following items have been done:

  • identified the principal investigator (cannot be a student)
  • completed a protocol template
  • completed consent forms or cover letters
  • Completed assent forms and parental permission forms (if your project involves minors) 
  • completed copies of recruitment materials and study instruments
  • identified the study team and had them complete CITI Training
  • reviewed the Special Considerations page to see if any of the topics apply to the study
  • gathered grant submission/other funding documents for upload in the event the project is funded
  • obtained site permissions, if needed
Protocol templates

Every submission must include one of the two protocol templates. Fill out every section of the form according to the guidance provided within it. If a section does not apply, provide a brief explanation as to why.

  • Form: Social Behavioral Protocol - research studying behavior, opinion, social history and educational practice
  • Form:  Bioscience Protocol - research involving invasive procedures, exercise, dietary manipulation, human physiology and effectiveness of medical products
Consent forms

Almost every study will require a consent form to be developed and attached to the submission. Use the appropriate form for guidance:

If the research involves minors, consult Research Involving Minors or Children for relevant consent, assent and permission form templates. For Medical Release Forms, see Medical Records and HIPAA.

Recruitment materials

You must submit any recruitment materials to be used for review and approval. You may create your own or use one of the following templates for guidance:

Site permissions

For projects taking place in a non-public or non-ASU setting (for example, a middle school classroom, a local organization or a clinic), you should obtain site permission. Contact the site to determine their policies for obtaining permission.

Special consideration:  Translating documents and materials

Translated documents should not be included in the initial IRB submission as there may be changes made to the materials during review. The initial submission should include English versions of all documents and the protocol should explain what languages will be used in the research. The reviewer will request translated materials after the English versions of the documents have been approved. A completed Translation Certification Form will need to be submitted with translated materials. The form outlines the translation process. Translators can be anyone sufficiently fluent in the language.

Special consideration: Another IRB is reviewing the study

When another institution’s IRB or a central IRB (such as WIRB) will be acting as the IRB of record, the submission will undergo a Local Context Review. Contact the ASU IRB before proceeding. A local context review requires different forms and materials to be submitted. For more information, visit Collaborating with Other Institutions: Affiliation Agreements and Review Procedures.

Special consideration: Multiphase studies

If the project will include multiple phases, some of which are not finalized, the researcher should submit for the phases that have been finalized. When a new phase is ready to be implemented, you can submit either a modification to the approved study or a new study.

Submitting the study to the IRB

Use our step by step tutorial or follow the steps below:

  1. Log into ERA using ASURITE ID and password
  2. Select “Create New Study”. 
  3. Fill in the fields as appropriate. Upload a completed Template: Social Behavioral Protocol OR Template: Bioscience Protocol to the Attach the Protocol section
  4. In the Consent Forms and Recruitment Materials section, attach any of the following as applicable:
     
    • Consent Form(s)
    • Assent Form(s)
    • Parental Consent Form(s)
    • Recruitment Script(s)
       
  5. In the Supporting Documents section, attach any of the following as applicable:
     
    • Surveys
    • Questionnaires
    • Interview Questions
    • Instruments
    • Other Documents
       
  6. When ready to submit the ERA application, the principal investigator (PI) will need to click the “submit” button, which is only viewable to him/her

    09-IRB-ModCRandClose-PISubmit.png
Confirming the study has been submitted for review

Check that the study is in the “Pre-Review” state and that “Submitted” is the most recent event.  If the study shows that it is still in the "Pre-Submission" state, it is likely that the principal investigator still needs to review and “submit

Need to find your study?

use our step by step tutorial.

 

 

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