{
  "url": "https://openlegislation.uk/eu-decision-2016-1250/annex-II/division-III/division-14/division-e",
  "json_url": "https://openlegislation.uk/eu-decision-2016-1250/annex-II/division-III/division-14/division-e.json",
  "legislation": "eudn/2016/1250",
  "legislation_title": "Commission Implementing Decision (EU) 2016/1250 of 12 July 2016 pursuant to Directive 95/46/EC of the European Parliament and of the Council on the adequacy of the protection provided by the EU-U.S. Privacy Shield (notified under document C(2016) 4176) (Text with EEA relevance) (revoked)",
  "legislation_url": "https://openlegislation.uk/eu-decision-2016-1250",
  "path": "annex/II/division/III/division/14/division/e",
  "kind": "division",
  "number": "e",
  "heading": "‘Blinded’ Studies",
  "text": "i..To ensure objectivity in many clinical trials, participants, and often investigators as well, cannot be given access to information about which treatment each participant may be receiving. Doing so would jeopardize the validity of the research study and results. Participants in such clinical trials (referred to as ‘blinded’ studies) do not have to be provided access to the data on their treatment during the trial if this restriction has been explained when the participant entered the trial and the disclosure of such information would jeopardize the integrity of the research effort.\nii..Agreement to participate in the trial under these conditions is a reasonable forgoing of the right of access. Following the conclusion of the trial and analysis of the results, participants should have access to their data if they request it. They should seek it primarily from the physician or other health care provider from whom they received treatment within the clinical trial, or secondarily from the sponsoring organization.",
  "extent": "E+W+S+N.I.",
  "status": "repealed",
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Decision revoked (31.12.2020) by The Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019 (S.I. 2019/419), Sch. 3 para. 1(o); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudn/2016/1250/annex/II/division/III/division/14/division/e",
    "retrieved_at": "2026-11-01T15:13:53.293736+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}