IRB Consent Guidelines: Potential Barriers to Diversity in Research
Research Article
Evan Decker, Tana Chongsuwat
Health Promotion Practice, 2 August 2024
Abstract
Despite initiatives aimed at improving study participation and inclusion among ethnic and racially minoritized and marginalized populations, participation remains low. While necessary to ensure ethical practice in human participant research, certain Institutional Review Board (IRB) guidelines may introduce additional barriers in research involving these populations. This work outlines guidelines pertaining to consent translation for non-English speaking populations and offers discussion on a greater emphasis for more inclusive methods for marginalized communities. The University of Wisconsin’s IRB approved alternative oral consent processes after the community partner determined that standard translation processes would be inefficient. Researchers used translated consent materials for four different ethnic groups (Hmong, Karen, Karenni, and Burmese). We provided recorded consents in each respective language to participants before study participation and obtained verbal consent prior to study participation at the study location. We experienced time and resource constraints in both access to translators and the consent-translation process itself. Furthermore, many participants were unable to read in their native language making standard written consent processes both difficult and impractical. Oral discussion and verbal consent processes were efficient. Adjustments to consent-related guidelines may prevent and eliminate time and resource-related barriers in consent processes. In eliminating such barriers, subsequent improved efficiency in both study design and study promotion areas can work to better promote diversity in research among populations that emphasize oral language and in instances where literacy rates in written non-English language may be lower.

Communication in healthcare contexts: Multilingual technological resources to improve the communicative effectiveness of the Informed Consent
Isabel García-Izquierdo, Anabel Borja Albi
Cadernos de Tradução, September 2024
Abstract
Scientific advances and the complexity of the sociological context in which medicine is practised in an increasingly globalised and interconnected world raise new ethical and legal questions about the rights and obligations of patients, health professionals and public health care services. Despite the significant and undeniable progress brought about by the paradigm shift in the doctor-patient relationship and the great development of medical law and bioethics in recent years, patients continue to encounter serious linguistic and cultural obstacles to exercising their right to information and decision-making in relation to their health. In this paper we present part of the results of the HIPOCRATES research project of the Spanish GENTT group, aimed at humanising health care by improving doctor-patient communication in multilingual environments. Specifically, we will focus on the advances made in the textual analysis of the Informed Consent (IC), a medical genre of great relevance in clinical translation and writing due to its ethical and legal implications. Its lexical-syntactic complexity and the lack of standardised patterns in its writing hinder its comprehensibility and makes it difficult to identify the rhetorical sequences in which the communicative and legal functions of this genre are embodied. We present a textual analysis tool (ProText GENTT), which uses machine learning to exploit corpora with traditional techniques and artificial intelligence and with which we have analysed a multilingual (Spanish, Catalan and English) corpus of IC texts compiled by our research group (GENTT_Corpus). This analysis has allowed us to identify the linguistic-textual and rhetorical elements that hinder comprehension. From these results, our team is currently working on proposing optimized models with different levels of complexity both in printed and digital formats (e-consent).

Editor’s note: Cadernos de Tradução is published by the Federal University of Santa Catarina, Brazil.

Words, words, words: participants do not read consent forms in communication research
Research Article
Daria Parfenova, Alina Niftulaeva, Caleb T. Carr
Communication Research Reports, 22 July 2024
Abstract
Informed consent is an essential part of conducting human subjects research; but its utility is dependent on participants actually reading the consent forms provided. This research conducted secondary analysis of data (N = 1,283) to assess how long participants spent on the consent forms. Participants spent an average of 35.4 seconds on consent documents: not a nonsignficant amount of time (i.e., different from 0 seconds), but insufficient to read or even skim consent forms. Women spent slightly less time on consent forms. Neither the length nor readability of a consent form predicted time spent reading, and neither readability nor gender moderated the relationship between word count and time spent reading. Results suggest participants in communication studies do not spend enough time on a consent document to be able to read it, and therefore modern practices of informed consent do not ensure informed participation in research.

