Protection Of Human Participants Research Articles

Contextualizing Contemporary Research Ethics Policies and Practices in Significant Historical Events

AbstractTheEthics Code for Behavior Analysts(BACB Code; Behavior Analyst Certification Board®, 2020) includes six items in “Section 6—Responsibility in Research'' that cover the protection of human participants in research activities conducted by Board Certified Assistant Behavior Analysts® and Board Certified Behavior Analysts®. This article provides a brief primer regarding significant historical events and foundational documents that have resulted in the contemporary research ethics policies and practices in the field of behavior analysis. This walk through the last century from the Nuremberg Code to the Declaration of Helsinki, the Belmont Report, and 45 CFR Part 46—Protection of Human Subjects provides a summary of why the codification of requirements such as “informed consent” and “Institutional Review Board” oversight was necessary. The linkages between these historical events and the current BACB Code items are discussed. In addition, situations in which the BACB Code does not provide explicit instruction but foundational documents may provide additional guidance are considered. Finally, opportunities for future data-driven decision making in research ethics are offered.

ALZ‐NET: Using Real World Evidence to Inform the Future of Alzheimer’s Treatment and Care

AbstractBackgroundThere are over 100 therapies being tested in clinical trials for Alzheimer’s disease (AD) today. With therapies undergoing regulatory review and a growing DRUG DEVELOPMENT pipeline, the field is entering a new era of molecular‐specific therapies. A national registry represents an opportunity to evaluate the longitudinal outcomes of patients treated with any novel FDA‐approved AD therapy in real‐world settings, to inform clinical practice.MethodThe Alzheimer’s Association, the American College of Radiology, the American Society of Neuroradiology, the Department of Biostatistics, Brown University School of Public Health and the Critical Path Institute, along with other clinical research and imaging experts, are launching Alzheimer’s Network for Treatment and Diagnostics (ALZ‐NET). ALZ‐NET will build on expertise from successful registries in other therapeutic areas and the IDEAS and New IDEAS studies which demonstrated large‐scale, real‐world data collection in dementia practice is feasible for addressing critical research questions. Networks of dementia practices and imaging facilities will provide the foundation of ALZ‐NET. Data collection and sharing will be fully compliant with human participant protections, privacy and patient/provider autonomy.ResultALZ‐NET will collect longitudinal clinical and safety data for enrolled patients treated with novel FDA‐approved AD therapies and will track patient long‐term health outcomes (effectiveness and safety), associated with use in real‐world settings. ALZ‐NET aims to assess clinical course of people from a variety of backgrounds and communities, to achieve representativeness beyond the populations historically enrolled in clinical trials.Objectives of ALZ‐NET:• Develop multisite network for enrolling providers and collection of patient data.• Collect baseline and longitudinal patient data, including measures of cognition, function, and long‐term safety.• Track health outcomes and resource utilization through existing databases.• Collect and archive diagnostic and safety data and neuroimaging, genetic and fluid biomarkers.• Share deidentified data, images and biosamples with research community and other stakeholders.ConclusionALZ‐NET will establish a network of sites with an expandable platform, allowing for the collection of real‐world data from enrolled patients receiving novel FDA‐approved AD therapies. ALZ‐NET will be a resource for evidence gathering, information sharing, and education across clinical and research communities, encouraging innovative, inclusive research and supporting opportunities to improve care.

“I don't feel like I'm a person”: Nursing knowledge of transgender care through the lens of transgender people

