The objective of this study was to determine whether consent forms in oncology clinical trials of commercially available treatments inform subjects that they may be able to obtain the treatments being investigated without participating in research. We acquired consent forms from a random sample of U.S. oncology clinical trials in the ClinicalTrials.gov database. We then examined a subgroup of the sample consisting of studies in which the treatments under investigations were commercially available. Less than 20% of (...) the consent forms in that group disclosed to subjects that they may be able to obtain the treatment being investigated without participating in the study . Our results suggest that potential research subjects are frequently not informed about important alternatives to research participation in studies involving commercially available treatments, which is a violation of both ethical and regulatory standards. (shrink)

We reviewed 272 phase I oncology trial consent forms and then created an improved informed consent template in both English and Spanish by redesigning and rewording the consent form to be specific to phase I trials, to avoid repetition, and to use simplified language, identifiable sections framed by first-person questions, and tables to present information. The resulting consent form template is shorter than average and considerably easier to read . The template also meets the recommended (...) eighth-grade maximum reading level for consent forms. Use of this template should help improve the informed consent process. (shrink)

This editorial provides an ethical analysis of the consent materials and other documents relating to the recent creation and birth of twin girls who had their genes edited using CRISPR-cas9 in a controversial Chinese research study. It also examines the “draft ethical principles” published by the leader of the research study. The results of the analysis further intensify serious ethical concerns about the conduct of this study.

Although research has examined factors influencing understanding of informed consent in biomedical and forensic research, less is known about participants' attention to details in consent documents in psychological survey research. The present study used a randomized experimental design and found the majority of participants were unable to recall information from the consent form in both in-person and online formats. Participants were also relatively poor at recognizing important aspects of the consent form including risks to participants and (...) confidentiality procedures. Memory effects and individual difference characteristics also appeared to influence recall and recognition of consent form information. (shrink)

Genetic research presents ethical challenges to the achievement of valid informed consent, especially in developing countries with areas of low literacy. During the last several years, a number of genetic research proposals involving Omani nationals were submitted to the Department of Research and Studies, Ministry of Health, Oman.The objective of this paper is to report on the results of an internal quality assurance initiative to determine the extent of the information being provided in genetic research informed consent (...) class='Hi'>forms. In order to achieve this, we developed checklists to assess the inclusion of basic elements of informed consent as well as elements related to the collection and future storage of biological samples. Three of the authors independently evaluated and reached consensus on seven informed consent forms that were available for review.Of the seven consent forms, four had less than half of the basic elements of informed consent. None contained any information regarding whether genetic information relevant to health would be disclosed, whether participants may share in commercial products, the extent of confidentiality protections, and the inclusion of additional consent forms for future storage and use of tissue samples. Information regarding genetic risks and withdrawal of samples were rarely mentioned (1/7), whereas limits on future use of samples were mentioned in 3 of 7 consent forms.Ultimately, consent forms are not likely to address key issues regarding genetic research that have been recommended by research ethics guidelines. We recommend enhanced educational efforts to increase awareness, on the part of researchers, of information that should be included in consent forms. (shrink)

Large-scale whole genome sequencing (WGS) studies promise to revolutionize cancer research by identifying targets for therapy and by discovering molecular biomarkers to aid early diagnosis, to better determine prognosis and to improve treatment response prediction. Such projects raise a number of ethical, legal, and social (ELS) issues that should be considered. In this study, we set out to discover how these issues are being handled across different jurisdictions.

Although written consent forms are standard in clinical research, there is little regulatory or empirical guidance regarding how to most effectively review consent forms with potential participants. We developed an algorithm for embedding five questions with corrective feedback while reading consent forms with potential participants, and then applied it in the context of seven clinical research studies. A substantial proportion of participants within each protocol displayed initially inadequate responses to at least one question, but (...) after the protocol elements were explained again, most people demonstrated adequate understanding of them. These data illustrate the need for more attention not just to the content of consent forms, but also to the manner in which the forms are incorporated into the consent process. Embedding explicit inquiries about key protocol elements during consent form review and giving corrective feedback appears to be a simple yet effective way to foster better understanding of disclosed information. (shrink)

It is becoming widely recognized that dissemination of research results to participants is an important action for the conclusion of a research study. Most research institutions have standardized consent documents or templates that they require their researchers to use. Consent forms are an ideal place to indicate that results of research will be provided to participants, and the practice of inserting statements to this effect is becoming more conventional. In order to determine the acceptance of this practice (...) across Canada we conducted an assessment of 121 institutional consent document templates from 65 institutions looking for language that endorsed results dissemination to participants. About half of the documents we examined had language included which stated that results should be made available. In an era where research participation in hospital settings and universities is becoming ubiquitous there should be a reciprocal expectation that results should be provide... (shrink)

