EVMS has developed several template consents for use with various types of studies.  These consents allow for EVMS to have standardized language in all documents and make it relatively easy for a consent to be developed (either alone or in conjuction with a sponsor's template).

Templates under Consent Forms can be used as the initial consent.  Templates under the Addendum Consents heading are used in conjunction with an initial consent and may be added at the start of a study, during a study, or even after a study has completed enrollment but subjects need to be informed of new information.

Subject Consent Form - for studies that have interventions, randomization, or greater than minimal risk associated with the study.

Registry Consent Form - use when the study is about subjects with a specific disease or condition in which data is recorded without a predefined treatment.

Drawings, Questionnaires, or Data Collection Only - for studies involving art drawing, questionnaires or only data collection.

Identified Specimen Collection - investigators planning to use data or specimens may use this consent form.  All data or samples collected for future use must be governed by an IRB approved protocol specific to the collection and storage.

Unidentified Specimen Collection -investigators planning to use data or specimens may use this consent form.  All samples collected for future use must be governed by an IRB approved protocol specific to the collection and storage.

Addendum Consent for New Information - used for additional consent, usually after a study has started, and a factor such as risks, compensation, etc. change during the course of a study.

Assent Form - for children ages 8 through 17, depending on the subject’s level of maturity and capacity for judgment.  For children less than 18, parental or guardian consent is required, and the regulations also requires assent by a competent child.

Employee / Student Addendum - use when planning to recruit employees or students as research subjects.

Identified Specimen for Future Use - to use/collect identified (directly or through a link) data or specimens for future research that is part of a “main study”; attach an appropriately edited copy of this addendum to the Subject Consent Form.  All samples collected for future use must be governed by an IRB approved protocol specific to the collection and storage.

Unidentified Specimen for Future Use - to use/collect unidentified data or specimens for future research that is part of a “main study”; attach an appropriately edited copy of this addendum to the Subject Consent Form.  All samples collected for future use must be governed by an IRB approved protocol specific to the collection and storage.