You can request that the Harvard IRB rely on the review of another (referred to as External IRB or ceded review). This type of submission can be appropriate when a study is conducted at two or more different institutions, and instead of getting a separate IRB approval from each institution, an agreement is made for one institution to conduct the review and the other institution(s) to rely on that IRB’s review. This submission is only appropriate if you are requesting that Harvard rely on the review of another IRB. Once submitted, the Harvard IRB will determine if a reliance agreement is possible or if Harvard IRB review is required. To have the Harvard IRB conduct the review see What to Include in a Study SmartForm.
The simplest approach is to follow the forms in order, answering the questions and clicking Continue to save your information and move to the next form. When you reach the end of the series of forms, click the Save & Exit button.
What to Include in the Initial Request for External IRB
To create a request for External IRB review see Creating a New Study. The SmartForm is the series of web-pages (or forms) where you can input specific information about a study. The following section describes what information should go into each space of the SmartForm.
Important! Completing elements of the SmartForm or Clicking “Save & Exit” does not send the request for review. The PI must click Submit (marked with a red arrow in the submission workspace) for the submission to proceed on for the next state of review.
SmartForm Section: Basic Information
1. Title of study. Enter the complete study title. Please avoid use of quotation marks in the study title.
2. Short title. The short title identifies the study throughout the system, such as in your inbox and in an IRB reviewer's list of submissions to review. This should be 80 characters or less, and should not contain quotation marks. If left blank, the system will automatically pull in the first 80 characters of the (long) study title.
3. Brief description or abstract. Enter a brief description of the study or the study abstract. This should be 225 words or less.
4. Name of Principal Investigator. Enter the name of the Principal Investigator. For details on who may be listed in this space, please visit your IRB website or Investigator Manual.
This field will default to the name of the person completing the form. It may be changed by selecting clear and typing the name in the space provided (a list will appear with names from which to select), or you can click the select option to search the list of names. Use the “%” symbol to replace portions of a name which are unclear or possibly not spelled correctly. This is called a “wildcard” character.
5. Does the investigator have a financial interest related to this research? Indicate if the Principal Investigator has a financial interest. For more information regarding what constitutes a financial interest, please visit your IRB website. If an individual has a financial interest, complete and attach “FORM: Financial Interest Disclosure Form” to the Supporting Documents page of the SmartForm.
6. Select the study's department. Indicate the name of the Principal Investigator or Faculty Sponsor’s department for this study.
Type the department name in the space provided (a list will appear with options from which to select), or you can click the select option to search the list of available departments and schools. Use the “%” symbol to replace portions of a word of which may be unclear or possibly not spelled correctly. This is called a “wildcard” character.
If the department name does not appear on the list provided, contact email@example.com for guidance on which department
Once chosen, saved and submitted, the department cannot be changed during review. To change the department after a study is submitted (but before the first determination by the IRB):
1. Complete the Withdraw activity on the study in review
2. Click “Edit Study” to change the name of the department on the SmartForm
3. Click “Save” then “Exit” on the SmartForm menu
4. The PI must complete the Submit activity on the study to send it back to the IRB
7. Are you requesting that an external IRB act as the IRB of record for this study? Select Yes. When you selected Yes, question 8 on the Basic Information SmartForm will disappear (it is not needed when requesting External IRB review). Click Continue to proceed to the External IRB page.
SmartForm Sub-Section: External IRB
On the following page you will need to enter information about the External IRB that will serve as the IRB of Record for the study.
1. External IRB: Click Select to indicate which institution will serve as the IRB of Record. If the reviewing institution is not listed, select Other.
2. IRB Cede Request Form or equivalent:
To request that the Harvard IRB rely on a Harvard Catalyst institution, visit this link to the Catalyst form. You will be expected to login using your HUID and PIN, eCommons, or HarvardKey login.
