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Q&A from ARDC webinar: ‘Data management in NHMRC’s revised National Statement on Ethical Conduct in Human Research’

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Answers to questions submitted in the ARDC webinar: ‘Data management in NHMRC’s revised National Statement on Ethical Conduct in Human Research’ on 5th September 2018. Answers provided by Jeremy Kenner, Expert Advisor – Ethics Research Quality and Priorities Branch NHMRC.

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Q&A from ARDC webinar: ‘Data management in NHMRC’s revised National Statement on Ethical Conduct in Human Research’

  1. 1. Answers to questions submitted in the ARDC webinar: ‘Data management in NHMRC’s revised National Statement on Ethical Conduct in Human Research’ on 5th September 2018. Answers provided by Jeremy Kenner, Expert Advisor – Ethics Research Quality and Priorities Branch NHMRC. Is this retrospective for existing studies or prospective from December 2018 onwards? Prospective. Sections 51 - 54 - is this guidance only relevant to internet data/information or to all publically available data? This guidance is relevant for all publicly available data or information that is associated with an individual with ‘common sense’ limitations, e.g. reference to individuals that is obtained from newspaper articles and historical documents are outside the scope of this guidance. The option for granting a waiver for consent currently exists, and leads to different and inconsistent decisions by ethics committees. Will the revised guidelines help to reduce this inconsistency in any way? The short answer is ‘no’. The interpretation and application of the National Statement by HRECs is outside the remit of NHMRC and there is no ‘appeals’ or ‘review’ process available. Will the HREA be revised by January 2019 to reflect the new 2018 National Statement? This is essential in my view to ensure widespread uptake and adherence to new NS and also will the updated HREA be available on all the different platforms that HREA is being used on throughout Australia? The revision of the HREA to reflect the revision of the National Statement is already in process and will be completed before the revised National Statement takes effect. Does NHMRC have a view of practicality of data custodian at different levels i.e. researcher level, research team level, departmental level, org-wide level? No, we have no view on this matter. Does the NHMRC have a position description/guidelines for a "Data Custodian?" No, we have no view on this matter. Will revised HREA be made available/licensed to all platforms using the HREA now - there are at least 4x different platforms Australia wide. NHMRC is in contact with the Australian jurisdictions to facilitate HREA being available on the current platforms in use or being introduced in the near future. What are the responsibilities of ethics committee reviewers with respect to data management - especially given that this was previously a research governance responsibility (i.e. included in the Australian Code for Responsible Conduct of Research)? The role of ethics review bodies is to assess whether the data management arrangements that are proposed in a research proposal are consistent with the requirements of the National Statement and are otherwise ethically appropriate, in the context of the specific research project. Institutions and researchers have parallel, complementary responsibilities for ensuring that research data is managed responsibly under the Code and institutional policy. This shared responsibility is unchanged from the current paradigm. Please could the NHMRC do an Australia wide, state by state roadshow in early 2019 to provide opportunity for as many HREC members, researchers and research administrators to learn about new NS? NHMRC is not able to do a roadshow due to resource constraints. There are other bodies in Australia that are actively engaged in preparing material and providing training opportunities on the revisions to the National Statement, the Code and other NHMRC guidelines. The New NS states that terms such as 'non-identifiable' are not used as descriptive terms. But, in 5.1.22(b) 'non-identifiable' seems to be used as a descriptive term for data. You are correct. This is because the majority of the content of Section 5 and all of the content of sections 1,
  2. 2. 2 and 4 was not within the scope of the review of Section 3. This issue will be addressed in the upcoming review of Section 5, which is currently in the planning stage. So previously the term 're-identifiable' was used in ethics applications where data was coded to researchers. What term should be used to reflect a similar status of the way data will be handled? NHMRC’s decision not to rely upon or emphasise terminology such as ‘re-identifiable’, ‘non-identifiable’ or ‘de-identified’ does not invalidate those terms. Instead, the National Statement focuses on identifiability of data and information as a contextual characteristic of that data or information, the processes used (successfully or otherwise) to ‘de-identify’ or ‘re-identify’ information and the risks associated with these activities. "use of data consistent with the expectations of those who provided it" seems problematic for data from social media, etc. a) how do we gauge "expectations"? and b) most people providing such data would not *expect* it to be used in research in general, much less any specific type of research. Is there a risk that this could easily be over-interpreted and restrict research? Inclusion of this consideration is intended to prompt researchers and reviewers to ask exactly these sorts of questions and to formulate responses that are appropriate in the context of a specific research project. 