Consent In Clinical Trials Research Articles

Language as a barrier to cancer clinical trial accrual: assessing consenting team knowledge and practices for cancer clinical trial consent among low English fluency patients

BackgroundLow English fluency in large culturally diverse institutions may contribute to meager minority accrual. Our objective was to: 1) Assess knowledge of proper consenting procedures among the research team when consenting a low English fluency patient. 2) Assess the enrollment rate of participants in cancer therapeutic trials who identify a preferred language other than English.MethodsAn anonymous web-based survey was distributed at a single institution to investigators, research staff and translator services to assess knowledge of consenting procedures. Patient enrollment data was retrieved from the clinical trials enrollment tracking system from January 2011 – October 2014 and matched to registration data indicating preferred language (N = 1521). The number and type of cancer cases from January 2011–October 2014 were retrieved from the institutional cancer registry and matched to registration data indicating preferred language.ResultsAlthough there are many organizational in-person and web-based trainings focused on the requirements for consenting low English fluency patients, members of the research team responded correctly to only 64.8% (σ = 24.6%) of the knowledge-based portion of the survey. Of the 12,538 index cancer cases indentified, 10% preferred a language other than English. Trial enrollment rates for cancer clinical trials were similar for English (13%), Spanish (11%), and, Armenian (10%) speakers. Populations speaking Russian and Arabic had the lowest participation at 5% each.ConclusionsIn order to increase enrollment into clinical trials, institutions must explore more effective training opportunities for research staff, engage interpreters and adopt recruitment and study materials in different languages.

Regulations and ethics surrounding cluster randomized controlled trials and other clinical trials in emergency medicine

Introduction: A cluster randomized controlled trial is performed as an intervention in a group of subjects (collectively labeled as a “cluster”), rather than for an individual. Despite practical challenges and ethical issues inherent in obtaining informed consent for patient participation in cluster randomized controlled trials, many countries and regions have aggressively pursued these trials to increase the quality of medical evidence. However, Japan has yet to create an established protocol for obtaining informed consent for clinical trials in emergency medicine, including resuscitation science, and cluster randomized controlled trials. The aim of this study was to develop a method for obtaining informed consent in cluster randomized controlled trials of resuscitation science in Japan and other regions.

User testing as a method for evaluating subjects’ understanding of informed consent in clinical trials in multiple sclerosis

The Patient Information Sheet (PIS) is an important aspect of the consent process in a clinical trial that provides potential participants the necessary information for deciding whether to take part in a specific study and for understanding their rights pertaining to participation. User Testing was originally developed to assess how written information about medicinal products performs with its intended users. User testing has been proposed in a small number of clinical trials and has been able to identify subjects’ ability or inability to find and understand important information related to providing a valid consent to participate. A 21-item ad hoc user testing questionnaire was applied to 2 PIS used in clinical trials in MS. Sixty subjects were allocated to a group testing an observational study PIS (O-PIS) or to a group testing an intervention study PIS (I-PIS). In the O-PIS group, 19.4% of subjects located all relevant information within the text (21/21) and 3.4% of subjects in the I-PIS group. Overall, 82.1% of subjects testing the O-PIS understood the text and 53.5% of subjects testing the I-PIS understood the text. In the category ‘nature and purpose of the trial’, one-third of subjects did not understand the text, including the aim of the study. User testing should be considered as a valid tool in evaluating the comprehensibility of PIS in the context of clinical trials MS to assure that subjects provide a valid consent to participate.

Patient reported measures of informed consent for clinical trials: A systematic review.

