Procedure Privacy Advice and Agreements

The procedure for obtaining privacy advice from Privacy Protection and Information Security (PB&IB) for contracts handled by LRS has been simplified. For specific types of agreements, researchers can now request support directly from LRS, without first obtaining privacy advice from PB&IB. The procedure and specific situations are outlined below.

Privacy Advice and Agreements for Scientific Research with External Parties

When researchers intend to conduct research with external parties involving the collection, sharing, and/or use of (coded) data and/or biological materials from research participants/patients, the following steps are required to reach a signed agreement:

A. Registration of Data Processing in the record of processing activities of Amsterdam UMC

If the research involves the collection, analysis, use, and/or transfer of data from research participants/patients, privacy regulations require that this be reported in the record of processing activities of Amsterdam UMC. This is also necessary when submitting to one of the review committees.

B. Submission of the Study to One of the Review Committees

If data or biological materials from Amsterdam UMC research participants/patients are to be used, the research must be submitted to one of the review committees, even if the research has already been declared non-WMO applicable elsewhere in the Netherlands. For WMO-applicable research that has been reviewed by a METC elsewhere, a Local Feasibility procedure must be initiated.All relevant information about these committees can be found on the website of the Medical Ethics Review Committee (METC) of Amsterdam UMC.Submissions are made via Research Manager: Research Manager - Medisch Ethische Toetsingscommissie (amsterdamumc.org).

C. Requesting Privacy Advice from PB&IB

Complete the form “Privacy: required information for PB&IB and LRS” and send it together with other relevant documents, such as the ICF or PIF including the consent form or objection letter, study protocol, any existing agreements, and draft agreement(if applicable) to: Serviceportaal PB&IB, tab Contact & Meldingen, Tile: Privacy questions.

Privacy advice from PB&IB is not required in the following situations:

  • Amsterdam UMC receives data/biological material
    Amsterdam UMC processes the data/biological material for its own research, where the provider has not contributed to the Amsterdam UMC research protocol and is therefore only a ‘supplier’ of data/biological material.
  • Amsterdam UMC provides data/biological material
    The recipient is a research institution (not a commercial organization) and processes Amsterdam UMC data/biological material for its own research. Amsterdam UMC has not contributed to the recipient’s research protocol, and the CTB has approved the release. CTB approval must also be sent to LRS.
  • Clinical Trial
    The clinical trial is conducted between hospitals or is industry-initiated, and Amsterdam UMC has not contributed to the research protocol.Note: Study support agreements in which Amsterdam UMC provides personal data to the other party (often commercial) are not included here.
  • Establishing a Consortium Agreement
    A consortium is being established to obtain funding for one or more studies that still need to be developed.

Note: LRS may always determine that PB&IB advice is still necessary.

! Privacy advice is in any case required for:

  • the provision/sharing of uncoded personal data with parties outside Amsterdam UMC;
  • extensive DNA analyses, such as whole genome or whole exome sequencing; or
  • linking (coded) personal data to data from another party.

D. LRS Advice for Drafting and/or Reviewing the Contract

Send an email to: lrs@amsterdamumc.nl with the following documents:

  • The form mentioned under C, including privacy advice (PB&IB), if applicable
  • LRS intake form: intake form NL or intake form EN
  • Relevant documents: for example: research protocol or project plan, any existing agreements, draft agreement if applicable, budget if available, declaration of approval of the non-WMO review committee or biobank review committee (CTB)

Source Article: Intranet VUmc - Contracten voor Research