Continuous quality improvement: reducing informed consent form signing errors.

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.

Comparative Effectiveness of eConsent: Systematic Review.

BACKGROUND: Providing informed consent means agreeing to participate in a clinical trial and having understood what is involved. Flawed informed consent processes, including missing dates and signatures, are common regulatory audit findings. Electronic consent (eConsent) uses digital technologies to enable the consenting process. It aims to improve participant comprehension and engagement with study information and to address data quality concerns. OBJECTIVE: This systematic literature review aimed to assess the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, and study enrollment and retention rates, as well as the effects of eConsent on the time patients took to perform the consenting process ("cycle time") and on-site workload in comparison with traditional paper-based consenting. METHODS: The systematic review was conducted and reported in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Ovid Embase and Ovid MEDLINE were systematically searched for publications reporting original, comparative data on the effectiveness of eConsent in terms of patient comprehension, acceptability, usability, enrollment and retention rates, cycle time, and site workload. The methodological validity of the studies that compared outcomes for comprehension, acceptability, and usability across paper consent and eConsent was assessed. Study methodologies were categorized as having "high" validity if comprehensive assessments were performed using established instruments. RESULTS: Overall, 37 publications describing 35 studies (13,281 participants) were included. All studies comparing eConsenting and paper-based consenting for comprehension (20/35, 57% of the studies; 10 with "high" validity), acceptability (8/35, 23% of the studies; 1 with "high" validity), and usability (5/35, 14% of the studies; 1 with "high" validity) reported significantly better results with eConsent, better results but without significance testing, or no significant differences in overall results. None of the studies reported better results with paper than with eConsent. Among the "high" validity studies, 6 studies on comprehension reported significantly better understanding of at least some concepts, the study on acceptability reported statistically significant higher satisfaction scores, and the study on usability reported statistically significant higher usability scores with eConsent than with paper (P<.05 for all). Cycle times were increased with eConsent, potentially reflecting greater patient engagement with the content. Data on enrollment and retention were limited. Comparative data from site staff and other study researchers indicated the potential for reduced workload and lower administrative burden with eConsent. CONCLUSIONS: This systematic review showed that compared with patients using paper-based consenting, patients using eConsent had a better understanding of the clinical trial information, showed greater engagement with content, and rated the consenting process as more acceptable and usable. eConsent solutions thus have the potential to enhance understanding, acceptability, and usability of the consenting process while inherently being able to address data quality concerns, including those related to flawed consenting processes.

Exploring healthcare professionals' perspective of the process of obtaining consent for adult patient's having planned surgery: A scoping review.

AIM: The aim of this scoping review was to provide an overview of the literature about the process of obtaining consent from adult patients undergoing planned surgery from the healthcare professionals' perspective and analyse knowledge gaps. BACKGROUND: The process of obtaining consent for planned elective surgery manifests an individual's fundamental right to decide what happens to their body. The process is often suboptimal and problematic, placing a significant resource burden on health systems globally. Deficiencies in the documentation on consent forms have also been shown to increase the risk of operating room error. DESIGN: Scoping review. METHODS: Arksey and O'Malley's (International Journal of Social Research Methodology, 8, 2005 and 19) five-step scoping review methodology was used. RESULTS: Fifty-three articles were included; 39 primary and 14 secondary research publications. Three key findings were identified; there is currently low-level evidence about surgical consent processes to inform clinical practice; junior doctors obtain surgical consent frequently, yet this process was likely undertaken sub-optimally; and current knowledge gaps include capacity assessment, decision-making and pre-procedural consent checks. CONCLUSION: Planned surgical consent processes are complex, and both surgeons and perioperative nurses are essential during the process. While surgeons have responsibility to obtain consent, perioperative nurses provide a safety net in the surgical consent process checking the surgical consent information is correct and has been understood by the patient. Such actions may influence consent validity and patient safety in the operating room. Knowledge gaps about capacity assessment, decision-making, pre-procedural checks and the impact of junior doctors obtaining consent on patient understanding, safety and legal claims are evident. RELEVANCE TO CLINICAL PRACTICE: This review highlights the importance of the surgical nurse's role in the planned surgical consent process. While the responsibility for obtaining surgical consent lies with the surgeon, the nurse's role verifying consent information is crucial as they act as a safety net and can reduce error in the operating room. NO PATIENT OR PUBLIC CONTRIBUTION: The authors declare that no patient or public contribution was made to this review in accordance with the aim to map existing literature from the healthcare professionals' perspective.