Responsible inclusion: A systematic review of consent to social-behavioral research with adults with intellectual disability in the US
Katherine E. McDonald, Ariel E. Schwartz, Robert Dinerstein, Robert Olick, Maya Sabatello
Disability and Health Journal, 2 July 2024
Abstract
Background
In recognition of their status as a health disparities population, there is growing emphasis on conducting research inclusive of adults with intellectual disability to generate new knowledge and opportunities to improve health and equity. Yet they are often excluded from research, and human research participant protection experts and researchers lack agreement on effective consent protocols for their inclusion.
Objective
We sought to identify approaches to consent in US-based social-behavioral research with adults with intellectual disability.
Methods
We conducted a systematic review on approaches to self-consent with adults with intellectual disability published between 2009 and 2023, identified via searching eight databases and reference list hand searches. We identified 13 manuscripts and conducted a thematic analysis.
Results
Our analysis identified themes related to guiding principles, strategies to enhance informed and voluntary consent, approaches to consent capacity, involving individuals subject to guardianship, and strategies for expressing decisions and enhancing ongoing decisions.
Conclusions
Manuscripts largely reflected an emphasis on identifying approaches to consent that reflect disability rights principles to promote the right to be included and make one’s own decisions based on assessment of relevant information, risks and benefits, and to employ reasonable modifications to achieve inclusion. To avoid the risks of exclusion and advance the responsible inclusion of adults with intellectual disability, we make recommendations to align consent approaches anchored in contemporary thinking about human research participant protections, including through integration with disability rights.

Informed consent to midwifery practices and interventions during the second stage of labor—An observational study within the Oneplus trial
Research Article
Cecilia Häggsgård, Christine Rubertsson, Pia Teleman, Malin Edqvist
PLOS One, 12 June 2024
Open Access
Abstract
Objectives
To study informed consent to midwifery practices and interventions during the second stage of labor and to investigate the association between informed consent and experiences of these practices and interventions and women’s experiences of the second stage of labor.
Methods
This study uses an observational design with data from a follow-up questionnaire sent to women one month after giving birth spontaneously in the Oneplus trial, a study aimed at evaluating collegial midwifery assistance to reduce severe perineal trauma. The trial was conducted between 2018–2020 at five Swedish maternity wards and trial registered at clinicaltrials.gov, no NCT03770962. The follow-up questionnaire contained questions about experiences of the second stage of labor, practices and interventions used and whether the women had provided informed consent. Evaluated practices and interventions were the use of warm compresses held at the perineum, manual perineal protection, vaginal examinations, perineal massage, levator pressure, intermittent catheterization of the bladder, fundal pressure, and episiotomy. Associations between informed consent and women’s experiences were assessed by univariate and multivariable logistic regression.
Findings
Of the 3049 women participating in the trial, 2849 consented to receive the questionnaire. Informed consent was reported by less than one in five women and was associated with feelings of being safe, strong, and in control. Informed consent was further associated with more positive experiences of clinical practices and interventions, and with less discomfort and pain from interventions involving physical penetration of the genital area.
Conclusion
The findings indicate that informed consent during the second stage is associated with feelings of safety and of being in control. With less than one in five women reporting informed consent to all practices and interventions performed by midwives, the results emphasize the need for further action to enhance midwives’ knowledge and motivation in obtaining informed consent prior to performance of interventions.

Who to engage in HIV vaccine trial benefit-sharing negotiations? An empirical proposition of a framework
Research
Godwin Pancras, Mangi Ezekiel, Erasto Mbugi, Jon F. Merz
BMC Medical Ethics, 14 May 2024
Open access
Abstract
Background
A morally sound framework for benefit-sharing is crucial to minimize research exploitation for research conducted in developing countries. However, in practice, it remains uncertain which stakeholders should be involved in the decision-making process regarding benefit-sharing and what the implications might be. Therefore the study aimed to empirically propose a framework for benefit-sharing negotiations in research by taking HIV vaccine trials as a case.
Methods
The study was conducted in Tanzania using a case study design and qualitative approaches. Data were collected using in-depth interviews (IDI) and focus group discussions (FGD). A total of 37 study participants were selected purposively comprising institutional review board (IRB) members, researchers, community advisory board (CAB) members, a policymaker, and HIV/AIDS advocates. Deductive and inductive thematic analysis approaches were deployed to analyze collected data with the aid of MAXQDA version 20.4.0 software.
Results
The findings indicate a triangular relationship between the research community, researched community and intermediaries. However, the relationship ought to take into consideration the timing of negotiations, the level of understanding between parties and the phase of the clinical trial. The proposed framework operationalize partnership interactions in community-based participatory research.
Conclusion
In the context of this study, the suggested framework incorporates the research community, the community being researched, and intermediary parties. The framework would guarantee well-informed and inclusive decision-making regarding benefit-sharing in HIV vaccine trials and other health-related research conducted in resource-limited settings.

