Informed consent (IC) is key to generating and maintaining research participants' trust and upholding the ethical principle of autonomy. Broad consent for future use, wherein researchers ask participants for permission to share participant-level data and samples collected within the study for purposes loosely related to the study objectives, is central to enabling ethical data and sample reuse. Ensuring that participants understand broad consent-related language is key in maintaining trust in the study itself and in public health research generally. Therefore, we conducted 52 cognitive interviews with the help of semi-structured interview guides to explore cohort research participants' understanding of the broad consent-related language in the University of California at Berkeley template IC form for biomedical research with participants from long-standing infectious disease cohort studies in Nicaragua and Colombia. After the first round of interviews, we used participants' explanations to modify the broad consent-related language in the IC template and consequently re-evaluated participants' understanding of and agreement with the new consent form. Participants generally supported data and sample sharing but expressed concerns about the intentions of for-profit groups as well as misuse of data or samples. Moreover, they felt uncomfortable not receiving information about incidental findings and results from future studies. Cohort participants did not understand abstract concepts including the collection and reuse of genetic data in either version of the IC. Trust in the research team and the belief that data and sample sharing could lead to new scientific insights and improved treatments were key to participant support for data and sample sharing. The study findings and research participants' language to describe broad consent provide essential insights for researchers who want to include broad consent and ethics review committees (ERCs) working to ensure research is conducted in keeping with the ethical principle of respect for persons.

The authors have declared no competing interest.

https://osf.io/uxvhk/

The Understanding and Evaluating Broad Consent for Future Use-related Language Study is part of the ReCoDID project, funded by the European Union Horizon 2020 Research and Innovation Programme (grant agreement 825746) and the Canadian Institute of Health Research Institute of Genetics (grant agreement 01886-000). The funder had no role in the design, execution, or dissemination of this research.

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study protocol and forms were approved by the Centro de Atención y Diagnóstico de Enfermedades Infecciosas- INFOVIDA (Bucaramanga, Colombia), Instituto de Ciencias Sostenibles (Managua, Nicaragua), and Universitätsklinikum Heidelberg (Heidelberg, Germany) ethics review committees.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

The study protocol and interview guides are available in Spanish and English on the OSF website (DOI 10.17605/OSF.IO/UXVHK). The de-identified cognitive interview study transcripts were uploaded to openICPSR (https://doi.org/10.3886/E173322V2).

https://doi.org/10.3886/E173322V2

https://osf.io/uxvhk/