Updated COUHES Requirements

COUHES is implementing several changes to the forms and procedures. The new requirements will go into effect on March 31, 2017 and listed below are a summary of all the expected changes. We will update the website and forms accordingly. These requirements are subject to change before March 31.

 

CHANGES TO EXISTING FORMS

Adverse Event

  • New language and additional fields added.
  • The type of event added which will clarify the type of AE.

Change form

  • Minor changes to the text.

All Consent Forms

  • Several changes to the text and requirements of the consent form.
  • New template will outline all new requirements.

Exempt Application 

  • Minor changes to the text.
  • New waiver of consent requirement added.

Standard Application

  • Minor changes to the text and format.
  • Added a separate personnel list.
  • New waiver of consent requirement added.

Continuing Review Questionnaire

  • Minor changes to the text and format.
  • Additional required fields.

 

ADDITIONAL FORMS

Final Report Closure Form

  • Required submission upon the completion of expedited or full board protocols.
  • The new form is a condensed version of the continuing review form and will only be required once the study is completed.

Waiver or Alternation of Informed Consent Request

  • Required when requesting a waiver or alteration of the informed consent.
  • Further information will follow with a full explanation of the required consent elements.

 

NEW REQUIREMENTS

Consent Forms

  • Investigators are now required to use stamped version of the consent material.
  • This does not apply to online consent forms but does apply to all studies where the investigator obtains consent.

Final Report Closure Form

  • Upon the completion of a research project, all investigators will be required to submit a Final Report Closure Form to close the study.
  • Approval letters and renewal reminders now include a Final Report reminder notice.

Personnel List

  • Investigators are required to submit personnel lists along with all new submissions, Continuing Review Questionnaires, and amendments that revise protocol personnel.

 

COUHES no longer mails hard copies of approved documents. We now email all approval letters and stamped documents to the PI and contact(s).

All of the changes will help ensure COUHES and MIT investigators are in compliance with federal, state, and institute policies.

Please contact the office with questions at 617-253-6787 or email couhes@mit.edu.