Protection Of Research Participants Research Articles

Research Ethics in Training Curricula of Cameroon Health Training Institutions: A Cross-Sectional Study.

Introduction The quality of protection for research participants in Africa is still marked by the lack of trained actors in this area. The study was conducted to assess the availability of health research ethics in the curricula of health-related sciences training institutions in Cameroon. Methods The study involved a cross-sectional analysis to describe the training curricula on research ethics in health training institutions in Cameroon. Data were collected using a structured questionnaire that was administered face to face to the heads of institutions in late 2020. Results Twenty-one health training institutions were identified, and 18 (85.71%) participated. Health research ethics courses were present in the curricula of 16 (88.88%) of the institutions. Lectures were either a standalone module or part of a module in 14 (77.78%) institutions. The three first topics covered in the courses were the fundamental principles of ethics, the role of the ethics committee in the protection of research participants, and respect for research participants. A total of 14 (77.78%) institutions declared ethical clearance mandatory before the implementation of students' thesis protocols. Eight (50.00%) training institutions declared having at least one qualified lecturer to deliver training in research ethics evaluation. The organization of the training of lecturers in delivering lectures on research ethics was declared to be the main assistance needed. Conclusions The delivery of research ethics education in Cameroon's healthcare institutions is still limited by the fact that it does not cover all eligible populations, is not standardized, and does not yet promote the practice of requiring all student protocols to undergo preethical review prior to implementation. These points should be taken into account by the authorities in charge.

Evolution of Regulatory Governance for Human Research in Costa Rica

Regulatory governance of human research derives from historical abuses of people participating in health related and non-health relates studies. Costa Rica was no exception and nowadays counts with a Regulatory Law of Biomedical Research (Law 9234) that guarantees the protection of research participants’ human rights. The aim of this narrative review is to overview the gradual development and state of the art of protections and oversight of research with humans in Costa Rica. A recapitulation of why regulatory governance for biomedical human research was enacted in 2014 will be discussed. Even so, there is no legal requirement in Costa Rica, as in other developing nations, for non-health related protocols with human participants, to undergo the scrutiny of research boards. Nonetheless, even before Law 9234 was passed, the University of Costa Rica made efforts to compel compliance with research ethics when studying humans. Therefore, another objective is to review the current ethical guidelines dictated by the University of Costa Rica and Scientifical Ethics Committee of the University of Costa Rica to conduct responsible human research. The University of Costa Rica’s institutional regulatory framework on human research, can serve as a model to other national and international institutions from developing nations, where ethical assessment of sociocultural research is relatively neglected, compared to the review of biomedical and clinical studies.

Promoting Children's Rights and Protections in Program Evaluation

The Nuremberg Code established ethics for the involvement of humans in research, initially in the area of health and medical research. While aspects of the code have been extended to the social and behavioral sciences, program evaluation does not always implement those policies, procedures, and protocols for protecting research participants, particularly children. Drawing on a children's rights framework and highlighting participatory and trauma-informed approaches, this article explores the areas of consent, assent, cultural considerations, protocol/data collection procedure review, and participant safety. It proposes recommendations that fit a range of evaluation settings and resource level.

The Association for the Accreditation of Human Research Protection Programs: 15 years of emphasizing research safety, ethics, and quality

This year marks the 15th anniversary of the founding of the Association for the Accreditation of Human Research Protection Programs (AAHRPP), an organization that has been instrumental in strengthening protections for research participants. AAHRPP was established by seven Founding Members in response to a series of high-profile incidents that shook the foundation of the U.S. research enterprise. The Founding Members viewed voluntary accreditation as one way to strengthen research protections and restore and preserve public trust. Today, AAHRPP accreditation is widely regarded as the gold standard for research protections. To attain accreditation, organizations must demonstrate that they adhere to rigorous standards covering three domains: The Organization, The Institutional Review Board or Ethics Committee, and Researcher and Research Staff. The emphasis is on system-wide policies and procedures that strengthen an organization’s commitment to participants and help ensure a more consistent, more effective approach to protecting them. Because AARHPP accreditation is considered an objective indicator of quality, the benefits to accredited organizations can be considerable. Their accreditation status sends a signal — to potential research partners, to sponsors and other funders, and to research participants — that the organization has the systems in place to conduct research in a scientifically and ethically sound manner.

