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dac_guide.html
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<p>
This guide describes how the DAC shall proceed in connection with request for data access in
FEGA Norway under the control of the members of the DAC. The guide also provides a generic
overview of the ethical and legal framework that should be in place before such access can be
accepted, including requirements set forth in General Data Protection Regulation (GDPR).
</p>
<h3 style="padding-top:2em">
Reviewing requests for data access to a dataset submitted in FEGA Norway
</h3>
<p style="padding-bottom:1em">
The responsible researcher must forward the request for data access to the DAC represented
by the PI for the dataset. Before the DAC can complete the request for access evaluation, the
researcher is responsible for providing the DAC with following documentation:
</p>
<ul style="padding-left:30px">
<li>Documentation of legal basis for the project from the researcher’s institution normally
represented by the institutions Data Protection Officer (DPO).</li>
<li>REK approval, including the approved research protocol.</li>
<li>Copy of Data Protection Impact Assessment (if applicable).</li>
</ul>
<p style="padding-bottom:1em">
When the relevant documentation has been provided (or processes to generate them has been
started), the DAC can proceed with the following:
</p>
<ul style="padding-left:30px">
<li>Negotiate a Data Access Agreement (DAA)</li>
<ul style="padding-left:30px">
<li>It is important that DAC adheres to its own institution's guidelines for which
agreement templates are to be used. FEGA Norway has developed generic Data Access
Agreement templates of different types:
<ul style="padding-left:30px">
<li><a href="/docs/DTA_template_FEGA_Norway_08.01.20.pdf" download target="_blank">DTA-based template</a></li>
<li><a href="/docs/DPA-between-DAC-and-DataRequestor-template.pdf" download target="_blank">DPA-based template</a></li>
</ul></li>
</ul>
<li>Before signing the DAA and proceeding with the approved data access, the DAC is
responsible to file a notification about the access through standard mechanisms for
notification on projects containing sensitive data in your institution. Such notification
should contain the following attachments:
<ul style="padding-left:30px">
<li>Copy of the final version of the DAA.</li>
<li>Documentation from the researcher requesting the data access (above).</li>
</ul>
</li>
<li>After receiving internal approval from your Research Support Unit or DPO, the DAC can
proceed the formalization and signing of the DAA. It`s important that the DAA is signed
by a authorized person from your institution.
<ul style="padding-left:30px">
<li>The signed final version of the DAA should then be filed according to your
institution's internal procedures.</li>
</ul>
</li>
</ul>
<p style="padding-top:1em">
We strongly advice the DAC to seek assistants from your own institution`s support units
and/or DPO in handling requests for access to datasets in FEGA Norway. The steps described
above shall be considered as generic and therefor can deviate from your institution`s
internal routines.
</p>
<!-- Temporarily removed, may be replaced with known contact addresses/detiails for Submitter organisations
<h3 style="padding-top:2em">
Institution-specific instructions
</h3>
<p style="padding-top:1em">
Known institutions with more detailed institution-specific references to internal systems for
the outlined procedures above:
</p>
<ul style="padding-left:30px">
<li>Oslo University Hospital is available <a href="/OUH_specific_dac_guide.html">here</a>.</li>
</ul>
<p style="padding-top:1em">
<u>Disclaimer:</u> the notes are provided as is and correct to the best of our knowledge through
our collaboration with GDPR functions/staff at the institutions.
-->
<!-- <ul>-->
<!-- <li>Forsker Y eller Forsker X mottar en henvendelse fra pasient eller forsknings-subjekt P om-->
<!-- at vedkommende vil trekke sine data fra studien.</li>-->
<!-- <li>DAA vil sammen med DAC-vedtekter sørge for at Forsker Y og Forsker X felles behandler en-->
<!-- slik forespørsel og sørger for at den blir dokumentert, og at OUH “Felles administrasjon-->
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