Balancing the freedom of scientific research and privacy in health data research: public interest, legal bases, and objection and opt-out rights
Laen...
Kuupäev
Autorid
Ajakirja pealkiri
Ajakirja ISSN
Köite pealkiri
Kirjastaja
Tartu Ülikooli Kirjastus
Abstrakt
Kuidas kasutada terviseandmeid teaduses nii, et inimese õigused ei kaoks?
Kas teadsid, et sinu terviseandmeid saab kasutada teadusuuringutes ilma, et sinult luba küsitaks? Tihti on vastus „ei“, millele järgneb kiire küsimus „aga minu nimi ja isikukood ei lähe ju sinna?“. Tõsi, tavapäraselt kasutatakse pseudonüümitud vormi, kus inimest otseselt tuvastada ei saa, ehk nimi, sünniaeg ja isikukood eemaldatakse.
Kuid ka pseudonüümitud andmete puhul jääb sageli oht, et inimest on endiselt võimalik tuvastada. Seega peame olema tähelepanelikud, et terviseandmeid ei jagataks ükskõik kellele ja ükskõik mille jaoks. Ühiskond on seadusandlikul tasemel, Euroopa Liidu andmekaitse üldmääruses kokku leppinud, et terviseandmeid tohib inimese nõusolekuta kasutada ainult konkreetsetel eesmärkidel, mille hulka kuuluvad ka teadusuuringud.
Kuid millal on tegemist teadusuuringuga, mis õigustab nõusolekuta terviseandmete kasutamist? Doktoritöös antakse soovitus tugineda Frascati käsiraamatule ja Euroopa ametkondade soovitustele, mille kohaselt peab teadusuuring olema 1) uudne; 2) loominguline; 3) ettemääramatu tulemusega; 4) süstemaatiline; ja 5) ülekantav või korratav ning vastama metoodika- ja eetikastandarditele ja avalikule huvile.
Kuid kes otsustab, kas tegemist on teadusuuringuga, mis panustab ka avalikku huvisse? Doktoritöös leitakse, et kuigi andmete juurdepääsule eelnevad sõltumatud kontrollmehhanismid nagu eetikakomitee või andmeloa menetlused võivad olla teadlase vaatest koormavad, on need siiski vajalikud inimese põhiõiguste kaitseks.
Doktoritöös antakse ka soovitus jätta inimesele vaikimisi alles võimalus keelata tema terviseandmete kasutamine teadusuuringus, võimaldades samas sellest erandeid. Terviseandmete kasutamine inimese vastuseisust hoolimata on põhjendatud juhtudel, kui teadusuuringut ei ole võimalik ilma kõiki andmeid kaasamata usaldusväärselt läbi viia ning kui teadusuuringust saadav kasu on kaalukam kui inimese huvi oma andmete kasutus keelata.
How can health data be used in scientific research while respecting fundamental rights? Did you know that your health data can be used in scientific research without your permission? Often, the answer is ‘no’, followed by the quick question, ‘But my name and personal identification number aren't included, are they?’ It is true that, in general, the pseudonymised form is used, which does not allow direct identification. However, even with pseudonymised data, often a risk remains that individuals can still be identified. Therefore, we must be vigilant to ensure that health data is shared only for well-justified purposes. Society has agreed in the General Data Protection Regulation that health data may be used without the data subject's consent only for specific purposes, including scientific research. But when does an activity constitute scientific research that justifies the use of health data without consent? This dissertation recommends relying on the Frascati Manual and the recommendations of the European authorities, according to which scientific research must be (1) novel, (2) creative, (3) open-ended, (4) systematic, and (5) transferable or reproducible, as well as comply with methodological and ethical standards and contribute to the public interest. But who decides whether it is scientific research that also contributes to the public interest? The doctoral thesis concludes that although the independent control mechanisms that precede data access, such as ethics reviews or data permit procedures, may be burdensome from the researcher’s perspective, they remain essential to protect fundamental rights. The thesis also argues that people should normally be able to block the use of their health data in research. However, exceptions must be available. Researchers may use someone’s data even if that person objects, when the research cannot be conducted properly without that person's data and when the value of the research outweighs the individual’s reason for refusing
How can health data be used in scientific research while respecting fundamental rights? Did you know that your health data can be used in scientific research without your permission? Often, the answer is ‘no’, followed by the quick question, ‘But my name and personal identification number aren't included, are they?’ It is true that, in general, the pseudonymised form is used, which does not allow direct identification. However, even with pseudonymised data, often a risk remains that individuals can still be identified. Therefore, we must be vigilant to ensure that health data is shared only for well-justified purposes. Society has agreed in the General Data Protection Regulation that health data may be used without the data subject's consent only for specific purposes, including scientific research. But when does an activity constitute scientific research that justifies the use of health data without consent? This dissertation recommends relying on the Frascati Manual and the recommendations of the European authorities, according to which scientific research must be (1) novel, (2) creative, (3) open-ended, (4) systematic, and (5) transferable or reproducible, as well as comply with methodological and ethical standards and contribute to the public interest. But who decides whether it is scientific research that also contributes to the public interest? The doctoral thesis concludes that although the independent control mechanisms that precede data access, such as ethics reviews or data permit procedures, may be burdensome from the researcher’s perspective, they remain essential to protect fundamental rights. The thesis also argues that people should normally be able to block the use of their health data in research. However, exceptions must be available. Researchers may use someone’s data even if that person objects, when the research cannot be conducted properly without that person's data and when the value of the research outweighs the individual’s reason for refusing
Kirjeldus
Doktoritöö elektrooniline versioon ei sisalda publikatsioone
Märksõnad
doktoritööd