Quality Assurance and Associated Challenges at the Resource Limited, Rural Research Site

Clinical trial oversight is a critical element in clinical research conduct, it ensures the protection of research participants and the integrity of study data. FDA governs clinical research. Several key parties contribute to and work with complementary coinciding responsibilities such as study sponsor, research site, IRB, independent monitoring committees, contract research organization, and site management organization as applicable. The efficiency, and knowledge coherence to guide and direct each other among these groups is crucial for the successful conduct of a clinical trial. Challenges lie in this area of fields in various aspects. In this paper, the researcher has reviewed several elements at the research site with particular emphasis on resource-limited research sites. The researcher discussed some of the strategies to achieve quality conduct of clinical trials while achieving significant study enrollment at the resource-restricted research sites.

Reducing the Harms of Nonclinical Psychedelics Use Through a Peer-Support Telephone Helpline.

A resurgence of interest in the use of psychedelics for mental health and wellness has stimulated greater experimentation with psychedelics in society. Although clinical psychedelic trials protect research participants by offering a safe setting, thorough preparation, and containment during and after ingestion of psychedelic medicines, many try these substances without the benefit of these safeguards. We analyzed data gathered from 884 callers to a psychedelic helpline to determine whether a helpline model could reduce the risks associated with nonclinical psychedelics use. In total, 65.9% of callers indicated that the helpline de-escalated them from psychological distress. If not for their conversation with the helpline, 29.3% of callers indicated they may have been harmed; 12.5% indicated that they may have called 911; and 10.8% indicated they may have gone to the emergency room. The data suggest that access to a psychedelic helpline surrounding psychedelic experiences may avert harmful outcomes and offset the burden on emergency and medical services.

Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration.

Introduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies. Methods: This qualitative exploratory study, conducted across seven sites in India, included 11 focused group discussions (FGD) and 31 in-depth interviews (IDI). A flexible approach was used with the aid of a topic guide. The data were thematically analyzed using grounded theory and an inductive approach. Emerging themes and sub-themes were analyzed, and major emergent themes were elucidated. Results: Seventy-two IEC members participated in the study including 21 basic medical scientists, 29 clinicians, 9 lay people, 6 legal experts and 7 social scientists. Three major themes emerged from this analysis-apprehensions about conduct of CHIM studies in India, a perceived need for CHIM studies in India and risk mitigation measures needed to protect research participants and minimize the associated risks. Conclusion: Development of a specific regulatory and ethical framework, training of research staff and ethics committee members, and ensuring specialized research infrastructure along with adequate community sensitization were considered essential before initiation of CHIM studies in India.

Institutional Review Boards and post-approval monitoring (PAM) of human research: content analysis of select university (academic health center) web pages across the USA

Objective To conduct a content analysis of IRB webpages of select universities (academic health centers) in the USA that describe post IRB- approval monitoring activities. Method This was a qualitative study. Thematic analysis was the method to review the webpage content of selected academic health centers (AHC) within the USA. Results Some US academic health “centers” IRB administrative or research compliance offices conduct post- approval monitoring (PAM) of human subjects’ research including clinical trials. The goals of this PAM programmes are to (a) ensure compliance to approved protocols, (b) preserve research integrity, (c) manage institutional risks, d) provide advisory/educational support to researchers, (e) recommend corrective actions for identified issues, and most importantly, (f) to protect the safety, rights, and well-being of research participants. Although not a requirement by law, the PAM program has legislative support in the US Code of Federal Regulations as part of the US Office for Human Research Protection’s (OHRP) Federal Wide Assurance (FWA). This is especially for institutions that conduct studies funded by the Federal government. PAM on-site checks reveal various incidents of protocol deviations and violations. This includes issues with recruitment processes, informed consent discrepancies, and incidents of non-compliance. When a study protocol is identified as non-compliant, the principal investigator works with the PAM monitor to develop a corrective action plan that would allow the study to become compliant and avoid sanctions from the IRB or the regulatory authority. Conclusions REC/IRB post-approval monitoring of clinical trials is a valuable mechanism of protection for research participants while giving educational and quality assurance support to researchers. The program enables early detection and resolution of non-compliance to approved protocols. The impact of the program in the USA requires further exploration.

