Double standards in special medical research: questioning the discrepancy between requirements for medical research involving incompetent adults and medical research involving children.
Medical research represents a substantial departure from conventional medical care. Medical care is patient-orientated, with decisions based on the best interests and/or wishes of the person receiving the care. In contrast, medical research is future-directed. Primarily it aims to contribute new knowledge about illness or disease, or new knowledge about interventions, such as drugs, that impact upon some human condition. Current State and Territory laws and research ethics guidelines in Australia relating to the review of medical research appropriately acknowledge that the functions of medical care and medical research differ. Prior to a medical research project commencing, the study must be reviewed and approved by a Human Research Ethics Committee (HREC). For medical research involving incompetent adults, some jurisdictions require an additional, independent safeguard by way of tribunal or court approval of medical research protocols. This extra review process reflects the uncertainty of medical research involvement, and the difficulties surrogate decision-makers of incompetent adults face in making decisions about others, and deliberating about the risks and benefits of research involvement. Parents of children also face the same difficulties when making decisions about their child's research involvement. However, unlike the position concerning incompetent adults, there are no similar safeguards under Australian law in relation to the approval of medical research involving children. This column questions why this discrepancy exists with a view to generating further dialogue on the topic.
Centre for Health And Society and Rural Health Academic Centre, University of Melbourne. n.stepanov@uq.edu.au
Nikola A
NA
Stepanov
Malcolm K
MK
Smith
D000328:Adult; D001315:Australia; D035843:Biomedical Research / Q000941:ethics* / Q000331:legislation & jurisprudence*; D002648:Child; D002651:Child Advocacy / Q000331:legislation & jurisprudence; D028744:Ethics Committees, Research; D006801:Humans; D016743:Mental Competency / Q000331:legislation & jurisprudence; D009359:Neonatology; D035842:Research Subjects / Q000331:legislation & jurisprudence*