Informed Consent: An Essential Tool for Medical Practice and Research
Review Article
Sukhvinder Singh Oberoi, Nilima Sharma, Sweta Rastogi, Sunil Kumar, Anand Suresh
Amrita Journal of Medicine, April-June 2025
Abstract
The concept of informed consent regulates the relationship between medical practice and patients, promoting human rights and dignity. It serves as both a legal and ethical mechanism for ensuring autonomy and self-determination. This review examines the concept of informed consent as it applies to both medical research and clinical practice, addressing its types, prerequisites, limitations, and challenges. Additionally, it explores waiver of consent and the concept of minimal risk in research. The review highlights the importance of shared decision-making (SDM), the barriers to informed consent, and the role of comprehension in the consent process. The discussion emphasizes the need for improvements in informed consent procedures, particularly in enhancing patient understanding and addressing legal and ethical gaps. Future research should focus on refining consent mechanisms to improve their effectiveness in modern healthcare.
Health system-led early consent and direct contact of at-risk relatives: Pilot study results
Health system-led early consent and direct contact of at-risk relatives: Pilot study results
Nora B Henrikson, Aaron Scrol, Jamilyn M Zepp, Melissa L Anderson, Paula R Blasi, John J Ewing, Jane Grafton, James D Ralston, Stephanie M Fullerton, Kathleen A Leppig
Public Health Genomics, 3 April 2025
Abstract
Introduction
At-risk relatives of probands with genetic variants associated with hereditary cancer risk should receive cascade genetic testing. In the U.S., probands are expected to notify their own at-risk relatives, but many relatives never learn of their risk, representing missed opportunity to reduce morbidity and mortality associated with hereditary cancers. Direct contact of relatives could reach relatives not contacted by the proband. We conducted a single-arm, prospective pilot evaluation of a direct contact intervention based on patient and family preferences. Here we report the study’s quantitative results, measured by proband and relative participation in the intervention follow-up survey.
Methods
We recruited adults receiving genetic counseling for inherited cancer risk at one U.S. integrated health system. A genetic counselor offered to contact at-risk relatives. We surveyed probands and relatives at study enrollment and 6-8 weeks and evaluated administrative data to assess the program’s outreach to probands and relatives, its acceptability, and its limited efficacy.
Results
We approached 148 probands before their genetic counseling appointment. 55 (37%) consented to study participation. Of these, 31 completed genetic testing, 29 of whom provided consent to contact 101 relatives. 44% (n=45) of relatives consented to be contacted by the study genetic counselor. Acceptability was high for both groups and no harms were reported. All relatives reached (n=43) received their proband’s test results, including 6 pathogenic/likely pathogenic findings.
Conclusion
A direct contact program was acceptable, reached at-risk relatives and communicated proband test results. Direct contact with early consent of relatives holds promise for future research.
Editor’s Note: Our Center is examining the nuanced underlying issues raised by this important article.
Challenges and Solutions in Implementing Informed Consent in Digital Environments: A Scoping Review
Challenges and Solutions in Implementing Informed Consent in Digital Environments: A Scoping Review
Ramona Schmidt, Ina Schiering, Harald Zwingelberg, Michael Friedewald
IEEE Access, 30 April 2025
Abstract
In times of ubiquitous data collection and processing, the need for privacy and control is stronger than ever. The implementation of informed consent is becoming increasingly important. The obligation to obtain informed consent and the user’s right to information and to refuse or withdraw consent is already defined in the GDPR. Particularly within the mHealth [mental health] sector, where the collection of particularly sensitive health data occurs, the realisation of informed consent presents an important challenge. However, many applications are still not compliant, and companies seem to struggle with the implementation of effective informed consent. This scoping review analyses how the technical implementation of informed consent has been addressed in the literature to date, what challenges need to be overcome when implementing informed consent, and what solutions are proposed and discussed in the current literature on the implementation of informed consent.
