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National Statement on Ethical Conduct in Human Research (2007)
Summary document information
Published year: 2007 |
Reference No: E72 |
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Synopsis of publication
This Statement entitled the National Statement on Ethical Conduct in Human Research ('the Statement') consists of a series of Guidelines made in accordance with the National Health and Medical Research Council Act 1992 ('the Act'). Updates and Errata to the statement can be found below
The Statement replaces the 1999 National Statement on Ethical Conduct in Research Involving Humans.
The NHMRC Embryo Research Licensing Committee has developed an information kit to assist researchers and Human Research Ethics Committees with applications made under the Prohibition of Human Cloning for Reproduction Act 2002 and the Research Involving Human Embryos Act 2002. The kit can be accessed here.
Updates
August 2009 – minor amendment made under s.14B(1)(b) of the Act to chapter 4.5 People with a cognitive impairment, an intellectual disability or a mental illness.
The NHMRC received a letter that pointed out an apparent ambiguity in the Statement at s4.5.5 and s4.5.7 where an independent person is required to witness a participant's consent in a study.
The Australian Health Ethics Committee (AHEC) examined the issue and recommended the following changes, which members of the NHMRC Council (Council) agreed to, and recommended the CEO issue them. The change splits the two sentences in s4.5.5 into two paragraphs to distinguish between:
- obtaining consent from a person with a cognitive impairment, an intellectual disability or mental illness that is ongoing or present during the process of negotiating and obtaining consent, therefore inhibiting the participant from providing independent consent, and;
- obtaining consent from a person who has a temporary or episodic impairment, disability or illness which is not present during the process of negotiating and obtaining consent.
As this is only a minor change (splitting one paragraph into two and renumbering) Council and AHEC members agreed that public consultation may be dispensed with in accordance with s.14B(1)(b) of the Act.
- In section 4.5.5, insert a paragraph break after the words “…authorised by law”.
- Number the remaining part of this paragraph that commences with “Where the impairment…” and concludes with “to give consent” as 4.5.6.
- Renumber the remaining parts of the section, so it ends with 4.5.11.
- In the newly numbered 4.5.8, the reference changes to the new 4.5.6, previously numbered 4.5.5.
- In the newly numbered 4.5.9, the reference changes to the new 4.5.7, previously numbered 4.5.6.
Previously reads:
Respect
4.5.5 Consent to participation in research by someone with a cognitive impairment, an intellectual disability, or a mental illness should be sought either from that person if he or she has the capacity to consent, or from the person’s guardian or any person or organisation authorised by law. Where the impairment, disability or illness is temporary or episodic, an attempt should be made to seek consent at a time when the condition does not interfere with the person’s capacity to give consent.
Amendment reads:
Respect
4.5.5 Consent to participation in research by someone with a cognitive impairment, an intellectual disability, or a mental illness should be sought either from that person if he or she has the capacity to consent, or from the person’s guardian or any person or organisation authorised by law.
4.5.6 Where the impairment, disability or illness is temporary or episodic, an attempt should be made to seek consent at a time when the condition does not interfere with the person’s capacity to give consent.
NHMRC CEO issued these changes on 10 August 2009.
Errata
August 2009
The incorrect printing of “Human Ethics Research Committee” appears in several instances:
- Page 34: right hand side column, lines 18-19 after the heading
- Page 40: left hand side column, lines 6-7 from the top of the page
- Page 42: left hand side column, lines 6-7 from the top of the page
- Page 48: left hand side column, lines 4-5 from the bottom of the page
- Page 51: left hand side column, line 15 after the heading
- Page 52: left hand side column, lines 23-24 from the top of the page
- Page 61: left hand side column, lines 10-11 from the bottom of the page
- Page 65: left hand side column, lines 4-5 from the bottom of the page
- Page 67: occurs twice, once in the left hand side column, line 4-5 from the bottom of the page, and once in the right
- hand side column on line 4 from the top of the page
- Page 69: right hand side column, line 5 from the bottom of the page
The correct term to replace the misprint of “Human Ethics Research Committee” is “Human Research Ethics Committee” (HREC), as listed in the definition section on page 100.
Page 39: left hand side column, line 5 after the beginning of the bold text, replace "2004" with "2007" so the line reads (NHMRC 2007)
June 2007
Page 25: line four after the heading “introduction” and after the word “them”, superscript reference should be 4 and the corresponding footnote reference at the base of the page should read Denzin NK & Lincoln YS (eds.) 2000 Handbook of Qualitative Research, Sage: California.
Page 29: line six, right hand side column, replace “it” with “is” so the line reads ‘de-identified data’, as its meaning is unclear.
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