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National Statement on Ethical Conduct in Human Research 2007 Human biospecimens submission

ID: 
19
Personal Details
First Name: 
Emma
Last Name: 
Kowal
Additional Information
Individual Background: 
Researcher – other
Specific Comments
Comments: 
General Comments
Comments: 

 

NHMRC biobanks consulation response

 

The draft revised chapter 3.4 is a significant improvement on the existing chapters 3.4 and 3.6. This reflects the massive changes that have occurred in the relevant fields in the past 5 years. My submission stems from my research on biospecimen collections that derive from samples collected in Aboriginal and Torres Strait Islander communities, including samples collected some decades ago and preserved in Australian institutions. I also draw on my broader expertise in Indigenous health research and the ethics of genetic research (from both an anthropological and a biomedical/public health perspective).

 

  • Ownership.

The question of ownership of biospecimens appears to hover in the background of this draft. This comes to the fore through the varying use of possessive pronouns and articles, that is, “the biospecimens” (eg 3.4.4b) vs “their biospecimens” (eg 3.4.4c). My understanding is that ownership of biospecimens is founded at the point of donation/collection and the institution where researchers are employed is generally the owner. I interpreted the use of the term “their biospecimens” in the chapter as relating to the rights and interests that donors may continue to have in biospecimens after their collection. This would be worth clarifying in the introductory remarks of the chapter and consistency established in the use of terms.

 

  • Use of specimens after death.

Section 3.4.2 rightly indicates that the collection of biospecimens needs to be carried out with the consent of donors. The consent provisions in Chapter 2.2 do not specifically require that research participants be asked what should happen to samples/data after their death (although some researchers do ask this in their consent process). This creates a potential problem where it is proposed that previously-collected samples be used for research that is not clearly within the purview of the original consent, because the proposed use differs significantly from that associated with the original consent, because the original consent was not consistent with accepted practice, and/or because there is grounds for renegotiating consent (as per Section 2.2.8).

 

While in many cases of this nature the use of data and samples from old collections could be subject to a waiver of consent, in some cases this may not be appropriate because of the nature of the research. For example, research with samples collected from Indigenous Australians is less likely to be considered low risk.

 

Section 3.4.5 indicates that samples can only be taken from a deceased person with the permission of their most senior available next of kin. This is consistent with advice about cadaveric specimens. It could be argued that this principle be extended to cover biospecimens collected from living donors who have since died where a renegotiation of consent is required. It would be useful to address this issue in the revision of 3.4 if possible.

 

  • Previously-collected biospecimens

Related to my previous point, Section 3.4.15 covers biospecimen collections that were obtained prior to the proposed guidelines. It suggests that biospecimens can be used “if there is sufficient evidence that the samples were obtained with consent in a manner consistent with any prior guidelines” or if a waiver of consent is warranted. It would be useful if the passage quoted could be expanded to cover samples collections obtained prior to the widespread use of consent forms in the late 1980s/early 1990s, and prior to the first Australian guidelines for human research were released in 1966 by the NHMRC (the Statement on Human Experimentation). I suggest the following wording:

 

“if there is sufficient evidence that the samples were obtained with consent in a manner consistent with any prior guidelines and/or accepted ethical practice at the time of collection.”

 

This wording would cover research before 1966 where there were no Australian guidelines for human research. It would also cover research before the widespread use of consent forms that present particular problems for ethics committees who must make a judgment about the ethics of collection without the benefit of clear documentation. An explicit statement that the ethical norms of the time are an acceptable yardstick would be particularly useful as there have been significant discrepancies between guidelines and accepted practice in the past. For example, there was a large temporal gap between the recommendation of the NHMRC in 1976 that all research be reviewed by ethics committees and the actual establishment of ethics committees in the late 1980s and early 1990s (after ethical review was made a condition of funding in 1985). While it is important not to reward bad research practices, it is also important not to hinder research unnecessarily by judging past researchers against standards that were met by few or no researchers at the time.

 

Related to this, it would be ideal for the NHMRC to make the 1966 and subsequent statements available on their website (they are not currently available) to assist ethics committees in assessing whether and under what conditions old samples collections are able to be used in the present.

 

  • Section 3.4.7 includes the phrase “and any known limitations on use.” This phrase is unclear. Does it refer to practical limitations (e.g. limits on scientific utility because of the type of specimen or condition of specimens)? Or to limitations to the consent associated with the collection? Some clarification would be useful.
 
  •  Section 3.4.9 allows the use of previously-collected biospecimens if (c.) there is no risk of harm or (d.) there is no expectation that information relevant to donors/relatives/communities will arise from the research. Why are these clause linked by an ‘or’ rather than an ‘and’? It is not clear why it would be acceptable to approve biospecimen research that did not propose a risk of harm but may produce relevant information; or that did propose a risk of harm but would not produce any relevant information.

 

Page reviewed: 3 June, 2013