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Online participant recruitment ("crowdsourcing") platforms are increasingly being used for research studies. While such platforms can rapidly provide access to large samples, there are concomitant concerns around data quality. Researchers have studied and demonstrated means to reduce the prevalence of low‐quality data from crowdsourcing platforms, but approaches to doing so often involve rejecting work and/or denying payment to participants, which can pose ethical dilemmas. We write this essay as an associate professor and two institutional review board (IRB) directors to provide a perspective on the competing interests of participants/workers and researchers and to propose a checklist of steps that we believe may support workers' agency on the platform and lessen instances of unfair consequences to them while enabling researchers to definitively reject lower‐quality work that might otherwise reduce the likelihood of their studies producing true results. We encourage further, explicit discussion of these issues among academics and among IRBs. [ABSTRACT FROM AUTHOR]

How research during a public health emergency is conducted is recognized as essential to the public health response to that emergency. Such research needs to undergo substantive and meaningful ethical review in a timely manner. Rapid ethical review may be accomplished through a number of mechanisms, including use of local rapid‐response institutional review boards (IRBs). We describe use of such a model in the setting of the 2014 Ebola virus disease epidemic and the Rapid‐Response IRB's subsequent transition to a multisite single IRB model during the current Covid‐19 pandemic. The rapid‐response review model is characterized by a small IRB with extensive use of alternate members with specific expertise and by close collaboration with the investigator in an iterative process. [ABSTRACT FROM AUTHOR]

A shift from single to multi-site health studies enabled a range of research benefits including faster recruitment of larger and more diverse samples; increased statistical power, greater rigour, generalisability, and external reliability; and increased likelihood of impacting policy and clinical practice. However, ethical review of multi-site studies by Institutional Review Boards (IRBs) raises specific challenges compared with single site studies, with requirements to apply to multiple local IRBs increasing the burden on research, possibly endangering the integrity of the research process or inhibiting development of multi-site studies. The option of a single centralised IRB may offer a clearer, more consistent and efficient review process. This study presents a case report and commentary from 15 years engaging with IRBs in multiple sites in Ireland by the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA). It examines the ethics review process for IDS-TILDA through its first four waves. While the majority of 48 IRBs granted ethical approval within 13 weeks, six IRBs took 21–47 weeks to approve, leading to delays in data collection of up to 11 months. Despite additional review time, no changes were required to the study protocol. Therefore, a critical impact of the process was the delay in starting data collection within a small number of organisations, and reduced involvement in the study for one organisation. The ethical review process with multiple IRBs increased the degree of complexity of the process, with added bureaucracy and far greater communication required across 48 IRBs, substantially adding to the resource commitment for the review process. The relatively quick approval from the majority of IRBs was partially a result of the longitudinal study building relationships with organisations throughout multiple waves. That other health studies may not accrue this benefit supports calls for a single IRB system for multi-site health studies.

Abstract 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

To be ethical, clinical trials must exhibit a favorable risk‐benefit balance at the time of their initiation. However, in some cases, the expected value of a study decreases while the study is ongoing, due to developments outside of the study itself, such as findings from other studies or an otherwise shifting evidence base. While such situations are acknowledged in the research community, they have not received sufficient attention, given the high costs of uninformative studies, both in material and human capital. In addition, the Covid‐19 pandemic has exposed serious shortcomings with current approaches to monitoring studies for continued relevance and value. In this article, with reference to a case study from the Covid‐19 pandemic, we identify and describe the importance and challenge of ensuring that clinical trials continue to exhibit scientific relevance and value once initiated. We explore the ethical dynamics of these situations and identify unresolved issues. While more empirical work is needed to ensure that proposed solutions to the issues are evidence based, we offer some provisional considerations that amount to a framework for approaching these challenging situations. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

With the rise in obesity and bariatric procedures worldwide, there has been a surge in new and innovative procedures that has been increasingly offered to patients. In this position statement, IFSO highlights the importance of surgical ethics in innovation and when offering new procedures. Furthermore, the task force reviewed the current literature to describe which procedures can be offered as mainstream outside research protocols versus those that are still investigational and need further data. [ABSTRACT FROM AUTHOR]

