Informed Consent is a dynamic, iterative process beginning with subject recruitment and continuing until the research study is closed.
The consent form serves as a written overview of the study procedures, associated risks of participation and identifies whom to contact concerning research procedures and the subject's concerns about involvement in a research study.
In order ensure that study subject's consent is truly informed, researchers must convey understandable information and provide answers to all questions posed by the subject at any time during their participation in the study. A truly informed research subject will possess a thorough, demonstrable understanding of the study in which they consent to participate.
Effective July 1, 2010, National Jewish Health is allowing HIPAA Authorization language to be included in the main consent form. Researchers may now choose whether to combine the authorization language into the consent form or present subjects with separate consent and authorization forms.
While the IRB offers template language to help ensure inclusion of required elements of informed consent, the IRB allows investigator to have flexibility with informed consent form and assent form wording. (The only exception to this flexibility pertains to the header, institutional research injury language, authorization language, and ICF signature templates, which must remain verbatim.)
It is important to note that use of the template language does not guarantee that the template language will be approved verbatim for all studies. Investigators must ensure that consent form wording is accurate and appropriate for each study.
Main study consent and assent templates
Informed Consent-Authorization Template - If using this combination template, a separate, standalone HIPAA authorization is not required. (updated 08 Aug 2011)
Informed Consent Template - If using this consent template, a separate, standalone HIPAA authorization must be provided to subjects. (posted 08 Aug 2011)
NEW! Guidance on Informed Consent and Authorization Elements (dated 09 Dec 2012)
Assent Template (updated 27 Jun 2010)
Consent form addenda to describe specimen collection and/or storage for future use
HIPAA considers collection and storage for future use to be a separate research activity requiring separate HIPAA Authorization from the Authorization provided for the main study. Either of the following two options may be attached as an addendum to the main study consent/authorization form. (They may not be used as independent consent forms because they do not contain all required elements of informed consent.)
Informed Consent-Authorization Specimen Addendum (updated 26 Jan 2011)
Informed Consent Specimen Addendum (updated 26 Jan 2011). If using this addendum (that doesn't contain authorization elements), you must also use a separate, standalone HIPAA Authorization (HIP-004) form.
Consent form addendum to describe optional genetic research
Use this addendum if genetic research will be the main focus of optional participation. If banking will be the main focus of the optional research and there may or may not be future genetics, use the Consent form addenda (above) to describe specimen collection and/or storage for future use.
Informed Consent-Authorization Genetics Addendum (updated 29 Jan 2011)
Consent form addendum to describe new findings
Use this addendum if there are new findings to communicate to subjects that may influence willingness to continue in the study.
Informed Consent New Findings Addendum (updated 26 Jan 2011)
Create a telephone script to describe verbal requests for subjects to provide information or withhold food/medication prior to providing written informed consent and authorization. When using a telephone script it is also necessary to submit a Waiver of Document of Informed Consent and a Partial Waiver of HIPAA Authorization (at the bottom of this page).
Telephone screening script - Example 1 (posted 05 Jul 2012)
Telephone screening script - Example 2 (posted 05 Jul 2012)
NEW! Telephone screening outline (posted 29 Nov 2012)
Helpful reference documents
HIPAA Authorization (HIP-004) (updated 14 Sep 2009)
ICF Signature Templates (updated 21 Jul 2010)
ICF Standard Statements (posted 28 Jun 2012)
Research Injury Language (2008)
Waiver of Consent / Authorization
Waiver of Informed Consent (created 08 Nov 2012)
Waiver of Documentation of Informed Consent (created 08 Nov 2012)
Waiver of HIPAA Authorization (updated Aug 2010)
NEW! Guidance on Waivers of Consent and Authorization (dated 09 Dec 2012)