Harmonising the human biobanking consent process: an Irish experience

Abbreviations

EU: European Union; GDPR: General Data Protection Regulation; HRR: Health Research Regulation; HRDPN: Health Research-Data Protection Network; ICF: Informed Consent Form; NBWG: National Biobanking Working Group; PIL: Participant Information Leaflet; PVCR: Patient Voice in Cancer Research; REC: Research Ethics Committee

Disclaimer

The views expressed in this article are those of the authors. Publication in HRB Open Research does not imply endorsement by the Health Research Board of Ireland.

Background

In the context of health research, biobanks are managed repositories of human biological samples and associated health data, which are collected, stored and used to facilitate scientific and medical research¹. Biobanks are an important component of clinical research in many disease areas and often represent the first step toward innovative treatments^2,3.

For biobanks to operate, researchers need human participants to voluntarily give their biological samples and relevant health data. In line with internationally accepted ethical standards in clinical research such as the Declaration of Helsinki⁴, in Ireland, participants must provide their freely-given informed consent for these samples and data to be taken and used for research purposes⁵. Research staff are responsible for communicating the relevant information to participants and ensuring participants understand the information they have been provided with before participants give their consent. This communication process is supported by Participant Information Leaflets/Informed Consent Forms (PILs/ICFs). PILs/ICFs should be concise⁶, intelligible⁵, and along with the conversation with the research staff, should give the relevant information so that a layperson can determine if they want to take part⁴. However, clinical research PILs/ICFs are becoming longer^7,8 and in the view of the authors of this letter, are not primarily written to meet the needs of a layperson. While the use of visuals to explain important or complex concepts is strongly recommended^9–11, they are often under-utilised in clinical research PILs/ICFs¹². This was identified as a limitation of current biobank PIL/ICFs in use nationally. The Irish Health Research Regulations (HRR)⁵ mandate suitable and specific measures for the processing of personal data for the purposes of health research in addition to the statutory obligations of the European Union (EU) General Data Protection Regulation (GDPR)^13–15. These pieces of legislation have presented additional challenges to research biobankers who aspire to provide clear, concise information which supports the decision-making of potential research participants.

Biobank-based research is frequently investigative in nature, and therefore, the research aims are often broad. Biobank research increasingly yields genetic findings, the relevance of which may be unclear at the time of the analysis. These factors, among others, present additional challenges to ensure that participant consent is informed, while simultaneously ensuring that researchers have the freedom to explore and adapt their research as findings emerge, thus ensuring clinical research continues to advance, achieving the maximum possible information from the samples and data. Research staff are obliged and wish to provide information to participants in a clear and comprehendible way. However, research staff alone may not always be the best judge of what is understandable to the general public. Therefore, it is crucial that members of the general public and patients are involved in co-producing patient-facing documents, including clinical research PILs/ICFs. It can also be challenging for research ethics committees (RECs) and data protection officers to ensure that all of the required information is included in PILs/ICFs due to differing templates produced and wording favoured by individual institutions.

The biobank community came together in Ireland in early 2018, prior to the application of the GDPR legislation and a number of individuals subsequently volunteered to be part of the National Biobanking Working Group (NBWG). The NBWG was established in May 2019, originally under the auspices of Clinical Research Development Ireland. The group consists of members from diverse research backgrounds who are located in universities, hospitals and research centres across Ireland, and a public/patient partner. Each member has a special interest in making information about health research biobanks accessible and understandable to members of the public. The NBWG was established at a crucial juncture in the Irish health research landscape just after the implementation of new EU data protection legislation (GDPR)¹⁵, Irish health research legislation (HHR)⁵ and also the publication of the first international biobanking standard International Organization for Standardization (ISO) 20387: 2018¹⁶. The main aim of the NBWG was to address foreseen challenges for compliance brought about by the new legislation and jointly work towards an improved understanding of the reshaping of the biobank landscape in Ireland.

The NBWG has developed a suite of tools and resources, including infographics, a video, a general biobanking awareness leaflet and single PIL/ICF template specifically designed for health research biobanks, via robust and meaningful public and patient engagement, which could be used nationally. The NBWG also seeks to engage with members of the public and patients to increase awareness about the value of taking part in research biobanks. The inclusive and unified approach taken by the NBWG removes the need for multiple biobanks within Ireland to develop their own resources separately, a process which can be time-consuming and costly.

The aim of this open letter is to describe the process whereby a national template for a biobank PIL/ICF was co-produced with public-patient partners.

Development of the PIL/ICF template

The NBWG initially convened via teleconference in May 2019. One significant challenge raised during this inaugural meeting was the lack of a standardized PIL/ICF template that could be used by all biobanks throughout Ireland. As informed consent is the cornerstone of all research, including biobanking, the group decided to prioritize this development.

