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Exploring broad consent in the context of the 100,000 Genomes Project: a mixed methods study.

ABSTRACT: The 100,000 Genomes Project (100kGP)-a hybrid clinical-research initiative-was set up to analyse whole-genome sequences (WGS) from patients living with a rare disease or cancer. The project positioned participant consent as being of central importance, but consent in the context of genomic testing raises challenging issues. In this mixed method study, we surveyed 1337 100kGP participants regarding their experiences of taking part in the project and conducted in-depth interviews with 24 survey respondents to explore these findings further. Survey responses were analysed using descriptive statistics and interview data were analysed thematically. The consent approach of the 100kGP resulted in a proportion of our study's participants not understanding the complexities of the project and what types of results they might receive; for example, 20% of participants who we surveyed from the cancer arm did not recall what decisions they had made regarding additional findings. It is not surprising that a project such as this, with such diverse aims and participant groups, would throw up at least some challenges. However, participants reported being satisfied with their experience of the project to date. Our study highlights that in the context of consent for more complex endeavours, such as the 100kGP, it is important to assess (and document) an agreement to take part, but complicated decisions about what and when to communicate may need revisiting over time in response to changing contexts. We discuss the implications of our findings with reference to participants of the 100kGP and the newly formed NHS Genomic Medicine Service.

SUBMITTER: Ballard LM

PROVIDER: S-EPMC7253456 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ObjectiveA mixed-methods study exploring the UK general public's views towards consent for the use of biosamples for biomedical research.SettingCross-sectional population-based focus groups followed by an online survey.Participants12 focus groups (81 participants) selectively sampled to reflect a range of demographic groups; 1110 survey responders recruited through a stratified sampling method with quotas set on sex, age, geographical location, socioeconomic group and ethnicity.Main outcome measures(1) Views on the importance of consent when donating residual biosamples for medical research; (2) preferences for opt-in or opt-out consent approaches and (3) preferences for different consent models.ResultsParticipants believed obtaining consent for use of residual biosamples was important as it was 'morally correct' to ask, and enabled people to make an active choice and retain control over their biosamples. Survey responders preferred opt-in consent (55%); the strongest predictor was being from a low socioeconomic group (OR 2.22, 95% CI 1.41 to 3.57, p=0.001) and having a religious affiliation (OR 1.36, 95% CI 1.01 to 1.81, p=0.04). Focus group participants had a slight preference for opt-out consent because by using this approach more biosamples would be available and facilitate research. Concerning preferred models of consent for research use of biosamples, survey responders preferred specific consent with recontact for each study for which their biosamples are eligible. Focus group participants preferred generic consent as it provided 'flexibility for researchers' and reduced the likelihood that biosamples would be wasted. The strongest predictor for preferring specific consent was preferring opt-in consent (OR 4.58, 95% CI 3.30 to 6.35, p=0.015) followed by non-'White' ethnicity (OR 2.94, 95% CI 1.23 to 7.14, p<0.001).ConclusionsThere is a preference among the UK public for ongoing choice and control over donated biosamples; however, increased knowledge and opportunity for discussion is associated with acceptance of less restrictive consent models for some people.

Project description:BackgroundDigital stories-first-person, self-made, 2- to 3-minute videos-generate awareness, impart knowledge, and promote understanding on topics such as mental illness. Digital stories are a narrative-based art form often created by individuals without formal training in filmmaking to relate personal experiences. Somewhat like digital narratives, video testimonies created within the social marketing or fundraising campaigns of government agencies and private or public corporations aim to reduce the stigma of mental illness while supporting research and services. In video testimonies, personal stories are captured on camera by professional filmmakers. Sharing critical life events greatly benefits tellers and listeners alike, supporting catharsis, healing, connectiveness, and citizenship.ObjectiveThis study explores digital stories and video testimonies featuring mental illness and recovery in their ability to elicit empathy and compassion while reducing stigma among viewers.MethodsUsing mixed methods, phase 1 will involve a search of Canadian social marketing activities and fundraising campaigns concerning mental illness and recovery. Phase 2 will involve the organization of digital storytelling workshops in which participants will create digital stories about their own experiences of mental illness and recovery. In phase 3, a pilot randomized controlled trial will be undertaken to compare marketing and fundraising campaigns with digital stories for their impact on viewers, whereas phase 4 will focus on knowledge dissemination.ResultsEthics approval for this study was received in March 2021. Data on the feasibility of the study design and the results of the controlled trial will be generated. This study will produce new knowledge on effective ways of promoting mental health awareness and decreasing stigma, with practical importance for future social marketing and fundraising campaigns. The anticipated time for completion within the 2-year study period includes 9 months for phase 1 (knowledge synthesis activities identifying social marketing and fundraising campaigns) and phase 2 (storytelling workshops), 11 months for phase 3 (feasibility assessment and data collection: randomized controlled trial), and 2 months for phase 4 (knowledge dissemination).ConclusionsThe knowledge generated will have practical implications for the public and for future social marketing and fundraising campaigns promoted by government agencies as well as nonprofit and for-profit organizations by enhancing our understanding of how individuals and societies respond to stories of mental distress and what prompts citizens to help others.Trial registrationClinicalTrials.gov NCT04881084; https://clinicaltrials.gov/ct2/show/NCT04881084.International registered report identifier (irrid)PRR1-10.2196/33525.

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Exploring broad consent in the context of the 100,000 Genomes Project: a mixed methods study.

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