Informed consent forms have been useful in clinical practice and they constitute a part of the shared decision making in the informed consent process. They provide information to patients about clinical procedures and techniques. They also act as a remainder of the information discussed after the medical interview. Sometimes these documents are not readable to everybody. Belgian law specifies that all information that patients receive has to be proportionate verbally, but written information is also handled. The present (...) research analyzes the readability of the Flemish informed consent forms located in the webs of all General Hospitals using a simple random sample of 75 informed consent forms. By using the Douma tool, which bases its analysis in the length of words and sentences, the readability mean of the sample was 46, level “Difficult”. The 59% of them had a difficult level. The 11% were normal. It is a fact, then, that the 59% of the informed consent forms evaluated in this study are not suitable for everybody in Flanders, especially those people with low literacy. There were some researches made in other countries that agreed with these results. Written clinical information was poorly written so the informed consent forms were not working helping patients to recall information nor helping patients to become a part in the shared decision making about their health. The use of readability formulas represented a simple way to discriminate those informed consent forms that had normal readability scores from those that should be adapted. (shrink)

BackgroundInformed consent forms are intended to facilitate research enrollment decisions. However, the technical language in institutional templates can be unfamiliar and confusing for decision-makers. Standardized language describing financial implications of participation, namely compensation for injury and costs of care associated with participating, can be complex and could be a deterrent for potential participants. This standardized language may also be misleading in the context of comparative effectiveness trials of standard care interventions, in which costs and risk of injury associated (...) with participating may not differ from regular medical care. In addition, the revised U.S. Common Rule contains a new requirement to present key information upfront; the impact of how this requirement is operationalized on comprehension and likelihood of enrollment for a given study is unknown.MethodsTwo online surveys assessed the impact of (1) changes to compensation for injury language (standard vs. tailored language form) and (2) changes to the key information page (using the tailored compensation language form with standard key information vs. modified key information vs. modified key information plus financial information) on both likelihood of enrollment in and understanding of a hypothetical comparative effectiveness trial.ResultsLikelihood of enrolling was not observed to be different between the standard and tailored language forms in Study 1 (73 vs. 75%; p = 0.6); however, the tailored language group had a higher frequency of understanding the compensation for injury process specific to the trial (25 vs. 51%; p < 0.0001). Modifications to the key information sheet in Study 2 did not affect likelihood of enrolling (88 vs. 85 vs. 85%; p = 0.6); however, understanding of randomization differed by form (44 vs. 59 vs. 46%; p = 0.002).ConclusionsThese findings suggest that refining consent forms to clarify key information and tailoring compensation for injury language to the nature of the study, especially in the context of comparative effectiveness trials, may help to improve study comprehension but may not impact enrollment. (shrink)

The mission of the Indian Health Service affects what research is done and how It is reviewed and managed and in turn affects the forms and process used to obtain informed consent. Consent forms must be Informative and understandable to American Indian and Alaska Native potential volunteers; the process used to obtain informed consent must minimize any institutional pressure to participate. The IHS Institutional Review Boards developed seven research Model Volunteer Consent Forms.

Consent plays a vital role in every aspect of medicine and surgery, facilitating the patient in making informed decisions about their treatment. The recently published Reference Guide to Consent, by the Department of Health (DH), notes that, although not a legal requirement, the completion of consent forms is good practice, particularly in interventions such as surgery. In addition, the Parliamentary and Health Service Ombudsman noted that a significant number of complaints about consent involved the complainant (...) feeling that they did not fully understand what was going to happen. It was often found that there was no documentation to clarify what the patient was told, when and by whom. We have performed an audit of 71 randomly selected consent forms, elective and trauma cases within our district general hospital orthopaedics department. Our data demonstrate that a significant number of consent forms were incorrectly or insufficiently completed. This could not only leave the patient confused about their procedure but also leaves the doctor open to litigation, with little in the way of documentation support. Minor changes in consenting methods and more precise documentation could significantly improve patient experience and satisfaction. (shrink)