IntroductionThe subjective assessment of the adequacy of informed consent for clinical trials, and the potential difficulties associated with it, has led several studies to develop objective measures of informed consent for clinical trials. These objective measures of informed consent are often specific to a particular population or clinical condition and largely focus on understanding of (some or all of) the key elements of informed consent. Many of the developed tools are study-specific, but some validated measures exist. Of these validated measures, those which are reported by participants are of particular interest. Whether these objective tools conceptualize and measure informed consent in the same way is not known. As such, it is not clear whether meta-analyzing data from studies reporting different tools is worthwhile. The aim of this systematic review was to critically appraise the evidence on the overall conceptualisation and item content of validated patient reported measures of informed consent for clinical trials, and to identify core domains of potential importance for informed consent.MethodsA systematic search of the literature was conducted to identify relevant articles that described the development, and/or validation, of patient-reported measures of adequacy of informed consent for randomised controlled trials. Data was synthesised by classifying the items identified into domains and sub-domains which were determined by the nomenclature reported in included studies. Both for descriptions of included studies and of the instruments reported in those studies, descriptive statistics were used to describe general information and instrument detail. A narrative synthesis of the instruments and their inter-related domains and subdomains was conducted to identify areas of both convergence and divergence.ResultsThe search identified 8193 citations. After screening titles and abstracts, 29 full text articles were retrieved for further assessment. Of these 29, 14 complied with our pre-specified inclusion criteria with 15 not being eligible. Of the 14 instruments, three explicitly reported a theoretical or conceptual framework underpinning their development, a further three implicitly referred to the ‘conceptual dimensions of informed consent’ or ‘principles of research ethics’ as informing their development and eight reported no guiding theoretical framework. Only three of the 14 studies reported patient or public involvement in the development of the tool. One hundred and seventy nine items were included across the 14 instruments. The primary focus of the instruments was on understanding. Five core domains were identified which included: Autonomy; Consequences; Expectations; Purpose; and Individualisation. There was substantial variability in the coverage of different domains across measures.ConclusionsThis study demonstrated the variability in the theoretical underpinning, development and domain coverage of existing patient-reported measures of informed consent for clinical trials. The conceptualisation of informed consent could benefit from being extended from a narrow focus on understanding to include broader considerations of decision-making. Meaningful involvement of potential trial participants during development of measures critical for tool relevance is also lacking. The identification of the key domains relevant to all stakeholders which could be measured to assess the informed consent process for clinical trials is needed.

A Digital Decision Support Tool to Enhance Decisional Capacity for Clinical Trial Consent: Design and Development.

BackgroundChallenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial.ObjectiveWe describe the design and development process of a tablet-based decision support tool.MethodsOur development process for the decision support tool employed a user-centered, feature-driven design approach. We began with an environmental scan to catalog relevant mobile apps, and we conducted interviews with people with a diagnosis of fragile X syndrome and clinicians at fragile X syndrome clinics. To develop content for the decision support tool, we extracted key concepts and elements from a real clinical trial consent form and rewrote it using plain-language principles.ResultsWe used iterative testing to continuously evaluate and revise the decision support tool content. The tool was finalized in 2016 and contained a series of vignettes, quiz questions, and a sorting activity. A randomized controlled trial was then conducted to compare the efficacy of the decision support tool with a standard verbal presentation of material that mimicked typical informed consent practice.ConclusionsThe informed consent process is primed to leverage digital health resources that promote increased understanding and engagement of research participants in the consent and research process. The process and experiences we describe may provide a model for other digital health design and development initiatives seeking to create more interactive and accessible decision support resources.Trial RegistrationClinicalTrials.gov NCT02465931; https://www.clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/6zx2KY9YW)

How to obtain informed consentfor research.

The process of obtaining informed consent for clinical trials is tightly regulated; complications arise in circumstances when consent may be waived, or when needed from vulnerable populations http://ow.ly/rEMe30j5MVq

Blockchain protocols in clinical trials: Transparency and traceability of consent.

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients' informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient's consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again. We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility.

National Cancer Information Service in Italy: an information points network as a new model for providing information for cancer patients.

The international literature data report that good information and communication are fundamental components of a therapeutic process. They contribute to improve the patient-health care professional relationship, to facilitate doctor-patient relationships, therapeutic compliance and adherence, and to the informed consent in innovative clinical trials. We report the results of a multicentric national initiative that developed a 17-information-structure network: 16 Information Points located in the major state-funded certified cancer centers and general hospitals across Italy and a national Help-line at the nonprofit organization AIMaC (the Italian oncologic patients, families and friends association), and updated the already existing services with the aim to create the National Cancer Information Service (SION). The project is the result of a series of pilot and research projects funded by the Italian Ministry of Health. The Information Service model proposed is based on some fundamental elements: 1) human interaction with experienced operators, adequately trained in communication and information, complemented with 2) virtual interaction (Help line, Internet, blog, forum and social network); 3) informative material adequate for both scientific accuracy and communicative style; 4) adequate locations for appropriate positioning and privacy (adequate visibility); 5) appropriate advertising. First results coming from these initiatives contributed to introduce issues related to "Communication and Information to patients" as a "Public Health Instrument" to the National Cancer Plan approved by the Ministry of Health for the years 2010-2012.

