Requesting External IRB Review

Overview

You can request that the Harvard IRB rely on the review of another IRB (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 type 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 instead have the Harvard IRB conduct the review of the study see What to Include in a Study SmartForm.
In brief, the process to request External IRB Review includes:

  1. Create a new study
  2. Complete the Study SmartForm provided to record a request for External IRB review
  3. Click Save & Exit on this Study SmartForm
  4. Click the link to the (automatically created) Site workspace
  5. Click Edit Site to revise the Harvard-site specific details
  6. Click Save & Exit on this Site SmartForm
  7. Complete the Submit activity on the site workspace to send the request for Harvard IRB review

See the following sections for detailed anticipated contents of each 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 Review

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!  

  • There is more than one SmartForm to complete for an External IRB submission.  One represents elements of the general project while the other is specific to the Harvard site/activities of Harvard researchers.  When a new External IRB submission is created, an associated Site SmartForm is also created.  The Site SmartForm must be further edited and submitted for IRB review to begin.
  • Completing elements of the Study/Site SmartForms or clicking “Save & Exit” do not send this request for review.  The PI must visit the associated Site workspace and click Submit (marked with a red arrow in the submission workspace) for the request to proceed on for the next state of review.

SmartForm Section: Basic Information (External IRB)

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 Harvard 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 Local Site Documents page of the associated Site SmartForm. 

6.    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 estrhelp@harvard.edu 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, the attachment space on the Basic Information SmartForm will disappear (it is not needed when requesting External IRB review).  

Important! Once this selection is made and then saved, it cannot be changed.  If the incorrect selection is made or if this must be changed after initial review, the submission will need to be recreated.

8.    What kind of study is this? 
Select Collaborative if the project may involve (at any point in the project):
• More than one site conducting the study (completely or in part), or
• Collaborators with primary affiliation with other institutions, or
• If it is unclear if there will be additional sites.
Select Single-Site Study if the project only involves work at Harvard, by Harvard affiliated researchers. 

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.  External study ID: If available, the study number given by the External IRB.

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  (External IRB)
On this page include any pending/awarded funding sources or financial support for this study, with the IRB of record.  Leave questions 1 and 2 blank to indicate that there is no non-Harvard funding for this study. You will have an opportunity later in the forms to indicate funding sources specific to the Harvard site.  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.

GMAS Chooser Drop Down

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. 

GMAS detailed search box

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. 

SmartForm Section: Study Scope (External IRB)

1. Does the study involve the use of a drug in one or more persons other than use of an approved drug in the course of medical practice? Indicate if drugs, biologics, foods or dietary supplements are used in the Human Research. 

SmartForm Sub-Section: Drugs 
Identify all drugs, biologics, foods and dietary supplements (approved and unapproved) being used in the Human Research. For each, indicate whether it has an IND number and for those that do, ensure that the application includes one of the following: (a) sponsor protocol with the IND number; (b) communication from the sponsor with the IND number; or (c) communication from the FDA with the IND number.  Additionally, attach the following items: 

  • Investigator Brochure for each investigational drug involved in the Human Research.
  • Current Package Insert.  Submit for each marketed drug involved in the Human Research.
  • Validation of IND#, e.g. FDA Approval letter or Sponsor Protocol

2. Does the study involve the use of a DEVICE in one or more persons that evaluates the safety or effectiveness of that device, or data regarding the use of a device on human specimens? Indicate if a device is used in the Human Research.

SmartForm Sub-Section: Devices 
Identify all devices being evaluated for safety or effectiveness or as a comparator (approved and unapproved).   For each, indicate whether it has an IDE number and for those that do, ensure that the application includes one of the following: (a) sponsor protocol with the IDE number; (b) communication from the sponsor with the IDE number; or (c) communication from the FDA with the IDE number. Indicate whether the device is being submitted under the “Abbreviated IDE requirements” in 21 CFR 812.2(b). Additionally, attach the following items: 

  • Current Product Information, e.g., Device Manual. Submit for each investigational device involved in the Human Research.
  • Validation of IND# or IDE#, e.g. FDA Approval letter or Sponsor Protocol

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. ​​​​​​

What to Include on the Harvard Site for External IRB Review

Important! On the External IRB workspace, click on the (automatically created) site workspace:

  • Complete the Assign Primary Contact activity and add your name in the space provided.  This will ensure consistent access to the submission, through IRB review.
  • Click “Edit Site” to proceed with composing this submission and to make additional Site SmartForm edits.

Site SmartForm Section: Basic Information (External IRB)

1. Title of site. Enter the site title. Please avoid use of quotation marks in the title.  

2. Short title. The short title identifies the submission 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 site activities.  This should be 225 words or less.

