Pathology Awareness Australia ambassador, Dr Nikolajs Zeps has been honoured with a National Health and Medical Research Council (NHMRC) Ethics Award in recognition of his leadership in the development of ethics policies and standards, both within Australia and internationally. As an NHMRC award winner, he is among Australia’s most talented senior and emerging researchers.
A prominent pathology-based researcher and research director, Dr Zeps was recently appointed Group Director of Research and Development at Epworth HealthCare in Melbourne. His ethics policies and standards have been adopted by researchers in Australia, Canada, the USA and Europe.
One of Dr Zeps’ biggest achievements is his involvement, as chair of the working group, in the re-writing of section 3.4 of the National Statement on Ethical Conduct in Human Research, conducted on behalf of the Australian Health Ethics committee (AHEC). Entitled Human biospecimens in laboratory based research, Dr Zeps and his team set out guidelines for managing biospecimens which are collected, stored and distributed by researchers, biobanks and clinical pathology services.
Human bio specimens refer to any biological material obtained from a person including tissue, blood, urine, sputum and any derivative from these including cell lines.
There is always a possibility that research performed on a biospecimen may reveal information that could be important to the donor’s health or to the health of their community, for example discovering that a tissue sample contains a more malignant type of cancer than previously thought. Knowing that these scenarios would present many ethical challenges, Dr Zeps and his team recommended guidelines that would help researchers prepare an ethically defensible plan to describe the management of any proposed disclosure or non-disclosure of sensitive information.
This plan must consider whether a recognised intervention exists that can benefit or reduce the risk of harm to the donor, from any health impact revealed by this information.
If sensitive information is likely to be revealed, before giving consent, the donor must be made aware whether they will have the choice to allow their blood relatives or their community to be informed.
These guidelines have encouraged researchers to take a practical, sensible approach to the management of consent and the return of research results.
Dr Zeps is one of the only researchers in Australia to have published papers on the responsibilities that can arise for pathology services in terms of returning individual research results (IGRRs) to research participants. In his paper, Managing the Ethical Issues of Genomic Research using Pathology Specimens, Dr Zeps states that pathology services that provide specimens to researchers may find themselves unwittingly caught up in having to commit time and resources to giving back IGRRs to participants.
Because this would place an extraordinary burden on clinical practices, Dr Zeps proposed a set of principles that would underpin a carefully constructed ethically defensible plan based upon clinical validity (whether anything can be done about the findings), analytical validity (the way the research test was done) and actionability (whether anything can be done in light of the finding). Once established, only these results would need to be analysed and possibly returned to participants.
For Dr Zeps, the most important element in ethical policies is to ensure a balance between facilitating and regulating research: “Pathology drives a great deal of medical research, and utilisation of specimens and data have contributed to major advances in medicine. This should not be unnecessarily impeded through bureaucratic approaches to regulating usage that are inconsistent with public expectation. However, it also means that good governance processes that are worthy of public trust are necessary.”
- National Statement on Ethical Conduct in Human Research (2007) – Updated May 2015
- Zeps, Nikolajs, and Marianna J. Bledsoe. “Managing the ethical issues of genomic research using pathology specimens.” The Clinical Biochemist Reviews 36.1 (2015): 21.