Upholding Informed Consent: Experiences of Note –Taking without Audio Recording of in-Depth Individual Interviews in a Qualitative Study on the Implementation of the Pregnancy ReEntry Policy in Zambia
Namakau Kakanda-Sinkala
International Journal Of Multidisciplinary Research And Analysis, 5 May 2024
Abstract
The context of the research study needs to determine the data recording method to be used in order to ensure that no harm is done to the participants. In-depth individual Interviews (IDIs) is one of the main data collecting strategy used in qualitative research on sensitive topics such as teenage pregnancy. Audio recording in capturing data during IDIs is a common practice. However, audio recording of IDIs should be done in the context of informed consent. The objective of this paper is to elaborate on how note-taking was used to capture data within the context of informed consent. The research design was multiplecohort Case studies involving Chongwe district plus national stakeholders of the Pregnancy Re-entry policy in Zambia. Semistructured interviews were conducted with hundred (100) participants from different cohorts of stakeholders using note-taking to capture the data. Ninety percent (90%) of the interviews involved physical note-taking with 10 % being electronic notes. The results are that note-taking increased the interview time but it afforded the interviewer the opportunity to probe further as the data was being collected. The major disadvantage with note –taking is that it reduces the pace of data collection as time has to be dedicated to consolidating the notes and memory recall of information shared. The conclusion drawn is that upholding informed consent in research is key, therefore the capturing of data during IDIs should be guided by what best upholds the rights of the participants. Therefore, note-taking offers an alternative to audio recording.

The participant’s voice: crowdsourced and undergraduate participants’ views toward ethics consent guidelines
Research Article
Nadine S. J. Stirling, Melanie K. T. Takarangi
Ethics & Behavior, 28 April 2024
Abstract
The informed consent process presents challenges for psychological trauma research (e.g. Institutional Review Board [IRB] apprehension). While previous research documents researcher and IRB-member perspectives on these challenges, participant views remain absent. Thus, using a mixed-methods approach, we investigated participant views on consent guidelines in two convenience samples: crowdsourced (N = 268) and undergraduate (N = 265) participants. We also examined whether trauma-exposure influenced participant views. Overall, participants were satisfied with current guidelines, providing minor feedback and ethical reminders for researchers. Moreover, participant views for consent were similar irrespective of trauma-exposure. Our study has implications for IRBs and psychological researchers.

No recognised ethical standards, no broad consent: navigating the quandary in computational social science research
Research Article
Seliem El-Sayed, Filip Paspalj
Research Ethics, 19 April 2024
Open Access
Abstract
Recital 33 GDPR has often been interpreted as referring to ‘broad consent’. This version of informed consent was intended to allow data subjects to provide their consent for certain areas of research, or parts of research projects, conditional to the research being in line with ‘recognised ethical standards’. In this article, we argue that broad consent is applicable in the emerging field of Computational Social Science (CSS), which lies at the intersection of data science and social science. However, the lack of recognised ethical standards specific to CSS poses a practical barrier to the use of broad consent in this field and other fields that lack recognised ethical standards. Upon examining existing research ethics standards in social science and data science, we argue that they are insufficient for CSS. We further contend that the fragmentation of European Union (EU) law and research ethics sources makes it challenging to establish universally recognised ethical standards for scientific research. As a result, CSS researchers and other researchers in emerging fields that lack recognised ethical standards are left without sufficient guidance on the use of broad consent as provided for in the GDPR. We conclude that responsible EU bodies should provide additional guidance to facilitate the use of broad consent in CSS research.

Toward a further understanding of assent
Discussion
Cody Morris, Jacob P. Oliveira, Jesse Perrin, Caitlyn A. Federico, Paula J. Martasian
Journal of Applied Behaviour Analysis, 15 February 2024
Abstract
Arranging assent opportunities is an increasingly common strategy for involving clients in therapeutic decisions within behavior analysis. Recent behavior-analytic articles have helped create a basic behavioral definition and conceptualization of assent, but much more guidance is needed for practitioners and researchers interested in embedding assent into their practices. The purpose of this article is to advance the conceptualization and understanding of assent and assent practices by refining previous definitions and conceptualizations of assent and providing six essential considerations for embedding assent into practice. The six considerations consist of determining the applicability and feasibility of assent, assessing assent-related skills, arranging assent procedures and teaching assent-related skills, arranging fair choices, selecting opportunities to assess assent, and informally assessing assent. Following the discussion of the considerations for assent practices, we issue a call for specific topics of research on assent.