One aim of this study was to discover and understand the perceptions of healthcare delivery for transgender people who have had interactions with nurses while receiving care. An additional purpose of this study was to identify if these perceptions of nursing knowledge have an influence on transgender individuals seeking future healthcare. Qualitative, interpretive description. Recruitment of participants and interviews took place between September and November 2020. Confidentiality and protection of human participants was prioritized, and data analysis concluded in early 2021. Ten participant interviews were completed until data saturation were determined. One overarching theme and five supporting themes were constructed from data. Based on participant experiences, these themes reflect transgender peoples' perceptions of nursing knowledge of transgender care and how these perceptions impact seeking future healthcare. Experiences that shaped transgender peoples' perceptions of nursing knowledge of transgender care varied depending on the locations of these services and the experience and understanding of registered nurses. These findings highlight the perceptions that transgender people have of registered nurses' knowledge of transgender care and the influence that those perceptions have on them seeking future healthcare. This research aimed to fill a gap in the literature viewing registered nurses' knowledge of transgender care through the lenses of transgender participants. These findings indicate the need to advance the nursing profession to provide equitable, nonjudgmental care to transgender people to minimize the health disparities that they continue to face.

When Is a Change Significant? The Update Problem of Apps in Medical and Behavioral Research.

Digital applications (apps) are commonly used across the research ecosystem. While apps are frequently updated in the course of clinical and behavioral research, there is limited guidance as to when an app update should trigger action related to human research participant protections and who should be responsible for monitoring and reviewing these updates. We term this the "update problem" and argue that, while it is the principal investigator's duty to track all relevant updates, the level of involvement and re-review by the institutional review board (IRB) of an approved research protocol should vary depending on whether the update may be classified as minor, not minor, or significant. Minor updates require at most annual notification of the IRB, updates that are not minor require prompt notification of the IRB, and significant updates may require full board re-review or another response. We also suggest how these policies might be implemented.

Knowledge, Attitudes, and Practices of Women and Healthcare Workers Regarding Routine Deworming in Pregnant and Lactating Populations

Background: In pregnant women, the primary consequence of soil-transmitted helminth infections is anemia which can lead to poor outcomes such as premature birth, low birth weight, and decreased breast milk production. Although treatment for STH infections is relatively low-cost and treatment after the first trimester of pregnancy is safe, treatment rates in pregnant populations are low. Understanding the knowledge, attitudes, and practices of women and healthcare workers can help inform policy changes and improve STH treatment rates during prenatal care. Methods: Cross-sectional Knowledge, Attitudes, and Practices surveys were administered to women, nurses, and midwives in the community to assess their perception of deworming and parasitic infections. The regional focus was on Eastern Visayas, Philippines, chosen due to its high endemicity for STH. Findings: The study included 290 women and 35 health workers. Women who were willing to participate in a mass deworming program had significantly higher knowledge across all categories, Modes of Infection (p<0.000), Symptoms of Infection (p<0.000), Maternal Consequences of STH (p=0.011), Fetal Consequences of STH (p=0.002) and Effective Treatment Methods (p<0.000), compared to women who were unwilling to participate. Interpretations: Lack of knowledge about STH infections was associated with decreased acceptability of a government-sponsored deworming program in women and healthcare workers. This study demonstrates a need for enhanced capacity of health workers through appropriate trainings and health education for women regarding STH infections in pregnancy and the importance of deworming. Funding Information: This research was supported by the University of Pittsburgh School of Medicine and American Society of Tropical Medicine and Hygiene. Declaration of Interests: None of the authors had any conflicts of interests regarding this research. Ethics Approval Statement: This study involved the use of human participants in a minimal-risk survey collecting nonsensitive information. The study protocol has been approved by the University of the Philippines Manila-Research Ethics Board (UPM-REB) to ensure adherence to ethical standards and protection of human participants. As the data is completely anonymous, the study was considered exempt from the University of Pittsburgh IRB process.

Development proposals of Human Research Protection Program.

