Continuous quality improvement: reducing informed consent form signing errors
Research
Tsui-Wen Hsu, Chi-Hung Huang, Li-Ju Chuang, Hui-Chen Lee, Chih-Shung Wong
BMC Medical Ethics, 4 August 2023; 24(59)
Open Access
Abstract
Background
Adherence to ethical guidelines and regulations and protecting and respecting the dignity and autonomy of participants by obtaining a valid informed consent form (ICF) prior to participation in research are crucial; The subjects did not add signatures next to the corrections made to signatures or dates on the ICF, Multiple signatures in other fields, ICF missing/missing signature, Incorrect ICF version Signed after modification, Correction tape used to correct signature, Impersonated signature, Non-research-member signature, however, ICFs are often not properly completed, which must be addressed. This study analyzed ICF signing errors and implemented measures to reduce or prevent these errors.
Methods
We used the plan–do–check–act (PDCA) cycle to help improve the correctness and validity of ICF signing.
Results
Interim and final reports from January 2016 to February 2020 including 363 ICFs were studied. The total proportion of correct ICF signatures (200, 83.3%) following the PDCA intervention was significantly higher than that before the intervention (P < 0.05). Analysis of the types of signing error demonstrated that signature errors were significantly reduced after the intervention, particularly for subjects did not add signatures next to the corrections made to signatures or dates on the ICF (16, 6.7%) and impersonated signature (0; P < 0.05).
Conclusions
The proportions of other error types—multiple signatures in other fields, missing or unsigned ICF, incorrect signature order, incorrect ICF version, use of correction tape to correct signature, and non-medical profession members signing the ICF—did not differ significantly.

Physician-Investigator, Research Coordinator, and Patient Perspectives on Dual-Role Consent in Oncology A Qualitative Study
Stephanie R. Morain, Dorit Barlevy, Steven Joffe, Emily A. Largent
JAMA Network Open, 25 July 2023; 6(7)
Abstract
Importance
Classic statements of research ethics generally advise against dual-role consent in which physician-investigators seek consent for research participation from patients with whom they have preexisting treatment relationships. Yet dual-role consent is common in clinical oncology research, as studies are often conducted in close relationship with clinical care.
Objective
To explore key stakeholders’ perspectives on dual-role consent in clinical oncology trials.
Design, Setting, and Participants
This qualitative study with 43 participants was conducted at a National Cancer Institute–designated comprehensive cancer center from 2018 to 2022. Semistructured qualitative interviews of physician-investigators, research coordinators, and patients were performed. Respondents were recruited from 3 populations: (1) physician-investigators engaged in clinical oncology research; (2) research coordinators engaged in clinical oncology research; and (3) patients, with and without prior clinical trial experience, who had received a new cancer diagnosis at least 2 months prior to enrollment in this study.
Main Outcomes and Measures
Interviews were audio recorded and professionally transcribed. A thematic analysis approach was used to develop a codebook that included both theory-driven, a priori codes and emergent, inductive codes. Two authors double-coded all transcripts and met regularly to compare coding, discuss discrepancies, refine the codebook, and draft memos describing relevant themes and their frequency.
Results
Among the 43 respondents, 28 (65.1%) were female; 9 (20.9%) were African American, 8 (18.6%) were Asian, 6 (14.0%) were Hispanic, and 21 (48.8%) were White; 15 were physician-investigators (6 [40.0%] with 6-10 years of experience, 4 [26.7%] with at least 20 years of experience), 13 were research coordinators (5 [38.5%] with 0-5 years of experience, 5 [38.5%] with 6-10 years of experience), and 15 were patients (9 [60.0%] aged 46-64 years). Four main themes were found: interviewees (1) perceived greater potential for role synergy than for role conflict; (2) reported dual-role consent as having mixed effects on the consent process, increasing prospective participants’ understanding and likelihood of agreement while also challenging voluntariness; (3) preferred a team-based approach to the consent process in which physician-investigators and research coordinators share responsibility for communicating with prospective participants and safeguarding voluntariness; and (4) offered strategies for managing tensions in dual-role consent.
Conclusions and Relevance
This qualitative study found that concerns about dual-role consent in clinical oncology, while valid, may be outweighed by corresponding advantages, particularly if appropriate mitigation strategies are in place. These findings support a team-based approach to informed consent, in which physician-investigators and research coordinators promote both the understanding and voluntariness of prospective participants.

Parents’ perceptions of parental consent procedures for social science research in the school context
Thabo J van Woudenberg, Esther Rozendaal, Moniek Buijzen
International Journal of Social Research Methodology, 21 June 2023
Abstract
Typically, parents or other legal guardians are asked for an active declaration that the participation of their child in scientific research is informed and voluntary. However, asking for active parental consent leads to lower quality studies and passive parental consent might be preferable. In this study, we used an online survey in which parents (N = 156) watched video vignettes of multiple types of research in the classroom and asked them to rate the appropriateness of using active and passive parental consent. The results indicated that parents perceived active consent procedures as more appropriate in most types of research. However, particularly for secondary school children passive consent was rated as comparably appropriate for several types of research (e.g. observation and questionnaire studies). Other aspects of providing consent are displayed in a supplementary online dashboard. We conclude with recommendations for parental consent procedures for social science research in the school context.

