Informed Consent in Qualitative Research: Lessons on Relationality from a Technologically Dense Classroom

Book Chapter

Fride Haram Klykken

Reframing Qualitative Research Ethics, 20 May 2025 [Emerald Publishing Limited]

Abstract

This chapter examines the challenges that informed consent poses in qualitative research. Drawing on examples from a video ethnography in a technologically rich classroom in Norway, this chapter highlights limitations of the current emphasis on anticipatory approaches to informed consent. I explore how a nuanced processual understanding of informed consent can be added to these established procedures so as to navigate the intricate dynamics of conducting ethical research in a relationally constituted world. This chapter illustrates how, from a relationally situated approach, explicit and implicit negotiations of informed consent can be incorporated throughout the research process. Informed by sociomaterial and material feminist theories, this chapter reflects on the iterative and material effects of contemporary informed consent practices. Encouraging a rethinking of the role of informed consent within qualitative research, I argue that engaging in informed consent practices is not only about formal procedures or written agreements but also entails a continuous relational negotiation that needs attention throughout the research process. In conclusion, I advocate that institutions and researchers should advance responsible research ethics by acknowledging ethical complexity, promoting trust, and building diverse and responsive ethical resource networks.

Factors Influencing Informed Consent Preferences in Digital Health Research: Survey Study of Prospective Participants
Brian J McInnis, Ramona Pindus, Daniah Kareem, Daniela G Vital, Eric B Hekler, Camille Nebeker
Journal of Medical Internet Research, 2025
Abstract
Background
Readability is important to consider when developing informed consent communications for prospective research participants, but not the most important consideration. Other factors to consider relate to learning preferences and literacy needs of people recruited to participate in research, as these factors can influence understanding of consent communications. To promote understanding among prospective participants, researchers should take a human-centered approach to develop consent communications.
Objective
This study aims to explore how factors related to readability, topic, and participant demographic characteristics play into preferences for digital health research consent material. These factors are important to consider as not attending to some details that matter to a specific subgroup of prospective participants may systematically exclude people from research.
Methods
People eligible to participate in a digital health study were recruited to review 31 paragraph length sections of a consent form, referred to as “text snippets,” for an existing institutional review board–approved digital health study. Participants (N=79) were surveyed and asked to choose between 2 variations of the text snippets, either indicating a preference for the institutional review board–approved original or a version that was modified to improve readability.
Results
A slim majority of participants provided feedback about the snippets (n=44; 55%). Our qualitative analysis of the feedback found that participants preferred shorter snippets, in general, but the snippets also elicited new questions not addressed by the original consent material. This observation is supported by our quantitative analysis, which found that when the character length of the original was longer, participants were less likely to prefer the original (P<.001) and more likely to prefer the modified text by a factor of 1.20 times (P=.04), and particularly for snippets explaining study risks (P=.03). Our analysis also found significant differences in participant demographic characteristics. For example, older participants tended to prefer the original more than younger participants, by a factor of 1.95 times (P=.004). The results present illustrative examples of how factors related to sex, age, physical activity, and ethnicity all play into preference for consent communication.
Conclusions
The findings point toward new ways of evaluating informed consent communication: (1) for responsiveness to specific prospective participant populations, and (2) effectiveness at eliciting informed questions from people considering participation. We discuss how creating partnerships with prospective participants to prototype informed consent materials, specifically study procedures and risks, can be a way to identify those details before launching a study. Furthermore, future research should go beyond “readability” to explore alternate measures of evaluating consent materials, such as the likelihood that the consent material and communication procedures will elicit “informed questions” for the research team.

