Addendum Template (DOCX)
For instances in which the Sponsor or Investigator need to provide specific limited new information about the project to subjects rather than having subjects sign an entire revised consent form.
Banking Template (DOCX)
For projects which will be solely focused on the collection and banking of clinical records or biospecimens at MCW/FH (local banking).
Clinical Interventions Template (DOCX)
For studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy.
EFIC Template (DOCX)
For projects involving planned emergency research. Consent prior to these interventions is waived because of the condition of the subject and urgency under which procedures need to take place. Template is to be used for obtaining consent for continued participation.
HUD Humanitarian Device Exemption (HDE) Template (DOC)
For projects which involve the use of an HDE-cleared device in the course of clinical treatment. This consent template should only be used if the Sponsor has not provided any documents or information to provide patients.
Informational Letter Template (DOCX)
For minimal risk projects only and can be used for projects where the research activities are generally limited to surveys, interviews, focus groups, educational interventions, and/or observational research.
IRB Review Deferred Consent Form Template - Minimal Risk (DOCX)
For projects involving minimal risk procedures/interactions where the MCW IRB defers review to another IRB.
IRB Review Deferred Consent Form Template - Clinical Interventions (DOCX)
For projects involving clinical interventions where the MCW IRB defers review to another IRB.
Minimal Risk Template (DOCX)
For projects which involve minimal risk procedures (ex. observation, interviews, audio recording, surveys, focus group discussion) and/or other minimal risk inventions/interactions (ex. blood draws, MRI, community or educational interventions.
Multi-institution MCW IRB of Record Consent Form Template - Minimal Risk (DOCX)
For projects involving minimal risk procedures/interactions where the MCW IRB will be serving as the IRB of record for one or more sites engaged in research.
Multi-institution MCW IRB of Record Consent Form Template - Clinical Interventions (DOCX)
For projects involving clinical interventions where the MCW IRB will be serving as the IRB of record for one or more sites engaged in research.
Multi-institution MCW IRB of Record Assent (DOCX)
This assent template may be used for multi-site projects involving minor subjects ages 7-13 where MCW is the IRB of record for one or more sites engaged in research. The language used should be at a 2nd-3rd grade reading level.
Multi-institution MCW IRB of Record Consent/Assent Minimal Risk (DOCX)
For projects involving minors and minimal risk procedures/interactions where the MCW IRB will be serving as the IRB of record for one or more sites engaged in research.
Multi-institution MCW IRB of Record Consent/Assent Clinical Interventions (DOCX)
For projects involving minors and clinical interventions where the MCW IRB will be serving as the IRB of record for one or more sites engaged in research.
NCI Template_CIRB Deferred (DOCX)
For all NCI cooperative group projects that will be deferred to NCI CIRB for review. This template contains all required MCW language which must be incorporated into the NCI CIRB approved consent and should be used in conjunction with the Standalone HIPAA Authorization - Deferred Projects.
NCI Template_Local Review (DOCX)
For all NCI cooperative group projects that will be reviewed by MCW/FH IRB. This template contains all required MCW language which must be incorporated into the NCI consent. This template should be used in conjunction with the Standalone HIPAA Authorization - Local Projects.
NMDP Template BMT-CTN Deferred (DOCX)
For all BMT CTN projects that will be deferred to the National Marrow Donor Program IRB for review. This template contains all required MCW language which must be incorporate into the NMDP approved consent form.
Standalone HIPAA Authorization - Deferred Projects (DOCX)
For use in conjunction with Sponsor templates for deferred projects
Standalone HIPAA Authorization - Local Projects (DOCX)
For use in conjunction with MCW consent templates when the HRPP Office has agreed that a standalone authorization can be used.
Trial Partner Template (DOCX)
For projects which require the assistance/participation of a caregiver or trial partner in addition to the main study subject.
