In 2007, the National Health and Medical Research Council (NHMRC) released a revised National statement on ethical conduct in human research.
Public submissions in the review process leading to the 2007 statement highlighted four main areas of concern: children’s competence to consent, mature minors and the requirement for parental consent, whether children can refuse to participate, and the provision of information to children.
A useful addition to the statement is the concept of levels of maturity, which help determine whether a child or young person’s consent is necessary and/or sufficient for participation in research.
Changes in terminology (“capacity” instead of “competence” and introduction of the term “vulnerability”) have the potential to create confusion, as the new terms are not clearly defined, and capacity is used in several senses.
- 1. National Health and Medical Research Council, Australian Research Council, Australian Vice-Chancellors’ Committee. National statement on ethical conduct in human research. Canberra: NHMRC, 2007. http://www.nhmrc.gov.au/publications/synopses/_files/e72.pdf (accessed Dec 2007).
- 2. National Health and Medical Research Council. National statement on ethical conduct in research involving humans. Canberra: NHMRC, 1999. http://www.nhmrc.gov.au/publications/synopses/_files/e35.pdf (accessed Dec 2007).
- 3. National Health and Medical Research Council. National statement on ethical conduct in human research — second consultation draft. Canberra: NHMRC, 2006.
- 4. United States Department of Health and Human Services. Additional protections for children involved as subjects in research. Code of Federal Regulations. Title 45, Part 46.402. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm#46.402 (accessed Dec 2007).
- 5. Medical Research Council. Medical research involving children. London: MRC, 2004 (revised Aug 2007). http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC002430 (accessed Dec 2007).
- 6. New Zealand Health and Disability Ethics Committees. Guidelines from operational standard. Appendix 1: Guidelines for health research with children. http://www.newhealth.govt.nz/ethicscommittees/applicationsandguidelines/specificresearchguidance.htm (accessed Dec 2007).
- 7. Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council policy statement: ethical conduct for research involving humans. Ottawa: Interagency Secretariat on Research Ethics, 1998 (with 2000, 2002 and 2005 amendments). http://www.pre.ethics.gc.ca/english/pdf/TCPS%20October%202005_E.pdf (accessed Dec 2007).
Publication of your online response is subject to the Medical Journal of Australia's editorial discretion. You will be notified by email within five working days should your response be accepted.