Fragmented understanding: exploring the practice and meaning of informed consent in clinical trials in Ho Chi Minh City, Vietnam

BackgroundThe informed consent process in clinical trials has been extensively studied to inform the development processes which protect research participants and encourage their autonomy. However, ensuring a meaningful informed consent process is still of great concern in many research settings due to its complexity in practice and interwined socio-cultural factors.ObjectivesThis study explored the practices and meaning of the informed consent process in two clinial trials conducted by Oxford University Clinical Research Unit in collaboration with the Hospital for Tropical Diseases in Ho Chi Minh City, Vietnam.MethodsWe used multiple data collection methods including direct observervations, in-depth interviews with study physicians and trial participants, review of informed consent documents from 2009 to 2018, and participant observation with patients’ family members. We recruited seven physicians and twenty-five trial participants into the study, of whom five physicians and thirteen trial participants completed in-depth interviews, and we held twenty-two direct observation sessions.ResultsWe use the concept “fragmented understanding” to describe the nuances of understanding about the consent process and unpack underlying reasons for differing understandings.ConclusionsOur findings show how practices of informed consent and different understanding of the trial information are shaped by trial participants’ characteristics and the socio-cultural context in which the trials take place.

Publication of Identifying Information and Protection of Research Participants

Dear Editor, We read with a lot of interest the Letter to Editor titled, “White/black bars to cover eyes, standard biomedical ethics, patient’s privacy, and consent for publication” authored by Joob and Wiwanitkit.[1] We appreciate the authors for initiating the discussion on a very important aspect related to patient’s privacy and autonomy. According to the recommendations of International Committee of Medical Journal Editors (ICMJE),[2] patients have a right to privacy that should not be violated without informed consent. We wish to take this discussion forward by highlighting certain important points related to consent of patients in regard to publication of photographs. The authors have written that the main concepts are “If consent has been provided by a patient for publication of clinical images, then there should be no requirement of obstruction of the eyes.” However, according to the ICMJE recommendations,[2] whenever anonymity is doubtful, informed consent should be obtained, for example, when the eyes are masked in photographs, in such cases, anonymity is doubtful. Interestingly, according to Robinson et al.,[3] the real test of anonymity is whether the patient could recognize his or her own image. So much so, even a tattoo or a unique mole included in a photograph might reveal the patient’s identity.[3] Identifying information of the patient should not be published in written descriptions and photographs, unless it is essential for scientific purposes and the patient has given written informed consent for publication. In case there is a potential of any identifiable material be available online or in print after publication, the authors should disclose this information to the patients. In fact, many journals require the authors[4,5] to obtain informed consent/patient permission form (specific for that journal) before publication for any patients who are identifiable in text descriptions or photographs. It is laudable that certain journals have made the forms available in different languages; the British Medical Journal[4] provides patient consent form in 23 different languages (including many Asian languages) and JAMA Dermatology[5] provides a template for patient consent for publication of identifying material in JAMA Network Journals in English language, with a provision of translated version in nine more languages on request. Some journals also require that the manuscript should be read by the patient before submission.[4,5] If the patient has not seen the final version of the paper, then the patient consent form should be amended accordingly.[4] Bennett et al.[6] argue that in spite of the patient permission forms, it remains uncertain whether all the potential risks for the patients have been taken care of or not. For instance, in case of vulnerable populations, such as children, non-English speaking etc., as they may not be able to comprehend the full information and thus are at risk of harm, in spite of the informed consent. We wish to invite discussion whether we should have separate consent forms for online publication of the photographs, considering that many journals are online and the digital foot print is permanent. Another point of further discussion can be the archival of these consent forms, whether the authors or the journals should archive these consent forms? Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest.

Avoiding Under- and Overrecruitment in Behavioral Intervention Trials Using Bayesian Sequential Designs: Tutorial.

Reducing research waste and protecting research participants from unnecessary harm should be top priorities for researchers studying interventions. However, the traditional use of fixed sample sizes exposes trials to risks of under- and overrecruitment by requiring that effect sizes be determined a priori. One mitigating approach is to adopt a Bayesian sequential design, which enables evaluation of the available evidence continuously over the trial period to decide when to stop recruitment. Target criteria are defined, which encode researchers' intentions for what is considered findings of interest, and the trial is stopped once the scientific question is sufficiently addressed. In this tutorial, we revisit a trial of a digital alcohol intervention that used a fixed sample size of 2129 participants. We show that had a Bayesian sequential design been used, the trial could have ended after collecting data from approximately 300 participants. This would have meant exposing far fewer individuals to trial procedures, including being allocated to the waiting list control condition, and the evidence from the trial could have been made public sooner.

