Changes to the Sample Consent Form, version 02/25/13
· Instruction page has been updated.
· The participant’s initials line in the footer of each page has been removed.
· Research Involving Children has been added to the first page of the sample consent form to provide information on when “you/your child” should and should not be used.
· The first section of the sample consent form is now Purpose of the Research and comes before the Explanation of Procedures section. The instructions for each section are under the appropriate headers.
· Instructions regarding HIV testing and reportable diseases have been added to the Explanation of Procedures section.
The Incidental Findings section, with instructions and sample language, has been added.
· Instructions and sample language regarding randomization risks have been added to the Risks and Discomforts section.
· Contact information for Billing Compliance Language instructions in the Confidentiality section has been updated.
· Instructions regarding reportable diseases have been added to the Confidentiality section.
· Instructions and sample language regarding genetic research have been added to the Confidentiality section.
· Refusal or Withdrawal without Penalty section header has been changed to Voluntary Participation and Withdrawal.
· Contact information for Medicare Advantage instructions in the Costs of Participation section has been updated.
· The Genome Wide Association Studies (GWAS) section, with instructions and sample language, has been moved and revised.
· The Storage of Specimens section, with instructions and sample language, has been moved and revised. Sample withdrawal of specimens language has been added.
· Contact information for the Office of the IRB has been updated in the Questions section.
Changes to the Sample Assent Form
· Instruction page has been updated.
· Formatting on top half of the first page has been updated to match the sample consent form.
· The Signatures heading has been added and the language in this section has been revised.
The sample assent form is available online by clicking this link.