Featured Journal Content
Current Protocols in Human Genetics
Volume 108, Issue 1 December 2020
Informed Consent for Genetic and Genomic Research
Jeffrey R. Botkin email@example.com
First Published:17 November 2020
Genetic research often utilizes or generates information that is potentially sensitive to individuals, families, or communities. For these reasons, genetic research may warrant additional scrutiny from investigators and governmental regulators, compared to other types of biomedical research. The informed consent process should address the range of social and psychological issues that may arise in genetic research. This article addresses a number of these issues, including recruitment of participants, disclosure of results, psychological impact of results, insurance and employment discrimination, community engagement, consent for tissue banking, and intellectual property issues. Points of consideration are offered to assist in the development of protocols and consent processes in light of contemporary debates on a number of these issues.
Volume 53 Issue 1, January 2021
Comment | 07 January 2021
Toward better governance of human genomic data
Here, we argue that, in line with the dramatic increase in the collection, storage and curation of human genomic data for biomedical research, genomic data repositories and consortia have adopted governance frameworks to both enable wide access and protect against possible harms. However, the merits and limitations of different governance frameworks in achieving these twin aims are a matter of ongoing debate in the scientific community; indeed, best practices and points for consideration are notably absent in devising governance frameworks for genomic databases. According to our collective experience in devising and assessing governance frameworks, we identify five key functions of ‘good governance’ (or ‘better governance’) and three areas in which trade-offs should be considered when specifying policies within those functions. We apply these functions as a benchmark to describe, as an example, the governance frameworks of six large-scale international genomic projects.
Kieran C. O’Doherty, Mahsa Shabani[…] & Wylie Burke
Journal of Law, Medicine & Ethics
Volume 48, Issue 1, pages 172–182 (Spring 2020)
From “Informed” to “Engaged” Consent: Risks and Obligations in Consent for Participation in a Health Data Repository
Jan 7, 2021
Elizabeth Bromley, Alexandra Mendoza-Graf, Sandra H. Berry, Camille Nebeker, Dmitry Khodyakov
The development and use of large and dynamic health data repositories designed to support research pose challenges to traditional informed consent models. We used semi-structured interviewing (n=44) to elicit diverse research stakeholders’ views of a model of consent appropriate to participation in initiatives that entail collection, long-term storage, and undetermined future research use of multiple types of health data. We demonstrate that, when considering health data repositories, research stakeholders replace a concept of consent as informed with one in which consent is engaged. In engaged consent, a participant’s ongoing relationship with a repository serves as a substitute or adjunct to information exchange at enrollment. We detail research stakeholders’ views of the risks of engaged consent and suggest questions for further study about engagement and consent procedures in initiatives that aim to store data for future unspecified research purposes.