Comitês de monitoramento para a proteção de participantes de pesquisa

Abstract Of increasingly relevance in public health and research projects involving human beings, the topic of safety has been intensely discussed. Participants in clinical trials are subject to risks, physical or otherwise, that impact their integrity, rights, or autonomy. This study outlines and discusses the performance of the Data and Safety Monitoring Committee for research participant protection and risk minimization in clinical research. An integrative literature review was conducted to identify the committees’ duties and role in protecting participants. Most of the analyzed articles confirm that the monitoring committees are mainly responsible for protecting research participants, as well as ensuring research integrity and credibility.

Monitoring committees for research participant protection

Resumen La seguridad ha sido un tema muy discutido, por lo que muestra su relevancia para la salud pública y los proyectos de investigación que involucran a seres humanos. Los participantes en estudios clínicos están sujetos a riesgos físicos o de otro tipo, que impactarán su integridad, derechos o autonomía. Este texto realiza un debate sobre el desempeño del Comité de Seguimiento de Datos y Seguridad destinado a la protección de los participantes de investigación y la mitigación de los riesgos en investigación clínica. Se realizó una revisión integradora de la literatura, con el propósito de identificar las funciones de los comités y su rol en la protección de los participantes. La mayoría de las publicaciones analizadas confirman que los comités de seguimiento tienen como principal responsabilidad la protección del participante de la investigación, además de garantizar la integridad y credibilidad de la investigación.

Monitoring committees for research participant protection

Resumo O tema segurança tem sido intensamente discutido, mostrando-se cada vez mais relevante na saúde pública e em projetos de pesquisa envolvendo seres humanos. Participantes de estudos clínicos estão sujeitos a riscos, físicos ou não, que impactam em sua integridade, direitos ou autonomia. Este trabalho apresenta e discute a atuação do Comitê de Monitoramento de Dados e de Segurança para a proteção do participante de pesquisa e minimização de riscos em pesquisa clínica. A metodologia consiste em revisão integrativa da literatura, realizada com o propósito de identificar as funções dos comitês e seu papel na proteção dos participantes. Identificou-se que grande parte das publicações analisadas confirmam que os comitês de monitoramento têm como responsabilidade principal a proteção do participante de pesquisa, além da garantia de integridade e credibilidade da pesquisa.

The role of nursing members in research ethics committees in Japan.

The International Council of Nurses (2012) and the Council for International Organizations of Medical Sciences (2016) determined and published ethical standards relevant to nursing researchers and practitioners; based on these standards, nurses are expected to participate in committees where decisions on ethical issues are made. While clinical practitioners and nursing educators actively serve on research ethics committees, their precise role in these platforms has yet to be elucidated. In this study, medical, humanities/social science, lay, and nursing members in research ethics committees across Japan were invited to participate in a semi-structured interview; data were analyzed through a qualitative analysis method. Specifically, we interviewed 23 research ethics committee members in Japan to clarify the role of nursing members in the committee. Our qualitative analysis yielded six themes: share perspectives and experiences in nursing, protect research participants, evaluate the research design, represent the voice of research participants, confirm the informed consent documents and ascertain research participants' free will. The analyses revealed a slight difference between what other committee members expected of the role of nursing members and nursing members' recognition of their own role. Nursing members make an important and independent contribution to ethics committees on deliberations and decision-making regarding research ethics. Within the context of research ethics committees, member selection and training are essential issues, and this study contributes to the literature by showing how these topics relate to the role of the research ethics committees and of their members.

The Post-Roe Political Landscape Demands a Morality of Caution for Women's Health.

The recent Supreme Court decision (ie, Dobbs v. Jackson Women's Health Organization), revoking the constitutional right to abortion in the United States, has the potential to dramatically disrupt progress in women's health research. The typical safeguards to ensure confidentiality and privacy of research participants in studies that collect certain types of personal health information may not hold against criminal investigations surrounding suspected pregnancy terminations. There are additional risks to participants in digital health research studies involving the use of wearable devices capable of tracking physiological measures, such as body temperature and heart rate, as these have shown promise for tracking conception and could be used to identify pregnancy termination signatures. There are strategies researchers can use to protect the safety of participants in health research who could get pregnant, while also maintaining integrity of research methods. The objective of this viewpoint is to discuss potential strategies to protect research participants' privacy that include the minimization of nonessential sensitive personal health information and anonymization protocols in the event of miscarriage or termination of pregnancy. We invite others to join this discussion so as to not let the current political landscape impede progress in women's health and reproductive research, while also protecting research participants.