Toward Ethical Digital Practices: Guidelines for Consent, Accountability, and Transparency in Anthropology
Toward Ethical Digital Practices: Guidelines for Consent, Accountability, and Transparency in Anthropology
Amber M Plemons, Micayla C Spiros
American Journal of Biological Anthropology, April 2025
Abstract
Objectives
Digital tools and imaging are now common practice in biological anthropology research. Ethical concerns around the management, use, and display of digital human remains are a budding topic of discussion. Currently, there are no formalized discipline-wide guidelines or standards for digital ethics in biological anthropology. To bridge the gap between ethical standards and digital practices, we need to gauge current digital tools and resources used by professionals, as well as the state of ethical codes for professional organizations regarding digital media in biological anthropology.
Materials and methods
This study reviews ethical statements from five professional organizations and survey responses from biological anthropologists on their use and opinions of digital remains. Text analyses were performed on ethics statements to identify terms related to digital remains and on survey responses to identify key themes in opinions of digital ethics.
Results
Results demonstrated that only one organization mentions digital ethics while survey results indicate researchers are creating and using digital tools in their research. Thematic text analyses underline the need for consent, digital ethical guidelines, anonymity, data security, and cultural sensitivity and respect.
Discussion
These results highlight the gap in practice and guidelines for digital ethics. We propose immediate action items, including the development of a cross-cultural, disciplinary working group to generate cohesive digital ethics standards, explicit statements on digital human remains in donor forms, the addition of digital best practice standards into organizations’ ethics codes, and ethics statements added to current digital platforms. These proposed ethical guidelines and questions for donor forms are provided for these action items.
Editor’s Note: “Digital remains” refers to the digital data and information a person leaves behind after death, including online accounts, emails, social media posts, documents, and other digital assets.
Co-designing and pilot-testing an infographic to support the consent process in an adaptive platform trial for adults in ICU with community-acquired pneumonia or COVID-19: a mixed methods study within a trial (SWAT)
Co-designing and pilot-testing an infographic to support the consent process in an adaptive platform trial for adults in ICU with community-acquired pneumonia or COVID-19: a mixed methods study within a trial (SWAT)
Research
Heather K. O’Grady, Kathy Smith, Sandra Dalziel, Barbara Dolanjski, Gyan Sandhu, Marlene Santos, Jackie Bosch, Lyn S. Turkstra, Srinivas Murthy, John C. Marshall, Michelle E. Kho
Research Involvement and Engagement, 25 April 2025
Open Access
Abstract
Background
Informed consent documents educate patients and families about research participation and alternatives. However, given their length and complexity, consent documents can be challenging to understand, particularly in high-stress environments such as the Intensive Care Unit (ICU) and for complex study designs such as platform trials.
Methods
This is an exploratory sequential mixed methods study-within-a-trial (SWAT) of REMAP-CAP (Randomized, Embedded, Multifactorial, Adaptive Platform Trial for Community-Acquired Pneumonia). Phase 1: We conducted focus groups with individuals with lived experience, including ICU survivors, substitute decision makers (SDMs) and research coordinators (RCs) to refine an infographic to augment a priori REMAP-CAP consent encounters. We analyzed data using inductive content analysis. Phase 2: We piloted the infographic with patients/SDMs approached a priori to participate in REMAP-CAP, who could communicate in English, at five sites in Ontario, Canada. We assessed implementation according to 1) eligible consent encounters (number of patients/SDMs eligible for SWAT / approached for REMAP-CAP), 2) receipt of infographic (number of patients/SDMs who received the infographic / eligible consent encounters), 3) consent to participation in this SWAT by patients/SDMs (number of patients/SDMs who consented / those approached), and 4) feedback questionnaire completion (number of patients/SDMs who completed the questionnaire / those who received it).
Results
Phase 1: We conducted two, two-hour focus groups with 5 participants (10 participants total). Participants identified important infographic design considerations (visual presentation, language) and content (study details, participation in research).
Integration: Results from Phase 1 were used to develop a final consent infographic.
Phase 2: Sixty-three patients were eligible for REMAP-CAP during the study period; 21 were eligible (33%) for the SWAT. Of these, 18 patients/SDMs (86%) received the infographic, 17 consented to the SWAT (94%) and 15 (88%) completed questionnaires. RCs completed case report forms for each consent encounter (n = 18, 100%).
