5.5 Use of the Short Form Consent Document

Last Revised: 11/30/2022

1.0 Purpose

The purpose of this policy is to describe the Organization’s requirements for use of a short form written consent document for enrollment in research.


2.0 Policy

It is the policy of the Organization that:


3.0 Definitions


4.0 Use of the Short Form


DOCUMENT HISTORY:

 Written: 2/5/2016 (Approved: 2/5/2016) - original author not recorded

 Revised: 6/18/2018 - revision not documented

 Revised: 5/13/2021 - Revised to state request form available thru RSS; added BMC staff as eligible interpreter or witness; deleted list of short form available languages; deleted requirement to record time spent in the process of consent; deleted requirement that interpreter separately document the process of consent; corrected references to revised Common Rule; minor stylistic changes.

 Revised: 10/14/22 – added definition of “Qualified interpreter” to harmonize with HRPP 5.7; clarified that approval to use short form is only valid for 2 weeks and may only be used for one subject; stylistic changes; correction of typographic errors.

 Revised: 11/30/2022 - corrected 4.1.2 from: "IRB-approved short forms are available in a variety of languages on the IRB website in the following languages, along with an English translation of the short form.", to: "IRB-approved short forms are available in a variety of languages on the IRB website, along with an English translation of the short form."


Revision #13
Created 24 October 2019 21:40:15 by Autumn M Eberly
Updated 17 April 2025 16:04:52 by Robert A Lewis