3.1.62 States that "stored" data that can identify individuals...cannot be used in research that is exempt. Q is - if a data custodian extracts the 'stored' data and removes identifiers, such that it makes the data non- identifiable, can it be then used in research that is exempt? With the caveat that this determination cannot be adopted as an absolute, but depends on a number of contextual factors, yes, research that proposes to use data that, in its original collected state could identify individuals, but from which identifiers have subsequently been removed, would be eligible for exemption. About Secondary use of data, currently in Europe GDPR regulations require explicit consent from every patient. Is NHRMC going towards the same path eventually? NHMRC has no plans to take this path; however, we cannot comment on future policy positions that we might take. Are there template agreements you can refer us, so we can use? This question is not clear; however, as a general matter, we do not publish template contracts, agreements or plans that are referred to in the National Statement or the Code. We note that organisations such as Medicines Australia, jurisdictional health departments and individual universities and research institutes have developed a number of templates for varied purposes. In the discussion on take home points it was mentioned that Research Data Management plans were not mandatory, however the revised s3.1.56 specifies that these are mandatory in some circumstances (i.e. if sharing data). Are RDM plans mandatory? And will NHRMC be developing a best practice template? Both of these statements are correct: as a general matter, RDMs are not mandatory (although strongly encouraged), while their development is mandatory if data/information sharing is planned. These statements are not contradictory. We will not be developing best practice templates, although we are hopeful that others might. ARDC note: for more information on data management plans, see the ANDS page https://www.ands.org.au/working-with-data/data-management/data-management-plans which has a guide on data management plans, and points to resources from both Australia and internationally including many data management plan toolkits and templates. Why is it should not must when it comes to data management plans? The best response is that not all human research projects merit the development of a formal data management plan, even when consideration of many or most of the issues that should be included in such a plan may need to be considered by researchers and reviewers. Will there be a proforma template to assist research groups in addressing the issues to be covered in the data management plans.
  3. 3. NHMRC will not be developing a template, but institutions are always encouraged to develop templates that they determine would be useful in the review and governance of research. ARDC note: for more information on data management plans, see the ANDS page https://www.ands.org.au/working-with-data/data-management/data-management-plans which has a guide on data management plans, and points to resources from both Australia and internationally including many data management plan toolkits and templates. Should we be stating in ethics applications that data will be kept indefinitely and may be available for other researchers/third parties? The storage, re-use and sharing of data and information are always conditioned by the context of the specific research project, the consent provided, agreements entered into or other requirements. The National Statement does not support statements that do not recognise variations in circumstances. There was mention of 'justification' for not having research data publicly available. Who is responsible for retaining the 'justification', and who do you envisage will this be required to be shared with/disclosed to? The intention of this statement was to alert the researcher and the reviewer to the expectation that a choice not to make research data available would need to be justified in a submission to a reviewing HREC or other ethics review body. What are the best ways to participate and stay abreast of ongoing discussions about innovation in trials data sharing? Bookmark the ARDC website!! ARDC note: you can sign up to the ARDC newsletter here https://ardc.edu.au/newsletters Also, ands.org.au/medical has information about managing and sharing medical data, and a new subpage on clinical trials is being planned. The Australian Clinical Trials Alliance may also be a good organisation to follow. When accessing genomic data from public websites such as 1000 genomes and the Cancer Genome Atlas, do we need institutional HREC approval? If a researcher plans to obtain access to this genomic data for the purposes of research, then certainly ethics review is required – in most cases by an HREC. If access is sought for other purposes, then other oversight may be required.

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