Guidelines For Permitted Boilerplate Language Additions

Guidelines For Permitted Boilerplate Language Additions

OVERVIEW

The National Cancer Institute’s (NCI’s) goal is to limit changes to the model consent form, and to ensure that any information added to the form is related to research specific to NCI-funded studies (New Guidelines For Permitted Boilerplate Language Additions).

In agreement with NCI’s guidance, the only permissible deletion to the model consent form for local boilerplate language is reproductive language specific for faith-based institutions. The permissible additions to the model consent form for local boilerplate language are very limited. There are 3 types of content of the CIRB-approved model consent where local context language may be added:

  • Local contact information.
  • State and local laws pertaining to informed consent.  
  • Institutional policy related to research on NCI-funded studies as allowed in this CIRB Quickguide.

Below please find a listing of each section of the model consent form followed by a description of what changes, if any, are permitted.

SUMMARY BY NCI INFORMED CONSENT TEMPLATE SECTIONS

Overview and Key Information

  • No changes permitted.

What am I being asked to do?

  • No changes permitted.

Taking part in this study is your choice

  • No changes permitted.

Why is this study being done?

  • No changes permitted.

What is the usual approach to my (*insert type of cancer, other*)?

  • No changes permitted.

What are my choices if I decide not to take part in this study?

  • No changes permitted.

What will happen if I decide not to take part in this study?

  • No changes permitted.

What are the risks and benefits of taking part in this study?

  • No changes permitted.

If I decide to take part in this study, can I stop later?

  • No changes permitted.

Are there other reasons why I might stop being in the study?

  • No changes permitted.

What is the purpose of the study?

  • No changes permitted.

What are the study groups?

  • No changes permitted.

What exams, tests, and procedures are involved in this study?

  • Generally, the additions to this section are not specific to research participants. Most additions to this section are related to requirements for anyone entering the institution and should be addressed for all patients outside of a research informed consent document. 
  • If there is a state law that has requirements related to the research it may be included in the informed consent document. The applicable state law must be documented or referenced with the request. No other additions are permitted to this section. 

What risks can I expect from taking part in this study?

  • No changes to the risk tables are permitted.
  • Faith-based institutions may replace reproductive risk language.
  • Dosimetry information related to research images or research radiation may be added. This may not be included if the scans or radiation are all standard of care.
  • GINA language is not research specific and should not be included in the informed consent document.  

What are my responsibilities in this study?

  • No changes permitted.

What are the costs of taking part in this study?

  • Only institutions that cover research expenses may make additions.  
  • The name of an institutional financial counselor may be inserted in this sentence in the template: “Ask your doctor or nurse for help finding the right person to talk to if you are unsure which costs will be billed to you or your insurance provider or you can contact ________.”
  • Any payment to the sites by the NCI should not be included in the consent form.
  • Do not insert financial conflict of interest (COI) for an institution or investigator in this section. COI should be included in its own section at the end of the document. 

What happens if I am injured because I took part in this study?

  • Institution-specific information may be added to identify what the institution does. Institutions enter this at their own risk and are liable for any statements related to their institution.

Who will see my medical information?

  • HIPAA language must not be embedded in the informed consent document and must be a standalone document. The HIPAA document should no longer be submitted on the Annual Signatory Institution Worksheet. The instructions in the NCI Informed Consent Template have been modified to exclude placing HIPAA language in the consent form.

Where can I get more information?

  • Resources available at the institution may be added.

Optional Studies and Contact for Future Research

  • Institutions can change the circling Yes or No to checking Yes or No. 
  • Institutions can add a sentence that an Optional Study is not offered at their institution or is closed to accrual. Text that is in the model consent form must remain.

My signature agreeing to take part in the study

  • No changes to template text permitted.  Institutions can add appropriate signature lines with dates and times. 

 

Posted: November 27, 2018