Research Integrity and Assurance

Protocol Submission

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
November 18, 2020 November 2, 2020 November 20, 2020 November 4, 2020
December 16, 2020 November 30, 2020 December 18, 2020 December 2, 2020
January 20, 2021 January 4, 2021 January 15, 2021 December 30, 2020
February 17, 2021 February 1, 2021 February 19, 2021 February 3, 2021
March 17, 2021 March 1, 2021 March 19, 2021 March 3, 2021
April 21, 2021 April 5, 2021 April 16, 2021 March 31, 2021
May 19, 2021 May 3, 2021 May 21, 2021 May 5, 2021
June 16, 2021 May 31, 2021 June 18, 2021 June 2, 2021
July 21, 2021 July 5, 2021 July 16, 2021 June 30, 2021
       
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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