This essay offers the metaphor of hungry ethics to think of ethics alternatively outside the epistemic boundaries of Institutional Review Boards. It argues that due to the ephemeral, embodied, and shifting nature of research relationships, there can be no predetermined definition of what ethical research is in ethnographic contexts. By building on the notions of radical vulnerability and hungry translation as conceptualized by Richa Nagar in Hungry Translations: Relearning the World Through Radical Vulnerability, this essay suggests that research ethics must be incessantly hungry and refuse to be satiated or saturated through a set of established rules and regulations. Hungry ethics are undisciplined, unstable, relational, and they are rooted in a dynamic praxis of becoming-sangtin. The author conceptualizes becoming-sangtin as the never-ending process of unlearning to occupy the privileged position of a researcher and relearning to embrace the role of a vulnerable companion. While becoming-sangtin echoes Deleuze & Guattari's formulation of becoming(-nomad-minority-woman) as a way to dissolve static and hierarchical identity categories, it also draws heavily from feminist epistemologies. Ultimately, this essay makes the case that instead of trying so hard to do ethnography or to be ethical—ideals almost exclusively tied to restraining academic aspirations and regulations—researchers should aspire to become a sangtin, an intimate comrade, to the limited extent that we can. [ABSTRACT FROM AUTHOR]

Much of precision medicine is driven by big health data research—the analysis of massive datasets representing the complex web of genetic, behavioral, environmental, and other factors that impact human well‐being. There are some who point to the Common Rule, the regulation governing federally funded human subjects research, as a regulatory panacea for all types of big health data research. But how well does the Common Rule fit the regulatory needs of this type of research? This article suggests that harms that may arise from artificial intelligence and machine‐learning technologies used in big health data research—and the increased likelihood that this research will affect public policy—mean it is time to consider whether the current human research regulations prohibit comprehensive, ethical review of big health data research that may result in group harm. [ABSTRACT FROM AUTHOR]

• Development of DNP Project ethical review process expedited QI determination. • Ethical review process provides scholarly and ethical determination that aligns with the IRB. • Review process protects participants, supports students, and empowers faculty. • Ethical review combines project management, understanding QI VS. HSR, and expert consensus. • Rationale and process for creating and implementing an ethical review committee. DNP Scholarly projects require review for scientific merit and human subject protection. Rapid growth of DNP programs and projects has increased Institutional Review Board (IRB) burden and increased the length of project approval time when most DNP scholarly projects are quality improvement (QI) projects and not deemed Human Subjects Research (HSR). Develop a process and describe the rationale for creating and implementing a Project Ethical Review Committee (PERC) in the School of Nursing and to evaluate the experience of the first cohort of submissions. Committee was formed using expert consensus approach, in collaboration with IRB. Standards of Procedures and training materials created. 100 projects submitted to committee; 95 deemed QI (95%) and 5 projects considered HSR (5%). First 94 projects were reviewed, and approval letters sent within 8 weeks. This paper discusses how PERC ensures rigorous and ethical review process for standardization, timeliness, and efficiency. [ABSTRACT FROM AUTHOR]

Duoethnography involves engaging in a personal critical dialogue between two people about a shared experience for the purpose of personal and social transformation. Research involving people usually requires prior formal ethical approval; however, in duoethnography where the researchers are also the participants, many have chosen not to do so due to the situated and ongoing nature of the ethical relationship. Instead, they report generally on the ethical principles enacted in their method. Embarking on our first duoethnography, we experienced conflicting perspectives between applying for formal ethical approval to guide us and autonomously negotiating our own ethics of care. By sharing our divergent experiences of obtaining formal ethical approval, we offer our stories as a springboard for provocations and guidance on the unique ethical considerations for future duoethnographers. Ethical principles include understanding the relationship dynamics, commitment to the project, vulnerabilities, consent and confidentiality, and working with differences. [ABSTRACT FROM AUTHOR]