Measuring the efficacy of community consultation in a pediatric exception from informed consent trial
Original Article
Ann R. Johnson, Naomi O. Riches, John M. VanBuren, Ana E. Corona, Kammy Jacobsen, Shu Yang, Manish I. Shah
Academic Emergency Medicine, 29 December 2024
Open Access
Abstract
Background
Community consultation activities are required by the Food and Drug Administration prior to conducting research using exception from informed consent (EFIC) for emergency research and aim to provide additional participant protections. However, it is difficult for institutional review boards (IRBs) to assess the efficacy of such activities. In this study, our primary aim was to evaluate the efficacy of the PediDOSE trial’s consultation activities by answering key questions about whether consultation efforts reached a relevant community and if the perspectives of the consulted community coincided with those of parents actually enrolled in the study.
Methods
Qualitative findings of semistructured interview data collected during community consultation efforts were compared with interview responses from parents of children enrolled in the PediDOSE trial to identify common themes.
Results
Most themes were identified in both groups, but additional themes emerged with parents of enrolled participants that may be important for future study teams and IRBs to consider. Even with an overrepresentation of White and non-Hispanic/Latino participants in the community consultations compared to those who were enrolled in the EFIC study there was common overlap of themes.
Conclusions
Parent interviews added to our understanding beyond the themes identified in the consultation interviews. The theme of therapeutic misconception was not found in the consultation interviews, possibly due to the child’s emergency medical care being theoretical. With modest accommodations, collection of additional demographic and follow-up interview data can successfully assess key elements of community consultation efficacy for EFIC trials.

Strengthening Informed Consent for Federal Research through Person-Centered Development and Administration
Research Report
Lauren Farrell, Mikaela Tajo, Elsa Falkenburger, Soumita Bose
Urban Institute, 26 December 2024
Summary
    In September 2021, the Office of Planning, Research, and Evaluation (OPRE) within the Administration for Children and Families (ACF) contracted with the Urban Institute to conduct the Advancing Contextual Analysis and Methods of Participant Engagement (CAMPE) project. The goal of the CAMPE project was to aid OPRE in better understanding, incorporating, and advancing equitable research practices in OPRE projects. To achieve this goal, the project was designed to support OPRE’s efforts to develop tools and guidance for applying an equity lens to research and evaluation projects in the federal context. A core focus of the project was on ways to better engage people who have lived experience with ACF programs as collaborators and partners in research and evaluation.

One key aspect of this work included developing and engaging a community advisory board (CAB) of individuals who have lived experience with ACF programs (Temporary Assistance for Needy Families, the Child Care and Development Fund, refugee resettlement, child welfare and foster care, and others) to get feedback and input on several OPRE documents and materials related to research processes. Urban recruited, onboarded, trained, and supported a 13-member CAB to review and comment on these materials. The CAMPE CAB reviewed multiple documents and processes within OPRE to advance the aim of more equitable research practices in OPRE projects. One OPRE process that the CAB reviewed was for informed consent.

The CAMPE CAB reviewed a sample OPRE study informed consent form, which includes the steps researchers take and the language they use to inform people of their rights, risks, and benefits when choosing whether to participate in a research study. This report contains the CAB’s recommendations on developing and implementing person-centered informed consent processes. A person-centered approach reflects an understanding of the perspective, position, and experience of the intended participant.

Women’s Experience of the Consent Process to Planned Caesarean Section and Its Surgical Risk: A Qualitative Study
Research Article
Malathy Nithiyananthan, Jacqueline Nicholls, Melissa Whitten, Katherine Maslowski, Anne Lanceley
British Journal of Obstetrics & Gynaecology, 25 December 2024
Open Access
Abstract
Objective
To explore how women appreciated the risks discussed within the consent process for planned caesarean section (CS).
Design
Exploratory qualitative interview study.
Setting
NHS Teaching Hospital in Central London.
Population
Women over the age of 18, English speaking, scheduled for a planned CS.
Methods
Semi-structured interviews were conducted before and after a woman’s CS. Eighteen women were recruited and interviewed prior to undergoing CS and 12 of these were interviewed following CS. Interviews were audio-recorded, transcribed and thematically analysed.
Main Outcome Measures
Themes generated from analysis of interviews exploring the experiences of women consenting to CS and specifically their awareness of postpartum haemorrhage (PPH), hysterectomy, organ damage and risk of placental abnormalities in future pregnancies.
Results
Two broad themes and four subthemes were identified (1) Untimely provision of risk information: (a) superficial risk discussions during the antenatal period and full risk disclosure on the day of surgery and (b) incompleteness absent or sparse risk disclosure prior to making the decision to undergo the CS, where women were unaware of specific risks and (2) Emotional overload: (a) fear of risks and (b) fear that a CS will be denied to them—women’s cognitive response and notably their emotional response to their situation limited their understanding of risks disclosed.
Conclusion
The consent process for planned CS was found to lack appropriate and full risk disclosure. Risk disclosure was ill-timed or deficient in facilitating women’s understanding of risks reflecting a consent process which does not meet legal and professional standards of informed consent.

