Human Subjects Research - Institutional Review Boards - IRBs
Consent and HIPAA GuidanceThe Committee has developed multiple templates for use. In addition, please refer to our Consent Form Guidance document and our Consent Form Checklist for additional guidance.
As of 09/01/16 the HIPAA authorization language will be included within the consent form. All new consent submissions received on or after this date must include the HIPAA language. Any protocols that are currently active must update the consent form either at time of next amendment or continuing review whichever comes first. Please refer to the "Consent for Medical Study" template found below to develop or modify the study consent form.
|Initial Informed Consent|
|Assent for Children (behavioral/social study) (10/12/16)||For use when the assent is a separate document from the parental consent.|
|Consent for Behavioral/Social Study (11/12/14)|
|Debriefing Consent||To be used to inform and obtain continued consent to
use subject's data when deception was used.
|Consent for Medical Study (10/12/16)||Consent Template WITH guidance (pdf) (08/22/16)|
|Information Sheet (04/30/15)||To be used when protocols are minimal risk and meet the criteria for a waiver of documentation.|
|Documentation of Consent Process Template||Good
Clinical Practice (GCP) for medical research recommends that
have documentation of the consent process for each participant.
This template can be used for this purpose.
|Short Form Consent Template (01/01/16)||To
be used for non-English speaking individuals. Refer to Section
8.B.3. of Research Manual.
UVMMC Interpreter Tips (new)
|Blood Drawing Consent Template (11/12/14)||To be used for blood collection protocols only.|
|Expanded Access Consent Template||This would only be used when the investigational products are to be used for serious or life-threatening conditions when there is no satisfactory alternative. Contact the office for assistance in these situations.|
|To be used anytime a subject is willing to share his/her experiences with the media in any format. The IRB does not need to review, but it should be executed and kept with the subject's research file.|
|HIPAA Forms and Guidance|
PHI from UVMMC Template (10/19/16)
|To be used as a replacement for the HIPAA authorization when you intend to review patient's PHI from UVMMC.|
PHI from LUSE UVM Template (10/19/16)
|To be used as a replacement for the HIPAA authorization when you intend to review patient's PHI from LUSE UVM.|
|Request for Partial Waiver of Authorization for Recruitment Purposes (2/5/15)||Submit this form to the IRB when you intend to review patient's PHI for recruitment purposes when you have no existing clinical relationship with the patient.|
|UVM Medical Center Data Use Agreement ("Limited Data Sets")||If the research includes use of a limited data set from the hospital you must enter into this agreement with the hospital.|
|UVM Medical Center Reviews Preparatory to Research||If you wish to review records (not taking any protected health information) to design a research study or to assess the feasibility of conducting a study, you must complete this form and forward to UVM Medical Center Privacy Officer Dept for approval.|
|This document was developed by the IRB, therefore an IRB approval stamp is not required. However, if you wish to change the content (other than inserting the names and numbers) it requires an amendment prior to use. See Research Manual 8.B.1.b.|
|To be used anytime you have some additional information for subjects that may affect their willingness to continue participation.|
Last modified October 19 2016 03:21 PM
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