Informed consent is a process, not
just a form. The procedures used in obtaining informed consent should be designed
to educate the participant population in terms that they can understand. The consent
process is necessary to assure that participants are fully informed when deciding
to voluntarily participate in a research project of any type. An important point
to remember when writing a consent document is to keep in short and simple.
Include necessary information, but do not burden the participant with information
that is not needed. The longer the consent document, the less likely the participant
will be able to read it in its entirety.
Consent documents should be written in a language appropriate to the participant population. For clinical trials, one should assume that the subject knows no medical terminology and all medical terms should be listed in simple non medical words. The only exception to this might be a study in a population with a long standing medical condition, where they are knowledgeable of this terminology.
The consent document is primarily used as a teaching tool, not as a legal instrument. Federal regulatory agencies (such as the FDA and OPRR) prefer that the consent form be written in second person (you/your) as this leads towards an interactive discussion and appears less coercive.
Federal Regulations require that certain information be included in all research consent documents. These informational items are as follows:
* Statement that the study involves research
* Explanation of the purposes of the research
* Duration of the subject's participation
* Identification of any experimental procedures and/or drugs
* Description of procedures to be followed
* Reasonably foreseeable risks or discomforts
* Direct benefits reasonably expected
* Appropriate alternative procedures or treatments
* Extent of confidentiality of records
* Availability of compensation
* Information regarding availability of medical treatment
* Who to contact with questions about the research project
* Who to contact with questions about rights as a research subject
* Statement that participation is voluntary and refusal to participate will involve no penalty or loss of benefits otherwise entitled to and that subject may discontinue participation at any time without penalty or loss of benefits
This information MUST be included in all consent documents. This includes studies which have no risk or benefit where the alternative is simply to refuse. In cases such as this, you may combine several categories into one statement. An example would be "There are no risks, benefits or costs to you for participating. Your alternative is not to participate in this study."
Other information which should be included when applicable to a particular study is as follows:
* Statement that participation may involve other unforeseeable risks
* Circumstances under which participation may be terminated by the investigator
* Additional costs to the subject
* Consequences of early withdrawal
* Statement that significant new findings will be provided to subject
The final paragraph and signature lines should not be alone on the final page of the consent as it could appear that the remainder of the document was not included when signature was obtained. Either reformat the consent form to include a portion of the previous paragraph on the last page or repeat the title of the study and state that the subject has read the previous number of pages.
Consent Forms for Children
For studies involving children (defined as less than 18 years of age) the consent must be written in a language in which the parent gives consent for the child to participate, for example: "You for your child" and/or "your child".
Some studies include children as their only participants. In these studies the consent forms should be written addressing the parent consenting on behalf of the child (e.g. Your child will have....You have not waived any of your or your childs rights...) Other studies involve either children or consenting adults. Two consent forms should be prepared for these studies, one for the adult to sign and one for the adult to sign on behalf of the child. There may be studies which involve only a few subjects under age 18 (i.e. entry age is 16-65). In a situation such as this, the IRB would prefer that one consent form is written with an explanation at the top which states "When the word "You" is used in this document it is referring to your minor child."
Please remember that although Oklahoma law does allow for certain individuals under the age of 18 to consent for themselves for medical treatment (emancipated minors), this law specifically excludes consent for research purposes. Therefore ANY participants under the age of 18 must obtain parental consent prior to enrollment in a research study, regardless of their emancipated status.
Unless one parent is deceased, unknown, incompetent, or not reasonably available, or only one parent has legal responsibility for the care and custody of the child, the consent of both parents is required by regulation where the research involves greater than minimal risk or will not directly benefit the individual child research subject. For this reason we request that all child consent forms include a signature line for each parent. We also ask that if both parents are available during the consent process (even if it both are not required to consent) that you obtain consent of both parents. This helps to assure that the parents are in agreement that this is in the best interest of their child and can be beneficial to all involved in this child's medical treatment.
When study participants are children who are old enough to understand what the study involves, the child must be given the opportunity to assent to the study. This typically applies to all children between the ages of 7 and 17. There are two ways that this can be done. The first is to use a simple (no more than one page) document (in addition to the parental consent form) which is written in a language appropriate to the child's age. This should be used in any study which will enroll subjects ages 7-12 and must be approved by the IRB. A second way to obtain assent is to add a signature line to the bottom of the parental consent form which reads as follows and have the child sign that same form along with his/her parents. This should only be done in studies where the youngest child subject is no less than 12 years of age.
The Board does expect that in studies regarding subjects with decreased mental capacity, assent is obtained in addition to the family member consent. This can be done in either of the ways described above as for children or in other ways as appropriate to the study population. In these cases, please address your plan for obtaining subject assent when submitting the request to the IRB.