Harmonising the human biobanking consent process: an Irish experience

Abbreviations

ICF: Informed Consent Form; NBWG: National Biobanking Working Group; PIL: Participant Information Leaflet;

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. (For the purposes of this article, we define laypersons to be members of the public who, due to their background, may not be familiar with aspects of the research process. These individuals may have a wealth of knowledge from their lived experience but are not generally familiar with e.g., research terminology, or the role of the health research biobank. This means that these individuals may find it difficult to understand written or verbal information if it is not simple and free of jargon.) 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. Systematic reviews have shown that clinical research participants often have not understood important aspects of a research study they have agreed to take part in 9, 10, particularly those with literacy challenges¹¹. While the use of visuals to explain important or complex concepts is strongly recommended^12,13, they are often under-utilised in clinical research PILs/ICFs¹⁴. This was identified as a limitation of current biobank PIL/ICFs in use nationally. The Irish Health Research Regulations⁵ 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 General Data Protection Regulation^15–17. 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. For example, this legislation requires that additional information about data protection measures should be provided to research participants. While we welcome research participants being provided with all the pertinent information about their data protection rights, we have found that this additional information is often provided in a format which is not well understood by laypersons. For example, legal jargon is often used and the use of the passive voice, verb nominalisations etc, can make it difficult to understand.

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 comprehensible 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^18–20. It can also be challenging for research ethics committees 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 in Ireland came together in early 2018, prior to the application of the General Data Protection Regulation legislation and several 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. Group members are involved in maternal, infant, paediatric, adult and older adult research areas. The public/patient member is a patient advocate who doesn’t have a scientific, medical or research background and is therefore ideally placed to represent the perspectives of laypersons. The NBWG was established at a crucial juncture in the Irish health research landscape just after the implementation of new European Union data protection legislation (General Data Protection Regulation)¹⁷, Irish health research legislation (Health Research Regulations)⁵ and also the publication of the first international biobanking standard International Organization for Standardization (ISO) 20387: 2018²¹. The main aim of the NBWG was to address foreseen challenges for compliance brought about by the new legislation and to 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 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 adopted nationally. The group also developed a video which describes some of the research at St James’ Hospital, Dublin and Trinity College Dublin: https://www.stjames.ie/cancer/research/biobanknetwork/ This video aims to increase awareness of the importance of health research biobanks, and has been shared widely on social media and is played in multiple waiting rooms in St James’ Hospital, Dublin. 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 by the NBWG, with public-patient partners from the Patient Voice in Cancer Research. While we recognise that regulatory and research governance requirements, and cultural perspectives will vary between countries, the process may be of interest to other countries seeking to develop a national template.

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 research ethics committee-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 reviewed 22. Based on the review process, it was agreed to divide the template PIL into three sections deemed most important (explained below). The group then reviewed and amended each section, using an iterative process, ensuring 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 NBWG’s public-patient member was involved in every stage of the development and review process and in particular advised on whether language was understandable and relevant to research participants. The three sections were as follows:

These three sections of the PIL are followed by the ICF, which is divided into two sections.

Best practice guidelines for communicating clearly with laypersons, including the National Adult Literacy Agency (NALA) guidelines²³ 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^24–26. The group valued input from all members, but particularly from our public-patient member 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 personnel 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) ) 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 Programme²⁷. The graphic was created with the participant at the centre of biobanking and highlights the 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 1²⁸.

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

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 research ethics committees. 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 4²⁸) 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, lengthy 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 National Adult Literacy Agency 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, using insights gained from the patient-public partners as part of this project, 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. The NBWG welcomes feedback from users of the PIL/ICF template and informal or formal evaluations of the template’s effectiveness. 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