Health Sciences Institutional Review Boards
Informed Consent & Subject Recruitment |
Informed consent is the process through which researchers provide
the necessary information to potential participants so that a knowledgeable
decision can be made about whether the individuals wish to take part
in a research study. This is an ongoing process that begins with initial
recruitment of subjects and continues after the initial oral or written
agreement from an individual to participate in a research study. This
page provides informed consent templates and guidance regarding the
consent process and when the consent process can be altered, obtaining
assent from children, surrogate consent guidelines, and the consent
process for illiterate or non-English speaking subjects. |
Special Consent Processes |
Enrollment of some subjects requires additional procedures or special adaptation of the consent process. Resources and guidance related to some of these situations follow.
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Subject Recruitment and Screening Procedures |
The identification and screening of potential subjects may involve the need for an altered consent process. In addition, the potential enrollment of some subject populations require special note in the IRB application, especially in terms of whether additional procedures or protections should be in place to minimize risks to those subjects.
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Consent Form Templates |
| NOTE: Consent Form documents more than 5 pages require a summary document, such as the Consent Form Summary Information Sheet below. |
Consent Form
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Assent Form
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Genetic Research and Use of Storable Tissues |
| Humanitarian Use Device (HUD) Consent Form |
Consent Form Summmary Information Sheet |
VA Consent Forms |
Emergency/One-Time Use Consent Form |
Consent Form Addendum for Reconsenting Subjects |
HIPAA Authorization Form Templates |
Authorization Form Templates can be found on UW's HIPAA Privacy Rule Research Guidance website. In addition, the Authorization Form Wizard can be used to generate HIPAA Authorization Forms for research with adults that do not involve any data or tissue banking. The Combined Consent/Authorization Form Wizard can be used to incorporate HIPAA language into some consent documents. |
Consent Form Wizard |
| These programs have been developed to help researchers draft a consent form by asking relevant questions to ensure the required elements of an informed consent document are included, and compiling the answers into a consent form format. |
| For studies that do not require the inclusion of the HIPAA Privacy Rule language (i.e., researchers not collecting protected health information or who are outside the UW’s Health Care Component) | |
| Best for studies that are not greater than minimal risk OR which are not industry-sponsored | |
| Best for industry-sponsored studies or other studies that involve the creation of a HIPAA authorization form separate from the consent document |
Reading Level |
| Consent, assent and authorization forms should be written at a maximum 8th grade reading level. For long consent forms (more than 5 pages), the IRB requires the use of a summary or information sheet at the beginning of the form that highlights the critical information about study procedures and risks of participation. Use the following tools to create and assess your forms. The following tools can be used to find lay language translations of commonly used medical terms. |
Additional Required Language |
| For protocols involving investigational imaging techniques (e.g. fMRI research protocols) | |
| NIH Suggested Language for studies with a Certificate of Confidentiality | |
| For protocols that involve the collection of samples from subjects and these samples may be used to develop tests, assays, or products that may have future commercial value | |
| For protocols conducted in the CTRC. This text should be included in the section of the consent form that describes who will have access to study and medical records. | |
| For protocols that intentionally expose subjects to radiation solely for research purposes (e.g., research x-rays or radiopharmaceuticals) | |
| For protocols that involve physical risks to subjects | |
| For protocols that enroll subjects in studies conducted by a VA Investigator or on VA property. | |
| For protocols that enroll subjects in studies conducted by a VA Investigator or on VA property. |
Other Informed Consent Resources |