Family caregivers support their patient's decision to participate in a phase 1 clinical trial: Weighing the pros and cons, bearing the costs.

OBJECTIVES: When patients with advanced cancer pursue phase 1 clinical trials, family caregivers are impacted as they adopt new roles and responsibilities in time-pressured, uncertain circumstances. This study explored the nature of the caregivers' participation in patients' decision to pursue phase 1 clinical trials and the early impact of the decision on the caregiver. METHODS: Semi-structured interviews were conducted with 19 family caregivers of advanced cancer patients who had agreed to participate in phase 1 clinical trials. They were coded for information about the caregiver's relationship with the patient, typical style of decision-making together, understanding of the patient's prognosis and trial, contributions to decision-making and the initial impacts of the trial on the caregiver. Codes illuminating the research questions were grouped into categories and themes, compared across transcripts and examined against the literature. RESULTS: Caregivers unequivocally supported the patients' decision to pursue the phase 1 trial as they hoped that the patient would derive medical benefit from the trial. They withheld their opinions and fears about the trial from the patients to support patient autonomy during the decision-making process. The patient's decision to participate increased the caregivers' burdens and deprived them of time spent on pleasurable activities at end of life. CONCLUSIONS: Respecting the patients' personal autonomy, caregivers supported the trial, despite the complex caregiving required. As the success of phase 1 trials relies on caregiver involvement, it is imperative that healthcare professionals be sensitized to the support needs of these caregivers.

Assessment of the quality of patient information sheets and informed consent forms for clinical trials at a hospital neurology service.

BACKGROUND AND PURPOSE: Clinical trials (CTs) aimed at vulnerable groups, such as patients with mental disorders, create ethical complexity. The patient information sheet (PIS) should provide all of the information about the CT that is relevant to the subject's decision to participate. After being informed, the subject will decide freely whether to take part in the CT and will read and sign the informed consent form (ICF). The objective was to assess the quality of PISs/ICFs from a hospital neurology service. The assessment was made using validated and reliable checklists of the information included in the PISs/ICFs of CTs with medicinal products. METHODS: The study comprised analyses of compliance with the checklists of 21 PISs and ICFs reviewed/approved during 2016-2017 by a medicinal research ethics committee. RESULTS: All PISs/ICFs were from multicenter CTs sponsored by pharmaceutical companies in different therapeutic areas, mainly Parkinson's (52.4%) and Alzheimer's (38.1%) diseases. The PISs from the neurology service demonstrated good compliance (≥80%) with the checklist, whereas ICFs should be improved. Sponsors omitted some relevant information, such as the study title or that the participant be informed of any information arising from the research that may be relevant to the subject's health, although this information may be in the PIS. CONCLUSIONS: The PISs/ICFs of CTs of medicinal products that are currently used need improvement. PISs and ICFs should be separate documents for each CT. In particular, the PISs/ICFs should consider the criteria related to the decision of participants, protect their rights and ensure that the information received is complete.

Remote monitoring of cardiac implanted electronic devices: legal requirements and ethical principles - ESC Regulatory Affairs Committee/EHRA joint task force report.

The European Union (EU) General Data Protection Regulation (GDPR) imposes legal responsibilities concerning the collection and processing of personal information from individuals who live in the EU. It has particular implications for the remote monitoring of cardiac implantable electronic devices (CIEDs). This report from a joint Task Force of the European Heart Rhythm Association and the Regulatory Affairs Committee of the European Society of Cardiology (ESC) recommends a common legal interpretation of the GDPR. Manufacturers and hospitals should be designated as joint controllers of the data collected by remote monitoring (depending upon the system architecture) and they should have a mutual contract in place that defines their respective roles; a generic template is proposed. Alternatively, they may be two independent controllers. Self-employed cardiologists also are data controllers. Third-party providers of monitoring platforms may act as data processors. Manufacturers should always collect and process the minimum amount of identifiable data necessary, and wherever feasible have access only to pseudonymized data. Cybersecurity vulnerabilities have been reported concerning the security of transmission of data between a patient's device and the transceiver, so manufacturers should use secure communication protocols. Patients need to be informed how their remotely monitored data will be handled and used, and their informed consent should be sought before their device is implanted. Review of consent forms in current use revealed great variability in length and content, and sometimes very technical language; therefore, a standard information sheet and generic consent form are proposed. Cardiologists who care for patients with CIEDs that are remotely monitored should be aware of these issues.