Background: “Therapeutic misconception” arises when human subjects interpret a clinical trial as aimed primarily at therapy rather than producing knowledge. Therapeutic misconceptions may be more prevalent in trials enrolling gravely ill subjects or involving novel and well publicised investigational agents.Objective: To examine the extent to which investigators express therapeutic optimism in phase 1 human gene transfer consent documents, whether highly active gene transfer researchers are more prone to expressing therapeutic optimism, and whether consent forms have grown more (...) optimistic in their descriptions of personal benefit over the last decade.Design: Content analysis was performed on 277 consent documents to measure the number of sentences describing possibility of benefit, terminology used for experimental agents, the proportion of statements describing personal versus societal benefits, and whether investigators attempted to thwart therapeutic misconceptions.Results: Consent forms generally used therapeutic terminology to describe study agents, devoted more sentences to describing possible personal benefits than to describing benefits to society, and infrequently explained that a particular benefit was unlikely. Consent documents used by highly active gene transfer researchers tended to portray significantly greater optimism about personal benefit than less active investigators, though they were also significantly more cautious with agent terminology. Finally, therapeutic optimism expressed in consent forms has declined over the past decade.Conclusions: Consent documents used in phase 1 gene transfer trials, although increasingly attentive to possible therapeutic misconceptions, are inappropriately optimistic about direct benefits of trial participation. Such optimism is expressed more emphatically in trials involving highly active gene transfer researchers as principal investigators. (shrink)

When researchers encounter preexisting psychological distress in participants, ethical codes provide little guidance on how to balance issues of beneficence and autonomy. Although researchers may inform participants what will occur given responses indicating distress, this information may lead to biased self-reports. This important issue was addressed in this study by manipulating consent form information regarding the type of psychopathology to be assessed and various levels of possible follow-up. In comparing responses on self-report measures of anxiety, depression, and general psychological (...) distress, men who believed depression was the focus of the study reported fewer symptoms of depression and less trait anxiety as intrusiveness of experimenter follow-up increased. These results are discussed within the framework of socialization theory. Given that half of the sample did not correctly answer questions regarding information contained in the consent form, guidelines to improve consent form comprehension are offered. (shrink)

Informed consent documents are central to the informed consent process and are required for participation in clinical trials in the U.S. The primary purpose of the document is “to assist a prospect...

ABSTRACTGenetic testing results and research findings raise concerns about access to genetic information by insurers. Recently, the Canadian Life and Health Insurance Association reaffirmed its prerogative to request, for underwriting purposes, the disclosure of clinical and research genetic test results if the participant/patient or his physician has knowledge of the results. Studies have shown that access to genetic information to determine insurability can, in limited instances, lead to actual, or fear of, genetic discrimination, result in individuals refusing to undergo testing (...) or declining participation in genomic research, and being asked to pay higher premiums or denied access to certain types of insurance. Obtaining informed consent for genetic testing and genomic research is crucial and should take into account the potential need to disclose possible insurability risks to patients and participants. Our study analyzed clinical and research consent forms, templates and guidelines from Quebec to investigate two questions: whether consent forms include clauses providing information on potential insurability risks and when such potential risks are included, what information is provided and how it is formulated. Our findings show that current information on insurability risks in Quebec’s forms/guidelines lack coherence, potentially resulting in patients/participants receiving inconsistent information. (shrink)

Background The use of lengthy, detailed, and complex informed consent forms is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to (...) participate in biomedical research. Methods This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 to 5. Results Of the 2484 questionnaires distributed, 2113 were returned. The majority of respondents considered most elements required in the ICF to be ‘moderately important’ to ‘very important’ for their decision making. Major foreseeable risk, direct benefit, and common adverse effects of the intervention were considered to be of most concerned elements in the ICF. Conclusions Research participants would like to be informed of the ICF elements required by ethical guidelines and regulations; however, the importance of each element varied, e.g., risk and benefit associated with research participants were considered to be more important than the general nature or technical details of research. Using a participant-oriented approach by providing more details of the participant-interested elements while avoiding unnecessarily lengthy details of other less important elements would enhance the quality of the ICF. (shrink)

The objective of this study—a substudy to a phase I bioequivalence study—was to compare the effect of standard and concise consent forms on research volunteers’ comprehension of and satisfaction with consent forms, as well as to assess the effect of select volunteer characteristics, such as financial motivations to participate in research, on their comprehension. A 36-item questionnaire measured volunteers’ comprehension, satisfaction, and motivations for participation. Volunteers were randomized to the standard Pfizer consent form or a (...) concise, easier-to-read form. We approached 139 volunteers to participate, and 138 completed the questionnaire . The cohorts did not differ in sociodemographic characteristics. We found that the average comprehension scores for the standard consent form cohort and the concise consent cohort were about the same, and that satisfaction with the consent form was high in both cohorts. Surprisingly, volunteers with a financial motivation had significantly greater comprehension of the study. (shrink)