Informed consent for clinical trials in acute stroke is characterized by challenges related to urgency, cognitive impairment, and geographical separation. Context‐appropriate approaches are needed for this setting. We conducted a mixed‐methods project involving focus groups and interviews as well as collaboration with a patient advisory panel and a central institutional review board (CIRB) to design and implement a patient‐driven consent process for a multicenter trial incorporating adaptive randomization. Remote consent was recognized as challenging but acceptable. Adaptive randomization was viewed positively, but significant potential for misunderstanding was appreciated. Collaboration between the patient advisory panel and the CIRB resulted in a shortened, more patient‐centered consent form that was approved at all sites with few modifications. An information sheet was developed as a resource for patients and surrogates after enrollment. Collaboration between investigators, patient partners, and a CIRB can facilitate innovation and implementation of patient‐centered, context‐appropriate consent strategies. [ABSTRACT FROM AUTHOR]

Clinical research involving human subjects and quality improvement (QI) projects share a common goal of seeking to improve human health, whether by directly changing the standard of care (research) or by improving the process(es) by which that care is delivered (QI). Whether a QI project requires informed consent (written or oral) is a function of the risk-benefit analysis of the study; such a determination should not be at the sole discretion of the investigators, but should come from an appropriately constituted review board with expertise in the ethics of biomedical research. [ABSTRACT FROM AUTHOR]

In the context of emergency research, researchers can ask the institutional review board (IRB) to waive the regulatory requirement that individuals provide informed consent when enrolling in research studies. A requirement of the waiver of informed consent is that the reviewing IRB must review and approve a community consultation and public disclosure plan. It is critical that an IRB serving as the single IRB (sIRB) for multisite research be thoroughly versed in the local context concerns for each participating site to determine whether the site's community is being adequately consulted about the research in which individuals will be enrolled under an exception to the informed consent requirement. We designed an sIRB review model for evaluating site‐specific community consultation plans that included a local evaluation and feedback step, and we piloted the model with a four‐site, pediatric exception from informed consent (EFIC) clinical trial. We identified three key roles for the model: the sIRB, the investigators, and the representative of the institution's human research protection program (HRPP). We successfully collected the information and local input needed to evaluate each site's community consultation plan and applied the information to a thorough IRB review, despite the geographic distance between the study site and the sIRB. [ABSTRACT FROM AUTHOR]

Institutional review boards (IRBs) have been criticized for inconsistency and lack of transparency in decision‐making, problems that undermine both trust in their ability to protect human research participants and respect for their decisions among researchers. The absence of robust documentation of their decisions and the inability or unwillingness to share those decisions together represent a missed opportunity for IRBs to learn from one another and advance debates about challenging ethical issues. The concept of IRB precedent, modeled upon the system of legal precedent, has been proposed as a potential solution to these problems. In theory, an IRB faced with a review decision could look back at previous IRB decisions, either its own or those of other boards, made in similar studies or circumstances to guide the present decision. Some IRBs attempt this informally within their institution, but few examples of a structured system of IRB precedent have been described in the literature, and none has been widely adopted. This article describes a pilot project to summarize IRB decisions in a way that could facilitate their use as precedent by creating a documentation tool that meets four criteria—comprehensiveness, validity, searchability, and efficiency. Though this process turned out to be more challenging than expected, we identified key features of such a tool that holds promise for future development and could promote more consistent, robust IRB decision‐making and advance discourse in human research ethics. [ABSTRACT FROM AUTHOR]

Perioperative nurses are responsible for generating and using evidence to improve patient care. To protect human participants during research activities, government regulations enacted after widely publicized research misconduct specify that institutions receiving federal funds must have an institutional review board (IRB) comprising at least five members. Board members have many responsibilities, including completing a thorough review of each section of the application and attachments (eg, consent documents). To expedite the IRB approval processes, applicants should create and submit a well‐written application. Applicants should understand that the application addresses the important ethical concepts of respect for persons, beneficence, and justice. Quality improvement activities (ie, local activities that seek to improve patient care or clinical outcomes) differ from research activities that focus on creating new knowledge. Depending on the purpose, design, and generalizability of a quality improvement project, the applicant may need to submit the project to the IRB for approval. [ABSTRACT FROM AUTHOR]