“You knew what you were getting into”: Perspective differences in gauging informed consent
Rachel Schlund, Vanessa K. Bohns
Organizational Behavior and Human Decision Processes, January 2025
Abstract
We examine differences between perceived and experienced consent in organizational contexts—specifically, the aspect of consent that reflects how informed consenters feel. We theorize that people tasked with soliciting consent overestimate the extent to which consenters feel fully informed of what they are agreeing to and thus feel they have truly consented. We provide support for these predictions across six pre-registered studies (N = 2,993) and eight supplemental pre-registered studies (N = 4,406) that establish causal and mediation evidence, downstream organizational consequences, and real-world relevance. This research reveals that even when an agreement meets the legal criteria for consent, there may be misaligned perceptions of employees’ feelings of consent, with consequences for employees’ relationship with their organization. The current studies offer a significant step forward in understanding the markedly understudied role of consent in organizations.

Scoping review and thematic analysis of informed consent in humanitarian emergencies
Research
Benjamin Thomson, S. Mehta, C. Robinson
BMC Medical Ethics, 20 November 2024
Open access
Abstract
Background
To identify and to summarize challenges related to the informed consent process for research completed during humanitarian emergencies.
Methods
Using relevant search terms, a search of 5 databases was completed, without language, date, or study type restriction. Studies were screened for inclusion, with eligible studies being those that were relevant to the informed consent process for research studies completed in humanitarian emergencies. A Grounded Theory Analysis was completed to identify themes and subthemes.
Results
Review identified 30 relevant studies. We identified 11 challenges (lack of trust, therapeutic misconception, reduced capacity, security and privacy concerns, harmful research, power differential, literacy, language/local and cultural context, researcher burden and re-evaluation of ongoing trials) and 7 strategies (engage local research communities, use alternative to standard written consent process, modify traditional process of research ethics board review, dynamic consent, training of research staff, mandating transparency of commercial interests, and mandating reporting of informed consent process in all publications) to confront the challenges. These challenges and strategies were unique to the informed consent process in research conducted during humanitarian emergencies.
Conclusions
This scoping review identified an evidence-based guide for researchers and research ethics boards to perform ethical informed consent procedures in humanitarian emergencies.

Emergency Verbal Consent for Intrapartum Research: A Grounded Theory Study
Research Article
Carol Bedwell, Wendy Taylor, Caroline Cunningham, Andrew D. Weeks, Dame Tina Lavender
BJOG: An International Journal of Obstetrics & Gynaecology, 7 November 2024
Open Access
Abstract
Objective
To understand the experiences of women, birth partners and health professionals of verbal followed by retrospective written consent in a prospective cohort study of a device to manage postpartum haemorrhage (PPH).
Design
Grounded Theory.
Setting
Tertiary facility in North-West England, UK.
Sample
We used purposive and theoretical sampling to recruit 51 participants; 12 women, 12 birth partners, 16 obstetricians and 11 midwives.
Methods
Semi-structured interviews were conducted, using a topic guide for focus, until data saturation was achieved. Data were analysed using framework analysis technique.
Results
Most women wanted sufficient information to make a decision at the time of the event, rather than in advance, and preferred not to be overwhelmed with detail. A key factor in making the decision to participate was a positive and trusting relationship with the attending obstetrician. Obtaining consent for research in emergencies was viewed by obstetricians as requiring a different approach and more challenging than consent for standard procedures in an emergency.
Conclusions
This is one of the first studies to explore verbal followed by retrospective written consent processes with women, clinicians and observers. This was acceptable to all, however information needs to be appropriate, and those discussing consent require adequate training.