Racial/Ethnic Differences in Comprehension of Biospecimen Collection: a Nationwide University of Rochester Cancer Center NCI Community Oncology Research Program Study.

To examine whether (a) non-minority participants differed from racial minority participants in the understanding of biospecimens collected for research purposes, (b) patients differed from comparison group in their understanding of the ways their biospecimens could be used by researchers, and (c) participants received adequate information before consenting to donate blood for research studies. We analyzed cross-sectional data from female breast cancer patients scheduled to receive chemotherapy at the National Cancer Institute (NCI) Community Oncology Research Program (NCORP) clinical sites and a healthy comparison group. After reading a consent form related to biospecimens and consenting to participate in a clinical trial, participants' understanding of biospecimen collection was evaluated. Linear models were used to compare scores between non-minority and racial minority participants as well as cancer and non-cancer comparisons adjusting for possible confounding factors. A total of 650 participants provided evaluable data; 592 were non-minority (Caucasian) and 58 participants were a racial minority (71% Black and 29% other). There were 427 cancer patients and 223 comparisons. Non-minority participants scored higher than racial minorities on relevance-to-care items (diff. = 0.48, CI 0.13-0.80, p = 0.001). Comparison group scored higher than cancer patients on relevance-to-care items (diff. = 0.58, CI 0.37-0.78). A moderate number of the participants exhibited a poor understanding of biospecimen collection across all racial/ethnic backgrounds, but racial minority participants' scores remained lower in the relevance-to-care subscale even after adjusting for education and reading level. Differences were also noted among the patients and comparison group. Researchers should facilitate comprehension of biospecimen collection for all study participants, especially racial minority participants.

Informational needs for participation in bioequivalence studies: the perspectives of experienced volunteers.

PURPOSE: The present study aimed to determine the extent of information that healthy volunteers need in an informed consent form (ICF) to support their decision whether to participate in a bioequivalence study, a type of clinical studies involving the testing of pharmacokinetic equivalence of a generic drug with a brand-name drug in volunteer subjects. METHODS: This cross-sectional, descriptive study determined the perspectives of individuals who used to participate in bioequivalence studies, using an electronic-based questionnaire. A 5-point modified Likert scale was used to indicate the importance of each element of the ICF content, with an anchored rating scale from 1 (not important) to 5 (very important) for each item. RESULTS: Of 300 questionnaires distributed, all (100%) were returned. The respondents considered most items to be necessary for their decision, with the score ranging from 3.25 to 4.60 (mean overall score = 4.16 ± 0.30). The four top-rated items were the "major foreseeable risk" (4.60 ± 0.72), "participant's responsibility during participation" (4.52 ± 0.72), "confidentiality and the limit of confidentiality" (4.52 ± 0.82), and "all possible adverse effects of the drug" (4.47 ± 0.74), while the relatively less concerned items were related to general information. CONCLUSIONS: Most elements of the ICF content required were considered as important by the previously experienced volunteers in bioequivalence studies, notwithstanding that some elements were perceived as more important than others. The data from this study could be used to better tailor relevant information in an ICF to the needs of research participants in bioequivalence studies.

Electronic informed consent: the need to redesign the consent process for the digital age.

The delivery of healthcare, which includes the informed consent process, is moving to a digital environment. This change in informed consent delivery will be associated with opportunities, risks and also unintentional consequences. Physicians are well placed to contribute to the ongoing dialogue about what is needed to make the informed consent process fit for purpose, in the digital age.

Cost effectiveness of school-located influenza vaccination programs for elementary and secondary school children.

