Patient and public involvement in biobank scientific committees 

Table Of Contents

Overview  #

Patient and Public involvement in biobank scientific committees refers to the active participation of patients, former patients, caregivers, research participants, patient representatives and representatives of patient organisations and civic groups in the bodies which are responsible for overseeing a biobank’s scientific activities.  

Decisions made by scientific committees can have significant implications for patients, caregivers and the public including which research projects receive access to samples, which research priorities are pursued, how samples and data are shared, whether commercial research is permitted, and how research findings are communicated. 

Patient and public involvement should extend beyond recruitment as a research participant: indeed, it is important to involve patients, caregivers, research participants and public representatives as active partners in institutional governance including as members of scientific advisory boards, research steering committees, biobank access committees and committees responsible for research priorities. Their involvement must reflect the committee’s mandate and the type of decisions being made. 

A committee should make clear whether patients, caregivers or public representatives have full voting rights, advisory status or another defined role.   

Their involvement can help biobanks: 

  • identify questions that matter to patients, caregivers and the public and address unmet medical needs. 
  • assess whether proposed projects respond to meaningful clinical or patient-centred outcomes. 
  • contribute to decisions about access to samples and data, secondary use, international sharing and commercial partnerships. 
  • improve consent and communication.  
  • highlight concerns about privacy, discrimination, return of results, incidental findings, etc. 
  • promote trust and accountability by making decision-making more transparent.   
  • support equitable research by identifying gaps in representation, neglected conditions and barriers affecting underserved populations.

Key ethical, legal and societal Issues  #

Meaningful involvement #

A central ethical concern is whether patient, caregiver or public participation has a genuine impact on decisions or merely provides symbolic legitimacy to decisions already made by researchers or institutional leaders. Meaningful involvement requires that patient, caregivers and public representatives receive relevant information, have sufficient time to contribute, are able to raise concerns and can influence committee deliberations. Their contributions should be documented, and the committee should explain how their input was considered.  

Representation, diversity and inclusiveness #

Patients, caregivers and the public are not a homogeneous group. Their perspectives may differ according to diagnosis, disease severity, age, disability, socioeconomic circumstances, ethnicity, cultural background, previous research experience and access to healthcare. Biobanks should therefore consider involving representatives from different disease and non-disease areas and demographic groups; consulting patient organisations where appropriate; including people from underrepresented communities; periodically reviewing the diversity and representativeness of committee membership. 

Confidentiality and access to sensitive information #

Scientific committees may discuss confidential research proposals and sensitive information relating to identifiable participants. Patient, caregivers, public representatives should receive appropriate confidentiality training and understand the information they are authorised to access.   

Scientific expertise and power imbalances #

Patient, caregiver, public representatives may feel less confident contributing in committees dominated by specialists. This creates a risk that scientific terminology or institutional hierarchies marginalise their contributions. Appropriate training and plain-language documentation can help address these imbalances.   

Compensation, accessibility and burden of participation #

Patient, caregiver, public representative involvement requires time, preparation and emotional effort. Participation may be particularly demanding for people living with chronic, progressive or life-limiting conditions. Biobanks should establish transparent arrangements for reimbursement of expenses, remuneration where appropriate, accessibility support and reasonable meeting schedules.   

Transparency, trust and accountability #

Patient, caregiver, or public involvement can strengthen trust only if it is accompanied by transparent decision-making and clear accountability. Biobanks should consider publishing information about committee membership, the role of patient, caregiver, public representatives, relevant conflict-of-interest policies and the general outcomes of committee deliberations, subject to confidentiality requirements.  

Legal and ethical international and EU sources  #

At the EU level there is strong support for involving patients, caregivers, and public representatives in biobank governance, including membership of governance and oversight committees. However, there is not an EU regulation or directive or other provision that makes it a general legal requirement to have a patient representative specifically on a biobank Scientific Committee. The only directive that mentions the importance of involving laypersons in the ethics committees is Clinical Trial Regulation (Whereas 18) but it leaves the decision to Member States. 

Therefore, it is up to the single institutions and ethics committees to choose whether and how to involve them: it is more a recommendation/good-governance expectation rather than a universal regulatory requirement. Patient and public involvement is in any case supported by international ethical standards, European governance frameworks and research-participation policies.