Abstract WP307: Patients’ and Surrogates’ Experiences and Views of Consent in Acute Stroke Trials

Introduction: Informed consent for clinical trials in acute stroke is challenging. Enrollment decisions must be made quickly, in stressful situations, and typically by a surrogate. Moreover, trials are complex and unfamiliar. Understanding patients’ and surrogates’ experiences may help maximize respect for them while facilitating important studies. Methods: Telephone interviews were conducted with consented patients or surrogates for patients enrolled in acute stroke trials at 3 US sites between 2011 and 2016. Interviews assessed trial recall, experiences with consent, and preferences regarding consent. Questions were primarily closed-ended. Descriptive statistics were calculated, and bivariate analyses (Fisher’s exact) were conducted to examine predictors of consent preference. Results: Eighty-four respondents (69 surrogates, 15 patients) across 3 sites and 10 trials were interviewed and included in final analysis. Nine did not recall enrollment, and only about half (53%) recalled that the trial involved an intervention. Of 75 respondents who remembered enrolling, 65 (87%) remembered signing a consent form, 52 (80%) of whom said they read at least some of it. Most respondents reported being treated respectfully during consent. Only 12 respondents (16%) wished they had been enrolled in the trial without prospective consent. Individuals with low health literacy were less likely to prefer enrollment without consent (p<0.0007) but more likely to wish they had not had to sign a consent form (p<0.0001). Forty-six (61%) recalled someone talking with them about the study after enrollment. Conclusions: Patients and surrogates in stroke trials reported mostly positive consent experiences and generally appreciated having been asked for consent prior to enrollment. Recall of trial details, however, was low, and post-enrollment contact was recalled to be somewhat infrequent. Further work may help to identify the most context-appropriate strategies.

Quality of informed consent in cancer clinical trials in India: A cross-sectional survey.

An 'informed consent' is a legal and ethical requirement for research involving human subjects. Studies assessing the validity of informed consent and determinants of its quality have highlighted problems in consent delivery and comprehension by trial participants. We report the findings of a questionnaire-based survey conducted to understand the quality of informed consent (QuIC) in cancer clinical trials. The survey was conducted in a single tertiary care cancer centre in India. Patients enrolled in phase 1, 2 or 3 interventional studies were administered the QuIC questionnaire by a trained study coordinator. The QuIC, expressed as knowledge score, was calculated from the proportion of correct responses expressed as a percentage. The mean (SD) knowledge score was 60.46% (1 5.21%). It was considerably higher in industry-sponsored trials compared to investigator-initiated trials (65.32% v. 52.21%, respectively; p<0.001). Faith in the treating oncologist positively influenced the patients' decision to participate in a trial. Nearly 97% of the respondents anticipated better care, while 85% felt that the new drug/procedure would be better than the existing treatment. Free treatment emerged as a strong inducement for patients to take part in clinical trials. Patients were aware of their autonomy, and responses showed that none of the patients were coerced or unduly influenced to participate in clinical trials. Our study revealed important deficiencies in research participants' understanding of essential elements of informed consent. Thorough patient counselling is crucial to minimize 'therapeutic misconception' to preserve the validity of informed consent in cancer trials.

Determining an effective and coherent theoretical basis for the validity of consent in clinical trials

Determining an effective and coherent theoretical basis for the validity of consent in clinical trials

Ethical issues in pragmatic trials of "standard-of-care" interventions in learning health care systems.

