Institutional Review Board Application Research Articles

Case study on communicating with research ethics committees about minimizing risk through software: an application for record linkage in secondary data analysis.

In retrospective secondary data analysis studies, researchers often seek waiver of consent from institutional Review Boards (IRB) and minimize risk by utilizing complex software. Yet, little is known about the perspectives of IRB experts on these approaches. To facilitate effective communication about risk mitigation strategies using software, we conducted two studies with IRB experts to co-create appropriate language when describing a software to IRBs. We conducted structured focus groups with IRB experts to solicit ideas on questions regarding benefits, risks, and informational needs. Based on these results, we developed a template IRB application and template responses for a generic study using privacy-enhancing software. We then conducted a three-round Delphi study to refine the template IRB application and the template responses based on expert panel feedback. To facilitate participants' deliberation, we shared the revisions and a summary of participants' feedback during each Delphi round. 11 experts in two focus groups generated 13 ideas on risks, benefits, and informational needs. 17 experts participated in the Delphi study with 13 completing all rounds. Most agreed that privacy-enhancing software will minimize risk, but regardless all secondary data studies have an inherent risk of unexpected disclosures. The majority (84.6%) noted that subjects in retrospective secondary data studies experience no greater risks than the risks experienced in ordinary life in the modern digital society. Hence, all retrospective data-only studies with no contact with subjects would be minimal risk studies. First, we found fundamental disagreements in how some IRB experts view risks in secondary data research. Such disagreements are consequential because they can affect determination outcomes and might suggest IRBs at different institutions might come to different conclusions regarding similar study protocols. Second, the highest ranked risks and benefits of privacy-enhancing software in our study were societal rather than individual. The highest ranked benefits were facilitating more research and promoting responsible data governance practices. The highest ranked risks were risk of invalid results from systematic user error or erroneous algorithms. These societal considerations are typically more characteristic of public health ethics as opposed to the bioethical approach of research ethics, possibly reflecting the difficulty applying a bioethical approach (eg, informed consent) in secondary data studies. Finally, the development of privacy-enhancing technology for secondary data research depends on effective communication and collaboration between the privacy experts and technology developers. Privacy is a complex issue that requires a holistic approach that is best addressed through privacy-by-design principles. Privacy expert participation is important yet often neglected in this design process. This study suggests best practice strategies for engaging the privacy community through co-developing companion documents for software through participatory design to facilitate transparency and communication. In this case study, the final template IRB application and responses we released with the open-source software can be easily adapted by researchers to better communicate with their IRB when using the software. This can help increase responsible data governance practices when many software developers are not research ethics experts.

Defining institutional review board application quality: critical research gaps and future opportunities

The quality of a research study application sends a distinct signal to the institutional review board (IRB) about the skills, capacities, preparation, communication, experience, and resources of its authors. However, efforts to research and define IRB application quality have been insufficient. Inattention to the quality of an IRB application is consequential because the application precedes IRB review, and perceptions of quality between the two may be interrelated and interdependent. Without a clear understanding of quality, IRBs do not know how to define quality and researchers do not know how to achieve quality. This position has not been systematically studied to date, and future research could provide much-needed empirical validation. This paper lays the conceptual groundwork for future investigation into what constitutes quality in an IRB application. It includes a landscape review of multidisciplinary research on quality, as well as a discussion of quality frameworks analogous to research with human participants that exist in the published literature. It also examines the background and significance of federal research regulations, regulatory burdens, researchers’ regulatory literacy, and the roles and responsibilities of IRB professionals within this ecosystem.

Do I Need Institutional Review Board Approval? Applying the 2018 Institutional Review Board Revised Common Rule to Athletic Training Educational Research

Do I Need Institutional Review Board Approval? Applying the 2018 Institutional Review Board Revised Common Rule to Athletic Training Educational Research

An academic and regional nurse research collaborative: Implications for nursing research.

A diverse group of nurses and research Network Coordinators formed a collaboration to advance nursing research within Johns Hopkins Clinical Research Network, a partnership of academic and community hospitals in the mid-Atlantic region. The purpose of the Nurse Research Collaborative (NRC) is to provide mentoring, mutual growth, and assist the health care organizations to fulfill nursing research requirements. We created a multiinstitutional nursing research organization with diversity of member participants and health care facilities. The NRC structure allowed nonacademic facilities to engage in a variety of nursing research projects. This allows for increases in study sample sizes of diverse populations to support and expand nursing research. The NRC is modeled after a physician clinical research network with an aligned mission, vision, goals, and strategic priorities across member organizations. To strengthen multiinstitutional nursing research capability, the NRC developed an infrastructure of leadership, regular meetings, and formal educational presentations. The NRC completed three research studies, facilitating the Institutional Review Board application process, reviewing documents and contracts, providing individual institutional support, and coordinating site leader functions. A research collaboration of nurses, across multiple hospitals provides efficiencies and expertise not otherwise available in every organization.

Developing a classification system and algorithm to track community-engaged research using IRB protocols at a large research university.

