The Children’s Centers have found themselves operating in a time of increasing ethical complexity. Particularly since the implementation of HIPAA, it has become more time-consuming to obtain participants’ informed consent. Concerns about potential lawsuits have increased and been exacerbated by the Grimes vs. Kennedy Krieger case (Mastroianni and Kahn 2002
). Finally, centers struggle with conflicting ethical issues, such as deciding when the health and safety of a child takes precedence over a promise of confidentiality.
Consent and assent.
Longitudinal studies demand lengthy and complex consent forms. Ensuring that participants are well informed has been challenging for the centers and has required the allocation of adequate time to inform participants about the study and to review the consent form. For centers using medical records, the completion of HIPAA subject authorization forms adds time to the consent process. Centers’ consent forms differ in level of complexity and in time needed to complete them.
Centers have found it important to inculcate in staff an understanding that consent is an ongoing process. Instead of training staff to simply procure participant signatures, centers have trained staff to solicit and answer participants’ questions so that they can make informed decisions.
All centers recognized the importance of writing consent forms at a reading level understandable to all. Some centers wrote consent forms at an eighth-grade level, whereas others felt that even sixth-grade level was too high to assure comprehension. In addition to providing consent forms in multiple languages, some centers read consents aloud to participants to ensure that everyone, including participants who are embarrassed to admit their low literacy level, fully understood the information. Some centers solicited feedback from community partners, community board members, and community-based staff (in addition to the IRB) to help ensure that appropriate language was used. The centers’ experiences suggest that the language and style of a consent form in one community may not be appropriate in others.
Some studies used additional measures to enhance understanding of consent forms. Several centers used timetables and schedules to communicate study procedures or provided lists outlining the important items on the consent. One developed a short checklist to verify that participants understood the key aspects of the study. Two centers divided consent between two documents, one covering enrollment through delivery, and one covering the period after birth. This decreased the amount of complex information that participants had to digest at each visit, and gave participants an opportunity to re-evaluate their participation at a midway point. However, some participants expressed frustration with the continuing requests, indicating they would prefer full disclosure of the protocol up front.
Centers gave careful thought to who must consent to participate at each stage of the research. In all cases, pregnant women or mothers were asked to consent to their own participation and that of her child. However, once children reached a certain age (generally 5–9 years), child assent was usually also required by the IRB, posing new challenges for the centers. Centers needed to clarify for themselves and for their staff the difference between encouraging a child to try a new task and coercing him or her to do so. Some centers also needed to consider consent procedures in cases when the mother no longer had custody of the child (either officially or unofficially). Finally, centers that conducted home visits considered whether it was adequate for the mother to consent to a visit in a home shared with other families. In some such cases, centers skipped home visits to these participants or limited the visit to the portion of the home in which the participating mother and child lived.
Banked samples and informed consent.
Many centers have banked samples for future studies. This process requires special consideration, in that participants must be informed about and consent to future uses of these samples. Several centers’ consent forms allowed participants the option of either not having samples banked or not allowing future analysis of samples for unrelated studies. At least one center has needed IRB reapproval for each new analysis of banked samples. The center at the University of Washington has participated in a consortium formed by the Centers for Disease Control and Prevention (CDC) to develop informed consent approaches for integrating genetic variation studies into population-based research (Beskow et al. 2001
); the group developed an informed consent template (CDC 2001
Confidentiality and consideration of children at risk.
All centers strove to protect the identity and personal information of all participants. Some centers found it challenging, however, to maintain confidentiality in small or close-knit communities, especially when the research staff was hired from the local community. Most centers instructed staff on when to remove themselves from assessments with participants they know personally and on how to interact with participants when they meet in other settings.
Centers were also vigilant to ensure confidentiality within computerized databases. Centers modeled their own data management systems around guidance provided by their IRBs. All computerized files were password protected with knowledge of passwords restricted to a small number of staff, and the number of computer or paper files containing both the participant study number and identifying information (e.g., name) was limited. In complex studies with multiple contacts, centers found it necessary to work with both the IRB and the research staff to identify the types of linked information necessary for day-to-day operations and to provide that information with the least possible risk to participants. Centers kept files linking study numbers with participant name separate from event and sample tracking databases, linking them briefly only when necessary (e.g., to generate mailing lists of participants missing a particular event).
Certificates of confidentiality, which protect identifiable research information from forced disclosure, including in the case of legal action, are an important component in protecting participant confidentiality. However, many centers faced or anticipated facing circumstances in which they would need to break the promise of confidentiality without participant consent, for example, in cases where child abuse, severe depression, drug use or traffic in the home, and other potentially dangerous conditions were observed. Some centers have elected not to report housing code violations that do not pose an immediate threat to the child, because there is no clear legal mandate or options for the families, and because participants may fear eviction or reprisals from landlords. Centers developed clear protocols that included provisions for referral or reporting, including lists for center staff of what constituted an immediate housing threat. Staff were trained on human subject’s protection requirements and child abuse and neglect reporting issues, including mandatory or discretionary reporting protocols. Because some variation exists in state laws regarding mandated reporting of child abuse, the centers’ experiences suggest that special care should be taken in planning a nationwide study to ensure that protocols are in compliance with both the specific state laws and IRB requirements. Disclosure of such requirements (e.g., the need to report child abuse) was incorporated into consent forms, despite concern that it would repel some participants.
Centers have also developed protocols on intervening in cases of clear developmental delays or undiagnosed physical health problems. Most protocols include timely screening of developmental assessments and questionnaires to ensure prompt referral or treatment. Another aspect of these protocols is the centers’ designated cutoff score for developmental tests (e.g., > 2–3 standard deviations below the mean), children scoring below which are referred with parental permission for further evaluation or intervention. To ensure adequate follow-up of identified children, centers found it useful to identify local resources beforehand; the number of such resources, of course, varied by community. Centers were also required to report some exposure measures, such as lead results, to public health authorities when they exceeded certain action levels.