Disentangling informing participants from obtaining their consent
Experience Report
Patricia Pearl O’Rourke, Joseph Ali, Judith Carrithers, David Magnus, Benjamin S. Wilfond, Sheana Bull, Laura M. Dember, Gail D’Onofrio, Julie Goldman, P. Michael Ho, Edward R. Melnick, Karen L. Staman, James A. Tulsky, Miguel A. Vazquez, Angelo Volandes, David Wendler
Learning Health Systems, 21 April 2025
Open Access
Abstract
Introduction
Pragmatic clinical trials conducted in the context of routine care frequently satisfy the regulatory criteria for a waiver of research consent. When they do, investigators and Institutional Review Boards might assume that there is no reason to communicate any information regarding the study to participants. Yet, this approach ignores the possibility that there may be value in providing information to participants, even when the study does not pose significant risks and researchers are not obtaining their consent.
Methods
Members of the NIH Collaboratory Ethics and Regulatory Core working group used ethical analysis to determine whether there are reasons to provide information to research participants, other than notifying them of significant risks or obtaining their consent. Study team members then provided examples of trials which illustrate the feasibility and different options for providing information to participants in the context of trials conducted with a waiver of research consent.
Results
Communicating information to participants can promote one or more of six goals: respect for persons, participant understanding of the research, participant understanding of their contributions, participant ability to voice any concerns, participant engagement, and trust and trustworthiness. Providing information can also raise potential concerns about feasibility and cost, which need to be balanced against these reasons to inform participants. Depending on the study, a variety of methods can be used to communicate information; for example, letters, email, flyers, posters, as well as brief conversations with clinicians.
Conclusion
Even when researchers are not obtaining participants’ consent, communicating information can promote one or more of six important goals. Providing information to participants should thus be the default for trials conducted under a waiver of research consent.

Human artificial placenta technology-trials: counselling and informed consent using healthcare professionals’ and parental perspectives
Basic Science Article
Angret de Boer, André Krom, Rania Kalaai, Marieke de Vries, Marije Hogeveen, Sylvia A. Obermann-Borst, Marijn Vermeulen, Juliette S. van Haren, Peter Andriessen, Martine C. de Vries, E. J. T. Verweij, Rosa Geurtzen
Pediatric Research, 16 April 2025
Abstract
Background
The Artificial Amnion and Placenta Technology (AAPT) is developed to improve outcomes of extremely premature birth, with first in-human trials expected in the coming years. Empirical research with key stakeholders is essential for responsibly designing these trials. This study aims to discuss considerations for counselling and informed consent for the first in-human trials of the AAPT, discussing legal and ethical considerations.
Methods
A qualitative study using both individual and focus group interviews with healthcare professionals (HCPs) and parents was performed. Interviews were thematically analysed.
Results
Fifteen parents and 46 HCPs were interviewed. The results are represented into key themes reflecting participants’ perspectives on: (I) the moral and legal status of the subject treated in AAPT trials, (II) the first participant: the pregnant person, and (III) the terminology used to describe the technology. Furthermore, considerations around the informed consent process and counselling, including parental hope, are described. The findings suggest these factors are interconnected, as the moral and legal context surrounding AAPT trials influences the approach to counselling and informed consent.
Conclusion
Resolving key ethical and legal issues important for counselling and informed consent is essential for establishing parental right and the development of a responsible, ethically sound informed consent process.

Impact

• Addressing ethical and legal issues surrounding counseling and informed consent is essential to safeguard a responsible and ethically sound consent process for future human artificial amnion and placenta technology (AAPT)-trials.
• This is the first study exploring stakeholder perspectives on the AAPT, highlighting the complexities in counselling and informed consent, such as the moral status of participants and the rights of all parties, which must be carefully navigated before trial designs can progress.
• The article underscores the importance of establishing consensus and maintaining open dialogue among all stakeholders to create a robust, ethically grounded framework for informed consent in future trials.