International Research and Philanthropy

International Research and Philanthropy

Ethics and regulatory complexities posed by a pragmatic clinical trial: a case study from Lilongwe, Malawi.

Pragmatic clinical trials generally rely on real world data and have the potential to generate real world evidence. This approach arose from concerns that many trial results did not adequately inform real world practice. However, maintaining the real world setting during the conduct of a trial and ensuring adequate protection for research participants can be challenging. Best practices in research oversight for pragmatic clinical trials are nascent and underdeveloped, especially in developing countries. We use the PRECIS-2 tool to present a case study from Lilongwe in Malawi to describe ethical and regulatory challenges encountered during the conduct of a pragmatic trial and suggest possible solutions. In this article, we highlight the following six issues: (1) one public facility hosting several pragmatic trials within the same period; (2) research participants refusing financial incentives; (3) inadequate infrastructure and high workload to conduct research; (4) silos among partner organisations involved in delivery of health care; (5) individuals influencing the implementation of revised national guidelines; (6) difficulties with access to electronic medical records. Multiple stakeholder engagement is critical to the conduct of pragmatic trials, and even with careful stakeholder engagement, continuous monitoring by gatekeepers is essential. In the Malawian context, active engagement of the district research committees can complement the work of the research ethics committees (RECs).

Training needs of health researchers in research ethics in Cameroon: a cross-sectional study

BackgroundResearchers are responsible for the protection of health research participants. The purpose of this study was to identify and prioritize the training needs of researchers involved in human health research in Cameroon.MethodsIt was a cross-sectional study conducted in all the Cameroon regions in the last quarter of 2020. It targeted researchers involved in human health research selected by systematic stratified sampling from health and training institutions, and health facilities. Data were collected using a face-to-face administered questionnaire deployed in Smartphones via the ODK-collect. The distribution of participants’ exposure to research ethics training was described as well as their knowledge on the related regulatory texts. A score was used to rank the training needs identified by the participants.ResultsOf 168 reached participants, 134 (79.76%) participated in the study. A total of 103 (76.87%) researchers reported having received training in human health research ethics and 98 (73.13%) perceived need of training in research ethics. Of those involved in clinical, vaccine, and field trials, 63.64, 33.33, 52.53% have been exposed respectively to related training regarding participants’ protection. Having received at least one training in research ethics significantly increase the proportion of researchers systematically submitting application for ethical evaluation prior to implementation (OR = 3.20 (1.31–7.78)). Training priorities identified by researchers include: guidelines and regulations on health research ethics and research participant’s protection in Cameroon, procedures for evaluating research protocols, protection of research participants in clinical trials, and fundamental ethics principles.ConclusionThe coverage of researchers in training regarding research participant protection remains limited in a number of areas including those related to clinical trial participant protection and research participant protection in Cameroon. Improving this coverage and addressing perceived needs of researchers are expected to contribute in improving their ability in playing their role in research participant protection.

Boosting ethics review capacity in public health emergency situations: Co-creation of a training model for French-speaking research ethics committees.

Ethics review preparedness is a major foundation for national effective response to public health emergencies, because it promotes pertinent research and enhances the protection of research participants and communities. In low-income countries, it can also promote equitable research partnership. However, most relevant literature is in English and not easily accessible for the members of research ethics committees in French-speaking African countries. A training module in French, addressing the issue of research ethics review during outbreaks and other public health emergencies, was designed based on a non-systematic literature review, and in order to be complementary to the Democratic Republic of Congo (DRC) national guidelines for ethics review. The module was administered to 42 members of the five ethics committees in DRC that expressed their interest for the training. This training, co-designed with local stakeholders, in the local working language and taking into account local circumstances and regulation, provided participants with up-to-date insights of research ethics (and research ethics preparedness) in public health emergencies. It resulted in rich reflection and knowledge-sharing on good practices across the ethics committees. As most participating ethics committees do not have yet explicit standard operating procedures for expedited review of protocols submitted in emergency situations, this would be a next important step to facilitate emergency reviews in the most efficient way.