Guidelines for Writing the Research Informed Consent and Assent Documents

The informed consent process is to be performed by key staff knowledgeable about the research to be conducted and trained in the informed consent process.

Consent forms should contain information in a language that is understandable to the subject or legally authorized representative. Target readability levels of consent forms should be between 8th and 10th grade. The Principal Investigator submitting the informed consent documents should determine the readability level using the Flesh Kincaid method (on Microsoft Word) or a hand calculation method.

Use the 2nd person (you/your) when writing the consent form. If technical terms must be used, define them. Avoid statements such as "you understand..." since it may imply that the research participant understands more than he/she may comprehend and could constitute a coercive influence over the participant. Informed consent documents should not include exculpatory language, that is, language that indicates somebody is free from blame.

Each page of the consent form must have a place for the research subject/participant to initial. Leave 1-1/2 inches on the bottom of the each page of the consent form for the HSIRB date stamp.

Basic Elements of Informed Consent

In seeking informed consent, the following information shall be provided to each subject:

  1. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures that are experimental.
  2. A description of any reasonably foreseeable risks and discomforts to the subject.
  3. A description of any benefits to the subject or to others that may reasonably be expected from the research.
  4. A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the subject.
  5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration and/or the Pharmaceutical Co. may inspect the records.
  6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury does occur and, if so, what they consist of, or where further information may be obtained.
  7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
  8. A statement that participation is voluntary, that refusal to participate 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 of Informed Consent

When appropriate, one or more of the following elements of information shall also be provided to each subject:

  1. 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.
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.
  3. Any additional costs to the subject that may result from participation in the research.
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject.
  5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
  6. The approximate number of subjects involved in the study.
  7. Please Note: Compensation of $600 or more is required to be reported to the IRS. Please add this statement if necessary.

GUIDELINES FOR WRITING ASSENT FORM DOCUMENT


The same basic elements of the consent form apply to assent forms (see guidelines for writing informed consent).

For children participating in a research study, additional federal regulatory protections have been established. Legally, children who have not attained the age where they can grant consent for research and treatment require parental permission and child’s assent where appropriate.

Children should be asked about their willingness or “assent” to participate. Information about the research study must be presented to children on their level taking into consideration age, maturity, and psychological state, so they can understand what is requested of them.

For research with very young children (pre-school), parent’s permission only is typically needed. For children between the ages of 5 and 13, two forms are generally advisable, one written at the basic level (as a script for oral presentation or for reading) and a more detailed form for the parent’s understanding and signature. For older adolescents between the ages of 14 and 17, a single form that both the minor and parent(s) sign would be adequate (see examples format of informed consent document, the informed consent document would be acceptable with a revised signature page).

If the research does not involved more than minimal risk or if it does involve greater than minimal risk but there is prospect of direct benefit to the child, permission of one parent may be sufficient. For research involving greater than minimal risk with no prospect of direct benefit, permission must be obtained from both parents, unless one parent is deceased, unknown, incompetent, not reasonably available, or when one parent has legal responsibility for the care and custody of the child.

Do not include a statement such as “your parent has agreed to allow you to take part in the research study” since this implies the possibility of parental pressure of participation.