In order to help collect the information needed for the various type of reviews, the IRB has several forms that must be used for submissions. Please download the appropriate form(s) below and complete for submission through IRBManager. If you have any questions about what form to use or how to answer any of the questions, please contact our office at 757.446.8423 or by email at IRB-INFO@evms.edu.
Access to Protected Health Information to Develop a New Study
Application for the Use of Protected Health Information - request access to protected health information for protocol preparation, to identify wheather a research study can be developed or to identify possible subjects for a research study.
Initial Review
Application for Approval of Research Involving Human Subjects- use this form for initial submission of exempt, expedited or covened IRB reviews.
COI FORM FOR IRB SUBMISSIONS - complete and include this form with your submission if you have an external sponsor for your study.
IRB Fee Waiver - request a waiver of IRB fees for a sponsored study to be reviewed by a convened Board. ( Exempt and Expedited studies do not need this form since they are not reviewed by a convened Board.)
Waiver of Consent Request- request that the IRB grant a waiver of consent so that subjects do not have be consented. This is typically done for a chart review of exisiting data but has other uses as well.
Waiver of Authorization for PHI request that the IRB waive the requirement for patient authorization to access protected health information for research purposes.
Request a Renewal of a Previously Approved Study
Continuing Review- request continuation of a study that was approved as Expedited or Full Board.
Report a Serious Adverse Event for an Ongoing Study
Serious Adverse Event (LOCAL) - submit an Serious Adverse Event for any subject enrolled at a site approved by EVMS.
Serious Adverse Event (NON-LOCAL) - submit an Serious Adverse Event for subjects enrolled at other sites in a multi-center study.
Request Any Change to a Previously Approved Study
Amendment Form - submit a request to make any change to a study.
Additional Documents
Investigator Assurance 2021 - each investigator on the study must have a current assurance on file. Assurances are vaild for three years. Print, sign, scan and upload forms to your electronic submissions.
Exempt Study Update Form - 2022 - submit an Exempt Study Update form to update the IRB on the progress of the Exempt study, and/or whether to continue or close out the study.
Close Out - close a completed or terminated study.