IntroductionLearning health care systems (LHS) hold the promise of improving medical care by systematically and continuously integrating the delivery of medical services with clinical research. One important type of integration would involve embedding trials that compare interventions that are already commonly in use (as “accepted” or “standard of care”) into the clinical setting—trials that could cost‐effectively improve care. But the traditional requirement of informed consent for clinical trials stands in tension with the conduct of such trials.MethodNarrative analysis.ResultsAlthough some have suggested that the idea of LHS makes the distinction between research and ordinary clinical care obsolete, the distinction remains ethically relevant even when it comes to randomized clinical trials (RCTs) that compare standard‐of‐care interventions. This paper presents an ethical framework for analyzing standard‐of‐care RCTs in resolving the tension between such trials and traditional requirements of research ethics.ConclusionIt is important not to treat all standard‐of‐care RCTs as a monolithic category of special ethical status. Close attention to ethical issues in specific standard‐of‐care RCTs is crucial if the LHS movement is to avoid ethical lapses that could be counterproductive to its long term vision.

Blockchain protocols in clinical trials: Transparency and traceability of consent

Clinical trial consent for protocols and their revisions should be transparent for patients and traceable for stakeholders. Our goal is to implement a process allowing for collection of patients’ informed consent, which is bound to protocol revisions, storing and tracking the consent in a secure, unfalsifiable and publicly verifiable way, and enabling the sharing of this information in real time. For that, we build a consent workflow using a trending technology called Blockchain. This is a distributed technology that brings a built-in layer of transparency and traceability. From a more general and prospective point of view, we believe Blockchain technology brings a paradigmatical shift to the entire clinical research field. We designed a Proof-of-Concept protocol consisting of time-stamping each step of the patient’s consent collection using Blockchain, thus archiving and historicising the consent through cryptographic validation in a securely unfalsifiable and transparent way. For each protocol revision, consent was sought again. We obtained a single document, in an open format, that accounted for the whole consent collection process: a time-stamped consent status regarding each version of the protocol. This document cannot be corrupted and can be checked on any dedicated public website. It should be considered a robust proof of data. However, in a live clinical trial, the authentication system should be strengthened to remove the need for third parties, here trial stakeholders, and give participative control to the peer users. In the future, the complex data flow of a clinical trial could be tracked by using Blockchain, which core functionality, named Smart Contract, could help prevent clinical trial events not occurring in the correct chronological order, for example including patients before they consented or analysing case report form data before freezing the database. Globally, Blockchain could help with reliability, security, transparency and could be a consistent step toward reproducibility.

Our Life Depends on This Drug: Competence, Inequity, and Voluntary Consent in Clinical Trials on Supervised Injectable Opioid Assisted Treatment

Supervised injectable opioid assisted treament (siOAT) prescribes injectable opioids to individuals for whom other forms of addiction treatment have been ineffective. In this article, we examine arguments that opioid-dependent people should be assumed incompetent to voluntarily consent to clinical research on siOAT unless proven otherwise. We agree that concerns about competence and voluntary consent deserve careful attention in this context. But we oppose framing the issue solely as a matter of the competence of opioid-dependent people and emphasize that it should be considered in the context of inequities in access to siOAT as a medical treatment. Consequently, we suggest that bioethics literature on nonexploitation, which focuses on clinical research in low-income countries, is helpful due to locating ethical issues within systemic social conditions. Finally, we consider the implications of our argument for the ethics of clinical research on siOAT.

Reporting of ethical considerations in clinical trials in Chinese nursing journals.

