title: Waiver of individual patient consent in research: when do potential benefits to the community outweigh private rights?
abstract: Health services research is important to ensure continued best quality of care, but often uses data obtained without explicit consent for this purpose. Obtaining consent may be difficult for many reasons, but excluding individuals may introduce biases that alter the significance of studies. Approval by ethics committees of a waiver of the need for consent allowed our study to proceed and provide evidence that has led to the implementation of a population-based screening policy for the prospective detection of hereditary non-polyposis colorectal cancer. This screening policy has resulted in more cases being detected routinely with better management for affected patients and their at-risk families. A need for consent would have prohibited this study, and the development of a more efficient screening policy could have been delayed for several more years. Ethics committees can effectively manage the need to uphold basic ethical principles without unnecessarily impeding socially useful research. Committees need to be familiar with the guidelines approved under sections 95 and 95A of the Privacy Act 1988 (Cwlth) in addition to the National Health and Medical Research Council National statement on ethical conduct in research involving humans.
authors.affiliation: Radiation Oncology, Sir Charles Gairdner Hospital, Perth, WA, Australia. nik.zeps@health.wa.gov.au.
authors.forename: Nikolajs
authors.initials: N
authors.lastname: Zeps
authors.forename: Barry J
authors.initials: BJ
authors.lastname: Iacopetta
authors.forename: Lyn
authors.initials: L
authors.lastname: Schofield
authors.forename: Jillian M
authors.initials: JM
authors.lastname: George
authors.forename: Jack
authors.initials: J
authors.lastname: Goldblatt
mesh_terms: D001315:Australia; D035843:Biomedical Research / Q000941:ethics*; D003123:Colorectal Neoplasms, Hereditary Nonpolyposis / Q000235:genetics*; D053843:DNA Mismatch Repair; D028744:Ethics Committees, Research; D006801:Humans; D007258:Informed Consent; D012189:Retrospective Studies