Synopsis - Health and medical data #3 - Planning for data sharing in research ethics applications
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00:00
PlanningInformationInformation privacyElement (mathematics)System identificationStatement (computer science)CodeRegulärer Ausdruck <Textverarbeitung>Condition numberPerspective (visual)Observational studyExpected valueVector potentialGUI widgetStandard deviationMaxima and minimaCommunications protocolComputer configurationModal logicRange (statistics)Sound effectObservational studyExtension (kinesiology)Thermal conductivityInformationInformation privacyCommunications protocolDependent and independent variablesStandard deviationComputer configurationSelf-organizationShared memoryProjective planeElectronic program guideGame controllerVector potentialStatement (computer science)Expected valueCartesian coordinate systemSource codeMedical imagingContext awarenessFamilyTerm (mathematics)Link (knot theory)Natural numberPerspective (visual)Greatest elementMoment (mathematics)CASE <Informatik>CodeLine (geometry)Theory of relativityBasis <Mathematik>Condition numberForm (programming)Set (mathematics)Function (mathematics)1 (number)AdditionElement (mathematics)System identificationView (database)Order (biology)Rule of inferenceSoftware maintenanceParameter (computer programming)Row (database)Feasibility studyComputer animation
Transcript: English(auto-generated)
00:00
I'm going to talk about planning for data sharing but from the research ethics perspective and what ethics committees are particularly concerned about. So the primary principle which guides research review is that it is in the common good
00:22
so that the premise is a utilitarian one and all ethics committees are aware of that and we understand that the purpose is good and that research should be maximized with public benefit for the common good and this also applies to data sourced and used in research
00:40
and the primary principle around that value of research is balanced with others that the committee looks at which are focused particularly on the individual, so about justice, beneficence and respect. And so we're interested in understanding that benefit is maximized for those participants
01:02
and the risks and burdens are minimized, that participants are appropriately engaged and recruited and they're given sufficient information and provided with that information sufficient to give a voluntary consent, that the privacy and confidentiality issues are well attended to so that there are no elements of data
01:28
which either during the research or subsequent to the research could lead to identification and of course as Phoebe and Abendine have already said that can be quite difficult but also we're aware that there is necessity to ensure the efficient use of research effort and funding
01:46
so how will it be used in the future to the best effect? There's a range of relevant guidance that ethics committees refer to and the National Statement on Ethical Conduct and Human Research is the most well known and the one that we apply to the greatest extent and refer to to the greatest extent.
02:04
The Australian Code for the Responsible Conduct of Research is something that's of particular relevance to researchers and to organizations which undertake research and then in more recent years the issue of data sharing and further use of data has come to the fore
02:20
and the NHMRC has responded to that with a statement on data sharing and also a fairly detailed consumer guide to the principles for accessing and using publicly funded data for health research and that I would suggest that everybody tries to access if they can. The NHMRC has more recently provided a set of principles about accessing
02:46
and using publicly funded data for health research and that isn't just research data but it also refers to other forms of publicly funded data and this is in agreement and in concert with other international guidance
03:01
such as from the Global Alliance for Genomics and Health, the International Cancer Genome Consortium and the Wellcome Trust and there are no doubt other ones as well but these are perhaps the most well known. So the NHMRC supports data sharing and public access to data and to the outputs of NHMRC supported research
03:24
and it says to the public that the use of these data for research provides our greatest opportunity to unlock the value in these records for the benefits of all Australians and that's a very powerful promise but they offset this promise or they in addition promise to participants
03:44
that data are collected subject to rigorous privacy and confidentiality conditions and the use of the data will maintain these requirements and in addition to that that any research which accesses such publicly funded data
04:01
are subject to very strict ethical approval processes so in order to establish that the research project is worthwhile and will add to that knowledge. So those are very important statements and promises that are made to participants in research. So the NHMRC therefore views research and data sharing
04:23
from the premise that it's important to promote it but it is equally important and more important to maintain trust in research endeavors and to ensure that it can be seen that the guidance is followed. So we focus on the participant interests and the perspective of the participant.
04:43
We try and consider what the research will mean to a participant. We're interested in knowing that research is facilitated and achieves its end so it's feasible and there is going to be the outcome as promised but in relation to data sharing it's important that conclusions can be confirmed
05:02
through data sharing and reanalysis and that the data that has been collected can be reused and therefore the benefit from all of that effort can be maximized. And we're also interested in understanding that all the stakeholders along the line of custody of those data
05:20
do understand the responsibilities and will follow best practice guidelines. So in particular we look at research merit and for that we're interested in the basis for the research, whether there's good literature surrounding the reasons for the research which can justify the aims
05:41
and also as I've said there will be a particular benefit that will flow from the research which will have a public and community benefit to it. We're interested in knowing that responsibilities are passed on with the data and the references that I've given here all relate to the national statement, the link to which is at the bottom.
06:03
Where there is a new project which is going to rely on previously collected research data we want to know that either the aims are closely related to the original research questions or there is some provision for seeking further consent and that there is adequate respect demonstrated
06:23
for autonomy of the participants. Their expectation of quality is said in the national statement on data sharing and that any prior agreements are followed through. So this means that we may wish to refer back to consent, the nature and the quality in the original study
06:43
and that this is sufficient for the further aims and if that's not the case then we will want to understand how participants are to be re-engaged and to have their consent agreed to. Now if that's considered not possible then there may be an opportunity to consider waiving
07:05
the expectation of consent but that would be a very rigorous argument that would have to occur regarding the quality of the research proposed and the protections that are in place for the data. The other concerns and interests that we have
07:22
are relating to justice, beneficence and respect. So we want to know, for example, that the population from which the cohort is drawn is likely to benefit from the generalizable knowledge which will result from the research or in some way the application of the findings from the research.
07:44
That if there are any implications from the research for participants and others, so community, the broader community, family members, that this will be acted on and this may relate to returning study findings or addressing potential harms and benefits. And we're also interested in understanding the rigor of the controls
08:04
and the governance around data and any agreements regarding access, use and release of information. So again that goes back to how the data are managed and the confidentiality and privacy undertakings. So this is just a summary to really wrap up what I've already said,
08:23
that there's a lot of guidance around the use of data in the future and the benefits that may accrue from it. The research studies should satisfy these certain quality standards and demonstrate that there will be a benefit, that that benefit will be maximized,
08:41
including in terms of the future use of the data. We're interested that the protocols and the agreements and the information provided in the reviewed application define these future possibilities of sharing. And we wish to know that participants are well informed about the current and the future research
09:01
and they're given options for consent to each so that they may be asked to consent for the current project but also are alerted to the fact that there would be future research and depending on the nature of that, that there would be an additional agreement for them to include their data in that future research
09:22
and that the research data, when it's used in future research, must comply with the prior consent agreements unless these can be renegotiated. Thank you.