Transplant Recipient Preferences Regarding Organ Donor Research: Their Role in Consent and use of Their Data
Research Article
Amanda Lucas, Patricia H. Strachan, Frederick D’Aragon, Aimee J. Sarti, Maureen O. Meade
Journal of Empirical Research on Human Research Ethics, 12 June 2023
Abstract
Research on deceased organ donors has been hindered by concerns related to seeking research consent from transplant recipients. We undertook this qualitative study to elucidate solid organ transplant recipients views on organ donor research, their role in the consent for such research, and their preferences related to providing their data. We conducted interviews with 18 participants and three themes emerged from the data. The first centered around participant research literacy. The second described practical preferences of participating in research, and the third related to the connection between donor and recipient. We concluded that previously held views about the requirement for transplant recipients to have a consenting role in donor research is not always suitable.

Challenges in Obtaining Informed Consent in Qualitative Research and Suggestions to Improve It- A Descriptive Qualitative Study
National Journal of Community Medicine, June 2023; 14(06) pp 386-390
Sindhuri, Amol Dongre
Abstract
Introduction
The dynamic and flexible nature of qualitative studies is expected to impose new challenges upon the researchers in obtaining informed consent. The study objectives were to explore the challenges perceived by the researchers in obtaining informed consent in qualitative research and their suggestions to improve it.
Material and Methods
It was a descriptive qualitative study in which In-depth interviews were conducted among ten qualitative researchers purposively selected from one medical college in Puducherry. Transcripts prepared from the audio recordings were thematically analyzed manually.
Results
The challenges identified were inadequate knowledge of the researcher in designing qualitative consent form, reluctance to sign consent document by participant, ensuring confidentiality and risk benefit communication. The main suggestions provided by the participants were to use of multimedia tools to improve their understanding and creating a rapport to enhance their trust to participate in the study.
Conclusions
Since most of the challenges were related to the reluctance of participants to provide consent due to various reasons and lack of adequate knowledge of the researcher, creating a good rapport with the participants and providing simple information through multimedia approaches and ethical training of qualitative researchers will aid us to overcome majority of these challenges.

‘It’s All Public Anyway’: A Collaborative Navigation of Anonymity and Informed Consent in a Study with Identifiable Parent Carers
Pam Joseph
Ethics and Social Welfare, 30 May 2023
Abstract
For qualitative researchers seeking the perspectives of people with unusual characteristics or circumstances, compliance with expectations about participant anonymity can be difficult, if not impossible. In the age of internet communications and emerging research methodologies, traditional strategies require ongoing re-examination to ensure cohesion between a project’s ethical framework and its research practice. This paper reflects on the approach to informed consent used in a study with parent carers whose children had high-level support needs. A two-step process of written consent was developed in response to concerns about the possible re-identification of these parents as a result of their highly individual circumstances. This approach acknowledged the potential for identification, and maximised participants’ agency in choosing the level of risk that they were comfortable to accommodate. The paper discusses the researcher’s and participants’ responses to the adapted consent process and recommends that researchers and ethics review committees remain open to the development of collaborative and innovative approaches that are also culturally and contextually relevant, to enable people to contribute perspectives that might otherwise be silenced by the very ethical frameworks that purport to protect their interests.

Get this thing out of my body! Factors determining consent for translational oncology research: a qualitative research
Research
Desprès Caroline, Mamzer Marie-France
Journal of Translational Medicine volume, 21 May 2023; 21(336)
Open Access
Abstract
Background
Depending on the needs of scientific research at a given time, biobanks make biological samples and data available to researchers. In this article, we aim to describe the reasons and underlying logic that determine the decision to grant or deny consent to the conservation of tumour samples in a biological resource platform for research purposes. We make use of the CARPEM biological resource platform model, where broad consent is required.
Methods
The results are based on semi-structured interviews, conducted between 2019 and 2021, with 25 individuals having various profiles.
Results
All the people interviewed readily accepted the principle of conserving a tumour sample for research purposes. They explained their decision by citing the desire to participate in research dedicated to improving therapeutic medicine. Their trust in research institutions or in doctors was an important factor in their consent. The tumorous nature of the samples also played an important role, as did the absence of constraints. Finally, the high level of consent was also based on the difficulty they had in conceiving what the future risks might be once the sample had been taken, whereas the fact that they did not know the nature or purpose of the research to be carried out when they signed the consent form posed some problems. These results stem from a lack of a culture of ethics among the people interviewed.
Conclusion
The information provided in the context of consent at the CARPEM tumour bank seems inadequate for consent to be considered ‘informed’, given the low level of knowledge that people have of the risks and issues. Information is missing even though we feel it would not change consent or only marginally. This raises questions, since part of the act of granting consent is based on the implicit trust French people have in the hospital that collects the data and in research practices in general. In the minds of those who participate, transparency is the ground on which trust rests. Lack of transparency could be deleterious for future research practices. However, it is not by striving to improve information leaflets that the consent-related information will improve but, rather, by more effectively helping future patients to assimilate that information.

