8/1/2023 0 Comments Consent formMulti-institution MCW IRB of Record Consent/Assent Minimal Risk (DOCX)įor 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. The language used should be at a 2nd-3rd grade reading level. 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. Multi-institution MCW IRB of Record Assent (DOCX) Multi-institution MCW IRB of Record Consent Form Template - Clinical Interventions (DOCX)įor 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 Consent Form Template - Minimal Risk (DOCX)įor 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. blood draws, MRI, community or educational interventions. observation, interviews, audio recording, surveys, focus group discussion) and/or other minimal risk inventions/interactions (ex. IRB Review Deferred Consent Form Template - Clinical Interventions (DOCX)įor projects involving clinical interventions where the MCW IRB defers review to another IRB.įor projects which involve minimal risk procedures (ex. IRB Review Deferred Consent Form Template - Minimal Risk (DOCX)įor projects involving minimal risk procedures/interactions where the MCW IRB defers review to another IRB. This consent template should only be used if the Sponsor has not provided any documents or information to provide patients.į or 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. HUD Humanitarian Device Exemption (HDE) Template (DOC)įor projects which involve the use of an HDE-cleared device in the course of clinical treatment. Template is to be used for obtaining consent for continued participation. Consent prior to these interventions is waived because of the condition of the subject and urgency under which procedures need to take place. 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.įor projects which will be solely focused on the collection and banking of clinical records or biospecimens at MCW/Froedtert Hospital (local banking).įor studies involving clinical interventions such as drugs, devices, surgery, or psychotherapy.įor projects involving planned emergency research.
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