“The data should uphold the human dignity for a common good.”
We need to and be re-purposeful across continents to represent a broad range of stakeholders. This includes input not just from WMA members but industry, pharma, researchers, clinicians, ethicists, religious leaders, ethic committee leaders, regulators, stakeholders, leaders of various medical specialities, NGOs, students, patients, comunity members, and government officials.
Inclusive Ethical Decision-making: The Role of RECs
WMA Declaration of Taipei 2016
Most important DoT ethics committee related provisions in paragraph 19
1. An independent ethics committee must approve the establishment of Heath Databases and Biobanks used for research and other purposes.
2. In addition, the ethics comittee must approve the use of data and biological material and check whether the consent given at the time of collection is sufficient for the planned use or if other measures have been taken to protect the donor.
3. The committee must have the right to monitor on-going activities.
3. Other ethical review mechanisms that are in accordance to para 6 can be established.
DoH 2024 Provisions Introduced After 2016
REC specific prargragh 26
The committee must have sufficient
• resources to fulfill its duties
• familarity with local circumstances, and context
• include atleast one member of the general public
When collaborative research is performed internationally, the research protocol must be approved by research ethics committee in both the sponsoring and host countries.
These amendments align well with the intentions to strengthen the principles of equity, justice and inclusivity in the updated DoT.
DoH 2024 new provision on consent in data and biobanking
DoH 2024 paragraph 32
-Where consent is impossible or impracticable to obtain, secondary research on stored data or biological material may be done only after consideration and approval of a research ethics committee.
-Such a scenario is not included in the DoT; however, DoT refers to other legal basis.
DoT paragrapgh 21
– … arrangements for obtaining appropriate consent or other legal basis for data or material collection.
– This seems to be a provision that will gain increasing relevance in the near future.
– Particularly in the context of upcoming European developments.
KEY CONCEPTS
In European Union countries, the General Data Protection Regulation (GDPR) provides a general legal framework for collecting and processing personal health data, which the GDPR classifies as special category data. The GDPR generally prohibits the processing of special category data, except when there is a valid legal basis of doing so. Both a lawful basis for processing, as stated in Article 6(1) of the GDPR, and a special category condition for processing in compliance with Article 9(2) of the GDPR are necessary [8].
1. The reuse of routine health data to generate knowledge and use this knowledge in the health care delivery process is an important aspect of what is called a “learning health system” [1,2].
The Dutch standards for data protection when data are used for research purposes have recently been refined in the code of conduct [11]. This code serves as an important normative framework and expresses the current consensus on the relevant European and Dutch legislation. It states that the consent (acquired by the health care provider) is, in principle, the first legal basis to release pseudonymized patient data for research. However, consent is not required in the following conditions: (1) if requesting consent from an individual is not reasonable or would impose too great a burden on the patient, for instance, in case the patient is terminally ill; (2) if the request for permission cannot reasonably be expected from the health care provider, for instance, owing to the large size of the study group; or (3) if asking for permission would lead to a low or selective response or participation rate that cannot be corrected for (ie, selection or consent bias). This can threaten the representativeness of the study sample [12-15] and ultimately render the research unreliable and, therefore, impossible.
If the exemption from obtaining informed consent applies, further conditions must be met, such as the research must be in public interest and that patients have not objected to the reuse of their data for research.
2. Opt-in consent means no data collection occurs until a user takes a deliberate affirmative action, clicking “Accept,” checking a box, or submitting a form. Opt-in assumes refusal by default.
3. Opt-out consent means data collection begins automatically, and users must actively stop it. Opt-out assumes permission by default.
More on opt-in and opt-out related to health data;
A Paradigm Shift 1: European Health Data Space Regulation (EHDS Regulation)
Entered into force on 26 March 2025 to optimise secondary use of electronic health data (HD) for research, innovation, and policy-making.
