Abstract â–¡ 129

This project investigated the process of informed consent and the influences on parents who had been asked to allow their baby to be part of a SIDS research protocol. The research looked at the ability of infants to respond to a mild asphyxial stress and a 60 head up tilt test. This project was prompted by public attacks on the integrity of the researchers, parents of participants, the safety and ethics of this internationally vindicated research project.

METHOD: Two questionnaires were designed: one for the parents who had agreed to parents who declined to do so (the non-questions for the participant parents were designed to assess three main issues: 1) The process and quality of informed consent 2) the influences and motivation of participation and 3) the effect of external influences on participation. Questions for non-participant parents were designed to determine why parents declined to participate. 60% of the 101 questionnaires were returned from the participant parents and 41% of the 104 questionnaires were returned from non-participant parents.

RESULTS: Non participant parents: participation in the research project was inconvenience. 53% of responders said factors such as other children and distance made the study inconvenient. 28% of responders felt the research was unsafe and were unhappy about the mild asphyxial test. The 3rd most common reason for non-participation was illness in the baby or the mother. Participant parents: Almost all of the participating parents felt they had understood the purpose and what would happen in the research study. They also felt able to ask questions before, during and after the study. 97% of participant parents easily summarised the research study, however 2 summaries were slightly concerning. 10% of participants had suggestions for improving the process including a more detailed written information sheet, an outline plan of the protocol and a question and answer sheet for interested family members. 90% felt the information for the study was very good and the other 6 felt more detail was required. 85% thought the researchers verbal explanation as the most useful source of information. 85% of responders wanted to take part for the benefit of medical science. All agreed that they participated to prevent SIDS and this reason was the main reason why most participated. The other important reason for participating was a personal interest in how their infant reacted to the test and how 27% were worried about the safety of the research tests, either because they did not know how their infant would respond, or what the effect of the carbon dioxide would be or because of the propaganda reports published in the media. 11% had felt concern about the study specifically due to the media. These fears, and all participants felt able to withdraw their child from the study at any time if they wished. After the test all responders felt happy with the safety of the tests.

CONCLUSION: We are reasonably happy with the process of informed consent in this research project. Parents gave us some useful suggestions for the future.