Share

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.

Instructions for Developing an Informed Consent Document

As part of the informed consent process, the consent document is designed to provide information to potential subjects about a research study so they can make an informed decision about their participation. The use of a form to document the consent process is required unless specifically waived by the IRB. One of the most common reasons for delay in IRB approval is an incomplete, inaccurate, and/or unclear consent form document. Informed consent templates (biomedical and social/behavioral versions) are available on the IRB Applications and Forms page. You can download a template and customize it to your research study.

General Information

Describe the purpose(s) of this research study in lay terms. Include a statement that indicates why this is considered a research study (e.g., testing how a non-FDA approved drug works and whether it is safe). Provide definitions for specific research design features (e.g., double-blind, randomization, placebo-controlled).

Purpose of the Study

Describe the purpose(s) of this research study in lay terms. Include a statement that indicates why this is considered a research study (e.g., testing how a non-FDA approved drug works and whether it is safe). Provide definitions for specific research design features (e.g., double-blind, randomization, placebo-controlled).

Procedures

Include a thorough description of the specific procedures involved in the study, which procedures are considered experimental and why. Include detailed inclusion/exclusion criteria, length of involvement. If the subject will be interviewed or asked to complete a questionnaire, describe the types of questions that he/she will be asked to answer. Provide a procedures table if subjects would benefit from the addition of a table.

Risks

This element will ask if the study involves more than minimal risk. If so you will be prompted for a detailed description of the potential risks and discomforts involved (physical, psychological, social, and economic). For some procedures you may choose to use standard text (e.g., blood draw). If applicable, include a statement that the treatment or procedure may involve risks, which are currently unforeseeable, to the subject (or to the embryo or fetus, if the subject is or may become pregnant). You may build a table or cut and paste an existing table into the Word document.

Benefits

Describe all expected benefits and who will benefit. Note: Compensation for participation is not a benefit; provision for free drugs or procedures is not a benefit.

Compensation, Costs and Reimbursement

If subjects will be compensated for their participation or reimbursed for costs (e.g., parking), describe in detail the type of payment, amount, and terms. Specify any additional costs to the subject that may result from participation in this study that will not be reimbursed.

Withdrawal or Termination from Study

When applicable, subjects should be informed of circumstances under which their participation may be terminated by the investigator without the subject’s consent. Subjects should also be informed of procedures for safe and orderly termination should they decide to withdraw from the study before it is completed.

Confidentiality

Include information about the protection of subject’s privacy, method of protecting research data, and who may have access to study records.

New Findings

Standard text explains that significant new information will be provided to the subject by the investigator.

Alternatives to Participation

Include applicable information on alternative procedures or courses of treatment that may be advantageous to the potential subject if he/she refuses to participate or withdraws from the study. Social/behavioral research - if compensation for participation in the research is extra course credit, explain that the course instructor is to provide a reasonable alternative way to earn extra course credit.

Compensation for Injury

Standard non-alterable text describes the provision for subject injury incurred as a result of this study, if applicable.

Other Considerations

If a research team member has a disclosable financial interest in the outcome of this particular study or research program, a statement to that effect should be inserted. If the study involves collection of specimens, the appropriate standard language should be included.

Contact Information

Includes contact information to answer study questions and standard text that instructs subjects to contact the Research Protections office if they have any comments or questions regarding the conduct of the study and/or their rights as research subjects.

Voluntary Participation

Standard text emphasizes that the decision to participate, or not participate, is solely up to the subject.

Signature Lines

Signature lines should be included for the subject and for the researcher obtaining informed consent. A “Legally-Authorized Representative” signature line should be included if you will obtain surrogate consent or are developing a parental permission form for enrollment of a minor in research. Also, you may obtain the assent of a minor ages 13-17 (as well as parental permission) using this consent form.

A “Witness” signature line must be included for specific types of research.  See How to Consent for more information on this topic.

Waiver of Written (Signed) Informed Consent

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; and
  • The research is not a clinical investigation subject to FDA regulations.

OR

  • 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 Appendix P of the electronic 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 provided the researcher documents in Appendix O of the electronic IRB Application and the IRB finds that: [45 CFR §46.116(d)]:

  • The research 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.
  • The research is not a clinical investigation subject to FDA regulations.

When an IRB waives the requirement to obtain informed consent, it waives the entire requirement for 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 Appendix O of the electronic IRB Application.