The experiences of clinical staff approaching families for organ donation consent: A systematic review and thematic synthesis of qualitative studies

Review Article

L.H.M. Pengel, V. Mazarello-Paes, D. Paredes-Zapata, G.C. Oniscu, C. Gouveia Gaglianone, L. Zhu, Y. Wang, N. Dhanda, J. Tocher, L. Aviles

Transplantation Reviews, July 2025

Open Access

Abstract

Healthcare professionals (HCPs) play an essential role in organ donation (OD) particularly when approaching families to discuss consent to OD. We synthesized the evidence on experiences of HCPs when approaching potential organ donor families. Fourteen electronic databases were searched to identify studies describing HCP experiences or associations between HCP experiences and consent rates. Methodological quality was assessed by independent reviewers using the Mixed Methods Appraisal Tool. Qualitative data were analysed using thematic synthesis, while quantitative data were summarized by narrative review. Ninety-two studies were included. HCP experiences were conceptualised as a paradox due to the challenges to negotiate the boundaries between life and death. Organisational and personal aspects broadly shape the experiences of professionals. Studies suggest that staff experiences can be improved by training and education, however, quantitative studies did not show a strong association between OD training and improved consent rates. The complexities of the family approach were evident in the variety of interactions between HCPs and the donor family, which may explain why there is no uniform approach across settings and countries. The review highlights the challenges faced by professionals when negotiating policy and practice and informs recommendations to support staff involved in the OD process worldwide.

The association of patient and clinician demographics and concordance with medicaid sterilization consent form validity

Research Paper

Lisa Jackson-Moore, Kim Malloy, Gene Urrutia, Kristen A. Berg, Emily S. Miller, Margaret Boozer, Tania Serna, Jennifer L. Bailit, Suzanna Larkin, Kavita Shah Arora

Journal of the National Medical Association, 23 May 2025

Abstract

Objective(s)

To evaluate the association between patient demographics, clinician demographics, and concordance of patient-clinician demographics and Medicaid sterilization consent form validity, defined as the waiting period having elapsed.

Study Design

Secondary analysis of a large, multi-center retrospective cohort study. This analysis included patients with Medicaid insurance desiring postpartum permanent contraception across three study sites. Our primary outcome was Medicaid sterilization consent form validity. Patient demographics were abstracted from the electronic medical record. Clinician demographics were obtained both through self- and peer-report. Descriptive, random effects modeling, and multivariable logistic regression analyses were utilized.

Results

Of the 1644 patients delivered by 124 clinicians in our cohort, 840 (51 %) had a valid Medicaid sterilization consent form. Descriptively, patients who were Black, unmarried, and not college educated were more likely to have valid forms (p < 0.001). The religious affiliation of the clinician (p < 0.001), but no other clinician characteristics, was associated with form validity. In multivariable models, patients who were of a different racial identity than their clinicians were more likely to have a valid form (aOR 1.32, 95 % confidence interval (CI) 1.05–1.66).

Conclusion(s)

While unable to determine the causes of our findings, the differential proportion of Medicaid sterilization consent form validity based on patient characteristics is concerning. Differences in form validity based on patient-clinician racial and ethnic concordance is deserving of further study.

A Modular Form of Informed Consent for the OPHL Surgeries

Book Chapter

Leone Giordano, Davide Di Santo, Andrea Galli, Mario Bussi

Atlas of Open Partial Horizontal Laryngectomy, 6 May 2025 [Springer]

Abstract

Open Partial Horizontal Laryngectomies (OPHLs) are well-established procedures for the treatment of laryngeal cancer. OPHLs have the advantage of being “modular,” such as they can be tailored to patients’ specific disease extent, and they can be intraoperatively extended according to unexpected tumoral infiltration. A modular informed consent form (ICF) should be implemented in such kind of surgery, being tailored to the patient as well and including any possible variation in the scheduled surgical plan. Furthermore, OPHLs may not be easy to understand for patients; in particular, their peculiar modularity may cause confusion. At the same time, the alliance between surgeon and patient is fundamental for postsurgical rehabilitation. To improve communication and cooperation, an information form should be provided to the patient days before the surgery. Both ICF and IF would improve communication and agreement between surgeon and patient and prevent any possible misunderstanding and litigation.

