INSTITUTIONAL REVIEW BOARD

An appropriately designed informed consent process is a key component for research involving human subjects. Informed consent is a process, not just a form. Potential subjects must be fully informed about the study and its potential risks and likely benefits in order to be able to freely choose to participate. Read the Handbook for Research with Human Subjects carefully as you develop the informed consent process for your research project.

Because each research project is unique, the IRB does not recommend a single informed consent form but refers, instead, to what a well-designed informed consent process will encompass. An outline (Form 495) for preparing your informed consent form is available for your use as a guide. Refer to the Handbook and to the following resources:

• Tips on Informed Consent (pdf)—The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services.
• Informed Consent Form Outline (pdf)—Adapted by the IRB from OHRP resources, you should use this outline when designing your informed consent form, adapting it as needed and referring to the IRB Handbook.
• "Your Rights as a Participant in Research" (pdf)—The IRB developed this one-page document, formatted with the UI&U logo, as a supplemental handout. The IRB strongly recommends that you use this document as a handout to potential subjects as part of your informed consent process. This handout is meant to supplement, not replace, informed consent forms.  
  

Informed Consent Process: General Requirements

A well-designed informed consent process includes all the following elements:

• Recruitment materials that explain clearly the research study and what subjects will be asked to do during the study
• A single, consistently used process for obtaining informed consent from each subject and/or the subject's legal representative before the subject participates in the research
• An informed consent form and/or oral presentation in language understandable to the subject or the subject's legal representative
• Provisions for answering all questions posed by potential subjects to assure that they understand the study and the part they will play in it
• Sufficient time for subjects to consider and decide whether to participate without feeling pressured or rushed
• A consent process free of coercion or undue influence
• A clear explanation that participants may withdraw at any time, choose to not answer any questions, or refuse to perform certain tasks and that no negative consequences will follow

Informed Consent: Basic Elements

• A statement that the study involves research
• An explanation of the purposes of the research
• An estimate of the expected duration of the subject's participation
• A description of the procedures to be followed
• A description of any reasonably foreseeable risks or discomforts to the subject
• A description of any benefits to the subject or to others that may reasonably be expected from the research
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
• An explanation of whom to contact for answers to questions about the research and research subjects' rights and whom to contact in the event of a research-related injury to the subject
• A statement that participation is voluntary, that refusal to participate or to decline to answer any question(s) will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled

Additional Elements – As Appropriate

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus if the subject is or may become pregnant) that are currently unforeseeable.
• Anticipated circumstances under which the subject's participation may be terminated by the investigator without the subject's consent
• Any additional costs to the subject that may result from participation in the research
• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
• A statement that if a subject withdraws, all data collected from, by, or about the subject will be destroyed and not used in the data analysis and writing of the findings of the research
• A statement that significant new findings developed during the course of the research that may relate to the subject's willingness to continue participation will be provided to the subject
• The approximate number of subjects involved in the study

Informed Consent with Children

Research projects involving children and involving greater than minimal risk according to 45 CFR 46.406 (no prospect of direct benefit but likely to yield generalizable knowledge about a subject's disorder or condition) and 46.407 (not otherwise approvable but presents an opportunity to understand, prevent, or alleviate a serious health or welfare of children problem) are prohibited.

Research involving no more than minimal risk to children may be approved only if the IRB finds that adequate provisions are made for soliciting the assent of the children and the permission of their parents, guardians, or legal representatives as set forth in 45 CFR 46.408 (taking into account age, maturity, and psychological state when determining a child's capability for providing assent).

This expectation is not age-based, because even a child as young as 4 or 5 years of age may be capable of limited understanding. To ensure that each child is given the opportunity to assent to participate without undue pressure, the IRB expects researchers to develop a consent process for children. Although the IRB will consider a consent process and form in which the child's assent is obtained simultaneously with parental consent, the IRB prefers to see a separate consent process / form for children—a form for the parent or guardian and a form for the child that is written in age-appropriate language. When subjects are minor children, using language that is entirely age- and comprehension-level appropriate is vital (another reason that separate parent and child consent forms are desirable).

The IRB does not stipulate whether the child's assent should be obtained before or after obtaining consent from a parent or guardian. In general, however, parental, guardian, or legal representative permission should be obtained before seeking permission from the child, particularly in studies involving more than minimal risk. This decision will often be dictated by the study design. For example, for a study involving minimal risk that will occur in a school setting, seeking assent from the children first may be best. If they agree, they are sent home with a request for parent, guardian, or legal representative permission. If a child's assent is obtained first, however, researchers need to make clear that the child cannot participate unless the parent, guardian, or legal representative also agrees—in all cases. Ultimately, the decision to participate is the child's, and parents, guardians, and legal representatives should not pressure their child into assenting. 

Informed Consent for Class-Related Research Projects

Learners who will conduct assigned class-related research projects that will be used only for class-grading purposes may use Form 620 Class Project Consent Form. This form is to be used only for class research projects that will not be used for a culminating project. published, or used in a professional presentation beyond the class environment.

Find out more:

Ethical Practice in Research  
Handbook and Forms 
CITI Course in the Protection of Human Research Subjects
Other Resources