Clinical genetic research is often regarded as more ethically problematic than other forms of research, and in some countries is subject to specific regulation, requiring researchers to follow specialised guidelines. In this paper, an approach to enhancing the ethical conduct of genetic research is proposed, which is believed to be more effective than simply attempting to follow general guidelines. The potential concerns, likely areas of misunderstanding and negative reactions of the participant group are systematically investigated before starting a study on genetics. This would constitute, in effect, an ethical pilot study, similar to a feasibility pilot study to test equipment, procedures and logistics. The findings of the ethical pilot study would be used to help in designing ethically important aspects of research protocol, such as recruitment procedures, written and other information for potential participants, informed consent processes and reporting of results including ambiguous or uncertain results.
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Funding: This study was funded by the US National Institute of Deafness and Communication Disorders (RO1 DC 005662-01).
Competing interests: None. All researchers were independent from the sponsor.
Ethical approval: The Royal Children’s Hospital Ethics in Human Research Committee, Royal Children’s Hospital, Parkville, Australia (EHRC 22056A), approved the study.
Contributors: LG, MW and investigators in the larger Hearing in Schools Study (other investigators were Henrik Dahl, Field Rickards, Kerryn Saunders; consultants Barbara Cone-Wesson and Jo Williams) initiated the project. ZP, ST and LG developed the protocols. ST and ZP carried out recruitment and data collection. ST and Fides Ferlin transcribed the interviews, and ST, ZP and LG carried out the thematic analysis. LG and ST wrote the paper. All authors contributed to reviewing and editing the paper. LG is the guarantor.