BACKGROUND: Studies have noted variations in the cost-effectiveness of school-located influenza vaccination (SLIV), but little is known about how SLIV's cost-effectiveness may vary by targeted age group (e.g., elementary or secondary school students), or vaccine consent process (paper-based or web-based). Further, SLIV's cost-effectiveness may be impacted by its spillover effect on practice-based vaccination; prior studies have not addressed this issue. METHODS: We performed a cost-effectiveness analysis on two SLIV programs in upstate New York in 2015-2016: (a) elementary school SLIV using a stepped wedge design with schools as clusters (24 suburban and 18 urban schools) and (b) secondary school SLIV using a cluster randomized trial (16 suburban and 4 urban schools). The cost-per-additionally-vaccinated child (i.e., incremental cost-effectiveness ratio (ICER)) was estimated by dividing the incremental SLIV intervention cost by the incremental effectiveness (i.e., the additional number of vaccinated students in intervention schools compared to control schools). We performed deterministic analyses, one-way sensitivity analyses, and probabilistic analyses. RESULTS: The overall effectiveness measure (proportion of children vaccinated) was 5.7 and 5.5 percentage points higher, respectively, in intervention elementary (52.8%) and secondary schools (48.2%) than grade-matched control schools. SLIV programs vaccinated a small proportion of children in intervention elementary (5.2%) and secondary schools (2.5%). In elementary and secondary schools, the ICER excluding vaccine purchase was $85.71 and $86.51 per-additionally-vaccinated-child, respectively. When additionally accounting for observed spillover impact on practice-based vaccination, the ICER decreased to $80.53 in elementary schools -- decreasing substantially in secondary schools. (to $53.40). These estimates were higher than the published practice-based vaccination cost (median = $25.50, mean = $45.48). Also, these estimates were higher than our 2009-2011 urban SLIV program mean costs ($65) due to additional costs for use of a new web-based consent system ($12.97 per-additionally-vaccinated-child) and higher project coordination costs in 2015-2016. One-way sensitivity analyses showed that ICER estimates were most sensitive to the SLIV effectiveness. CONCLUSIONS: SLIV raises vaccination rates and may increase practice-based vaccination in primary care practices. While these SLIV programs are effective, to be as cost-effective as practice-based vaccination our SLIV programs would need to vaccinate more students and/or lower the costs for consent systems and project coordination. TRIAL REGISTRATION: ClinicalTrials.gov NCT02227186 (August 25, 2014), updated NCT03137667 (May 2, 2017).

Biobanking in Israel 2016-17; expressed perceptions versus real life enrollment.

BACKGROUND: As part of the preparations to establish a population-based biobank in a large Israeli health organization, we aimed to investigate through focus groups the knowledge, perceptions and attitudes of insured Israelis, toward biobanking, and then, after input from focus groups' participants, to empirically assess the impact of a revised recruitment process on recruitment rates. METHODS: 1) Six Focus group discussions were conducted (n = 10 per group) with individuals who had routine blood laboratory tests taken in the last 2 years. 2) After addressing the issues raised in the focus groups and revising the recruitment process, individuals undergoing routine blood tests in phlebotomy clinics (N = 10,262) were invited to participate in the future biobank. RESULTS: At the outset of the focus groups there was an overall positive response to the prospect of a population-based biobank. Concerns revolved around infringement on privacy, fears of the "big brother"(e.g. insurance companies), and anxiety about inequality. Reaction to the language of the informed consent document revolved around concerns over ability to maintain anonymity, to withdraw consent, involvement of commercial entities, and the general tenor of the informed consent, which was perceived as legalistic and unilateral. In general, the longer participants were exposed to discussion about the biobank, the less likely they were to consent to sign in. Overall, only 20% (12) of the 60 participants stated they would agree to sign in by the end of the 2 hour group session. The feedback obtained from the focus groups was used in the second stage ("real life") of the study. A team of recruiters received extensive training to enable fruitful discussion and a detailed explanation to questions and concerns raised during the recruitment process. During the second stage of the study, after revising the consent form and training recruiters, a 53% consent rate was observed among 10,262 participants, more than 4 fold higher than estimated at the focus group stage. CONCLUSIONS: The qualitative focus group research helped identify important perceptions and concerns, which were subsequently addressed in the revised consent form and in the discussion the recruiters had with potential biobank donors.

An audit cycle of consent form completion: A useful tool to improve junior doctor training.

BACKGROUND: Consent for surgical procedures is an essential part of the patient's pathway. Junior doctors are often expected to do this, especially in the emergency setting. As a result, the aim of our audit was to assess our practice in consenting and institute changes within our department to maintain best medical practice. METHODS: An audit of consent form completion was conducted in March 2013. Standards were taken from Good Surgical Practice (2008) and General Medical Council guidelines. Inclusion of consent teaching at a formal consultant delivered orientation programme was then instituted. A re-audit was completed to reassess compliance. RESULTS: Thirty-seven consent forms were analysed. The re-audit demonstrated an improvement in documentation of benefits (91-100%) and additional procedures (0-7.5%). Additional areas for improvement such as offering a copy of the consent form to the patient and confirmation of consent if a delay occurred between consenting and the procedure were identified. CONCLUSION: The re-audit demonstrated an improvement in the consent process. It also identified new areas of emphasis that were addressed in formal teaching sessions. The audit cycle can be a useful tool in monitoring, assessing and improving clinical practice to ensure the provision of best patient care.