Informed consent and coercion in recruitment advertisements for oocyte donors
Research
Ruby Lake, Isa Berzansky, Andrea Lanes, Serene Srouji, Elizabeth Ginsburg, Iris Insogna
BMC Women’s Health, 20 September 2024
Open Access
Abstract
Background
As the use of donor eggs for in vitro treatment has increased, both medically affiliated and private donor egg agencies have turned to online advertisements to recruit donors. The American Society for Reproductive Medicine provides recommendations encouraging ethical recruitment of donors, however there is no formal regulation for the informed consent process for egg donor recruitment and compensation. Underrepresentation of risks and targeted financial incentives may pose a risk to the informed consent process.
Methods
Data from online advertisements for egg donors active between January 1 – August 31, 2020, were collected to analyze content related to risks, Covid-19 precautions, donor payment, and desired donor characteristics. Advertisements for egg donors on Google, Craigslist, and social media were analyzed. Primary outcomes included the mention of the risks of egg donation, including the risk of Covid-19 exposure, in donor egg advertisements. Secondary outcomes included language targeting specific donor characteristics and financial compensation.
Results
103 advertisements were included. 35.9% (37/103) of advertisements mentioned some risk of the egg donation process, and 18.5% (19/103) mentioned risks or precautions related to Covid-19 exposure. Of advertisements for private donor egg agencies, 40.7% (24/59) mentioned any risk, compared to 29.6% (13/44) of medically affiliated egg donation programs; the difference was not statistically significant (p-value = 0.24). Agencies targeting students and donors of a specific race were more likely to offer payments over $10,000 for an egg donation cycle. Among advertisements offering over $20,000 for donor compensation, 72.7% (8/11) recruited women under the age of 21.
Conclusion
Egg donor recruitment advertisements, for both medically affiliated programs and private agencies, were unlikely to mention risks including the risk of exposure to Covid-19. Non-medically affiliated private donor egg agencies were more likely to violate multiple American Society for Reproductive Medicine ethics guidelines, including offering higher than average compensation, and recruiting donors from young and vulnerable populations.

Co-designing body donor program consent processes
Georgina C. Stephens
Anatomical Sciences Education, July 2024
Abstract
Objective
It is widely accepted that body donation programs should obtain informed consent from prospective donors during life. However, consent forms vary in detail, are typically developed by anatomical and legal experts, and may not include features valued by prospective donors. Concomitantly, anatomy students report concerns that prospective donors are not adequately informed about dissection procedures. To address these issues, this study aimed to bring together prospective body donors, anatomy students, anatomy educators, and a governance expert to co- design a donor-centered consent process.
Methods
Utilizing participatory co- design, focus group discussions were used to explore participants’ perspectives on informed donor consent. The facilitator worked with participants to identify priorities for inclusion in donor consent processes. Framework analysis is being used to analyze data, and priorities identified in each group will inform the development of a draft donor consent process, on which further participant feedback will be sought.
Results
Forty-one people expressed interest in study participation. Two focus groups (n = 11 participants) have been held, wherein prospective body donors emphasized their desire for their bodies to contribute to anatomical education, including dissection and representation in educational resources. Group members agreed consent forms should explicitly detail how donor bodies are utilized for learning and include personalized elements such as naming preferences. Further focus groups are planned for September and October 2023.
Conclusion
This ongoing study is expected to yield recommendations for community involvement in developing body donor program consent processes, and how community participation can enhance educational activities, such as preparing students for dissection.