So, How Do You Submit An IRB Proposal?

All submissions and reviews are completed via ESTR, our Electronic Submission Tracking and Reporting System, which automates the IRB review process for the Harvard IRBs (Harvard University Area and Harvard Longwood Campus). You will fill in a SmartForm and be prompted to attach other documentation if needed (information on forms and templates is below).

About the Submission Process:

• The PI must submit the initial application. A Primary Contact can be added at the time of submission. That person can complete many actions and be the main point of contact but cannot submit formal requests. Once the study is approved, a PI Proxy can be added via ESTR and can submit formal modification and continuation requests on behalf of the PI.
• An HUID is required to log in to ESTR. See the ESTR Job Aids page for information on getting an HUID and logging in.
• You will be required to attest that you understand and will adhere to the Principal Investigator Responsibilities and ESTR Assurance Statement, which you can review in the ESTR library.
• Once you submit, most communication with your study's reviewer will be via ESTR.
  • You will receive an email notification when an action has been taken that requires you to respond or act.
  • You can leave comments/questions for your reviewer.
    

  ESTR How-To Guidance

  • The ESTR Study Submission Guide will walk you through the submission process.
  • You can also find more information in the ESTR Help Center
  • Contact ESTR Support for technical assistance.
  • The Protocol Template and other documents you may need can be downloaded via the ESTR Library. You will need to be logged in to ESTR for access.
    

  Templates, Forms and Other Ancillary Documents

  You may need to prepare one or more forms to be submitted with your application. These forms can be downloaded via the ESTR Library.

  1. Click on the "Templates and Forms" tab.
  2. Navigate to pages 2 and 3 to find the documents labelled with “HUA” (these are the documents of the Harvard University Area IRB).
  3. Download the forms, fill them out, and attach them to your submission in ESTR. ESTR will prompt you when one or more of these forms is needed. If one is missed, don’t worry – IRB staff will let you know.
     
  • IRB TIP! Be sure to download documents labelled “HUA” when you are in the ESTR Library. These are specific to the “Harvard University Area” (do not use HLMA or HLC documents; they are specific to the Longwood Medical Area - Harvard Longwood Campus).

  
  The most commonly used initial review forms are:

  • HUA Research Protocol Template(HRP-503) - This is the main application form where you will provide most of the details of your study.
  • Not Human Subjects Research Determination Request(HRP-213) - Used to apply for a formal determination that your activities do not constitute research with human subjects. You may use IRB Worksheet HRP-310 for reference (see "Worksheets" tab in ESTR Library).
  • Consent Forms - In most cases, a consent process for research participants is required. The consent templates include all elements that are required by the regulations. If a certain element does not apply, delete that section from the template form. These templates are the most general starting point and can be filled in according to the type of research that you are conducting.
    • HUA Adult Consent Form Template (HRP-502) - For Expedited and Convened IRB research with individuals who are considered adults.
    • HUA Exempt Research Consent Script (HRP-502-c) – For Exempt research with individuals who are considered adults. See HRP-312 - Worksheet – Exemption.
    • HUA Child Assent Form Template (HRP-502-a) - For Expedited and Convened IRB research with individuals who have not attained the legal age for consent to participate in research under applicable law of the jurisdiction in which the research will be conducted. Generally, the law considers any person under 18 years old to be a child.
    • HUA Parental or Guardian Permission Template (HRP-502-b) - For Expedited and Convened IRB research with parents or guardians of those considered a ‘child.’
    • HUA Short Form Consent Template (HRP-507) - For the unexpected involvement of individuals with limited English proficiency. If you expect to enroll more than one participant with limited English proficiency, or if your study is being conducted internationally, you are expected to translate all study documents provided to participants into the appropriate language(s) and not use this form. See HRP-317 - Worksheet - Short Form of Consent Documentation.
    • GDPR Notification for Participants (HRP-502-d) – For use with studies that include individuals located in the European Economic Area. Note that this notification is only for research that began prior to May 25, 2018 will involve the collection of new data for the same research purpose as the pre-May 25, 2018 data, such that the new data collection falls within the scope of the terms of the original consent obtained. For all other research involving individuals located in the EEA, please use the informed consent form according to your research (see above) as these forms include a “GDPR Addendum” located at the end of the form. See HRP-325 - Worksheet - GDPR.

    Supplemental Forms

    • Non-Harvard Study Personnel Form (HRP-220) - Used to report study staff only if they do not have a Harvard ID. Be sure to attach human subjects training certificates for these staff.
    • Financial Interest Disclosure Form (HRP-221) - Must be submitted for any member of the study staff with a financial interest related to the research.
    • Individual Investigator Agreement (HRP-225) - Used to request inclusion of a study team member who is neither affiliated with a Harvard University Area School nor under another institution’s IRB.

    Helpful Resource Links

    Click for helpful resource links if you would like information on the following:

    • Research-related Harvard offices
    • Research-related Harvard policies and guidance
    • Harvard research study participant pools
    • Federal resources