Researchers typically attempt to fulfill disclosure and informed consent requirements by having participants read and sign consent forms. The present study evaluated the reading levels of informed consent forms used in psychology research and other fields (medical research; social science and education research; and health, physical education, and recreation research). Two standardized measures of readability were employed to analyze a randomly selected sample (N = 108) of informed consent forms used in Institutional Review (...) Board-approved research projects at a midwestern university during the 1987-1988 academic year. Results indicate that informed consent forms are typically written at a higher reading level than is appropriate for the intended population and that there are no consistently significant differences in readability among areas of research or between college student and noncollege student participants. Due to the unacceptably high reading level of the consent forms, one must question whether participants can comprehend the information contained in the consent forms. (shrink)

BackgroundThis study aimed to determine the elements and the extent of information that child participants and their parents would like to read in an informed assent form /informed consent form of a pediatric drug trial.MethodsA descriptive survey was conducted to determine the perceived importance of each element of the ICF content from child participants and their parents who underwent informed assent/consent of a multi-center pediatric drug trial. The respondents were asked to indicate the level of importance of each (...) item in a questionnaire, by giving a rating scale from 1 to 5.ResultsA total of 22 families, 17 child participants with the diagnosis of hematology or oncology diseases and 27 parents, were enrolled. Among 30 items, risk–benefit aspects were perceived to be of most concerning items from both child participants’ and parents’ viewpoint. None of the items were considered ‘slightly important’ or lower by more than 20% of the respondents.ConclusionsFor pediatric drug trials, risk–benefit information should be made a salient feature of an IAF/icf. This empirical data could help related stakeholders arrange essential information in order of importance and tailor an IAF/icf to better suit child participants’ and parents’ needs, particularly for pediatric drug trials involving children with the diagnosis of hematology or oncology diseases. (shrink)

Background The post-trial period is the time period after the end of study drug administration. It is unclear whether post-trial arrangements for patient surveillance are routinely included in study protocols and consents, and whether research ethics boards (REB) consider the post-trial period. Objectives The objective was to determine whether trial protocols and consent forms reviewed by the REB describe procedures for post-trial period surveillance. Methods An observational study of protocols of randomised trials of chronic therapies for cardiac conditions, (...) approved by the REB of two academic institutions affiliated with the University of Toronto in Canada (University Health Network and Mount Sinai Hospital) from 1995 to 2007. Plans for patient surveillance in the post-trial period described in the protocol or in the consent form before and after REB approval were recorded. Results 42 studies were identified including 18 heart failure and 15 coronary artery disease trials. Only four studies planned a clinical visit after trial termination, and an additional three planned a telephone contact after trial completion. Five trials submitted consent forms to the REB with a discussion of the post-trial period. Conclusions The majority of protocols and consent forms did not discuss plans for post-trial period surveillance. The post-trial period and the REB approval process could be improved by systematic follow-up being described in the protocol and consent form. The small number of trial protocols evaluated in the study may impair the degree to which the results can be generalised. (shrink)

BACKGROUND: The offer of return of research results to study participants has many potential benefits. The current study examined the offer of return of research results by analyzing consent forms from 2 acute lymphoblastic leukemia studies of the 235 institutional members of the Children's Oncology Group. METHODS: Institutional review board (IRB)-approved consent forms from 2 standard-risk acute lymphoblastic leukemia studies (Children's Cancer Group [CCG] 1991 and Pediatric Oncology Group [POG] 9407) were analyzed independently by 2 reviewers. (...) RESULTS: The authors received replies from 202 of the 235 institutions that were contacted (85%). One hundred eighty-one institutions had CCG 1991 (n = 96) or POG 9905 (n = 85) protocols that were approved by an IRB. Most institutions provided contact information for the principal investigator (n = 175; 97%) and a member of the institution's research services office (n = 154; 85%). Only 5 (2.8%) institutions provided an indication of a participant's right to receive a summary of research results; most of these institutions provided details on how (n = 5) or when (n = 5) this was to occur. All of these institutions (n = 162; 89.5%) provided a specific statement offering new information that might affect a participant's decision to continue to participate in a study. Only 2 institutional consent forms offered participants the option to receive research results, and only 10 (5.5%) consent forms contained an unambiguous, specific statement offering to provide new information after the study was closed. CONCLUSIONS: Few institutional review board-approved consent forms explicitly indicate the right of research recipients to receive a summary of the results of the research in which they have participated. (shrink)

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. (shrink)