China's ethics committees alone are unable to meet the growing need for human participant protection. Several scandals in recent years indicate weaknesses in the protection of human participants in China. The aim of the study is to summarize the status and problems of human research protection program in China and to explore its establishment proposals at national and hospital levels. To conduct literature retrieval, Chinese National Knowledge Infrastructure, Chinese Biomedical Document Database, and English databases Web of Science and PubMed were searched; laws, guidelines, and regulations were also searched on web by Google and Chinese search engine Baidu. No data were collected from human participants, and ethical review was not required. There are problems for China's Human Research Protection Program, such as weak relevant legal systems, insufficient administrative supervision, and incompetent ethics committee capacities. To fully protect human participants, China should promote the development of Human Research Protection Program, which can formulate ethics-related laws, improve regulations for the protection of the safety and rights of human participants, strengthen supervision, and enforce compensation for human participants. Owing to the frequency with which human participants are recruited in hospitals in China, hospitals can utilize existing ethics committees and establish data and safety monitoring committees, quality control, fund and contract management, and conflict of interest management offices. As a growing program, it remains necessary to learn from the experience of developed countries with high ethics standards and reformulate them to fit China's conditions to explore potential future development. The program will also be an experience for other developing countries. Human Research Protection Program can strengthen communication and coordination among various hospital departments to effectively protect the rights and welfare of human participants.

Operational Managers’ Experiences Regarding Supportive Supervision at Primary Healthcare Facilities in the North West Province, South Africa

A lack of supportive supervision of operational managers is a disturbing phenomenon in the management of primary healthcare facilities in developing countries. The North West province of South Africa is not exempt from a lack of supportive supervision of operational managers. This occurs despite the burden of disease and a high demand for the provision of quality services. The study explored and described experiences of operational managers regarding supportive supervision by local area managers in the facilities of the North West province. Operational managers’ perceptions of how supportive supervision can be facilitated effectively were also described. A qualitative, descriptive, exploratory, and contextual study was conducted. The population comprised operational managers who worked for at least one year in the primary healthcare facilities. Purposive sampling was used and fundamental ethical principles underlying the protection of human participants were adhered to. Four semi-structured in-depth focus group interviews were conducted in the four districts of North West. The analysis of data followed Tesch’s method of content analysis. The first theme that surfaced concerned the participants’ experiences of factors related to compromised critical aspects of supportive supervision. The second theme embodied experiences of factors related to a lack of the qualities and competencies of a supportive supervisor. Perceptions of how effective supportive supervision of operational managers can be facilitated constituted the third theme. Based on the results, it was apparent that supportive supervision of operational managers in primary healthcare facilities should be enhanced.

Commentary on Point-of-Care Clinical Trials in Sports Medicine Research: Identifying Effective Treatment Interventions Through Real-World Evidence.

Commentary on Point-of-Care Clinical Trials in Sports Medicine Research: Identifying Effective Treatment Interventions Through Real-World Evidence.

Thirty-Five Years Later: Long-Term Effects of the Matlab Maternal and Child Health / Family Planning Program on Older Women's Well-Being

Background Family planning programs are widely believed to have substantial long-term benefits for women’s health and well-being, yet longitudinal studies are rare and mechanisms of impact are complex. We evaluated the effects of an in-home maternal and child health / family planning (MCH/FP) program in Matlab, Bangladesh on women’s lifetime fertility, adult health, and economic production 35 years after program initiation. Methods In 1977, women were assigned to treatment and comparison areas that were similar across most baseline characteristics. Comparable services were added to the comparison area from 1989. We followed 1,820 women born 1938-1973 from a census in 1974 to surveys in 1996 hand 2012-14. We estimated single-difference models of program impact using an intent-to-treat design with controls for baseline characteristics and potential confounders. Findings We found significant impacts on contraception, completed fertility and birth timing in aggregate and cohort-stratified models. We observed no significant positive impacts on health or economic production. Aggregate models found modest effects on poorer overall health (+0.07 SD) and respiratory health (+0.12 SD). Among women born 1950-1961, we observed poorer overall health (+0.11 SD) and metabolic health (+0.15 SD). For the 1950-1961 cohort, we observed significant increases in BMI in 1996 (0 · 76 kg/m2) and 2012 (0 · 57 kg/m2), along with a +2.5 kg/m2 secular change in BMI. As a result, treated women had a lower risk of underweight in 1996, but a higher risk of being overweight or obese in 2012. Interpretation: We found no long-term health or economic benefits of an in-home MCH/FP program. We observed modest negative health impacts among treated women that likely reflected an accelerated nutritional transition among treated women. Our findings suggest that we should not expect significant secondary health benefits from programs aimed at fertility reduction. Funding: This study was funded and supported by the US National Institute on Aging, the International Initiative for Impact Evaluation (3ie) and the Population Reference Bureau. Declaration of Interests: The authors have no conflicts of interest to report. Ethics Approval Statement: Protection of human participants during fieldwork and data analysis was ensured under icddr,b Ethical Review Committee Protocol #PR-10005.