This article provides pragmatic advice for organizations interested in creating a research ethics consultation service (RECS). A robust RECS has the potential to build capacity among investigators to identify and consider the ethical issues they encounter while conducting their research. Determining whether to establish an RECS should begin with an institutional‐needs assessment that includes three key questions: What are the current resources available to research teams to navigate ethical concerns that arise from their research? Is there a demand or perceived need for more resources? Is there institutional support (financial and otherwise) to establish and maintain an RECS? If this results in the decision to establish the consultation service, relevant institutional stakeholders must be identified and consulted, and personnel with the requisite skills recruited. The next step is to establish an RECS and build the infrastructure to process and respond to requests. The RECS's long‐term sustainability will depend on a stable source of funding and a mechanism to receive constructive feedback to ensure that the service is meeting the institutional needs it set out to address. [ABSTRACT FROM AUTHOR]

Human research protection programs (HRPP) generate an abundance of data on performance, capacity, and compliance. When used effectively, this information can be instrumental in helping HRPPs meet programmatic and institutional goals, demonstrate growth and success, and improve the HRPP overall. Metrics must be grounded in professional insight so that HRPPs can pair analytics with strategies for future action or improvement. The purpose of this paper is to demonstrate how high‐performing HRPPs develop, adopt, and implement a metrics framework that benefits everyday operations and produces real‐world results. Through a three‐part thematic framework (of insight, data, and action) and by providing case examples and actionable strategies, this article will address how HRPPs iteratively develop and characterize their metrics, build a metrics framework that leverages both quantitative and qualitative data to validate outcomes, and activate human insight to produce meaningful communication, visualization, and dissemination of data. [ABSTRACT FROM AUTHOR]

This article describes an interdisciplinary community resilience research project and presents a case study that supports bringing researchers together before a disaster to develop plans, procedures, and preapproved Institutional Review Board (IRB) protocols. In addition, this article explains how researchers from various academic institutions and their federal agency partners can effectively collaborate by creating an IRB Authorization Agreement (IAA). Such preparations can support interdisciplinary rapid response disaster fieldwork that is timely, ethically informed, and scientifically rigorous. This fieldwork preplanning process can also advance interdisciplinary team formation and data collection efforts over the long term. [ABSTRACT FROM AUTHOR]

Exception from Informed Consent (EFIC) regulations detail specific circumstances in which Institutional Review Boards (IRB) can approve studies where obtaining informed consent is not possible prior to subject enrollment. To better understand how IRB members evaluate community consultation (CC) and public disclosure (PD) processes and results, semi-structured interviews of EFIC-experienced IRB members were conducted and analyzed using thematic analysis. Interviews with 11 IRB members revealed similar approaches to reviewing EFIC studies. Most use summaries of CC activities to determine community members' attitudes; none reported using specific criteria nor recalled any CC reviews that resulted in modifications to or denials of EFIC studies. Most interviewees thought metrics based on Community VOICES's domains (feasibility, participant selection, quality of communication, community perceptions, investigator/IRB perceptions) would be helpful. IRB members had similar experiences and concerns about reviewing EFIC studies. Development of metrics to assess CC processes may be useful to IRBs reviewing EFIC studies. [ABSTRACT FROM AUTHOR]

