CUHS ESTR Implementation FAQ

Content

• Where to Go for ESTR Help.
• Prepare for using ESTR with your existing studies by locating electronic copies of the most current version of all documents, which must be uploaded into ESTR when you modify or renew a study.
• Download and use the ESTR forms and templates.
• Obtain HUIDs for any study staff who do not have one.
• Download the ESTR Go Live Announcement Email

1. How can I get help with ESTR?

Two ways:

• Visit the ESTR Support website. You can view reference materials and other resources, and also sign up for Interactive ESTR Trainings, which are scheduled four times per month starting on June 4, 2013. If any session is full or specific date is not available, please email ESTRhelp@harvard.edu to request one.
• You can contact CUHS with specific questions, for specialized training or to find out the schedule for open office hours for one-on-one training: cuhs@fas.harvard.edu, 617-496-2487.
2. What happened to existing studies?

All active research protocols will be migrated into ESTR. However, this migration includes a minimum amount of identifying data, and it does not include attachments. Once the migration is complete and ESTR goes live on June 26, the “skeleton” record will have to be completed by study staff. This completion is required at the time of modification or continuing review.

An important part of completing a migrated study is uploading 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 redlined application form. You may contact CUHS (617-496-2847, cuhs@fas.harvard.edu) if you need assistance in locating copies.

Instructions on managing and updating a migrated study can be found here: http://estrsupport.fss.harvard.edu/fs/docs/icb.topic1226265.files/Managing%20and%20Updating%20a%20Migrated%20Study.pdf

3. Where can I download the new forms and templates?

• INITIAL REVIEWS: From now until July 8, 2013, you may attach the old application form to the Study Scope page of ESTR instead of the Protocol Template; however, we encourage you to use the Protocol Template because its questions are updated so that we will not have to contact you for additional information as often.

• 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: All renewals and modifications now require that you upload current versions of all study documents, unless the study is in the data analysis phase only.

• FORMS AND TEMPLATES

  Guidance:

  • Template Guide- this guidance document describes how to fill out the templates and submit applications through ESTR.

  Description of Research:

  • CUHS Protocol Template- use this form to describe your research plan; all submissions require filling out wither this Protocol Template or HRP-215.

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

  Consent templates: these templates are the most general starting point and can be filled in for any type of minimal risk research (see Template Guide for guidance).

  • CUHS Adult Consent Form Template
  • CUHS Parent Permission Template
  • CUHS Child Assent Form Template

  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

  Interview and online experimental research consent samples:

  • CUHS adult consent form interview example
  • CUHS adult consent form online example

5. How do I get an HUID for study staff?

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.huid.harvard.edu/forms/id_request.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 1 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.

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[Last modified: 06/28/13 ]