Download and fill out the applicable forms from the list below, then go to our online submission system ESTR (irb.harvard.edu), sign in with your HUID, and click on Create New Study. Fill out the online pages and upload these forms in the appropriate places.
For help with navigating ESTR, see the ESTR Study Submission Guide.
CUHS Protocol Template (use this form also for exempt studies)
HRP-215 Not Human Subjects Research Determination Request
Continuing Review Progress Report / Study Closure Template
Harvard Investigator Scope of Work Description Template
CUHS Adult Consent Form Template
CUHS Parental or Guardian Permission Template
CUHS Child Assent Form Template
Financial Interest Disclosure Form
Non-Harvard Study Personnel Form
Translation Attestation Form
IRB Cede Request Form
Individual Investigator Agreement (IIA)
PI Waiver for Undergraduate Research in the Social Sciences
INITIAL REVIEWS: We accept only the 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.
SHORT DESCRIPTIONS OF THE FORMS AND TEMPLATES
A. Description of Research
CUHS Protocol Template - use this form to describe your research plan.
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. IRB Worksheet HRP-310 - for reference. Investigators: Complete form HRP-215 only.
B. 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 Parental or Guardian 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:
Exempt consent samples:
iii. Consent examples- these are completed example consent forms for (fictitious) interview and online experiment research.
C. 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.
D. 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.
- Non-Harvard Study Personnel Form - 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 Cede Request Form - This form is used for multi-site studies if the request is not submitted through Harvard Catalyst
- Individual Investigator Agreement (IIA) - 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.
- PI Waiver for Undergraduate Research in the Social Sciences - This form is used under limited circumstances and must accompany the undergraduate's research submission.