Towards Excellence: Virtue and the Principle of Autonomy in Informed Consent for Clinical Trials
Alexander Montes
The Journal of Medicine and Philosophy, 1 April 2025
Abstract
In this article, I argue that approximating virtues such as care and respectfulness are necessary to conduct an informed consent discussion for clinical trials adequately. I argue against Beauchamp and Childress’ principlism insofar as it claims that virtues do not have “advantages” over the principle of respecting autonomy. When we elaborate what it means to facilitate autonomy in a consent discussion adequately, we find we are describing the virtues. This is because virtues do have an advantage over principles insofar as virtues provide us with rich descriptions of not only what we should do (respect autonomy), but how to do so (with the virtues of respectfulness, care, etc.). Thus, the principle of respecting autonomy points back to the virtues. I conclude by showing how cultivation of these virtues can help rectify well-known shortcomings in the informed consent process.

The Second Legacy of Henrietta Lacks
Viewpoint
Jerry Menikoff
JAMA, 17 February 2025
Abstract
Henrietta Lacks has already provided the world with one extraordinary legacy: her cells were used to create the first cell line, which has produced uncountable medical breakthroughs since 1951. But history also puts her at the center of another important issue: determining the extent to which it is ethical to conduct secondary research on a nonidentified biospecimen without that person’s consent. Recent developments create an opportunity for the research community to take an important step forward in clarifying that issue.

Consent to recontact for future research using linked primary healthcare data: Outcomes and general practice perceptions from the ATHENA COVID-19 study
Research Article
Kim Greaves, Amanda King, Zoltan Bourne, Jennifer Welsh, Mark Morgan, Maria Ximena Tolosa, Trisha Johnston, Carissa Bonner, Tony Stanton, Rosemary Korda
Clinical Trials, 29 December 2024
Abstract
Background
The ATHENA COVID-19 study was set up to recruit a cohort of patients with linked health information willing to be recontacted in future to participate in clinical trials and also to investigate the outcomes of people with COVID-19 in Queensland, Australia, using consent. This report describes how patients were recruited, their primary care data extracted, proportions consenting, outcomes of using the recontact method to recruit to a study, and experiences interacting with general practices requested to release the primary care data.
Methods
Patients diagnosed with COVID-19 from 1 January 2020 to 31 December 2020 were systematically approached to gain consent to have their primary healthcare data extracted from their general practice into a Queensland Health database and linked to other datasets for ethically approved research. Patients were also asked to consent to allow future recontact to discuss participation in clinical trials and other research studies. Patients who consented to recontact were later approached to recruit to a long-COVID study. Patients’ general practices were contacted to export the patient files. All patient and general practice interactions were recorded. Outcome measures were proportions of patients consenting to data extraction and research, permission to recontact, proportions of general practices agreeing to participate. A thematic analysis was conducted to assess attitudes regarding export of healthcare data, and the proportions consenting to participate in the long-COVID study were also reported.
Results
Of 1212 patients with COVID-19, contact details were available for 1155; 995 (86%) were successfully approached, and 842 (85%) reached a consent decision. Of those who reached a decision, 581 (69%), 615 (73%) and 629 (75%) patients consented to data extraction, recontact, and both, respectively. In all, 382 general practices were contacted, of whom 347 (91%) had an electronic medical record compatible for file export. Of these, 335 (88%) practices agreed to participate, and 12 (3%) declined. In total, 526 patient files were exported. The majority of general practices supported the study and accepted electronic patient consent as legitimate. For the long-COVID study, 376 (90%) of those patients recontacted agreed to have their contact details passed onto the long-COVID study team and 192 (53%) consented to take part in their study.
Conclusion
This report describes how primary care data were successfully extracted using consent, and that the majority of patients approached gave permission for their healthcare information to be used for research and be recontacted. The consent-to-recontact concept demonstrated its effectiveness to recruit to new research studies. The majority of general practices were willing to export identifiable patient healthcare data for linkage provided consent had been obtained.