– applies to genetic data, molecular research data, medical records and lifestyle information
EHDS requires Health Data Holders – public or private entities (e.g. universities) to
– generate, collect, or process electronic health data.
– to make this data available for authorised secondary use by third parties, such as researchers and commercial entities
Biobanks are considered “health data holders” according to the EHDS
A Paradigm Shift 2: EHDS Regulation
DoT, para 19 not applicable?
An independent ethics committee must approve the establishments of health databases and biobanks used for research and other purposes
Provides for a differenrt type of secondary research infrastructure directly enforced by legal binding regulation
Shift from Ethics Committees to Health Data Access Bodies (HDABs) – the decision on whether data is released rests on the HDAB, not the REC
Ethics assessment is only required if it is mandated by the national law of the EU member state:
-E.g. a member state may opt to include ethical bodies within the HDAB
Key Concern
-may limit or marginalise the role of RECs in approving the establishment of health databases/biobanks and reviewing research studies
A Paradigm Shift 3: EHDS Regulation
DoT para 19 not applicable?
…ethics committee must approve the use of data and biological material and check whether the consent given at the time of collection is sufficient for the planned use or if other measures have to be taken to protect the donor.
All electronic HD/ or HD associated with biobanks samples will automatically available for secondary use unless the individual decides to opt out.
– eliminates the need for RECs to evaluate the validity of consent
– a significant shift for biobanks that historically relied on explicit consent modalities, particularly broad informed consent.
Risk of a broad, non-specific opt-out option:
– Due to the complexity of modern health data sharing, people may not be aware that their data is being used (Lutomski, Manders 2024)
Potential Consent Ambiguities
Confusion between different types of consent applicable to the secondary research use of personal data and human biological materials:
– explicitly expressed (opt-in) informed consent vs implied (opt-out) presumed consent/procedure
– has very different implementation strategies
On a broader normative level, opt in and opt out strategies are based on different types of normative frameworks:
– expressed (opt-in) informed consent normative framework of research ethic guidelines: DoH, DoT
– data protection regime which aligns with the opt-out model:
– E.g. the GDPR “research condition” provides a “research-friendly” approach as it does not give consent any predefined priority as a legal basis for health data processing GDPR
An example of consent misconception
Participants in clinical trials may assume that their consent to take part in a research project also includes consent for the processing their personal data (Dove and Chen, 2020), As a result they might mistakenly believe that they still have the right to access their data, object to its further processing or request its deletion, even if these rights are limited by national or EU law.
Will participants of biobanks governed by broad consent face similar misconceptions when the EHDS regulation is implemented?
CIOMS International Ethical Guidelines for Health-Related Research Involving Humans, 2016
Guidelines 11 and 12 dealing with research on biological materials and health data are explicit about:
1. specific or
2. broad informed consent
3. or may be substituted by an informed opt-out procedure (not called consent!)
Which is applicable:
– For research on residual tisue
– When data are used that were colected in the context of routine clinical care
Stakeholder Engagement: Exclusive Decision Making
Gobal Governance to Promote Equity and Justice
The major changes in health data in the past 10 years; increasingly valuable, increasingly complex.
Conditions for Global Governance are challenging due to;
☆ international deregulation – endangered respect for international rights and cross-national cooperation
☆ institutional mistrust – endangered indepency and impartiality of procedures, and decisions, and citizens’ participation
☆ distortion of reality – endangered the perception of the “common good” and the ability to contribute to public causes
The direction for the governance of a broader framework would be human dignity, individual autonomy, privacy/confidentiality, and discrimination.
Governance Structures for Health Research Ethics in EMR
All Keynote Speakers;
Federico De Montalvo
Jack Resneck
Eugenijus Gefenas
Manfred Lütz
Karla Childers
Leah Wapner
Maria Do Céu
M Patraõ Neves
Renzo Pegoraro
Part 3 Declaration of Taipei
https://youtu.be/CzGpa9hfPBQ?si=SPXKuJLj_B7nWzJU
Sources;