Competing Interests: These questions emphasize the importance of transparency as it relates to the protections of patient safety and the independence of science. Are investigators acting in the best interests of the patients or are they benefitting financially, either directly or in the promotion of their career? In the past research subjects have died in clinical studies and investigators have falsified data which brought needed scrutiny on assuring research data integrity and protecting participants (1, 2). Transparency of conflicts of interest is directly linked to this concept and contributes to ensuring the public trust in the ethics of medical science. Some patient populations have been exploited in the past in research and that has led to a reasonable distrust of medical research (3). The Trust in Medical Researchers Scale was created to assess the potential mistrust patients and in particular, minority populations may have (4). A question in the scale exemplifies this belief that researchers are acting in their interests and not in the best interests of the patient, “Researchers are more interested in helping their careers than in learning about health and disease” (4). Acting in the interest of the investigator instead of the patient could mean that investigators have financial gain from the study that is dependent on enrolling patients and showing that a treatment works. Some investigators are paid directly for each patient that they enroll in a study (5). The patients are seen as a conduit to financial success that may take precedence in the behavior of the investigator rather than focusing on the potential risk for the patient or the advancement of science. It seems reasonable that a patient would like to know if they are contributing to a direct financial benefit to the investigator rather than helping the more noble cause of advancing science. A second way that the study may be in the investigator's financial interest and potentially not in the best interest of the patient or science could be in research that directly impact corporate interests to which the investigators benefit. Investigators affiliated with companies may have additional incentives to having study results support the use of a drug. Insider trading laws include charges of trading based on material nonpublic information about a clinical drug trial conducted to obtain Food and Drug Administration (FDA) approval to market a new drug. In other words, it is important for companies and investigators to show a benefit of the drug. The demonstration of the success or failure of a new drug may have millions of dollars in implications. Keeping corporate interests separate from scientific issues and interpretation of results is critical to move knowledge forward and provide confidence in the conclusions of a study. Addressing these financial concerns through transparency in conflict of interest declarations is a key.The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision.

A shift from single to multi-site health studies enabled a range of research benefits including faster recruitment of larger and more diverse samples; increased statistical power, greater rigour, generalisability, and external reliability; and increased likelihood of impacting policy and clinical practice. However, ethical review of multi-site studies by Institutional Review Boards (IRBs) raises specific challenges compared with single site studies, with requirements to apply to multiple local IRBs increasing the burden on research, possibly endangering the integrity of the research process or inhibiting development of multi-site studies. The option of a single centralised IRB may offer a clearer, more consistent and efficient review process. This study presents a case report and commentary from 15 years engaging with IRBs in multiple sites in Ireland by the Intellectual Disability Supplement to the Irish Longitudinal Study on Ageing (IDS-TILDA). It examines the ethics review process for IDS-TILDA through its first four waves. While the majority of 48 IRBs granted ethical approval within 13 weeks, six IRBs took 21-47 weeks to approve, leading to delays in data collection of up to 11 months. Despite additional review time, no changes were required to the study protocol. Therefore, a critical impact of the process was the delay in starting data collection within a small number of organisations, and reduced involvement in the study for one organisation. The ethical review process with multiple IRBs increased the degree of complexity of the process, with added bureaucracy and far greater communication required across 48 IRBs, substantially adding to the resource commitment for the review process. The relatively quick approval from the majority of IRBs was partially a result of the longitudinal study building relationships with organisations throughout multiple waves. That other health studies may not accrue this benefit supports calls for a single IRB system for multi-site health studies., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 McCausland D et al.)

The increased use of big data in the medical field has shifted the way in which biomedical research is designed and carried out. The novelty of techniques and methods brought by big data research brings new challenges to institutional review boards (IRBs). Yet it is unclear if IRBs should be the responsible oversight bodies for big data research and, if so, which criteria they should use. A large but heterogenous set of ethics guidelines and normative responses have emerged to address these issues. In this study, we conducted a scoping review of soft‐law documents and guidelines with the aim of assessing ongoing normative efforts that are proliferating in this domain. We also synthesize a set of recurrent guidelines that could work as a baseline to create a harmonized process for big data research ethics. [ABSTRACT FROM AUTHOR]

The implementation of pragmatic clinical trials (PCTs) can be accompanied by unique regulatory challenges. In this paper, we describe the experience and management of regulatory noncompliance during a 25‐site acute care PCT. During the trial, the study team conducted a comprehensive audit of all enrollment forms (informed consent and Health Insurance Portability and Accountability Act authorization forms) and related study documentation. A review of 997 participants' enrollment forms identified 138 (13.8%) that required reporting to the institutional review board due to noncompliance. To prevent subsequent noncompliance, the study team developed and introduced a revised participant tracking system, reviewed all enrollment documentation, and retrained sites regarding study procedures. Based on these experiences, we developed a set of recommendations for future PCTs to ensure both operational success and regulatory compliance. [ABSTRACT FROM AUTHOR]