To undertake this task, it was determined that the NBWG would meet on a bimonthly or monthly basis, initially in person, and subsequently via videoconference due to COVID-19 pandemic restrictions. As a starting point, the group collated and reviewed more than eight RECs-approved biobank PIL/ICF templates in use at that time across Irish universities and hospitals. A PIL/ICF developed by Cancer Trials Ireland, the leading cancer research organisation in Ireland was also reviewed¹⁷. Based on the review process, it was agreed to divide the template PIL into two sections deemed most important (explained below). The group then reviewed and amended each section, using an iterative process, to ensure that the resulting template was applicable to a broad range of biobank research, disease areas and research environments (hospitals, academic institutions, not for profit organisations etc) within Ireland. The two sections were as follows:

These two sections of the PIL are followed by the ICF, which is divided into two sections that correspond with the sections in the PIL (as described above).

Best practice guidelines for communicating clearly with laypersons, including the National Adult Literacy Agency (NALA) guidelines¹⁸ were incorporated. For example, sentences were written in the active voice; plain, commonly used words were included whenever possible, and the section headings were posed as conversational-style questions to prompt pre-processing of information. Guidelines for optimal layout were also incorporated, such as using adequate line spacing and font size. Bold font was used for section headings as it is more accessible for dyslexic readers and those with literacy challenges, rather than underlining and all-capitals^19–21. The group valued input from all members, but particularly from our public-patient partner to ensure that the language and content was understandable and relevant to research participants. The group informally shared the PIL/ICF with a selection of friends and family members who are neither medical professionals nor currently attending a hospital. It is important that those without regular medical contact or a previous diagnosis can understand the PIL/ICF, as individuals are often presented with the option of joining a biobank prior to confirmation of disease diagnosis.

The group decided to include a glossary of key terms at the beginning of the PIL/ICF template to which readers could refer. Terms which laypersons may not be familiar with, such as ‘coded data’ and ‘identifiable data’ were included. To assess how well the template worked, the group decided to apply it to a well-established biobank at St James’s Hospital, Dublin; biobank-specific and site-specific information was added. Once the provisional content was decided, the group invited a professional graphic designer to design an infographic (see Figure 1).

Figure 1. Infographic from the PIL/ICF template – How a biobank can help future patients.

) to explain how a health research biobank works. The graphic designer is a graduate of the Irish Platform for Patient Organisations, Science and Industry (IPPOSI) Patient Education Programme²². They created a graphic with the participant at the centre of biobanking “where their voice and perspective is being seen and used as a valuable resource for the biobank”. The graphic highlights benefits to the participant and the wider society. A larger infographic was also developed which included some relevant facts about biobanks and health research (see Extended data: Supplementary File 1²³).

Evaluation of the draft PIL/ICF template

Implementing the PIL/ICF template

Some research groups have adopted the template PIL/ICF and it has been submitted for approval to various local RECs. Established biobanks have also requested the documents for use at their institutions. The PIL/ICF template has received positive feedback from the biobank community and the patient advocacy community. We welcome requests for use and feedback from other researchers or patient groups.

The infographic and biobank awareness leaflet (see Extended data: Supplementary File 4²³) are currently in use in Irish Cancer Society Daffodil Centres, several research centres and hospital clinics nationally.

Limitations

There are some limitations to this project. The PIL/ICF template developed by this group is intended for adult readers with the capacity to consent. Therefore, additional and/or different considerations will be needed for PIL/ICFs for children or adults lacking the capacity to give their consent. However, the process for the design and evaluation of a PIL/ICF could easily be adapted to facilitate stakeholder engagement for children and vulnerable research participants. While this PIL/ICF template was designed with the health research biobank in mind, the overall structure and much of the content could be applied to other forms of health research.

Future directions

The experience of the NBWG members is that the standard data protection information included in biobank PILs is often too complicated and poorly understood by research participants. For this reason, the group attempted to use easy-to-understand language and to explain terminology, which is not in common use. To receive feedback on this aspect, the group intends to submit the PIL/ICF to the NALA for a full review. In addition, the group hopes to receive feedback from the Data Protection Commission on the accuracy of the explanations of the data protection terminologies. Ongoing work is focused on the production of a video version of the PIL/ICF specifically aimed at making the information more accessible to individuals with literacy challenges. Finally, the group hopes that the newly-developed biobank PIL/ICF template will eventually be adopted nationally as a standardised template, with the option to accordingly adapt it for specific patient groups. Ideally the group would favour a national standardised suite of documents and are willing to engage with other public/ patient groups, including those representing minorities such as those with disabilities and members of the travelling community, to achieve this goal.

Data availability