Forms

Please Use These Submission Forms

WE HAVE NEW INITIAL SUBMISSION FORMS!  The most recent forms can be found in Self Service under the Academics Tab (sub-folder - Human Research).  Please download and use the word version of forms and templates housed in the Self Service Site.  (We do not have the capability to review Google Docs; therefore please do not covert the forms to Google Docs and share them with the irb.

  • To be environmentally friendly and reduce paper consumption, we accept electronic submissions only. Send all materials as attachments to irb@ehc.edu. 
  • Separate all individual parts (informed consent, appendices, flyers, recruitment materials, etc.) into individual, clearly labeled files (with PI last name,nature of form, date) Use PDF or Word — NO JPGs.  Example:  Smith.Informed Consent.Aug.2016

Please note:  All students must be working with and under the supervision of faculty or approved staff members.  Only faculty or approved staff members may be listed as principal investigator.  

FORMS:

Initial Submission Forms
All initial applications, exempt, expedited, and full board should be submitted should be submitted to the IRB at irb@ehc.edu. Exempt and Expedited/Full Board are separate forms with subforms to be used when applicable. Case studies, decedent research, and coded biospecimens/data also have a separate application for review.  The instructions within each form will guide you as to which subforms should be used.  

Continuation of Study Approval 
The approval for all expedited (approved prior to January 21, 2019) and all full board studies have an expiration date.  To continue beyond the expiration date, submit this form at least 30 days prior to expiration. 

Modification to the Study
All modifications to the study should be submitted to the IRB for approval prior to implementation.  

Study Closure
Once you have completed both data collection and data analysis, please let the IRB know by closing your study. 

CONSENT TEMPLATES:

Exempt and Alteration of Consent (for Expedited and FB Studies)

Anonymous surveys: for studies involving surveys using the Qualtrics platform, for which the anonymous setting is used. The statement should be the first page of your survey. 

Focus groups, Surveys, Interviews  (Adult):  For surveys that are not anonymous, interviews and focus groups.  The statement should either the first page of your survey, or read to the interviewee, or focus group attendee. 

Focus groups, Surveys, Interviews  (Children) and Assent Script:  For surveys, interviews and focus groups involving children.  Alteration of consent is required. 

Expedited-Full Board Studies 

Expedited - Full Board Consent Template: 
 should be used for all Expedited and Full Board Studies unless a waiver or alteration of consent is requested and justified.

HIPAA language template:  This should be included in the consent form when the study involves the collection of HIPAA protected information. 

Assent Script: Should be used when children are under 8 years of age and/or a child could not understand a written assent. Gives the child an opportunity to say “yes” or “no” to participation. 

Written Assent: Should be used when children are ages 8 years and older and/or could understand a written document (which will be explained orally). Gives the child an opportunity to say “yes” or “no” to participation. 

 

 

If you need any help reading and/or with the completion of these forms, please contact us for assistance at irb@ehc.edu or give us a call at 276-944-6921.