The role of research ethics committees in South Africa when human biological materials are transferred between institutions

The role of health research ethics committees (RECs) has evolved dramatically over the past few decades. Novel and specialised research, multicentre trials across borders and commercially sponsored research, coupled with a huge increase in the number and complexity of research protocols, and capacity and resource constraints on the part of RECs, have led to serious breaches regarding the protection of human participants. Research involving the exchange or cross-border transfer of human biological materials (HBMs) requires specialised legal and ethical knowledge relating to multiple governance frameworks. RECs may be required to monitor compliance not only with contractual requirements, but also the national laws and national ethical guidelines and standards of selected jurisdictions, not to mention adherence to international regulatory instruments governing biomedical research generally, and the conditions for the collection and use of HBMs specifically. The South African (SA) legislator’s decision to make RECs signatories to the prescribed material transfer agreement (MTA) template is a first step in the right direction, reinforcing the role and responsibilities of RECs, and their duty of care towards human participants in research. In addition, there has to be a transformation of the general mindset, towards accepting ethical principles within legal documents, particularly legal documents that involve the REC and create binding provisions that have a direct impact on participants. It is time that African views and participant protections are respected and accepted with the same vigour commanded by the Western world. In this article, the role of RECs in general is considered, prior to focusing on their responsibilities with respect to HBM transfer. The ethico-regulatory framework for REC functioning is discussed both from global and national perspectives. Also deliberated is the critical role that RECs play in reviewing health research proposals when HBMs are transferred between institutions, and the REC as a party to the SA national MTA template.

The role of research ethics committees in South Africa when human biological materials are transferred between institutions

The role of health research ethics committees (RECs) has evolved dramatically over the past few decades. Novel and specialised research, multicentre trials across borders and commercially sponsored research, coupled with a huge increase in the number and complexity of research protocols, and capacity and resource constraints on the part of RECs, have led to serious breaches regarding the protection of human participants. Research involving the exchange or cross-border transfer of human biological materials (HBMs) requires specialised legal and ethical knowledge relating to multiple governance frameworks. RECs may be required to monitor compliance not only with contractual requirements, but also the national laws and national ethical guidelines and standards of selected jurisdictions, not to mention adherence to international regulatory instruments governing biomedical research generally, and the conditions for the collection and use of HBMs specifically. The South African (SA) legislator’s decision to make RECs signatories to the prescribed material transfer agreement (MTA) template is a first step in the right direction, reinforcing the role and responsibilities of RECs, and their duty of care towards human participants in research. In addition, there has to be a transformation of the general mindset, towards accepting ethical principles within legal documents, particularly legal documents that involve the REC and create binding provisions that have a direct impact on participants. It is time that African views and participant protections are respected and accepted with the same vigour commanded by the Western world. In this article, the role of RECs in general is considered, prior to focusing on their responsibilities with respect to HBM transfer. The ethico-regulatory framework for REC functioning is discussed both from global and national perspectives. Also deliberated is the critical role that RECs play in reviewing health research proposals when HBMs are transferred between institutions, and the REC as a party to the SA national MTA template.

The Contribution of Ethics Review to Protection of Human Participants: Comment on "Measuring the Quality and Performance of Institutional Review Boards".

Measuring the quality and performance of IRBs requires clarity about what IRBs are supposed to do. Although many agree that IRBs are supposed to protect the rights and welfare of human subjects, exactly how review by an IRB contributes to protection is not always clear. Originally, ethics review was instituted as a way to check the interests, possible conflicts, and enthusiasm of investigators whose relationship to participants is different from physicians' relationship to patients. IRB performance might include evaluating how well IRBs do this.