4.  Principal Investigator. Enter the name of the Harvard 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 Local Site Documents page of the Site SmartForm. 

Site SmartForm Section: Funding Sources (External IRB)

On this page include any pending/awarded funding sources or financial support for this study, with the Harvard.  Reminder: If the funding status changes following IRB determination, submit a modification to this site.

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.

GMAS Chooser Drop Down

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.
GMAS detailed search box

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 Local Site Documents page of the SmartForm, when applicable, and remove or black-out any salary information.

Site SmartForm Section: Study Team Members (External IRB) 

The Study Team Members page of the SmartForm should include the name of individuals at Harvard that a) have contact with human subjects, b) have access to data that is identifiable; or c) are responsible for the design, conduct, or reporting of the research.  Take care to follow the instructions that display on the SmartForm page.

1.    List study team members with an HUID.

  • Individuals can be selected from a list of names.  Begin typing a piece of the person’s name in the space provided on the pop up, or you can click the “add” option to search the list of available names.  Use the “%” symbol to replace portions of a name of which may be unclear or possibly not spelled correctly.  This is called a “wildcard” character.  Use the email address column for search or as a guide to selecting the correct person.  If the correct person cannot be found via name or email, click the ellipses […].  Choose a Filter by: option to search on a single criteria.  Select UserID to search by HUID.   
  • If you would like a person on the study team to access ESTR, and his/her name does not appear in the search results; this individual must obtain an HUID.  Please visit the ESTR support site for detailed instructions on how to obtain an HUID for use with ESTR.  
  • Each of the individuals listed must complete human research training unless you clearly indicate that the individual is listed simply for access to this study record (in the Study Team Member details and via “Add comment” on the submission workspace).
  • Indicate whether each listed individual has a financial conflict of interest relating to the Human Research.  For more information about what constitutes a conflict, please visit your IRB website. If an individual has a financial interest, complete “FORM: Financial Interest Disclosure Form” and attach it to item 2 on this page of the SmartForm.

2. Attach other relevant documents. In addition to any relevant training documentation, indicate whether each listed individual has a financial conflict of interest relating to the Human Research.  For more information about what constitutes a conflict, please visit your IRB website. If an individual has a financial interest, complete “FORM: Financial Interest Disclosure Form” and attach it here.

SmartForm Sub-Section: Research Location 

Identify other research locations where the Harvard investigator will conduct or oversee the research. Indicate details as prompted on the research location details. For each location, the country is a required selection.  If the location country is not available select the option “[country not listed]”.

Upload information for each location to the Local Site Documents page of the SmartForm, via the last document attachment prompt, when applicable. 

Site SmartForm Section: Local Site Documents (External IRB)

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.  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.  

Use the “other” category to attach non-document type attachments which must be part of the review (such as compressed/zip, video, audio, or htm file formats).  

Items to attach to this page:

  • IRB Cede Request Form or equivalent
    • To request that the Harvard IRB rely on a participating institution of the SmartIRB Master Reliance Agreement, visit this link to the Online Reliance System. If it is your first time using this system, you will need to “Request Access” before you can complete an IRB cede request  
    • Draft or Executed IRB Authorization Agreement
  • 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 External IRB record may be updated at any time, only with changes as approved by the IRB of record.  

To provide a status update (for continuing review or closure) of the Harvard site, the Harvard Principal Investigator must visit the associated site workspace to complete the Report Continuing Review Data activity (on the left side of the site workspace. Within the activity, provide status information and relevant attachments.  To request closure, indicate the request in the text box provided on the activity.  Note that only the Harvard Principal Investigator (named on the Harvard Site SmartForm) will see/have access to the Report Continuing Review Data activity.

To request a modification for on an External IRB project:
1.    Log in to irb.harvard.edu
2.    Navigate to the External IRB’s associated site workspace (see Accessing a Submission for more information on finding the External IRB record, and clicking the site link).
3.    Click the “Modify Site” button on the left side of the workspace, a SmartForm will open.
Note: If the "Modify Site" button is not visible, be sure that: (1) a primary contact is assigned to the site and (2) as appropriate, an IRB coordinator is assigned to the site. One or both of these additions will update the workspace for the “Modify Site” button to display.
4.    Provide a brief description of the contents of the modification.
5.    By selecting ‘Continue’ the system take you to a copy of the Site SmartForm.  Refer to the section of this page: What to Include in the Initial Request for External IRB, Site SmartForm 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.

Important! External IRB submissions completed prior to October 2015 cannot be edited via modification.  Contact the IRB office to determine if an update is required.  If one is required, the submission will need to be recreated under new requirements and processes.