Previous research shows that students often do not read informed consent forms to understand their rights. Four hundred fifty-eight students participated in an advertised temperament study that actually measured whether they noticed a manipulation within the consent form. Answering five questions about the form raised the percentage of students noticing the manipulation in multiple settings; however, overall rates were low. Fewer than 10% of ethnic minority students noticed the manipulation. If the goal of consent forms (...) in higher education remains an informed decision, these results indicate the need for increased interaction within the consent process. (shrink)

Ojectives Low energy hip fractures are one of the greatest causes of morbidity and mortality in orthopaedics. This study aims to evaluate written consent forms with respect to basic standards as set out in the Good Practice in Consent Initiative. In particular the stated risks and benefits of each procedure were assessed. Methods 100 consecutive consent forms were reviewed prospectively. The stated procedure, side and complications were recorded. Appropriate signature and legibility was assessed. 13 consultant (...) orthopaedic surgeons were surveyed to identify what risks and benefits they thought should be stated. Results Of 100 consent forms, 31 were for patients who are unable to consent. All 100 consent forms were correctly filled in with patient details and signed. 98% were legible. All stated the side of the operation. The number of complications listed per form ranged from 4 to 11. Infection, bleeding and thromboembolic complications were stated in the majority of consent forms. In total, 30 different complications were recorded; some were only stated once. Discussion and Conclusions This work suggests consent forms are completed well with respect to patient identifiers, legibility and procedure. The variability of complications stated is vast. We suggest standard pre-printed consent forms containing risks and benefits should be used as this may improve standards of informed consent. This has also been recently supported by the British Orthopaedic Association. (shrink)

BackgroundAlthough patient advocates have developed templates for standard consent forms, evaluating patient preferences for first in human (FIH) and window of opportunity (Window) trial consent forms is critical due to their unique risks. FIH trials are the initial use of a novel compound in study participants. In contrast, Window trials give an investigational agent over a fixed duration to treatment naïve patients in the time between diagnosis and standard of care (SOC) surgery. Our goal was to (...) determine the patient-preferred presentation of important information in consent forms for these trials.MethodsThe study consisted of two phases: (1) analyses of oncology FIH and Window consents; (2) interviews of trial participants. FIH consent forms were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH information); Window consents were analyzed for the location(s) of information stating the trial may delay SOC surgery (delay information). Participants were asked about their preferred placement of the information in their own trial’s consent form. The location of information in the consent forms was compared to the participants’ suggestions for placement. Results34 [17 FIH; 17 Window] of 42(81%) cancer patients approached participated. 25 consents [20 FIH; 5 Window] were analyzed. 19/20 FIH consent forms included FIH information, and 4/5 Window consent forms included delay information. 19/20(95%) FIH consent forms contained FIH information in the risks section 12/17(71%) patients preferred the same. Fourteen (82%) patients wanted FIH information in the purpose, but only 5(25%) consents mentioned it there. 9/17(53%) Window patients preferred delay information to be located early in the consent, before the “Risks” section. 3/5(60%) consents did this.ConclusionsDesigning consents that reflect patient preferences more accurately is essential for ethical informed consent; however, a one-size fits all approach will not accurately capture patient preferences. We found that preferences differed for FIH and Window trial consents, though for both, patients preferred key risk information early in the consent. Next steps include determining if FIH and Window consent templates improve understanding. (shrink)

French healthcare networks aim to help healthcare workers to take care of patients by improving cooperation, coordination and the continuity of care. When applied to palliative care in the home, they facilitate overall care including medical, social and psychological aspects. French legislation in 2002 required that an information document explaining the functioning of the network should be given to patients when they enter a healthcare network. The law requires that this document be signed. Ethical issues arise from this legislation with (...) regard to the validity of the signature of dying patients. Signature of the consent form by a guardian or trustee, a designated person—the Person of Trust—transforms the doctor–patient relationship into a triangular doctor–patient–third-party relationship. (shrink)

Deficiencies or unclear statements in consent forms used for research with human participants may lead to publicly-funded research data being unsuitable for sharing with other researchers. Long-term data use is encouraged or required by many of the UK research councils and other funding bodies. Researchers may fail to address long-term use and sharing of data when obtaining informed consent and when arranging to keep data obtained from participants confidential. Sharing data should not compromise confidentiality if care is (...) taken to anonymize information where this is needed or has been explicitly requested. Whilst researchers should consider all potential uses of their research data in confidentiality and consent agreements, research ethics committees can provide better guidance by pointing out to researchers that long-term use, preservation and sharing of research data should be taken into account when informing participants and obtaining their consent. (shrink)