processes are not matters of signing or updating forms but, rather, of continuing communication based on appreciation of the difficult and even overwhelming circumstances in which parents may be asked to make grave decisions about their child’s future.
Parents will inevitably vary in their levels of understanding of their child’s health status, the difference between clinical care and clinical research, and other matters critical to informed decision making. To some extent, but not entirely, this variation may reflect differences in educational and reading levels and, possibly, proficiency in English. Sociocultural differences may also shape how parents understand and engage in the process of deciding about their child’s participation in research. Regardless of the study population, consent and permission forms and processes should avoid language that creates or reinforces confusion about the difference between research and clinical care.
In designing and reviewing procedures and related written materials for seeking parental permission, investigators and IRBs should consider what is known or expected about the educational, language, cultural, and other relevant characteristics of the populations to be involved in particular studies. Studies consistently indicate that informed-consent materials are geared to individuals with reading skills at levels higher than those that many prospective research participants or the parents of prospective child participants possess. Some research also suggests that most information in consent documents can be presented in much simpler language that will still convey information essential for decision making. For groups with low levels of literacy, investigators and IRBs should consider the use of information tools (e.g., simple graphics and oral explanations or special videos) that do not depend on written documents. Again, investigators should view the presentation of consent, permission, or assent forms as the end of the process, not the beginning.
When language barriers exist, investigators should see that the consent forms translated from English to other languages are adequate and that the content is equivalent to that in the original. As necessary for a meaningful process of seeking parental permission, investigators should use interpreters who have the knowledge, language skills, and awareness of cultural factors that are necessary both to translate information about clinical research and to assess the level of understanding of that information by the participant of the participant’s parents. In support of effective communication with patients, accreditation standards and various federal and state policies now expect hospitals to have available interpreters of the languages frequently used by their constituent groups of patients (see, e.g., Perkins et al., 1998;