Conclusions
We engaged individuals with lived experience to co-design a consent infographic. We achieved three of four pre-specified feasibility objectives during pilot testing of the infographic for a priori REMAP-CAP consent encounters. Although there were fewer eligible consent encounters than anticipated, we identified acceptable rates of infographic delivery, consent to SWAT participation and questionnaire completion.
A Randomized Controlled Trial of Video-Assisted Electronic Consent Versus Standard Consent for Percutaneous Kidney Biopsy
A Randomized Controlled Trial of Video-Assisted Electronic Consent Versus Standard Consent for Percutaneous Kidney Biopsy
Pedro H Franca Gois, Vera Y Miao, Rebecca B Saunderson, Marina Wainstein, Julia Jefferis, Rebecca Hudson, Shaun Chandler, Kylie-Ann Mallitt, Martin Wolley, Belinda Elford, Ann Bonner, Helen G Healy
Clinical Journal of the American Society of Nephrology, 9 April 2025
Abstract
Background
Informed consent is crucial in healthcare, as it respects and honors patient autonomy. However, the process of consenting a patient to a procedure or intervention is often unstandardized, leading to gaps in comprehension, which in turn affects decision-making. This study aimed to assess the patient-reported benefits of video-assisted electronic consent (eConsent) compared with the usual consent practices for percutaneous kidney biopsies (PKB).
Methods
In this single-center, open-label, randomized controlled trial, consecutive patients undergoing PKB between July 2021 and January 2024 were randomized (1:1) to either video-assisted eConsent (intervention) or usual practice of consent (control). The intervention group accessed an eight-minute explanatory animation on an online platform covering the procedure, its risks, and pre- and post-biopsy care before providing digital consent. The control group was consented to by clinicians in the usual manner and signed a paper form. The primary outcome was questionnaire-based patient comprehension, with secondary outcomes including patient-reported experience, anxiety, and satisfaction with the consent process.
Results
Of 178 eligible patients, 120 were enrolled (60 in each group), with a median age of 52 (IQR 34-65) years, 56% were female, and 59% had less than 12 years of education. Comprehension scores were significantly higher in the eConsent group, with participants answering on average three more questions correctly out of nine compared to the control group (p<0.001). Comprehension did not differ significantly by sex or education level, but younger patients scored higher. The eConsent group also had better comprehension of pre- and post-PKB care. No significant differences were observed in patient-reported experience, anxiety, or satisfaction between groups.
Conclusions
Video-assisted eConsent improves patient comprehension of PKB compared to usual consent practice without affecting patient experience, anxiety, or satisfaction.
An informational video for informed consent improves patient comprehension before total hip replacement- a randomized controlled trial
An informational video for informed consent improves patient comprehension before total hip replacement- a randomized controlled trial
Research
Sebastian von Hertzberg-Boelch, Konrad Fuchs, Johanna Schubring, Dominik Rak, Kilian List, Konstantin Horas, Axel Jakuscheit, Maximilian Rudert
International Orthopaedics, 2 April 2025
Open Access
Abstract
Purpose
Effective patient comprehension is critical for informed consent, particularly in Total Hip Arthroplasty (THA), a globally prevalent procedure. This study evaluates the efficacy of an informational video to improve the patients’ understanding, self-perceived knowledge, and emotional comfort in the context of THA informed consent. This randomized controlled trial investigates the impact of an additional informational video on (I) the patients’ understanding, (II) self-precepted knowledge and (III) emotional comfort during the informed consent process for THA.
Methods
Participants were randomized to receive either the standard informed consent procedure or the standard procedure supplemented with an informational video. The effect of the video was tested with post-consent questionnaires.
Results
The informational video significantly (p = 0.014) improved the patients’ understanding from 78.6% to 86.5%. Self-precepted knowledge and Emotional comfort was not effected by the video (p = 0.986; p = 0.333).
Conclusions
The informational video significantly improved patient comprehension during the informed consent process before THA.
