Ethical challenges experienced by clinical research nurses:: A qualitative study.

BACKGROUND:: Clinical investigation is a growing field employing increasing numbers of nurses. This has created a new specialty practice defined by aspects unique to nursing in a clinical research context: the objectives (to implement research protocols and advance science), setting (research facilities), and nature of the nurse-participant relationship. The clinical research nurse role may give rise to feelings of ethical conflict between aspects of protocol implementation and the duty of patient advocacy, a primary nursing responsibility. Little is known about whether research nurses experience unique ethical challenges distinct from those experienced by nurses in traditional patient-care settings. RESEARCH OBJECTIVES:: The purpose of the study was to describe the nature of ethical challenges experienced by clinical research nurses within the context of their practice. RESEARCH DESIGN:: The study utilized a qualitative descriptive design with individual interviews. PARTICIPANTS AND RESEARCH CONTEXT:: Participating nurses (N = 12) self-identified as having experienced ethical challenges during screening. The majority were Caucasian (90%), female (83%), and worked in outpatient settings (67%). Approximately 50% had > 10 years of research experience. ETHICAL CONSIDERATIONS:: The human subjects review board approved the study. Written informed consent was obtained. FINDINGS:: Predominant themes were revealed: (1) the inability to provide a probable good, or/do no harm, and (2) dual obligations (identity as a nurse vs a research nurse). The following patterns and subthemes emerged: conflicted allegiances between protocol implementation, needs of the participant, desire to advance science, and tension between the nurse-patient therapeutic relationship versus the research relationship. DISCUSSION:: Participants described ethical challenges specific to the research role. The issues are central to the nurse-participant relationship, patient advocacy, the nurse's role in implementing protocols, and/or advancing science. CONCLUSION:: Ethical challenges related to the specialized role of clinical research nurses were identified. More research is warranted to fully understand their nature and frequency and to identify support systems for resolution.

Using Social Media as a Research Recruitment Tool: Ethical Issues and Recommendations.

The use of social media as a recruitment tool for research with humans is increasing, and likely to continue to grow. Despite this, to date there has been no specific regulatory guidance and there has been little in the bioethics literature to guide investigators and institutional review boards (IRBs) faced with navigating the ethical issues such use raises. We begin to fill this gap by first defending a nonexceptionalist methodology for assessing social media recruitment; second, examining respect for privacy and investigator transparency as key norms governing social media recruitment; and, finally, analyzing three relatively novel aspects of social media recruitment: (i) the ethical significance of compliance with website "terms of use"; (ii) the ethics of recruiting from the online networks of research participants; and (iii) the ethical implications of online communication from and between participants. Two checklists aimed at guiding investigators and IRBs through the ethical issues are included as appendices.

Development of a plain-language library of educational resources for research participants.

There is a paucity of educational resources for potential clinical trial participants, particularly resources in plain language, attentive to health literacy principles and translated into native languages. The New England Research Subject Advocacy Group was formed to explore common issues, interests, and concerns related to the experience of participation in clinical research and research participant safety. Specifically, the group sought to increase community awareness and trust through the development and distribution of publicly accessible informational resources. In support of these aims, the group developed a robust library of high-quality, plain-language educational materials covering topics in health research, research participation, and common research procedures, and translated the majority of the materials into an additional 15 languages. These resources have been downloaded over 130,000 times. After English, the most common languages downloaded are Vietnamese, Spanish, and Korean.

Research coordinator networks and support models among academic health centers in the CTSA consortium.

INTRODUCTION: Research coordinators (RCs) are vital to the clinical research enterprise, ensuring research is conducted ethically, results are scientifically sound and human research subjects are protected. Given the absence of a prior systematic inquiry, we sought to understand the ways in which Clinical & Translational Science Award-funded academic health centers support RCs. METHODS: Our survey asked questions about existing coordinator networks and where none existed, collected data on the characterization of resources and services provided to support RCs (outside of salary). RESULTS: Findings show 4 mechanisms support RCs: identification of the workforce, professionalization of the position, dissemination of information, and offering of services. CONCLUSION: An academic health center that wishes to deliver research training and services to their RC workforce will need identification and communication structures in place before supportive activities can be effectively implemented.