A Comprehensive Risk Assessment Method for Pediatric Patients Undergoing Research Examinations Using Ionizing Radiation: How We Answered the Institutional Review Board.

OBJECTIVE: The objectives of this study are to establish a comprehensive method for radiation dose estimates for the most common imaging examinations performed for research, for internal use of institutional review board (IRB) and radiation safety committees; to provide investigators with relative examination doses so that they may better assess the potential radiation effects and risks for research subjects; and to provide simplified language that investigators can use in consent documents. MATERIALS AND METHODS: Nineteen common radiation-based examinations used in clinical research at our institution were identified. For each modality (CT, digital radiography, dual-energy x-ray absorptiometry, PET/CT, and nuclear medicine), a comprehensive patient-specific dosimetry method was established. Effective dose was calculated according to average population calculated doses for the following age groups: 0-1, 2-8, 9-13, 14-15, and older than 15 years. RESULTS: Estimated effective dose values were tabulated and posted on our institutional IRB intranet site for use by IRB and radiation safety committee members and institutional investigators. Relative examination dose levels were compared for all ages and for all examinations. A three-tiered approach to establish consent language for radiation exposure was established for research subjects receiving an effective dose less than 3 mSv, a dose between 3 and 50 mSv, and a dose greater than 50 mSv. CONCLUSION: The method to estimate effective dose was tabulated for 19 of the most common ionizing radiation examinations at our institute. These results will act as a resource to help investigators better understand the implications of radiation exposure in research and can assist investigators in protocol development and correct categorization of radiation exposure risk.

How well informed is the informed consent for cancer clinical trials?

AIMS: The purpose of this study was to analyze the content of informed consent forms for clinical trials in medical oncology to assess readability, determine their completeness, and identify any shortcomings. METHODS: Informed consent forms for Phase I-III studies that were conducted at two tertiary care cancer centers over a 3-year period were reviewed. Information pertaining to length of the informed consent form, research regimen/methods, treatment agent, potential risks, and benefits was extracted. The reading level was assessed by Flesch-Kincaid and Gunning-Fog index readability tests. RESULTS: All of the 112 informed consent forms clearly stated the voluntary nature of participation. Nearly one half of the forms (51.8%) were of Phase I studies. The median length of informed consent form was 20 pages (range: 8-28). A detailed estimation of the frequency or intensity of risks (range: 3-8 pages) was provided. The average reading level of the informed consent forms was high (Flesch-Kincaid Grade Level of 9.8), which corresponds roughly to 10th-grade reading level. Less than 15% of all consent forms were written at the recommended eighth-grade reading level. A substantial number of forms did not report a potential risk to pregnant/lactating women (16.9%), mechanism of action of the investigational agent (34.8%), study schema (77.6%), a possibility of receiving sub-therapeutic dose (37%), or death (12.5%). Nearly one half of the forms (49.1%) stated clearly that individual participants may not benefit. CONCLUSION: Overall, these informed consent forms provided a detailed description of the trials in accordance to international guidelines. However, there remains room for improvement, particularly in areas of readability and document length.

Contraception Requirements in Clinical Research Consent Forms: Assessing and Supporting Gender Inclusive Practices.

Gender-diverse individuals are underserved in clinical research settings. Reliance on gendered language throughout the consent process for clinical research contributes to the marginalization of these populations. The research objective was to assess use of gender-inclusive language used to describe the contraception requirement in consent forms. We categorized and analyzed contraception language in 289 clinical trial consent forms using a deductive and summative content analysis approach. We found that 79% (n = 227) of consent forms contained gender-inclusive language, 80% (n = 231) used terms that fell under the biological sex language, and 91% (n = 264) used gendered language. No consent forms used exclusively gender-inclusive language and the majority 63% (n = 182) featuring a combination of all three language types. There were many consent forms which would have been entirely gender-inclusive language if section headings with references to biological-sex-specific contraceptives were excluded, suggesting that gender-inclusive language may be attainable with minor revisions.

Longitudinal assessment of an Ebola vaccine trial understanding among healthcare providers in the Democratic Republic of the Congo.

