Drafting the Informed Consent Form
Format and Style of Informed Consent Documents- Key Points
- The IRB strongly encourages Investigators to use the standard UCI IRB consent template, which is available on the Applications and Forms page. The template is written in the 2nd person. IRB requires that the consent and assent documents be written in the 2nd person, i.e., "you" rather than "I." Do not start sentences with "You understand..."
- Consent forms should be written in lay language, at a level understandable to the participants in the study (6th to 8th grade reading level for adult participants). Researchers may use flowcharts and tables to enhance reading comprehension. Also, try to avoid medical/scientific/technical language or include simple definitions/explanations for such terms if they must be used, also see Consenting Subjects Who Do Not Read, Speak or Understand English.
- The use of a 12-point font is recommended. A larger type size may be appropriate for some populations, such as, children, the elderly, or the visually impaired.
- Documents must be typewritten.
- A place for the subject and researcher signature and date must appear on the consent document. A witness signature is required in specific circumstances. See How to Consent for more information on this topic.
- The consent form should identify any external sponsor or funding agency.
An IRB may waive the requirement to obtain a signed informed consent document in two situations:
- The only record linking the participant and the research would be the consent document;
- The principal risk would be potential harm resulting from a breach of confidentiality;
- Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern;
- The research presents no more than minimal risk of harm to participants and
- The research involves no procedures for which written consent is normally required outside of the research context.
In cases where the documentation requirement for informed consent is waived, the IRB often requires the researchers to provide participants with a written statement regarding the research. This written statement requires IRB approval. The template Study Information Sheet can be used as a guide.
Researchers interested in obtaining a waiver of written (signed) informed consent should make sure that their research qualifies for one of the above options, and should address how the research qualifies for each of the option's requirements in the IRB Application.
Waiver or Alteration of Informed Consent
An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent if:
- The research or clinical investigation involves no more than minimal risk to the participants;
- The waiver or alteration will not adversely affect the rights and welfare of the participants;
- The research could not practicably be carried out without the waiver or alteration;
- Whenever appropriate, the participants will be provided with additional pertinent information after participation.
When an IRB waives the requirement to obtain informed consent, it waives the entire requirement for the informed consent process. However, when the IRB grants an alteration of some or all of the elements of the informed consent (e.g., removes a required element of consent from the document), the process of obtaining informed consent is still required. Researchers interested in obtaining a waiver or an alteration of the consent process should address how the research qualifies for each of the above requirements in the IRB Application.