Comprehension and Satisfaction with Informed Consent for Hip Arthroscopy Using Supplemental Online Educational Materials
Comprehension and Satisfaction with Informed Consent for Hip Arthroscopy Using Supplemental Online Educational Materials
Molly Piper, Kira Smith, Margaret Sinkler, Michael Salata, Jacob Calcei
Journal of Hip Preservation Surgery, 27 March 2025
Abstract
Background
Informed consent is a crucial component of building the patient-physician relationship, and it typically involves a conversation between patient and provider along with a written document. The purpose of this study was to determine whether the use of electronic educational resources in addition to paper handouts would improve patient comprehension and retention of informed consent for hip arthroscopy procedures.
Methods
Patients undergoing hip arthroscopy were enrolled prospectively, and they were randomized into two groups at their preoperative visit. The first group of patients received a handout discussing their procedure following the informed consent process with the physician, while the second group received the handout as well as access to an online educational forum. The online educational materials included information regarding the procedure, risks, benefits, and alternative options to surgery. The patient’s comprehension, retention, and satisfaction were assessed with a survey on their day of surgery prior to the hip arthroscopy procedure.
Results
There were 26 patients who completed the survey preoperatively, and 65% of those patients were females (n= 17). The average age was 30 ± 9.6 years. 13 of those patients accessed the online educational materials, and 13 patients only had a paper copy of the information. There was no significant difference in the proportion of patients who were very or extremely informed of their procedure (p > 0.99). Additionally, there was not a significant difference in the awareness of the risks, benefits, and alternatives to hip arthroscopy between patient groups (p > 0.99). Over 75% of patients in each group were very or extremely satisfied with the information and teaching they received during the informed consent, but there was not a significant difference between groups (p= 0.59). Of the patients who utilized the online educational materials, 62% agreed that the materials helped improve their understanding of the surgery (n= 8).
Conclusion
Despite an additional online educational forum, there was not a difference in patients’ comprehension of information from the informed consent process for those undergoing hip arthroscopy. There was also not a difference in patient satisfaction between patients receiving only a paper handout versus the additional online educational forum.
Pediatric Acute Appendicitis as a Model for Shared Decision-Making
Pediatric Acute Appendicitis as a Model for Shared Decision-Making
Book Chapter
Lindsay A. Gil, Loren Berman, Peter C. Minneci
Difficult Decisions in Pediatric Surgery, 28 March 2025 [Springer]
Abstract
Shared Decision-Making (SDM) in pediatric surgery is challenging given that the treatment decision typically involves three parties (surgeon, caregiver, and patient), and at least one of the treatment choices usually involves an operative intervention. There has been mounting evidence to support the safety and efficacy of non-operative management of pediatric uncomplicated acute appendicitis with antibiotics alone, making SDM an essential and valuable tool for pediatric surgeons. This chapter highlights both the importance and challenges of applying SDM in pediatric surgery by exemplifying its application to the treatment choice between non-operative and operative management of pediatric uncomplicated acute appendicitis. The appendicitis example is one of several in which SDM has the potential to reduce healthcare resource utilization and costs by increasing uptake of non-operative conservative treatments.
Ethical Considerations in the Surgical Care of Children: Balancing the Interests of the Child, the Family, and the Surgeon
Ethical Considerations in the Surgical Care of Children: Balancing the Interests of the Child, the Family, and the Surgeon
Book Chapter
Johnathan Kent, Miranda Ortega, Manish Tushar Raiji
Difficult Decisions in Pediatric Surgery, 28 March 2025 [Springer]
Abstract
Pediatric surgeons take part in the care of children across a wide spectrum of development and maturity. The relationships between patients, their families, and their surgeons can form an inclusive and supportive team to help children navigate complex health concerns. However, these relationships can also form the basis of complex ethical challenges. The care of children involves an understanding of the development of a child’s maturity and subsequent ability to participate in medical decision making. Under specific circumstances, adolescents can become fully independent to make medical decisions. But in the vast majority of instances, children and adolescents require surrogate decision makers to choose for them. This chapter explores several of the tensions that may arise when considering medical and surgical care for children.
Editor’s note: We note the authors’ assertion that “…in the vast majority of instances, children and adolescents require surrogate decision makers…” We express concern about the imprecision and underlying assumptions of this assertion and continue to examine issues around assent, capacity and children’s rights in our Center for Informed Consent Integrity work.
Center for Informed Consent Integrity 