The near‐routine exclusion of pregnant women from clinical research has resulted in evidence gaps that endanger the health of pregnant women and their future offspring. Although existing literature documents numerous obstacles along the clinical trial pathway that can stymie research involving pregnant women, there is little guidance on how to facilitate such research. This qualitative study aims to fill that void by examining the experiences of individuals involved in conducting, approving, or overseeing research involving pregnant women at one academic institution. The study identifies factors throughout the clinical pathway—from protocol development, to IRB review, and ultimately trial execution—that likely contribute to the successful conduct of research with pregnant women. Attention to those factors, coupled with agreement among stakeholders that research with pregnant women should and can be done ethically and legally, is critical to shifting the narrative from "why we cannot" do such research to "how we can." [ABSTRACT FROM AUTHOR]

Introduction: This tutorial article explicates some of the 2017 updates to the 1991 Common Rule. Implemented in January 2019, these changes impact the evolving landscape of research with human participants in the US. The introduction provides context for the article as well as framing research questions. Key concepts: These include a brief definition of research for the purposes of the article; a discussion of the foundational ethical principles of autonomy (respect for persons), beneficence, and justice; and a brief overview of the recent policy revision process and its impact on scholarship in the field. After establishing this context, readers are provided five key lessons from the policy revisions. Key lessons: The lessons for researchers working with human participants include discussion of the impact of policy changes in the Common Rule associated with broad consent, single Institutional Review Board (IRB) mandate/cooperative review, updated exemptions, modified definitions of vulnerability, and international research. These are all contextualized within a specific example for professional communication researchers. Implications for practice: Although educative efforts are underway at both the federal and institutional levels, it is important for disciplines and researchers to understand how policy changes will impact the IRB review process. Attendance to the infrastructures that guide our research design and development warrants attention. [ABSTRACT FROM AUTHOR]

The purpose of this article is to stimulate research in orofacial myology. The research-to-practice gap may be reduced by highlighting concepts relating to evidence-based practice. Information is also presented on the International Association of Orofacial Myology Institutional Review Board process. [ABSTRACT FROM AUTHOR]

Abstract Background The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate informed consent. The committee must consider various matters before deciding whether the process is appropriate, including the adequacy and completeness of the written information provided to study participants, and the process of obtaining informed consent. This study aimed to identify, quantitatively and qualitatively, consent-related issues in different types of malaria proposals submitted to the Faculty of Tropical Medicine, Ethics Committee. Methods This study reviewed proposal documentation submitted to two panels of the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, from 2011 to 2015. The documentation included proposals, notifications to researchers of review outcomes and ethical issues of concern to committee members. Each element of the informed-consent process was identified and analyzed by study classification, design, and specimen use, including whether the study involved a vulnerable population. Summative content analysis was used to analyze patterns of common issues raised in reviews. Results Of the 112 proposals reviewed, 63 required an informed consent process. All researchers proposed communicating with their study participants; however, about two-thirds needed to improve their explanations of study procedures (study activities and specimen/data-collection process) to participants. About 40% of the proposals attracted comments on informed-consent process elements--risk and discomfort, vulnerable status, and compensation. Studies that planned to collect or use new/linked specimens raised more issues around informed consent than studies using linked data/records. Studies that involved vulnerable populations raised more issues than those that did not. The committee usually asked researchers to clarify, elaborate, revise, or paraphrase the consent process elements that were considered to involve inadequate information exchange between researcher and study participant. Conclusions This study aimed to describe lessons for malaria researchers about common informed-consent process issues in different types of malaria proposals. The information and analysis of informed-consent elements should assist the preparation of malaria-research proposals.

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)’s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.