Guidance for ensuring fair and ethical broad consent for future use. A scoping review protocol.

Background

Research funders¹, regulatory agencies, and journals^2,3 are increasingly advocating for and requiring that participant-level data obtained from various forms of health research are shared to maximize their utility. The advantages of sharing data include improving research transparency, facilitating innovation and the conduct of subgroup analyses, and reducing the burden and costs of unnecessary duplication of research^4,5. The public health benefits of sharing data for purposes other than those for which the data were collected, i.e. future use of data, must be balanced with the risk to research participants and the team that collected the data and legal, equity, and ethical concerns, including re-identifiability, incidental findings, benefit sharing, and respecting community values^6–8. These concerns are especially important for researchers and communities in low-and-middle-income countries (LMIC) who may experience a disproportionate proportion of the burden related to data sharing without the same level of benefits as those received by research participants and their communities and researchers in higher income countries^7,8.

Informed consent speaks directly to the core principle of respect for persons and is of central importance to the ethical conduct of human subjects research⁹. Broad consent for future use is a type of informed consent whereby participants are asked to prospectively agree to the use of data or samples derived from them by unspecified groups for unspecified purposes that are not necessarily related to the objectives of the original study, pending the development or establishment of ethically sound governance for said sharing^10,11. The wording used for broad consent explicitly states or implies that participants will not be re-contacted when sharing their data or samples. While ensuring that the benefits of data or sample sharing outweigh the risks to research participants, researchers and ethics review committees (ERCs) must also take care to ensure that participants understand and agree to data and sample sharing¹².

Data sharing can both engender and undermine participants’ trust in the research process. For example, data sharing may accelerate innovations that directly benefit research participants or lead to improved treatments that are only accessible to high income populations¹³. While the Council for International Organizations of Medical Sciences’ (CIOMS) published guidance for the application of broad consent in 2016, there is a need to supplement this guidance through understanding best practice as it relates to ensuring research participants and their communities understand broad consent for future use and define and realize the benefits of data and sample sharing and that different stakeholders’ interests, risks, and benefits are recognized and addressed in the application of broad consent for future use.

Study rationale and objectives

In this scoping review, we will summarize empirical findings from primary research and other forms of guidance from international stakeholder groups related to: 1) recommendations around when broad consent should or should not be applied, 2) how to ensure ethical and equitable implementation of broad consent; and 3) and recommended language for broad consent in the health research context. Several prior evidence synthesis efforts have summarized attitudes and best practice related to data sharing. This rapid evidence synthesis will allow for the identification of existing resources for helping ERCs and research teams and communities understand and implement best practice for broad consent for future use and to identify priority areas for future research. This research responds to the challenges faced by researchers and ERCs who must ensure the voluntary and informed participation in the research that they conduct or review and balance the risks and benefits that data sharing represents to different stakeholders while responding to the public health imperative or journal or funder requirements to share data and biological samples derived from clinical trial participants. Findings will be used to develop a research agenda for better addressing key concerns in the ethical and equitable application of broad consent for future use, including re-identifiability, incidental findings, community and research team engagement, and benefit sharing.

Review methods

Scoping reviews provide a broad overview of existing literature and may be used to identify priority areas for further exploration in a subsequent systematic review¹⁴. The key scoping review questions are based on a review of the literature and feedback from subject matter experts and will be updated as needed based on the scoping review findings. This scoping review will follow the Arksey and O’Malley approach to scoping reviews¹⁵ and will present the results in keeping with the PRISMA Extension for Scoping Reviews guidance (PRISMA-ScR)¹⁶. We will undertake the following steps, from Levac, et al.’s recommendations for the conduct of scoping reviews:¹⁷

This scoping review protocol was developed in keeping with the PRISMA-P guidelines¹⁸.

Stage I: Identifying the research question

The initial review questions were developed with feedback from members of the Reconciliation of Cohort Data in Infectious Disease (ReCoDID) and COVID-19 Clinical Data Research Consortia and the Special Programme for Research and Training in Tropical Diseases (TDR), research groups and an international organization that work on public health data sharing with a focus on ethical and equitable sharing of data and samples collected by research teams in LMIC.

Stage II: Identifying relevant studies

In order to identify studies relevant to the subject of this review, we will systematically search the following electronic databases: Ovid (Medline), Cumulative Index to Nursing and Allied Health Literature (CINAHL), and Web of Science. Search strategies include a combination of text and MeSH terms, tailored for each database. Searches will be limited to published papers from the year 2000 onward in order to capture recent broad consent-related studies but will not be restricted by geography or language of publication. We will also search Google and the websites of national or international bodies whose work focuses on data sharing for guidance documents (e.g. Wellcome Trust, Bill and Melinda Gates Foundation, CIOMS). Search results from each database will be imported to EndNote X9 and duplicates will be removed. We will apply snowball sampling wherein we search the reference lists of included studies or related systematic reviews for additional eligible studies. If warranted, the search will be updated and reconducted to further explore emerging research questions. The search strategy for each database is presented in Table 1.

Stage III: Study selection and eligibility criteria

Citations will be exported to EndNote for deduplication. Title and abstract screening will be conducted independently by two reviewers. Review of full texts for inclusion will be conducted independently by two reviewers and may result in changes to the inclusion criteria, in accordance with the iterative nature of a scoping review. Title-abstract screening, full text screening, and data extraction will be managed in Covidence¹⁹. Inter-reviewer disagreements in the title-abstract or full text screening will be resolved by a third reviewer.

Stage IV: charting the data

We will develop and pilot a charting form to facilitate the descriptive synthesis of scoping review findings prior to beginning the charting process. We will extract the key data detailed in Table 2 from included studies to facilitate the summary of available guidance and existing gaps in the literature. We will pilot the data extraction forms using two-three full text articles. Data extraction and charting will completed independently by two reviewers, in keeping with best practice. We will not include an assessment of the quality of included studies. The full text of included studies will be exported to MAXQDA 2020²⁰ for thematic analysis using deductive codes and inductive codes that emerge from the review of full text articles.

Stage V: collating, summarising and reporting results

Results from the data charting work will be presented in narrative form. A PRISMA flow diagram will be used to report the final number of included studies in the review and basic study information will be presented in table format. The results summary will present both quantitative and qualitative aspects of included studies.

Stage VI: consultation, patient & public involvement

A group of experts in the field of data sharing and broad consent for future use will inform the analysis and summary of findings and assist with the dissemination of any recommendations. Research findings will be shared publicly through a webinar and through the websites of partner institutions.

Ethics and dissemination

No ethical approval is required for this systematic review as published articles, rather than primary data, will be used in the analyses. Findings will be presented in an Open Access publication and disseminated on the COVID-19 Clinical Data Consortium’s website and through Twitter.

Study status

The current study status and anticipated timeline are presented in Table 3.

Conclusion

The global coronavirus disease 2019 (COVID-19) pandemic has foregrounded the public health importance of sharing participant-level data and samples. In response to the urgent need for supplementary guidance to support the inclusion of broad consent for future use in research protocols and informed consent forms, we will review and summarize empirical research and guidance related to broad consent for future use of data or samples collected in health-related research. By applying best practice to a rapid scoping review, we hope to facilitate the ethical and equitable application of broad consent for future use in the public health research response to COVID-19.

Data availability