International ethical sources  #

  • World Medical Association (WMA) – Declaration of Taipei on Ethical Considerations Regarding Health Databases and Biobanks (2016). Paragraph 20 expressly identifies participation and inclusion as principles of trustworthy governance and calls on biobank custodians to consult and engage individuals and their communities. Paragraphs 19–21 address independent ethical oversight, accountability and governance arrangements. The Declaration supports meaningful patient involvement in governance, although it does not require every scientific committee to include a patient member.  
  • WMA – Declaration of Helsinki (2024 revision). It explicitly states that meaningful engagement with potential and enrolled participants and their communities should occur before, during and following medical research (principle 6). Researchers should enable participants and their communities to share priorities and values, participate in research design and implementation and other relevant activities; and participate in understanding and disseminating results. This is not a biobank regulation and does not prescribe committee composition, but it provides a contemporary ethical basis for moving from “patients as research subjects/donors” towards “patients as partners in research governance”.   
  • UNESCO – Universal Declaration on Bioethics and Human Rights (2005). Relevant principles include human dignity, autonomy, informed consent, privacy, equality, justice, social responsibility and benefit sharing. Articles 18 and 19 address decision-making, professional conduct, multidisciplinary dialogue and independent ethics committees. The Declaration provides a normative basis for inclusive and socially accountable research governance. It does not establish a specific entitlement to patient representation on scientific committees. 
  • IARC/WHO – Common Minimum Technical Standards and Protocols for Biobanks Dedicated to Cancer Research which recommends that the composition of biobank committees be considered carefully when participants, patient groups or public representatives are asked to serve. Its model governance structure includes scientific oversight, ethics oversight, executive/steering, data/sample access and public engagement committees. This is useful because it supports the practical governance model. 

EU ethical sources  #

EU Commission’s 2012 expert-group report Biobanks for Europe – A Challenge for Governance: it identifies public/patient participation as an element of good biobank governance. It recommends sustainable governance mechanisms to involve and engage the public and specifically patients, research participants and the wider public in biobank governance. Its discussion of patient involvement states that patient representatives should be considered partners in the research effort and that their experience and expertise should be considered when establishing sample, tissue and data banks. It also specifically discusses their involvement in ethical issues and interaction with Research Ethics Committees. 

Importantly, the report acknowledged that, at that time, actual patient involvement in biobank creation and governance was still exceptional, although examples already existed, particularly in rare-disease biobanking. 

EU legal sources  #

Regulation (EU) No 536/2014 governing the authorisation, conduct, and supervision of clinical trials on medicinal products for human use across the EU, replacing Directive 2001/20/EC – see Whereas 18

National sources  #

Having consulted our BBMRI Network (National Nodes), these are the remarks regarding national frameworks: 

  • In Greece, Malta, Spain, Latvia, Norway, Greece, Czech Republic, Estonia and Poland there are no specific guidelines or legal obligations / requirements on the topic 
  • In Finland most of Finnish biobanks have the requirement to involve patients in scientific committees, but it is up to each biobanks’ own design and Finland doesn’t have any legal requirements for them 
  • In the Netherlands, a guideline titled “The Donor as Partner” was developed in 2014. This guideline describes methods and levels of patient participation in biobank governance and serves as a guide for biobanks and participants in identifying the most suitable participation model 
  • In Austria there are no legal requirements regarding patient-partner involvement in biobank scientific committees. However, patient-partner involvement is a requirement in adjacent matters : for example, the Oncology Advisory Board – Onkologiebeirat – must include, in every iteration of its formation, at least one patient representative 
  • In Hungary, the Hungarian Biobank Act (Act XXI of 2008) regulates the establishment and operation of biobanks and assigns specific responsibilities to the head of the institution and a designated responsible person, but it does not prescribe patient representation in scientific governance 
  • In Italy, there are some specific guidelines produced by BBMRI Italy (see below)

BBMRI-ERIC Resources  #

Headquarters #

BBMRI-ERIC PPIE in Biobanking https://www.bbmri-eric.eu/news-events/new-publication-public-and-patient-involvement-and-engagement-ppie-in-biobanking/ 

It is a document which explicitly addresses the question of involving patients, caregivers and public representatives in biobank governance. Most importantly, in Principle 2 (page 7) it is stated that “Biobanks should engage and involve research participants in existing governance structures” such as Biobank Steering Committee, Scientific and Ethics Oversight Committee, Data and Sample Access Committee, Lay/Community Advisory Groups. It further states that participants can serve in an advisory capacity or, where appropriate, have decision-making rights alongside other members. So, the recommendation is to have patients/public representatives sitting within formal biobank governance structures, including scientific oversight committees. 

