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ESTR - The New IRB Submission System

 

1. What is ESTR?
2. How can I learn more about ESTR?
3. What will happen to existing studies?
4. What forms and guidance are available?
5. How do study staff obtain HUIDs?
6. CUHS ESTR How-To's

 

1. What is ESTR?

ESTR stands for Electronic Submission, Tracking & Reporting and is the mechanism for all submissions to CUHS: initial applications, modification requests (amendments), continuing reviews (renewals), and Reportable New Information (called RNI: noncompliance, adverse events, etc.).

Basic information on all active studies has been migrated to ESTR so that modifications and continuing reviews on these studies can be made through ESTR.

CUHS will no longer accept applications via email; all submissions must be made through ESTR.

For new applications, we recommend that you complete the appropriate templates before logging in to ESTR.

Log in to ESTR using your HUID and PIN at http://irb.harvard.edu.

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2. How can I learn more about ESTR?

Four ways:

  • Visit the ESTR Support website to view reference materials and other resources.
  • Visit the ESTR Support website to sign up for Interactive ESTR Trainings, which are scheduled twice a month starting in June, 2013. If any session is full or specific date is not available, please email  This email address is being protected from spambots. You need JavaScript enabled to view it.  to request one.
  • Log in to ESTR and navigate with the assistance of the help text and Study Submission Guide
  • Contact This email address is being protected from spambots. You need JavaScript enabled to view it. with specific questions, for specialized training or to find out the schedule for open office hours for one-on-one training:   This email address is being protected from spambots. You need JavaScript enabled to view it. , 617-496-2847.

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3. What will happen to existing studies?

All active research protocols have been migrated into ESTR. However, this migration includes a minimum amount of identifying data, and it does not include attachments. The migrated study will have to be populated with the currently approved information for the study the first time you need to file a modification or renewal. The way this completion will be done will be to submit a modification through ESTR. This is not a true modification of the protocol, but simply a way of getting the information into ESTR, and your research does not have to wait for the "approval" action to continue.

An important part of completing a migrated study is uploading files that represent the approved activities of the study. This includes electronic copies of the most current version of the protocol and all other study material (consent forms, advertisements, debriefing material, etc.). The protocol is represented by the latest CUHS application form, plus any modifications that were submitted and approved without concurrent approval of a red-lined initial application form. You may contact This email address is being protected from spambots. You need JavaScript enabled to view it. (617-496-2847,  This email address is being protected from spambots. You need JavaScript enabled to view it. ) if you need assistance in locating copies.

Instructions on managing and updating a migrated study can be found under #9 of the CUHS How-to's document.

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4. What forms and guidance are available?

INITIAL REVIEWS: Beginning July 9, 2013, we will accept only the new CUHS Protocol Template.

CONSENT FORMS: We will approve any CUHS forms that contain all the required elements, so you may use the old sample forms, the new templates, or a modification of an existing form that is already in use in your lab.

MODIFICATIONS and RENEWALS: there are no separate forms in ESTR; instead, information is entered directly into ESTR. You must also upload current versions of all study documents, unless the study is in the data analysis phase only.
The following is a list of the new forms and templates:

A. Guidance:
Template Guide - this guidance document describes how to fill out the templates and submit applications through ESTR. It contains an appendix specifically addressing how to use the templates for exempt research.

B. Description of Research:
CUHS Protocol Template - use this form to describe your research plan; all submissions require filling out either this Protocol Template or HRP-215.

HRP-215 Not Human Subjects Research Determination Request - use this form to apply for a formal determination that your activities do not constitute research with human subjects.

C. Consent, assent and permission

i. Consent templates - these templates are the most general starting point and can be filled in for any type of non-exempt minimal risk research (see Template Guide for guidance).
·         CUHS Adult Consent Form Template
·         CUHS Parent Permission Template
·         CUHS Child Assent Form Template

ii. Consent samples - these samples assume a particular type of research (interview, lab study, survey) so certain portions are already filled in.

Non-exempt consent samples:
·         CUHS sample consent form for lab studies
·         CUHS sample interview information sheet
Exempt consent samples:
·         CUHS sample exempt interview oral script
·         CUHS sample exempt survey information sheet

iii. Consent examples- these are completed example consent forms for (fictitious) interview and online experiment research.
·         CUHS adult consent form interview example
·         CUHS adult consent form online example

D. Continuing Review (Renewal) and Closure
·        The main information for continuing review or closure is submitted directly into ESTR. There is a Continuing Review Progress Report Template that can be used to provide the required brief summary of progress.

E. Supplemental Forms
·        Financial Interest Disclosure Form The Principal Investigator is responsible for submitting this form for any member of the study staff with a financial interest related to the research.
·        Study Personnel Information This form is for submitting study staff only if they do not have a Harvard ID. Be sure to attach training certificates for these staff as well.
·       Translation Attestation Form This form is required when documents are to be translated into a language other than English.
·       IRB Authorization Request This form is used for multi-site studies if the request is not submitted through Harvard Catalyst
 ·      Individual Investigator Agreement This form is used for a researcher on your project who is neither affiliated with a Harvard University Area school nor under another institution’s IRB.

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5. How do study staff obtain HUIDs?
All study staff need to have an HUID so that they can log into ESTR and have their ethics training tracked.
·         Complete the “Temporary Photo ID Card Request (POI Role)” application, available at: http://www.campusservicecenter.harvard.edu/sites/campusservicecenter.harvard.edu/files/temporary-photo-id-card-request-poi-role.pdf

·         Complete all sections of this application, including the required information for the Harvard HUID-holding sponsor. Applications must be completed by a faculty or staff sponsor and may be rejected if they do not have a Harvard-based sponsor. A sponsor may be the Principal Investigator of the study, Lab Manager, Project Coordinator, etc.

Information for Section 2 should include:
·         Email: Must have a valid active email address,
·         Role: May be marked “other: IRB”, and
·         ID Card Required?: Should be marked “no” unless this application includes a request for building access.
·         Harvard Library HUID Holders (HUIDs issued by Weidner or another Harvard library): Indicate the existing Library issued HUID number in the question “Has this individual been at Harvard before?“ Clearly indicate that this is a request for an additional number for access to ESTR.

·         Sign and fax the completed application to the number at the top of the form (not to CUHS). It should take about three days to receive the HUID.