To request that the Harvard IRB rely on a non-Catalyst institution, attach “FORM: IRB Cede Review Request”
3. Approval letter from external IRB: Upload the External IRB’s approval letter here, if available. If local approval is not available at the time of submission, a copy must be submitted to the IRB prior to beginning any human subjects research at the external site(s).
4. Initial approval date by external IRB: Enter date of initial IRB approval if/when known.
5. Last date of approval period: Enter date of the most recent IRB approval if/when known.
6. Specify the reason the study should be reviewed by an external IRB: Write in the rationale for the request for Harvard to rely on another institution.
SmartForm Section: Funding Sources
On this page include any pending/awarded funding sources or financial support for this study. Leave questions 1 and 2 blank to indicate that there is no funding for this study. Reminder: If the funding status changes following IRB determination, submit a modification to this study.
1. List any grant proposal that has been submitted to the sponsored programs office (SPA or OSP), any proposal that was created in GMAS, or any federal or other sponsored funding for the study. Find and add all funding sources listed in the Harvard Grants Management Application Suite (GMAS) that are associated with this study.
To search for funding in the space provided, begin typing the grant project ID, the grant PI full name (first and last name), or the GMAS fund number and a list will appear with options from which to select.
If additional search options are needed, can click the ellipses […] button option to search the list of available funding sources. Use the “%” symbol to replace portions of a word of which may be unclear or possibly not spelled correctly. Click “Go” and select the correct funding source. Click “OK” on the pop up.
2. List any financial support for this project from a non-sponsored source such as a department, gift or Harvard program. List all other funding sources. Attach a complete copy of the funding application or agreement for these listed sources to the Supporting Documents page of the SmartForm, when applicable, and remove or black-out any salary information.
SmartForm Section: Study Team Members
The Study Team Members page of the SmartForm is disabled for External IRB submissions.
SmartForm Section: Supporting Documents
Attach supporting files: Be sure to name the file itself in a manner that identifies it as associated with your study. The suggested best practice for file names: StudyNumber_DocumentName_VersionNumber
When uploading documents to this page, you are prompted to select the appropriate attachment category. Select the correct category when uploading the first version and if possible minimize use of the “other” category. Once chosen and saved, the attachment category cannot be changed. To change a category, a document must be removed and then re-uploaded with the new category. Items to attach to this page:
- Data use agreements or other Agreements. Submit copies of any documents authorizing Harvard Investigator use of data, or other contracts or agreements associated with the study.
- Financial Interest Disclosure Form. Submit this form if the Principal Investigator self-identifies a financial conflict of interest related to the research on the SmartForm: Basic Information page.
- Funding Source Attachments. If not associated with GMAS and as applicable, submit a complete copy of the grant applications, subcontract, and/or any funding agreements regardless of funding source.
Upon clicking continue from this page, the browser will direct to the last page of the SmartForm where you will have the opportunity to select “Save & Exit” to return to the submission workspace. The PI must click Submit (marked with a red arrow in the submission workspace) for the submission to proceed on to the IRB for review.
Updating External IRB Review
After the Harvard IRB confirms External IRB review, you can provide an update to the submission, as applicable. The Update Study function allows for providing the Harvard IRB with:
- An update on the status of the study with the reviewing IRB, including closure; or
- An update to the information previously provided to the Harvard IRB (such as a change in funding).
To create and submit an update on an External IRB project:
1. Log in to irb.harvard.edu
2. Navigate to the External IRB workspace (see Accessing a Submission for more information).
3. Click the “Update Study” button, a SmartForm will open.
4. Provide a brief description of the contents of the update.
5. By selecting ‘Continue’ the system take you to a copy of the External IRB SmartForm. Refer to the What to Include in the Initial Request for External IRB section above for additional instructions for what is required for each element of this SmartForm.
6. Follow the remaining steps to Edit a Submission or Save & Exit when edits are complete.
7. The PI or PI Proxy must click Submit (marked with a red arrow in the submission workspace) for the submission to proceed on to the IRB for review.