• Use everyday vocabulary and write the consent form at a 6th - 8th grade reading level.  Glossaries of lay terms for use in preparing consent forms can be found on websites such as The National Comprehensive Cancer Network (NCCN) NCCN Informed Consent Language (ICL) Database. You can also simplify consent forms by using short sentences, shorter paragraphs, consistent terminology, and active verbs.
• Use a font that is no smaller than 12 point, and bolded headings to enhance readability of the consent document.  If subjects are likely to have low or impaired vision, use a larger font.
• Incorporate user-friendly formatting, such as tables to outline visits or graphics to illustrate unusual or complicated study procedures. Also use bullet points, especially when listing study risks.
• In clinical research consent forms, use the term “subject” rather than “patient.” This wording is important because it reinforces the fact that research procedures are distinct from clinical procedures, even though the Principal Investigator may be the treating physician and the research subject may also be a patient.  For non-interventional studies, it may be acceptable to use “volunteer” or “participant” instead of “subject” based on the nature of the study.
• Include the term “Research” in the title or header of the consent form. For example, “Research Information and Consent Form” or “Consent to Participate in a Research Study.”
• If your target population includes individuals who are not proficient in English, obtain a translation of the consent form(s). Also decide whether you would like to request approval to use a short form consent process for the occasional and unexpected enrollment of a non-English-speaking subject on your study. Additional translation resources are available on the CHR website.
• An assent form for minors may be necessary if you will be enrolling children in the study.
• Subjects may also need to sign a HIPAA Authorization form. Your IRB approval letter will state whether the HIPAA Authorization is required.
• Under California law, you must also give a copy of the Experimental Subjects Bill of Rights to subjects enrolled in studies involving biomedical procedures, placebo controls, innovative therapy, and/or normal volunteer subjects.

Special Considerations for Research Involving Tissue Storage

If you plan to save blood or tissue for future research, review the Guidelines for Using Human Biological Specimens.

Some of the issues that may need to be addressed in the Biological Specimens consent form include:

• Whether the tissue be used for future studies or a different research purpose in the future
• Whether the tissue will remain identifiable
• What the risks of breach of confidentiality are

Regulatory requirements
The Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA) enforce federal regulations covering informed consent in research involving human subjects.

• Title 45-Code of Federal Regulations (CFR)-Part 46, Section 46.116 and 46.117 applies to human research conducted or funded in whole or part by the Department of Health and Human Services (DHHS).
• Title 21 CFR-Part 50 applies to research involving products regulated by the FDA.

These regulations are applied to all human research at UCSF. The purpose of these guidelines is to assist investigators in planning the consent process and consent documents to be used in their research studies, in accord with federal regulations and UCSF standards.

Need assistance or have clinical study management questions?
Please email the IRB or call 415-476-1814