It is acknowledged that publishers now require all primary research papers to demonstrate that they have obtained ethical approval for their research. To assess the rate of reporting of ethical approval in clinical trials in core nursing journals in mainland China. A retrospective observational study. All clinical trials published in all of the 12 core nursing periodicals from 2016 edition China Science and Technology Journal Citation Report (core version) between 2013 and 2016 were retrieved by hand to explicate rate of reporting ethical approval and informed consent. The study did not require approval from the research ethics committee as it did not involve human subjects or records. In total, 40,278 papers were published in 12 nursing periodicals between 2013 and 2016. Out of these, 9488 (23.6%) focused on clinical trials. Informed consent obtained from patients or the legally authorized representative was reported in 51.8% of clinical trials. Notably, only 27.4% of clinical trials reported that they had obtained written consent. Furthermore, 25.9% of clinical trials described ethical approval; however, the rate of reporting informed consent and ethical approval in these 12 nursing journals in China during 4 years from 2013 to 2016 improved markedly, with 38.1%, 44.0%, 59.0% and 66.6%, respectively (p < 0.001), and 17.6%, 21.9%, 28.6% and 35.8%, respectively (p < 0.001). In addition, both reporting informed consent and reporting written informed consent had a positive significant correlation with the reporting ethical approval (p < 0.05 or < 0.01). Chinese scientific nursing journals have improved the rate of reporting informed consent and ethical approval in clinical trials during the last 4 years. However, it should be noted that nearly half of clinical trials still did not report either ethical approval or whether informed consent was obtained. Efforts from editors, researchers, sponsors and authors are needed to ensure the transparency of ethical scrutiny and adherence to ethical guidelines in publishing clinical trials in Chinese nursing journals.

Survey of risks and benefits communication strategies by research nurses.

An ethical, informed consent process requires that potential participants understand the study, their rights, and the risks and benefits. Yet, despite strategies to improve communication, many participants still lack understanding of potential risks and benefits. Investigating attitudes and practices of research nurses can identify ways to improve the informed consent process. What are the attitudes, practices, and preparedness of nurses involved in the informed consent process regarding communication of risks and benefits? A survey was developed and administered online to a national purposive sample of 107 research nurses with experience obtaining informed consent for clinical trials. Survey responses stratified by selected work-related characteristics were analyzed. Participants were instructed they need not answer each question and could stop at any time. They consented by clicking "accept" on the email which linked to the survey. The study was approved by the Northeastern University Institutional Review Board, Boston, Massachusetts (NU-IRB Protocol #: 13-06-17). Most research nurses (87%) used a teach-back method to assess participant comprehension, while 72% relied on their intuition. About one-third did not feel prepared to communicate related statistics. About 20% did not feel prepared to tailor information, and half did not feel competent using supplemental materials to enhance risks and benefits comprehension. Only 70% had received training in the informed consent process which included in-person training (84%), case studies (69%), online courses (57%), feedback during practice sessions (54%), and simulation, such as role playing (49%) and viewing videos (45%). Perceived preparedness was significantly associated with greater informed consent experience and training. Research nurses may have inadequate training to encourage, support, and reinforce communication of risks and benefits during the informed consent process. Relevant purposeful education and training should help to improve and standardize the ethical informed consent process.

Challenges to Informed Consent in First-In-Human Trials Involving Novel Treatments: A Case Study of Parkinson's Disease.

Obtaining informed consent in clinical trials can be challenging both for researchers and for patients, albeit in different ways. The challenge concerns not only how to provide the needed information, but also what information to focus on when dealing with individual patients who have different goals, needs, histories, etc. This paper aims to contribute to a better informed consent process for Parkinson’s patients taking part in first-in-human clinical trials of cell replacement therapies. It outlines a range of problems which patients and researchers may face in this process and provides practical advice to researchers engaged in such trials.

NRG Clinical Trial Consent Forms: Consenting Ourselves and Forgetting the Patient

