Background.Patient engagement efforts often rely on a participatory research approach, which means engaging patients and community members in all aspects of research. As research team members, they require familiarity with the principles of human subject protection, privacy, and institutional review boards (IRB). However, the time required for individual IRB training may be a barrier to engaging community members in participatory research. As more community members participated in research, the State Networks of Colorado Practices and Partners (SNOCAP) was faced with finding a balance between including community members as part of the research team and the significant time commitment and institutional requirements for human subjects research oversight.Objective.Design and implement a community training on human subject protection in research.Methods.The SNOCAP team worked with the leadership from the Colorado Multi-Institutional Review Board (COMIRB) to develop a training programme that included the ethical principles and guidelines for the protection of human subjects. Results.The final training programme was based on the core principles of the Belmont Report: respect for persons, beneficence and justice. Privacy was taught using the Health Insurance Portability and Accountability Act (HIPAA) national guidelines.Conclusions.The members of the High Plains Research Network Community Advisory Council were fully engaged in developing the training programme, as well as in the training itself. They were committed to the principles and guidelines for protecting the rights and welfare of human subjects. Patients and community members have become a critical part of our research team. They understand the principles of human subjects protection and privacy and incorporate these principles into their research activities.

The Emergency Medicine Specimen Bank (EMSB) was developed to facilitate precision medicine in acute care. The EMSB is a biorepository of clinical health data and biospecimens collected from all adult English-or Spanish-speaking individuals who are able and willing to provide consent and are treated at the UCHealth-University of Colorado Hospital Emergency Department. The EMSB is the first acute care biobank that seeks to enroll all patients, with all conditions who present to the ED. Acute care biobanking presents many challenges investigator-initiated research. AAM owns stock in Illumina, the company that makes the MEGA chip genotyping platform utilized at the University of Colorado. There were no financial inducements or services donated by Illumina for this work. Illumina had no role in designing this project, had no access to data, and had no involvement in the preparation of this manuscript. Author Contributions: JLS-protocol concept, design, and implementation; regulatory management and daily oversight; training personnel on protocol; and drafting of the manuscript. SKS-protocol concept and design, training personnel on protocol, and daily project management. AJHprotocol concept and design, training personnel on protocol, and daily project management. BJS-protocol concept and design, training personnel on protocol, and daily project management. EBM-protocol concept and design, training personnel on protocol, and daily project management; MWel and MWes-daily project implementation; RZ-protocol design and implementation and critical revision of the manuscript for important intellectual content. AAG-protocol concept, design, and implementation and critical revision of the manuscript for important intellectual content; KB-protocol design and implementation and critical revision of the manuscript for important intellectual content. JO-protocol design and implementation. MC-protocol design and implementation. MD-critical revision of the manuscript for important intellectual content. AL-protocol concept and design, regulatory oversight, and critical revision of the manuscript for important intellectual content. JH-protocol concept and design, regulatory oversight, and critical revision of the manuscript for important intellectual content. LBR-protocol design and implementation and critical revision of the manuscript for important intellectual content. ERR-daily project management. MT-protocol concept and design and critical revision of the manuscript for important intellectual content. MJA-critical revision of the manuscript for important intellectual content. KCprotocol concept and design and critical revision of the manuscript for important intellectual content. SJW-protocol concept and design and critical revision of the manuscript for important intellectual content. KCB-protocol concept and design, critical revision of the manuscript for important intellectual content, and acquisition of funding. AAM-protocol concept and design, critical revision of the manuscript for important intellectual content, and acquis...

Despite multiple initiatives in post-acute and long-term nursing home care settings (NHs) to improve the quality of care while reducing healthcare costs, research in NHs can prove challenging. Extensive regulation for both research and NHs is designed to protect a highly vulnerable population but can be a deterrent to conducting research. This paper outlines regulatory challenges faced by NHs and researchers, such as protecting resident privacy as well as health

Background: Clinical research is a central mission of the University of Colorado Anschutz Medical Campus (CU-Anschutz). On March 18, 2020, due to rising COVID-19 rates and personal protective equipment (PPE) shortages, an emergency approval process for critical research essential to the care and safety of patients, including COVID-19 trials, was enacted. All other clinical research studies requiring face-to-face visits were placed on hold to protect participant and staff safety. Methods: A clinical research TaskForce was rapidly assembled, consisting of a cross- section of campus clinical research operations leaders, including affiliate hospitals. This group developed a guidance document and process where the primary prioritization factor was positive therapeutic benefit/risk (Groups 2-5). A REDCap form demarcating items including research visit types and safety plans was designed. A separate Space Plan Committee approval was required to gauge environmental health and safety. Results: A total of 654 protocols were approved over 31 weeks using this process. Group 2 review and approvals occurred within 5 days of campus reactivation, and 65 days after original clinical research hold. Groups 3 through 5 were opened for submission and review in a phased approach. The majority proactively submitted IRB protocol amendments to minimize face-to-face participant/staff contact. There were no cases of COVID-19 outbreak in research participants. Conclusion: Clinical research reactivation was rapidly implemented in a transparent, collaborative, broadly supported, and efficient process of staged reactivation while prioritizing the health and safety of participants and staff at CU-Anschutz. This model is practical and easily generalizable to other medical research campuses.

This case study illustrates several of the potential challenges frequently encountered by clinical investigators working in the area of pulmonary arterial hypertension (PAH). It raises the issues of therapeutic misconception and clinical equipoise, and illustrates the importance of informing potential research participants of all their options in explicit detail.20 It also emphasizes the importance of explaining to patients that they are being asked to participate in a study to advance medical knowledge and develop therapies for the population of patients with PAH, and not for their own benefit. While they may benefit from the study drug, if they in fact receive it, this should not be offered as a reason for their potential participation. In addition, investigators should disclose any potential conflicts of interest to potential participants. During the past 2 decades, such clinical trials have advanced the treatment of patients with PAH and continue to offer the possibility of further improvements in our treatment of this devastating disease.