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 conjunction with a sponsor's template).
Templates under Initial Consents can be used as the initial consent.
Templates under the Addendum Consent heading are used in conjunction with an initial consent and/or 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.
Initial Consents
EVMS 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.
Questionnaire Data Collection Drawing Consent Form - for studies involving art drawing, questionnaires or only data collection.
Consent for the Use and Storage of IDENTIFIED Human Biological Material- 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.
Consent for the Use and Storage of UNIDENTIFIED Human Biological Materialinvestigators 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
Addendum Consent - 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 of the Child - 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. Attach this to the Subject Consent Form; Registry Consent Form; Drawings, Questionnaires, or Data Collection Consent Form; or the Use and Storage of Identified/Unidentified Biological Materials Consent Form.
Employee and Student Addendum Consent Form-use when planning to recruit employees or students as research subjects.
IDENTIFIED Tissue Specimen for Future Research Addendum Consent Form 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 Tissue Specimen for Future Research Addendum Consent Form- 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.