Collaborative storage and research use of human biospecimens between MSKCC and AUB

Background: As biospecimens are ultimately institutional resources, biologic specimens-tissue, blood or other body fluids- with benign or malignant disease that are left over after all intended diagnostic tests for clinical care are stored at our facilities. This project aims to procure and maintain a repository of human biological specimens for distribution to investigators, while maintaining confidentiality of patients. Methods: Left over biospecimens are procured and stored in the pathology department by the Tissue procurement service in a manner consistent with high standards for the protection of human participants in research. Patients are approached by consenting professionals to obtain the consent as part of the informed consent process. The objective and nature of the study is explained, as well as the voluntariness of the process. Results: In the course of 3 years, over 500 samples were collected from the patients to perform research studies. The sample types vary, the organ from which samples were procured include among others: thyroid samples, breast, brain, stomach, pancreas, liver, intestine, colon, and rectum. They include a vast variety of pathologies. Conclusion: The stored biospecimens will play a vital role in the development of anticancer interventions benefitting from the size, diversity, and richness of demographic and clinical information linked to the specimens. Our repository of human biospecimens has grown and will continue to grow as more samples are being stored daily.

Assessment of a shortened informed consent form for pediatric research: a pilot study.

Inherent to clinical research is the informed consent process, with the informed consent form (ICF), a key component of human participant protections. We wished to examine whether a shortened and simplified ICF, accompanied by an appendix, improved participant understanding of a study compared with a conventional ICF. A shortened ICF was developed from an existing conventional ICF for a neonatal study. Either the shortened or conventional ICF was randomly distributed to members of two parental advocacy groups. Participants answered survey questions about the form they received. Thirty-one out of forty-one (76%) parents in the shortened ICF and 28/41 (68%) in the conventional ICF group responded. Significantly more parents in the shortened ICF group found their form "short and to the point". Although they also stated that the shortened ICF did not provide enough information, there were no significant differences between groups measuring the understanding of key study components. A shortened ICF did not impact the understanding of the clinical trial. It will be important to compare the shortened and conventional forms in actual clinical trials.

Protection of the human research participant: A structured review.

The history of health research, and concerns about the protection of human participants, dates back as far as the 1800s. The regulation, legislation and ethics-review requirements regarding the protection of the human research participants cause lively debates among researchers and scientists. The objective of this article is to share the findings of a structured review that was aimed at investigating the impact of and challenges with regard to the legislation, governance and research regulations aimed at protecting human research participants. The thematic analysis of the findings revealed dissatisfaction with diverse operational practices; different legislation and regulation practices; and institutional governance. Simplified and universally agreed-upon regulations and operational practices are needed, as is a common understanding of all concepts relating to ethical research conduct.

Rethinking Data Sharing and Human Participant Protection in Social Science Research: Applications from the Qualitative Realm

While data sharing is becoming increasingly common in quantitative social inquiry, qualitative data are rarely shared. One factor inhibiting data sharing is a concern about human participant protections and privacy. Protecting the confidentiality and safety of research participants is a concern for both quantitative and qualitative researchers, but it raises specific concerns within the epistemic context of qualitative research. Thus, the applicability of emerging protection models from the quantitative realm must be carefully evaluated for application to the qualitative realm. At the same time, qualitative scholars already employ a variety of strategies for human-participant protection implicitly or informally during the research process. In this practice paper, we assess available strategies for protecting human participants and how they can be deployed. We describe a spectrum of possible data management options, such as de-identification and applying access controls, including some already employed by the Qualitative Data Repository (QDR) in tandem with its pilot depositors. Throughout the discussion, we consider the tension between modifying data or restricting access to them, and retaining their analytic value. We argue that developing explicit guidelines for sharing qualitative data generated through interaction with humans will allow scholars to address privacy concerns and increase the secondary use of their data.

Research ethics for a globalised world: the revised CIOMS international guidelines.

