Human Subjects Research - Institutional Review Boards - IRBs
Consent and HIPAA Development 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.
Note 11/12/14: All consent templates (and HIPAA) that reference Fletcher Allen Health Care or FAHC have been revised to reflect the new hospital name. We have taken this opportunity to update some other areas of our consent templates. Please be sure to reference these prior to your next protocol submission.
Note 4/16/15: The compensation for injury boilerplate language has been revised. This new language can be found in our Medical Consent Template below.
04/16/15 - Consent Form Update
(This is to be provided to subjects who have already consented or who you plan to consent prior to revising your consent form with the name change and new injury language.)
|Initial Informed Consent|
|Assent for Children (behavioral/social study) New 10-23-14||For use when the assent is a separate document from the parental consent.|
|Assent for Children (medical study) pending|
|Blood Drawing Consent Template (11/12/14)||To be used for blood collection protocols only.|
|Consent for Behavioral/Social Study (11/12/14)|
|Consent for Medical Study (04/16/15)||To be used for medical studies. Click here
for template with guidance for development of consent.
Medical Consent Template WITH guidance (pdf) (04/16/15)
|Consent Form Update (04/16/15)||This is to be provided to current and new subjects to make them aware of the hospital name change and the new injury language per the updated announcement on 04/16/15.|
|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.
|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.|
|Short Form Consent Template (11/12/14)||To be used for non-English speaking individuals. If you believe this applies, please contact the office prior to development and submission for guidance.|
|HIPAA Authorization Development|
|HIPAA Authorization Template (09/18/15)||Must be submitted if the research is being conducted within the covered entity or you are receiving identifia ble private information directly from a covered entity.|
|Request for Partial Waiver of Authorization for Recruitment Purposes (2/5/15)||Submit this form when you intend to review patient's PHI for recruitment purposes when you have no existing clinical relationship with the patient.|
|UVM Medical Center HIPAA Forms|
|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 Risk Management 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.|
|Debriefing Consent (new 4/18/14)||To be used to inform and obtain continued consent to
use subject's data when deception was used.
|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.|
|Information Sheet (04/30/15)||To be used when protocols are minimal risk and meet the criteria for a waiver of documentation.|
Last modified October 08 2015 10:07 AM
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