Engaging Institutional Review Boards in Developing a Brief, Community-Responsive Human Subjects Training for Community Partners.

BACKGROUND: Engaging community partners as co-investigators in community-based participatory research (CBPR) requires certification in the rules, ethics, and principles governing research. Despite developments in making human research protection trainings more convenient and standardized (eg, self-paced Internet modules), time constraints and the structure of the content (which may favor academic audiences) may hinder the training of community partners. OBJECTIVES: This paper is motivated by a case example in which academic and community partners, and stakeholders of a community-based organization actively engaged the leadership of a pediatric hospital-based institutional review board (IRB) in implementing a brief, community-responsive human subjects training session. METHODS: A 2-hour, discussion-based human subjects training was developed via collaborations between the IRB and the community and academic partners. Interviews with trainees and facilitators after the training were used to evaluate its acceptability and possible future applications. CONCLUSIONS: Local IRBs have the potential to assist community partners in building sufficient knowledge of human subjects research protections to engage in specific projects, thereby expediting the progress of vital research to address community needs. We propose the need for developing truncated human subjects education materials to train and certify community partners, and creating formally organized entities within academic and medical institutions that specialize in community-based research to guide the development and implementation of alternative human subjects training certification opportunities for community partners.

The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: an innovative approach to multisite IRB review and oversight.

Reduction of duplicative Institutional Review Board (IRB) review for multiinstitutional studies is a desirable goal to improve IRB efficiency while enhancing human subject protections. Here we describe the Harvard Catalyst Master Reciprocal Common IRB Reliance Agreement (MRA), a system that provides a legal framework for IRB reliance, with the potential to streamline IRB review processes and reduce administrative burden and barriers to collaborative, multiinstitutional research. The MRA respects the legal autonomy of the signatory institutions while offering a pathway to eliminate duplicative IRB review when appropriate. The Harvard Catalyst MRA provides a robust and flexible model for reciprocal reliance that is both adaptable and scalable.

Harvard Catalyst | The Clinical Translational Science Center IND/IDE Consult Service: providing an IND/IDE consult service in a decentralized network of academic healthcare centers.

The Food and Drug Administration (FDA) regulations require sponsors of clinical investigations involving an investigational drug or device to submit an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application. Strict adherence to applicable regulations is vital to the success of clinical research. Unlike most major pharmaceutical sponsors, investigator sponsors often do not fully appreciate their regulatory obligations nor have resources to ensure compliance. As a result they can place themselves and their institutions at risk. Nevertheless, investigator-initiated clinical trials are vital to the further development of innovative drugs, biologics, and medical devices. The IND/IDE Subcommittee under the Regulatory Knowledge and Support Program at Harvard Catalyst, The Harvard Clinical and Translational Science Center worked in collaboration with Harvard and Harvard affiliated institutions to create and launch an IND/IDE Consult Service in a decentralized network of collaborating Academic Healthcare Centers (AHC). The IND/IDE Consult Service offers expertise, resources, and shared experiences to assist sponsor-investigators and IRBs in meeting regulatory requirements for conducting and reviewing investigator-initiated IND/IDE studies. The scope of the services provided by the Harvard Catalyst IND/IDE Consult Service are described, including the specifics of the service, lessons learned, and challenges faced, in a scalable model that builds inter-institutional capacity.

A distributed model: redefining a robust research subject advocacy program at the Harvard Clinical and Translational Science Center.

The Harvard Clinical and Translational Science Center ("Harvard Catalyst") Research Subject Advocacy (RSA) Program has reengineered subject advocacy, distributing the delivery of advocacy functions through a multi-institutional, central platform rather than vesting these roles and responsibilities in a single individual functioning as a subject advocate. The program is process-oriented and output-driven, drawing on the strengths of participating institutions to engage local stakeholders both in the protection of research subjects and in advocacy for subjects' rights. The program engages stakeholder communities in the collaborative development and distributed delivery of accessible and applicable educational programming and resources. The Harvard Catalyst RSA Program identifies, develops, and supports the sharing and distribution of expertise, education, and resources for the benefit of all institutions, with a particular focus on the frontline: research subjects, researchers, research coordinators, and research nurses.