Valid consent in the acute hospital setting: perspectives of nursing and medical professionals from a survey-based study
Original Article
Charmaine Zahra, Motheo Kobua, Živa Kovic, Mary Fogarty, Catherine Buckley, Jane Murphy, Julie Walshe, Paul Zambra, Declan Byrne, Una Geary, Marie E. Ward
Irish Journal of Medical Science, 2 May 2025
Open Access
Abstract
Background
In healthcare, consent refers to the act of granting permission or agreement for treatment and care, investigation, receiving or utilising a service, or participating in research or teaching. Consent should be an ongoing process that involves clear communication about the proposed intervention, including its nature, benefits, and potential risks.
Aim
This survey-based study gathered experiences from junior doctors and nurses in a large acute teaching hospital about current consent practices and suggestions for improvement.
Method
Two surveys were developed and distributed to junior doctors in 2022 and nurses in 2023.
Results
The response rate for junior doctors (n = 58) was 21% (interns) and 57% (senior house officers) and 10% of the total nursing population responded (n = 184). Descriptive statistics and content analysis were used to analyse the results. Both junior doctors and nursing professionals believed there were areas for improvement in terms of consent processes and practices including in relation to better information for patients and more education and training for healthcare professionals.
Conclusions
The process of informed consent is central in the planning and provision of safe, effective person-centred healthcare as it encompasses healthcare professionals and patients communicating about and together deciding on and agreeing to medical interventions. This survey-based study looked at the experiences, attitudes, and perceived needs of junior doctors and nursing professionals in relation to the informed consent process in clinical practice at an acute hospital and informed the development of recommendations for improvement.

Optimizing the Performance of the Surrogate Informed Consent Process for Critical Care Research
Avallone Mantelli, C. Glaros, C. Tietbohl, K. Torres, D.C. Files, M.F. Mart, M.A. Matthay, K.E.A. Burns, D. Matlock, M. Wynia, M. Moss
American Journal of Respiratory and Critical Care Medicine, May 2025
Abstract
Rationale
Research in intensive care units (ICUs) is essential to improving care for critically ill patients; however, patients are often unable to consent for themselves. Surrogates are often required to participate in the informed consent process for critical care research, though how to best engage surrogates in this process remains unclear. This study seeks to identify best practices for conducting surrogate consent for critical care research.
Methods
We conducted a mixed-methods study including quantitative surveys with open-ended questions, focus groups, and semi-structured interviews with principal investigators (PIs), research coordinators (RCs), surrogate decision makers who had been approached about a critical care research clinical trial, and when possible, the patient who had been critically ill.
Results
In total, 230 individuals (105 RC, 90 PI, 27 surrogates, 8 patients) completed surveys, and 61 participated in focus groups or interviews. In both surveys and focus groups/interviews, participants across all groups believed that RCs (as opposed to PIs) should conduct the consent process, as RCs are not considered to be authority figures and have fewer perceived conflicts of interest that could influence surrogates decision-making. Surrogates appreciated it when research staff waited until an optimal time to initiate contact and were given physical space and a defined period to consider their decision before follow up with them. When compared to PI/RCs, surrogates and/or patients attributed more importance to seeing the research team as an additional resource in explaining the progress of the patient’s care and were appreciated having additional team members whom they perceived as advocating for adherence to clinical protocols for their loved ones (p<0.0001 and p=0.0016). Compared to PI/RCs, surrogates thought the written consent was more important and were less concerned with its length, (p=0.001 and p<0.0001). In general, all participants felt that phone and electronic consent was less effective than in-person consent, though these modalities could facilitate the process for distant surrogates. Consent timing, respect for surrogate decision-making autonomy, and clear communication of the patient’s presumed wishes were additional significant themes.
Conclusions
Our study highlights the need for better guidance for carrying out the surrogate consent process in ICU research and identifies several themes that could serve to develop recommendations including designating trained RCs as primary facilitators, improving consent timing and setting, and for implementing accessible consent documentation. This study supports developing standardized training and guidelines for the surrogate informed consent process that could be consistently applied by ethics review boards in reviewing consent processes for clinical care research.

