Evidence map›Paper›PMID 32342789›Full record

ArticleThe Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics2020

From "Informed" to "Engaged" Consent: Risks and Obligations in Consent for Participation in a Health Data Repository.

Elizabeth Bromley, Alexandra Mendoza-Graf, Sandra Berry, Camille Nebeker, Dmitry Khodyakov

Abstract read
PubMed Publisher
In one paragraph

Article in The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Review
  2. Considerations for the Design of Informed Consent in Digital Health Research: Participant Perspectives.Journal of empirical research on human research ethics : JERHRE · 2024
    Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. What Should We Be Asking of Informed Consent?The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics · 2020
    Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Elizabeth BromleyElizabeth Bromley, M.D., Ph.D., is Associate Professor in Residence in the Departments of Psychiatry and Anthropology at the University of California, Los Angeles. Alexandra Mendoza-Graf, M.A., is an Assistant Policy Researcher at RAND and Doctoral Fellow at the Pardee RAND Graduate School in Los Angeles, CA. Her research focuses on the social determinants of health. Sandra Berry, M.A., is a senior behavioral scientist at RAND Corporation and senior director of RAND's Survey Research Group. Camille Nebeker, Ph.D., is Director of the Research Center for Optimal Digital Ethics (ReCODE.health) at UC San Diego. Her faculty appointment is with the Division of Behavioral Medicine in the Department of Family Medicine and Public Health at UC San Diego. Dmitry Khodyakov, Ph.D., is a Senior Behavioral/Social Scientist at the RAND Corporation. His research focuses on research ethics, partnered research, stakeholder engagement, and methods of expert elicitation.
Alexandra Mendoza-GrafElizabeth Bromley, M.D., Ph.D., is Associate Professor in Residence in the Departments of Psychiatry and Anthropology at the University of California, Los Angeles. Alexandra Mendoza-Graf, M.A., is an Assistant Policy Researcher at RAND and Doctoral Fellow at the Pardee RAND Graduate School in Los Angeles, CA. Her research focuses on the social determinants of health. Sandra Berry, M.A., is a senior behavioral scientist at RAND Corporation and senior director of RAND's Survey Research Group. Camille Nebeker, Ph.D., is Director of the Research Center for Optimal Digital Ethics (ReCODE.health) at UC San Diego. Her faculty appointment is with the Division of Behavioral Medicine in the Department of Family Medicine and Public Health at UC San Diego. Dmitry Khodyakov, Ph.D., is a Senior Behavioral/Social Scientist at the RAND Corporation. His research focuses on research ethics, partnered research, stakeholder engagement, and methods of expert elicitation.
Sandra BerryElizabeth Bromley, M.D., Ph.D., is Associate Professor in Residence in the Departments of Psychiatry and Anthropology at the University of California, Los Angeles. Alexandra Mendoza-Graf, M.A., is an Assistant Policy Researcher at RAND and Doctoral Fellow at the Pardee RAND Graduate School in Los Angeles, CA. Her research focuses on the social determinants of health. Sandra Berry, M.A., is a senior behavioral scientist at RAND Corporation and senior director of RAND's Survey Research Group. Camille Nebeker, Ph.D., is Director of the Research Center for Optimal Digital Ethics (ReCODE.health) at UC San Diego. Her faculty appointment is with the Division of Behavioral Medicine in the Department of Family Medicine and Public Health at UC San Diego. Dmitry Khodyakov, Ph.D., is a Senior Behavioral/Social Scientist at the RAND Corporation. His research focuses on research ethics, partnered research, stakeholder engagement, and methods of expert elicitation.
Camille NebekerElizabeth Bromley, M.D., Ph.D., is Associate Professor in Residence in the Departments of Psychiatry and Anthropology at the University of California, Los Angeles. Alexandra Mendoza-Graf, M.A., is an Assistant Policy Researcher at RAND and Doctoral Fellow at the Pardee RAND Graduate School in Los Angeles, CA. Her research focuses on the social determinants of health. Sandra Berry, M.A., is a senior behavioral scientist at RAND Corporation and senior director of RAND's Survey Research Group. Camille Nebeker, Ph.D., is Director of the Research Center for Optimal Digital Ethics (ReCODE.health) at UC San Diego. Her faculty appointment is with the Division of Behavioral Medicine in the Department of Family Medicine and Public Health at UC San Diego. Dmitry Khodyakov, Ph.D., is a Senior Behavioral/Social Scientist at the RAND Corporation. His research focuses on research ethics, partnered research, stakeholder engagement, and methods of expert elicitation.
Dmitry KhodyakovElizabeth Bromley, M.D., Ph.D., is Associate Professor in Residence in the Departments of Psychiatry and Anthropology at the University of California, Los Angeles. Alexandra Mendoza-Graf, M.A., is an Assistant Policy Researcher at RAND and Doctoral Fellow at the Pardee RAND Graduate School in Los Angeles, CA. Her research focuses on the social determinants of health. Sandra Berry, M.A., is a senior behavioral scientist at RAND Corporation and senior director of RAND's Survey Research Group. Camille Nebeker, Ph.D., is Director of the Research Center for Optimal Digital Ethics (ReCODE.health) at UC San Diego. Her faculty appointment is with the Division of Behavioral Medicine in the Department of Family Medicine and Public Health at UC San Diego. Dmitry Khodyakov, Ph.D., is a Senior Behavioral/Social Scientist at the RAND Corporation. His research focuses on research ethics, partnered research, stakeholder engagement, and methods of expert elicitation.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

Biological Specimen BanksBiomedical ResearchFemaleHumansInformation Storage and RetrievalInformed ConsentInterviews as TopicMaleStakeholder Participation

Identifiers

PMID32342789

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.