Multiple studies have shown that short consent forms with appropriately written patient information improve clinical trial enrollment and patient comprehension. The Department of Health and Human Services recommends that consent forms be written at a 7th grade level and be 7 pages or less in length. We hypothesized that NRG clinical trial consent forms would be written at a 7th grade level and less than 7 pages in length. We accessed the most recent consent forms for 20 open NRG clinical trials. We performed a readability analysis of these consents of 10 commonly used readability tests: the New Dale–Chall Test, Flesch Reading Ease Score, Flesch-Kinkaid Grade Level, FORCAST test, Fry Score, Simple Measure of Gobbledygook, Gunning Frequency of Gobbledygook, New Fog Count, Raygor Readability Estimate, and Coleman-Liau Index. These readability tests take into account sentence length, syllables per a word, and complexity of grammar. We also measured the number of words per a document and consent length in pages. We sought to test the hypothesis that the readability of patient information found on NRG clinical trial consent forms was written at the 7thgrade level and condensed to less than 7 pages per consent. We were able to access 20 NRG clinical trial consent forms. Per review, these consent form language was all based on similar templates but adapted for each NRG trial. The average words per a consent form were 4,940 (range 2,263 – 6,927). Each consent form was an average of 12.4 pages (sd 2.9) in length (range 6-16 pages). This was significantly above the target length of less than 7 pages (p<0.01). The readability of consent formed varied across different tests (see Table 1), but were universally above the 7thgrade level. A composite measure of grade level was constructed using the readability measures that provide a single grade level output. These measures were strongly correlated and formed a reliable measure (SI alpha = 0.96). A one-sample t-test found that the average grade level of these documents (10.32, sd = 0.51) was significantly higher than a seventh grade reading level, t (19) = 28.92, p < .001. NRG consent forms are more complex for patients than recommended. At their current length, taking into account average reading speeds, it may take a patient 20 minutes to read through the consent form only once. This may impede patient understanding and discourage NRG trial enrollment. Simplifying of consent language may help encourage comprehension and trial enrollment.Abstract 2981; Table 1Reading TestGrade Mean [Min, Max]Coleman-Liau9.8 [9, 10.6]Flesh-Kincaid10.3 [9.3, 11.9]FORCAST10.3 [9.8, 10.5]Fry10 [10, 12]Gunning Fog11.4 [10.4, 13.3]New Dale-Chall8.3 [7.5, 9.5]New Fog Count9.3 [8. 11.5]Raygor Estimate9 [8, 10]SMOG12.2 [11.5, 13.4]Flesch Reading Ease test does not provide a grade level output. Flesch Reading Ease score 57 (53-63). 60-70 corresponds to 7th grade. New Dale-Chall provides an individual score range (shown as a mean above). Open table in a new tab

Access to clinical trials among oncology patients: results of a cross sectional survey

BackgroundClinical trials are necessary for the advancement of cancer treatment and care, however low rates of participation in such trials limit the generalisability of findings. The objective of this study was to examine the proportion of medical oncology outpatients in Australia who are invited and consent to participate in clinical trials and the factors associated with this.MethodsA sample of adult medical oncology patients was recruited from three Australian cancer treatment centres. Consenting patients completed two paper-and-pencil surveys; one at the time of consent and another approximately 1 month later. A multivariate logistic regression was conducted to explore factors associated with invitation and participation in a trial.ResultsThirty-eight percent (n = 146) of the 383 participants reported they had been invited to take part in a clinical trial. Of those invited, 93% reported consenting to participate in the trial, with the majority indicating that they did not regret their decision (89%). Treatment centre and time since diagnosis were significantly associated with being invited to take part in a clinical trial. None of the factors examined were associated with clinical trial consent rates.ConclusionsThe main barrier to clinical trial participation is not being invited to do so, with the centre the patient attends being a modifiable determinant of whether or not they are invited. Increasing the resources available to treatment centres to ensure all patients are offered participation in trials they are eligible for may help to improve rates of trial participation.

A systematic review finds underreporting of ethics approval, informed consent, and incentives in clinical trials

ObjectivesIn this study, we aim to review researchers' reporting practices of the ethics statement, financial incentives, and local ethical committees' profile in their clinical trials. Study Design and SettingA systematic search was done through top-ranked 50 medical journals (Scimago Ranking) to retrieve 2,000 latest publications. Only primary clinical trials were included with no restriction to language or participants. ResultsAmong the 927 included trials, 14 trials (1.5%) did not report an ethical statement and two-third (63%) did not completely report the investigated components (Institutional Review eBoard approval, Helsinki Declaration, and informed consent). Moreover, 21 trials (2.26%) reported motivational incentives with the method and amount of payment for participants. Of them, 15 trials offered monetary incentives to participants in different forms. In the remaining six trials, the incentives were mainly medical benefits. Only one trial reported the profile or quality of local Institutional Review Board. ConclusionA potential gap in the reporting practices of ethics statement and financial incentives was addressed in this review. Authors are urged to fully report all ethical components related to their study, including incentives and compensations plan. Medical journals are also recommended to implement further publication requirements concerning ethics reporting.