Impact of Multilingual Informed Consent on Lung Transplant Recipients Participating in Explant Tissue Collection at the University of California, San Diego
S.S. Gaboyan, E. Golts, K. Afshar, J. Verheyden, J. Chin, C. Pathak, I.N. Advani, C.M. Lin, A. Meier, X. Sun, Z. Borok, L.E. Crotty Alexander
American Journal of Respiratory and Critical Care Medicine, May 2025
Abstract
Background
Traditional ischemic times for human lung tissue studies often range from hours to days, compromising transcriptomic data accuracy due to the rapid impact of hypoxia on gene transcription. In 2021 we established a pipeline at UC San Diego for the rapid collection of explanted lungs from the operating room (OR) at time of lung transplantation. Multilingual consent forms were adopted in 2024 to increase inclusivity and improve data accuracy across a diverse range of patient populations and disease states.
Methods
Institutional Review Board (IRB) approval was obtained and all subjects provided informed consent. Initially, only English consent forms were used. In early 2024, Arabic, Hebrew, and Spanish consent forms were added. Descriptive statistics and logistic regression were used to assess changes pre- and post-implementation of multilingual consent forms. Explant methodology: immediately after blood flow cross-clamping, explanted lung is handed to the research team in the OR, and multiple 1 cm³ cubes from upper and lower lobes are harvested. Adjacent segments undergo fresh frozen storage, OCT cryo-embedding, and 4% paraformaldehyde fixation. Sample quality has been validated through single-cell RNA sequencing (scRNAseq) and immunofluorescent staining.
Results
Lung tissues has been collected from 103 lung explants representing various pathologies, including IPF, COVID-19-related fibrosis, COPD, and other interstitial lung diseases. Average ischemic time was 8 minutes (SD=3). Among participants, 39% were female with a mean age of 56 years (SD=12), 62% were non-Hispanic White, 27% Hispanic, and 27% other/mixed. In 35 months, 76 explants (74%) were collected using English consent forms. Following the introduction of multilingual forms, 27 explants (26%) were collected in 8 months, increasing the explant rate from 2.2 to 3.4 per month. Among patients using multilingual consent forms, 37% were female, 50% non-Hispanic White, 33% Hispanic, and 44% other/mixed. These patients were less likely to be White (OR: 0.03, 95% CI: 0.00-0.81) and more likely to require pre-transplant mechanical ventilation (OR: 15.0; 95% CI: 1.1-201.1) or high-flow O₂ (OR: 18.4; 95% CI: 3.2-105.0).
Conclusion
An extremely low-ischemic time bank of explanted lung tissues from a racially/ethnically, and gender-diverse population of lung transplant recipients has been achieved using an established procurement protocol and enhanced with the addition of multilingual informed consent forms. These tissues are well-suited for modern research applications and have already been successfully utilized for scRNAseq across various disease states. Expanding our multilingual consent forms to include Mandarin and Farsi will further diversify our sample population, enhancing future analyses.

New Emphasis: Medications and Informed Consent
Robert C. Accetta
Caring for the Ages, May 2025; 26(3) pp 12-13
Outline
    Post-acute and long-term care providers are preparing with renewed vigilance for the revisions made to the Centers for Medicare & Medicaid Services State Operations Manual (SOM), Appendix PP, which become effective at the end of April 2025. I refer the reader to the advance copy, which has been available since November 2024 (https://www.cms.gov/files/document/qso-25-14-nh.pdf). Sections of the SOM, including the revised F605 tag, pertain to chemical restraints, psychotropic medications, resident rights, and consent for treatment, and F757 pertains to unnecessary drugs.

Renewed verbiage in the guidance emphasizes the concepts of residents’ autonomy and freedom to accept or decline proposed interventions for their care, which aligns with the person-centered care planning directives. The guidance reaffirms the duty of facilities and prescribers:

• To provide behavioral or nonpharmacological interventions.
• To have conversations with the residents or their representative about the benefits and risks associated with any proposed treatment or alternative available options.
• To document consent to the agreed-upon plan.

As this pertains to medications, disclosure about the risks, benefits, and warnings (including boxed warnings for antipsychotics) and consent to the proposed initiation or increase of a medication regimen are now of utmost importance.

A cross-sectional analysis of the reliability, content and readability of orthodontic retention and retainer informed consent forms
Original Article
Maurice J. Meade, Sven Jensen, Xiangqun Ju, David Hunter, Lisa Jamieson
International Orthodontics, September 2025
Open Access
Summary
Objective
The aim of the study was to determine the reliability, quality and readability of content contained within informed consent forms concerning orthodontic retention and retainers provided by orthodontic treatment providers.
Methods
An online search strategy identified informed consent forms for evaluation. The DISCERN instrument was used to determine content reliability. Each form was assessed for the presence of pre-determined content regarding 11 domains. Analysis for quality of the domain content was via a 4-point scoring scale. The Simple Measure of Gobbledegook (SMOG) and the Flesch-Kincaid Grade-Level (FKGL) were employed to determine readability.
Results
Thirty-four forms satisfied selection criteria. The majority (n = 20; 58.8%) were sourced from websites in the US, with most (n = 22; 64.7%) from specialist orthodontist websites. The mean (SD) DISCERN score per form was 31.9 (4.5). The mean (SD) number of domains present within each form was 7.76 (1.65). The mean (SD) number of points scored per form was 14.82 (3.01) from a maximum of 33. Information regarding retainer review and relevant potential impacts on quality-of-life was lacking and scored poorly. The requirement for lifetime retention was stated in 25 (73.5%) forms. Forms sourced from specialist orthodontist websites scored higher (P = 0.016) than those sourced from general dentist and multi-disciplinary clinic websites. The median (IQR) SMOG and FKGL scores were 10.11 (9.55) and 9.95 (9.18) respectively.
Conclusions
The reliability and quality of the informed consent forms concerning orthodontic retention and retainers was generally poor. The readability of the forms failed to meet recommended guidelines, meaning that many are likely not to comprehend the information provided.

