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Consent Form Checklist for Initial Review for WIRB Studies
October 2015
Please use the Consent Form template for specific language to be added to your consent. Use this form
to indicate what sections have been added to your consent document. Please acknowledge that you
have addressed each consent section listed below.
Acknowledged
Consent Form Section
Procedures: Please verify that the following information has been included in the
consent document

Number of study visits

Length of study visits

How long subjects will be enrolled in study

Number of subjects from UW-Madison
Risks and Discomforts: Please select which section(s) are included with your
consent document

Imaging Studies

Laboratory Testing May Reveal Sexually Transmitted or other
Communicable Diseases

Protocol Specifically Tests for HIV, Hepatitis B and C

Information About Illicit Drug Use and Alcohol Abuse

Certificate of Confidentiality Will Be or Has Been Obtained

Pregnancy Testing in Minors
Confidentiality: Please indicate whether an optional sponsor statement is include in
your consent document

Sponsor statement included

Sponsor did not include an additional statement
Costs: Please indicate whether subjects may be billed for pharmacy dispensing
charges.

Subjects may be billed for pharmacy dispensing charges and the
required language is included in the consent document

Subjects will not be billed for pharmacy dispensing charged
Commercial Products: Please indicate whether this study includes blood or tissue
banking.

This study includes banking and the required commercial products
language is included in the consent document.

This study does not include banking.
Tissue Stored for Research: Please indicate the type of blood and/or tissue banking
associated with this study

Optional Banking

Mandatory Banking

No banking is included in this protocol
Genetic Information and Nondiscrimination Act (GINA): Please indicate whether
genetic testing is a component of this study

This study includes genetic testing and the required GINA language is
included in the consent document.

This study does not include genetic testing
Treatment and Compensation for Injury: Please indicate whether or not the
sponsor has a policy to pay for research-related injuries

The sponsor does not have a policy to pay for research-related injuries
and the appropriate language is included in the consent document.

The sponsor does have a policy to pay for research-related injuries
and the appropriate language is included in the consent document.