BACKGROUND: The long-term retention of information disclosed during the informed consent in clinical trials lasting over a year cannot be guaranteed for all volunteers. This study aimed to assess the level of participants' retention and understanding of the trial information after two years of participation in a vaccine trial. METHODS: In total, 699 health care providers (HCPs) and frontline workers were enrolled in the EBL2007 vaccine trial conducted between February 2019 and September 2022 in the Health District of Boende, Democratic Republic of the Congo (DRC). Individual scores obtained from a questionnaire (test of understanding, TOU), specifically designed to assess the understanding of the consent at baseline, were collected before the clinical trial started and at one-year and two-year intervals. RESULTS: TOU scores were high in the beginning of the trial (median TOU = 10/10), but significantly decreased in both the first and second years following (median TOU = 8/10 in year 1 and median TOU = 9/10 in year 2, p-value < 0.0001). The decrease in scores was significantly higher among individuals with occupations requiring shorter education such as midwives (median TOU = 7/10 in year 1 and 8/10 in year 2, pvalue = 0.025). Furthermore, older participants exhibited poorer retention of information compared to younger individuals (median TOU = 8/10 vs 9/10, p-value = 0.007). CONCLUSION: We observed a significant decline in the informational knowledge of informed consent, specifically in terms of basic knowledge on the study vaccine and trial procedures. As participant safety and understanding is a paramount ethical concern for researchers, it is crucial for participants to fully comprehend the study's objectives and potential risks. Therefore, our findings suggest the need for clinical researchers to re-explain participants to optimize the protection of their rights and wellbeing during the research.

Role of procedure-specific consent forms in clinical practice: a systematic review.

INTRODUCTION: Consent forms play an active role in the consent process with generic, handwritten consent forms (GCF) often the standard across the National Health Service. Increasingly, procedure-specific consent forms (PSCF) are being used as an alternative. However, concerns remain about whether they meet the standard for consent. We therefore conducted a systematic review with the objectives of investigating evidence for PSCF, study methodology and medicolegal criteria. METHODS: This systematic review was prospectively registered on PROSPERO (CRD42023392693) and conducted from 1 January 1990 to 17 March 2023 using the MEDLINE, Embase, CINAHL, CENTRAL and Emcare databases. A grey literature search was also performed. All studies evaluating PSCF in medical and surgical settings were included. Risk-of-bias analysis was performed using 'RoB 2' and 'ROBINS-I'. Meta-analysis was not possible because of the results' heterogeneity. FINDINGS: We identified 21 studies investigating PSCF with no systematic reviews and meta-analyses reported. Most studies were quality improvement projects (n = 10) followed by randomised studies (n = 5). No definitive legal guidance for PSCFs and no studies assessing their role in litigation post-procedural complications were identified. PSCFs were associated with improved documentation (70%-100%; n = 11) and legibility (100%; n = 2) compared with GCF. Randomised studies (n = 4) investigating patient understanding and recall for PSCF were inconclusive compared with GCF. CONCLUSIONS: The heterogeneous evidence available merely demonstrates superior documentation of PSCF compared with GCF. Studies do not adequately investigate the impact on informed consent and fail to address the associated legal concerns. Further randomised studies with patient-centric outcomes and consideration for medicolegal criteria are needed.

What Is "Key Information"? Consideration of the Reasons People Do or Do Not Take Part in Research.

We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

Redefining informed consent form in cell and gene therapy trials.

Informed consent is a foundation of the ethical conduct of research involving human participants. Based on the ethical principle of respect for persons, the goal of informed consent is to ensure that participants are aware of the risks and potential benefits and make a voluntary decision about participating in clinical trial research. The extraordinary scientific advances happening globally, have demonstrated the potential of regenerative therapies in transforming the health of the nation by providing a therapeutic option for diseases that were previously considered incurable. These therapies, which include cells and gene therapy (GT) labeled as Advanced Therapeutic Medicinal Products globally, have complex mechanisms of action. Owing to their highly personalized and intricate nature of these therapies, developing the latter often presents unique challenges above and beyond those encountered for small molecule drugs. We recently looked through some cell and GT clinical trials and realized the lacunae in the informed consent form (ICF) provided by the investigators. Especially in a country like India, where the general understanding and perception of patients is limited regarding clinical trials, it is felt that any lapses in the consent process may jeopardize the informed decision-making and safety of the participants and tarnish the reputation of India globally. The present article highlights the need for appropriate patient and public education on the various aspects of cell and gene therapies and aims to address all the elements of ICF in light of the challenges associated with these innovative therapies.