Editorial 3/2016

Open Science for the Benefit of Research and Participants

Annaleena Okuloff

Duty of confidentiality is taught to every health professional right at the beginning of their studies. In working life, all health professionals knows it by heart, and it is present in every work task, every single day. For a doctor or a nurse, the requirement that patient information is not revealed to outsiders is self-evident.

When information related to participants’ health is used in research, duty of confidentiality is an obvious factor. The researcher must go through a thorough permit obtaining process, and often submit the research plan to an ethical review as well. If needed, the researcher will also obtain consent from research participants and pledge to destroy the information collected from them after the research is completed.

Taking all this into consideration, the idea of open access to data containing sensitive, confidential patient information may seem absurd at first. The fact that open access to data is most often considered to mean that data are available to all users without restrictions does not help either.

However, access to clinical trial data is most often granted only to other researchers, not to all users. The use of data can be limited very strictly in regard to who can access it, and what part of the data they can access. Data are not disseminated with identifiers included. For example, the FSD only disseminates data that have been completely anonymised.

The International Committee of Medical Journal Editors (ICMJE) has argued that open access is necessary even for data containing sensitive information, such as clinical trials.

According to the ICMJE, the researchers have an ethical obligation to share data generated by interventional clinical trials because participants have put themselves at risk by taking part in the trials. Data archived for further research will decrease the need for unnecessary duplication of research which may be harmful to the participants. The writers emphasize that the confidentiality of trial participants must still be protected when research data are opened.

According to the ICMJE, opening research data is the logical next step after the registration of clinical trials. The aim is to prevent selective publication and selective reporting of research outcomes where negative results are not reported, which may lead to false conclusions. Declaring the plan for sharing data will further promote transparency of research.

Archiving will also lessen the pressure directed at small demographics. In the world of education, some Finnish schools and principals have already begun to refuse new data collection requests due to the large number of requests they receive. The same risk exists in the world of health sciences, where advancements in science and technology have opened up more diverse ways of conducting research.

The committee preparing new Finnish legislation for reuse of register data aims to promote research and innovation. The basis for the new law is that a secure remote access system, where the researches can gain access to register data without gaining access to the actual research data, must be built in Finland. The development of the remote access system is funded by Sitra, in close cooperation with the drafters of the new law. After the system is launched, the confidentiality of participants is more secure than ever. You can find more information about Sitra’s ISAACUS project in this issue of FSD magazine.

The field of health science is faced with many changes at the legislation level during the next few years, and the legislation process is worth following. EU’s data protection regulation comes in to effect in the spring of 2018. By then at last, every research group should ensure that their policies match the act. In this issue, the data protection regulation will be examined especially from the point of view of research.

After the legislation comes into effect, researchers must take special care to obtain consent from participants in a manner required by the act. The sustainable opening of research data is possible only if we ensure that the confidentiality of the participants is not endangered at any point.

Annaleena Okuloff
Health Research Specialist