Informed Consent and Debriefing When Deceiving Participants: A Systematic Review of Research Ethics Guidelines
Review Article
Kamiel Verbeke, Tomasz Krawczyk, Dieter Baeyens, Jan Piasecki, Pascal Borry
Journal of Empirical Research on Human Research Ethics, 15 May 2023
Abstract
Informed consent and debriefing of research participants in studies that use deception are ethical safeguards for which existing scholarly work on their implementation remains variable and insufficiently clear. A systematic review of research ethics guidelines was conducted to sketch a picture of whether, why and how informed consent and debriefing are recommended when using deception. Documents roughly agreed on several general principles, but varied significantly in the specifics of why and whether these safeguards are necessary, in which conditions and how they should be implemented. Various aspects that appear in the literature could not be found in the guidelines. In our review, guidance was integrated and showed a variation of implementation strategies that could help in contextualizing these safeguards.

The Effects of Expectation Setting and Bundle Consent on Acute Caregiver Stress in the PICU: A Randomized Controlled Trial
Goldstein G, Karam O, Miller Ferguson N
Pediatric Critical Care Medicine: a Journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies, 1 May 2023
Abstract
Objectives
Having a child admitted to the PICU is a stressful experience for parents and can have long-term negative mental health consequences. The objective was to determine if formalized expectation setting and bundled consent for invasive procedures upon admission impacts the acute stress burden on parents.
Design
Prospective cluster randomized controlled trial.
Setting
Single-center, tertiary PICU.
Subjects
Parents/guardians of patients, 0-18 years old, admitted to PICU.
Interventions
During experimental weeks, all patients admitted to PICU were bundled-consented for common procedures and given a novel unit introductory letter and “Common Procedures Explained” document. During control weeks, all patients were consented for invasive procedures with separate consents for each procedure. Parents then completed a demographic survey and Stress Overload Scale-Short (SOS-S) 48-72 hours after their child’s admission. For each participant, the SOS-S generates a Personal Vulnerability (PV) score and an Event Load (EL) score. Parents’ perception of the life-threatening nature of their child’s condition was also evaluated.
Measurements and main results
Over 73 weeks, 1,882 patients were screened and 261 consented to the SOS-S. Median PV score was 10.4 in the control group and 9.1 in the experimental group (p = 0.15). Median EL score was 11.3 for the control group and 10.5 in the experimental group (p = 0.42). Adjusting for demographic variables and severity of illness, there was no independent association between either PV or EL and bundled consent. However, a parent’s perception of threat-to-life was significantly related to the allocated group (p = 0.036), which resulted in a decreased percentage of parents who rated their child’s illness as “Extremely” life-threatening (experimental group, 17% vs control group, 26%).
Conclusions
This study did not demonstrate a decrease in stress when bundled consent was obtained. However, this intervention decreased the parents’ perceived severity of illness. Further multicenter studies are needed to evaluate the effects of bundled consent on parents.

A cross‑sectional audit of informed consent of online survey: Characteristics and adherence to prevalent guidelines
Himel Mondal, Shaikat Mondal, Sachin Soni
Perspectives in Clinical Research, 17 April 2023
Abstract
Background
Research on human participants requires formal approval from a competent ethics committee. During the recruitment of the research participants, obtaining informed consent is a prerequisite. The online survey method is used by many researchers as it can collect the data from a diverse population in a short time.
Aim
This study aimed to observe the characteristics and adherence to prevalent guidelines (set by the Indian Council of Medical Research [ICMR]) of informed consent coupled with online surveys.
Methods
We collected the informed consent text from online survey links obtained from a network of colleagues who got a request to participate in a survey. Data were collected from July 2020 to June 2022. The text was anonymized for further analysis. The word count, sentences, and Flesch reading ease score were calculated. The adherence to ICMR guidelines where checked by two authors individually and a consensus was reached to prepare the final result.
Results
A total of 44 online surveys in English were audited and among them, 10 did not have informed consent. The informed consent in 34 surveys had a median of 6 sentences and 84 words. The median reading ease score was 45.7 (college level). The majority of the consent states the purpose of the research (91.18%), the voluntary nature of the participation (85.29%), and mentioned that it is research (64.71%). However, the rest of the components are ignored by the majority of the survey consent form.
Conclusion
Informed consent form with online surveys lacks adherence to the components suggested by ICMR. Hence, the forms should be made carefully by the researchers so that the vigor of informed consent is maintained in the online surveys.