 The below resources have been developed by those included in the BBMRI network:    

Italy #

  • BBMRI.it: in 2019 it co-produced, together with all relevant stakeholders in the biobanking community, including patient and citizen representatives, a national guideline entitled “Access and Sharing: Towards Best Practices for Sharing (from Data to Results) in Research Biobanking”. The guideline is available here: https://repository.bbmri.it/s/6n92fsKDA84c8XY?dir=/&editing=false&openfile=true. The document includes specific sections on “Sharing Benefits – Community Sharing” and on the “Configuration and Composition of the Access Committee”. The latter establishes that at least one third of the committee members should be representatives of patients and citizens 

Hungary #

  • The Hungarian Biobank Node does (https://www.bbmri.hu/?utm) explicitly refers to engagement with stakeholders “from researchers to patients”, suggesting a broader commitment to stakeholder involvement rather than a formal committee requirement 

Germany #

External Resources   #

  • EUPATI – European Patients’ Academy on Therapeutic Innovation. EUPATI provides practical guidance on involving patients in research and development, including ethical review of clinical trials. Its guidance covers the roles of patients, carers and patient representatives, preparation and training, transparency, appropriate representation and the conditions necessary for meaningful involvement. Although the guidance is not biobank-specific legislation, it can be adapted when establishing patient participation in scientific and ethical committees. 
  • Telethon Network of Genetic Biobanks (TNGB), Italy. The Telethon Network of Genetic Biobanks has involved patient organisations in its governance and has had a patient representative on its Advisory Board. The role includes contributing to ELSI-related policies and procedures such as informed consent, privacy, sample/data ownership and access, and return of results. 
  • Radboud Biobank, Netherlands. Radboud Biobank provides an especially clear example of institutionalised patient representation. Its governance gives the patient a permanent voice: the chair of its Advisory Council is reserved for a patient representative, and a patient representative is also involved in the medical-ethical review structure (https://www.radboudumc.nl/en/research/technology-centers/radboud-biobank/patients see “Patients: an integral role”) 
  • RD-Connect / rare-disease biobanking. The European RD-Connect project provides another strong precedent. Patient representatives were integrated into governance, including a Patient Advisory Council and Patient and Ethics Council. An expert patient representative was also included in the Panel for Biobank Assessment, specifically to advise on biobank operations and facilitate understanding between biobanks and the patient community (https://cordis.europa.eu/project/id/305444/reporting/it) 

Relevant literature  #

  • Mitchell D, Geissler J, Parry-Jones A, Keulen H, Schmitt DC, Vavassori R, Matharoo-Ball B. Biobanking from the patient perspective. Res Involv Engagem. 2015 Jun 25;1:4. doi: 10.1186/s40900-015-0001-z. PMID: 29062493; PMCID: PMC5598087. 
  • Luna Puerta L, Kendall W, Davies B, Day S, Ward H. The reported impact of public involvement in biobanks: A scoping review. Health Expect. 2020 Aug;23(4):759-788. doi: 10.1111/hex.13067. Epub 2020 May 6. PMID: 32378306; PMCID: PMC7495079.  
  • Erikainen S, Friesen P, Rand L, Jongsma K, Dunn M, Sorbie A, McCoy M, Bell J, Burgess M, Chen H, Chico V, Cunningham-Burley S, Darbyshire J, Dawson R, Evans A, Fahy N, Finlay T, Frith L, Goldenberg A, Hinton L, Hoppe N, Hughes N, Koenig B, Lignou S, McGowan M, Parker M, Prainsack B, Shabani M, Staunton C, Thompson R, Varnai K, Vayena E, Williams O, Williamson M, Chan S, Sheehan M. Public involvement in the governance of population-level biomedical research: unresolved questions and future directions. J Med Ethics. 2020 Oct 6:medethics-2020-106530. doi: 10.1136/medethics-2020-106530. Epub ahead of print. PMID: 33023977. 
  • Simon CM, Newbury E, ‘heureux JL. Protecting participants, promoting progress: public perspectives on community advisory boards (CABs) in biobanking. J Empir Res Hum Res Ethics. 2011 Sep;6(3):19-30. doi: 10.1525/jer.2011.6.3.19. PMID: 21931234. 
  • Gilfoyle, M., et al. (2023). “Recruitment of patients, carers and members of the public to advisory boards, groups and panels in public and patient involved health research: a scoping review.” BMJ Open, 13:e072918.   
  • Riva L, Petrini C. Regulation (EU) 536/2014 and the role of ethics committees: a proposal for a review system model. BMJ Open. 2024 Nov 7;14(11):e073451. doi: 10.1136/bmjopen-2023-073451. PMID: 39510791; PMCID: PMC11552528. 
  • Klingmann I, Heckenberg A, Warner K, Haerry D, Hunter A, May M, See W. EUPATI and Patients in Medicines Research and Development: Guidance for Patient Involvement in Ethical Review of Clinical Trials. Front Med (Lausanne). 2018 Sep 7;5:251. doi: 10.3389/fmed.2018.00251. PMID: 30246010; PMCID: PMC6137130.
ELSI
Updated on 27 October, 2026
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