Permission to Die? The Conflict of Consent in Brain Death Testing
Karrah St. Laurent-Ariot, George Clement, Bailey Brislin, Paul Zimmerman, Laura Hanson
Journal of Pain and Symptom Management, May 2025
Outcomes

1. Understand the ethics and laws regarding brain death testing.
2. Understand processes of brain death testing in ventilated patients and how these interact with patient and family values.

Key Message
Brain death testing can be inconsistent with patient’s cultural beliefs. While consent is not required to evaluate for brain death, apnea testing for a ventilated patient is an involved process which can be traumatic for families. Moral distress can be reduced by using thorough communication early on to establish a care plan that incorporated her spiritual and cultural beliefs.
Abstract
While there is ongoing debate about the need for consent for brain death testing, American Academy of Neurology guidelines state there is “no obligation to obtain consent”. However, familial objection to brain death testing can present care teams with unique challenges.
Case
An 18-year-old woman was found unresponsive after going to sleep with a severe headache. Evaluation at a local hospital showed respiratory arrest triggering intubation, GCS 3, unresponsive pupils, and hypothermia; CT head demonstrated a large intracranial hemorrhage and evidence of brain herniation. She was transferred to a tertiary medical center where brain death testing was recommended once hypothermia resolved. Her father was initially amenable, but after consultation with faith leaders, declined apnea testing, the remaining step to diagnose brain death. Her hospitalization was complicated by substantial barriers to trust and communication. Her family recounted inconsistent information and policies, over-adherence to algorithms, and shades of historical manipulation of minorities. They employed video surveillance and threats of litigation and requested transfer to New Jersey where brain death criteria are not endorsed. Ultimately, the patient received tracheostomy and PEG and was discharged to a long-term acute care hospital.
Discussion
Apnea testing for a ventilated patient can be traumatic for families. Both the family and the medical team experienced immense moral distress which may have been ameliorated by early and thorough communication to establish a care plan that incorporated her spiritual and cultural beliefs. Only one state in the U.S, New Jersey, allows for religious exemptions to Death by Neurologic Criteria under its Declaration of Death Act. It is often helpful to let family witness serial neurological exams to better understand the condition of their loved ones. Lastly, incorporating palliative care and chaplaincy services can decrease moral distress of both families and medical teams.

Editor’s note: We note the reference to the American Academy of Neurology guidelines and it’s apparent treatment of consent, which we will be examining further within our Center for Informed Consent Integrity.

Standardization of written informed consent forms to improve patient care, a quality improvement project
Jaweria Akram, Madeha Khalid, Rawand Abdelnaser Jebril, Isra Saleh Alsheikh, Amina Bougaila, Esha Subhash, Muhammed Zahid
BMJ Open Quality, 23 April 2025
Open Access
Abstract
Background
Informed consent taken by inadequately explaining the procedure to the patient or patient representative, along with incomplete documentation of the process, can have ethical, legal and administrative implications. We conducted a baseline survey from the patient’s representative admitted to the Acute Medical Assessment Unit (AMAU), Hamad General Hospital (HGH) [Doha, Qatar], and their representatives to assess the level of satisfaction and understanding with the current informed consent taking process for thoracocentesis, ascitic tapping, lumbar puncture, blood, and blood product transfusion. It showed only 64% were satisfied. We conducted a Quality Improvement project to standardize the process of taking informed consent for the above-mentioned procedures in order to improve patient satisfaction from 64% to 80% by December 2021 by providing them with individualized informed consent forms along with patient information template in their preferred language.
Methods
A thorough process mapping showed different factors that can lead to inadequate informed consent. We introduced the use of individualized informed consent forms for each above-mentioned procedure with the already printed complications along with patient information template in their preferred language with pictorial presentation of the procedure. Ten Plan/Do/Study/Act (PDSA) cycles were conducted with each cycle lasting four weeks. Before each cycle, the quality team conducted extensive training sessions for the residents and nurses. Different reinforcements were provided with each cycle to ensure the utilization of the interventions.
Results
After 10 PDSA cycles, the level of satisfaction with the process of taking informed consent improved from 64% to 94%.
Conclusion
A standardized informed consent form, along with a patient information template written in their preferred language, improves patients’ understanding to make a well-informed decision and therefore improves their satisfaction with the process, acting as a marker of quality improvement.