On December 6, 2016, the Council of International Organisations of Medical Sciences published a new version of its guidelines with the title "International Ethical Guidelines for Health-related Research Involving Humans." In this article we briefly describe the revision process and the structure and content of these guidelines. We outline some of its main guidelines such as the ones on social value, post-trial access, and risk-benefit ratio. In our overall evaluation we come to the conclusion that the CIOMS guidelines manage to strike a balance between the protection of human participants in health-related research and the promotion of such research activities in an exemplary way. The guidelines combine key principles with a guide to their application based on the state of the art in research ethics. Thus they represent a timely and indispensable orientation for researchers, ethics committees, and other stakeholders in health-related research.

A Comprehensive Analysis of Reasons for Neglected Status of Institutional Ethics Committees (IECs) in Health Research Institutes of Punjab, India

Background: Institutional Ethics Committees (IECs) in India are in their infancy stage which has significant implications in context to oversight of the protection of human participants. The critical and first step to support the protection of research participants and improve the scientific quality of health research is to understand how these IECs currently function. Keywords: IEC, training, lack of budget, review process, bioethics, DCGI.

Research in disaster settings: a systematic qualitative review of ethical guidelines.

BackgroundConducting research during or in the aftermath of disasters poses many specific practical and ethical challenges. This is particularly the case with research involving human subjects. The extraordinary circumstances of research conducted in disaster settings require appropriate regulations to ensure the protection of human participants. The goal of this study is to systematically and qualitatively review the existing ethical guidelines for disaster research by using the constant comparative method (CCM).MethodsWe performed a systematic qualitative review of disaster research ethics guidelines to collect and compare existing regulations. Guidelines were identified by a three-tiered search strategy: 1) searching databases (PubMed and Google Scholar), 2) an Internet search (Google), and 3) a search of the references in the included documents from the first two searches. We used the constant comparative method (CCM) for analysis of included guidelines.ResultsFourteen full text guidelines were included for analysis. The included guidelines covered the period 2000-2014. Qualitative analysis of the included guidelines revealed two core themes: vulnerability and research ethics committee review. Within each of the two core themes, various categories and subcategories were identified.ConclusionsSome concepts and terms identified in analyzed guidelines are used in an inconsistent manner and applied in different contexts. Conceptual clarity is needed in this area as well as empirical evidence to support the statements and requirements included in analyzed guidelines.Electronic supplementary materialThe online version of this article (doi:10.1186/s12910-016-0148-7) contains supplementary material, which is available to authorized users.

Consenting for Current Genetic Research: Views of Canadian Institutional Review Board Members

The widespread use of next generation sequencing (NGS) technologies in genetic research protocols creates a need for sequencing material that has been already collected, be it for similar or different purposes, in addition to increasing the need for sharing both material and the genetic generated data to enrich study results. Along with this comes the need to recontact participants for a variety of reasons where consent for unanticipated use and obtaining additional health information are only some examples. Following an earlier content analysis on a sample of Canadian Institutional Review Boards (IRB) consent form templates and accompanying guidelines, and IRB-approved consent forms, we developed an online survey addressing the opinions and experiences of Canadian IRB members on the use of NGS in research. We report herein the results pertaining to secondary use, sharing of material and data and recontacting participants. Participants in our survey agree with the need for clear identification on the matter of secondary use on consent form documents as well as the importance of differentiating use of material from the generated data. Our responders seem to be unsure how these separate options could affect the research enterprise. Respondents to our study agree with study participants opinions obtained elsewhere about the importance of providing options when it comes to share their data. While all responders agree on the importance of increasing grounds for recontacting, not all accept a clause allowing researchers to contact participants by default and giving always the possibility to refuse any further communication at time of recontact. Furthermore, our survey allowed us to make connections between the information stated on consent documents resulting from our earlier analysis with member’s views of said Boards. Adapting to new modalities of research is a challenging endeavour for IRB members. Continuous empirical research will allow the ethical oversight of research projects to keep pace with technological changes, simultaneously ensuring protection of human participants.