Community-engaged research (CEnR) is now an established research approach. The current research seeks to pilot the systematic and automated identification and categorization of CEnR to facilitate longitudinal tracking using administrative data. We inductively analyzed and manually coded a sample of Institutional Review Board (IRB) protocols. Comparing the variety of partnered relationships in practice with established conceptual classification systems, we developed five categories of partnership: Non-CEnR, Instrumental, Academic-led, Cooperative, and Reciprocal. The coded protocols were used to train a deep-learning algorithm using natural language processing to categorize research. We compared the results to data from three questions added to the IRB application to identify whether studies had a community partner and the type of engagement planned. The preliminary results show that the algorithm is potentially more likely to categorize studies as CEnR compared to investigator-recorded data and to categorize studies at a higher level of engagement. With this approach, universities could use administrative data to inform strategic planning, address progress in meeting community needs, and coordinate efforts across programs and departments. As scholars and technical experts improve the algorithm's accuracy, universities and research institutions could implement standardized reporting features to track broader trends and accomplishments.

Looking Into Perioperative Nurses’ Other Roles

Looking Into Perioperative Nurses’ Other Roles

Exploring Residency Program Directors, Preceptors, and Residents' Intentions to Participate in Multicenter Pediatric Pharmacy Resident Research Projects.

The purpose was to explore preceptors, residency program directors (RPDs), and residents' beliefs and intentions in participating in multicenter pediatric resident research projects (PRRPs). This exploratory qualitative study used the theory of planned behavior to explore beliefs, attitudes, and intentions toward participation in a multicenter PRRP. Two focus groups were formed: RPDs/preceptors and pharmacy residents. The primary objective was to identify attitudes/salient beliefs, subjective norms, and perceived behavioral controls regarding participation in multicenter PRRPs. The secondary objectives included identifying potential barriers and mitigation strategies for multicenter PRRPs. Descriptive statistics and a thematic analysis were performed. The 2 focus groups included 24 participants: RPDs/preceptors (n = 16) and pharmacy residents (n = 8). The RPD/preceptor group had a mean of 7.4 ± 5.4 years of research experience; all residents had prior research experience as students. Participants shared and contrasted their salient beliefs, subjective norms, and perceived behavioral control beliefs about logistical challenges, networking, mentoring, sample size, collaboration, workload, shared responsibilities for data collection and the institutional review board application, and resources associated with participation in multicenter PRRPs. Other items that participants felt were important were discussion of authorship order and dedicated research time for residents. Participants provided favorable comments toward multicenter PRRPs but acknowledged some barriers. The resident, preceptor, and RPD intention to participate in multi-center PRRPs is very likely if they perceive this as an opportunity for increased networking and mentorship, increased likelihood of publication, enhanced research skill experience, and shared resources and responsibilities.

Clinical Data Extraction During Public Health Emergencies: A Blockchain Technology Assessment.

We sought to explore the technical and legal readiness of healthcare institutions for novel data-sharing methods that allow clinical information to be extracted from electronic health records (EHRs) and submitted securely to the Food and Drug Administration's (FDA's) blockchain through a secure data broker (SDB). This assessment was divided into four sections: an institutional EHR readiness assessment, legal consultation, institutional review board application submission, and a test of healthcare data transmission over a blockchain infrastructure. All participating institutions reported the ability to electronically extract data from EHRs for research. Formal legal agreements were deemed unnecessary to the project but would be needed in future tests of real patient data exchange. Data transmission to the FDA blockchain met the success criteria of data connection from within the four institutions' firewalls, externally to the FDA blockchain via a SDB. The readiness survey indicated advanced analytic capability in hospital institutions and highlighted inconsistency in Fast Healthcare Interoperability Resources format utilitzation across institutions, despite requirements of the 21st Century Cures Act. Further testing across more institutions and annual exercises leveraging the application of data exchange over a blockchain infrastructure are recommended actions for determining the feasibility of this approach during a public health emergency and broaden the understanding of technical requirements for multisite data extraction. The FDA's RAPID (Real-Time Application for Portable Interactive Devices) program, in collaboration with Discovery, the Critical Care Research Network's PREP (Program for Resilience and Emergency Preparedness), identified the technical and legal challenges and requirements for rapid data exchange to a government entity using the FDA blockchain infrastructure.

Clinical Data Extraction During Public Health Emergencies: A Blockchain Technology Assessment

We sought to explore the technical and legal readiness of healthcare institutions for novel data-sharing methods that allow clinical information to be extracted from electronic health records (EHRs) and submitted securely to the Food and Drug Administration's (FDA's) blockchain through a secure data broker (SDB). This assessment was divided into four sections: an institutional EHR readiness assessment, legal consultation, institutional review board application submission, and a test of healthcare data transmission over a blockchain infrastructure. All participating institutions reported the ability to electronically extract data from EHRs for research. Formal legal agreements were deemed unnecessary to the project but would be needed in future tests of real patient data exchange. Data transmission to the FDA blockchain met the success criteria of data connection from within the four institutions' firewalls, externally to the FDA blockchain via a SDB. The readiness survey indicated advanced analytic capability in hospital institutions and highlighted inconsistency in Fast Healthcare Interoperability Resources format utilitzation across institutions, despite requirements of the 21st Century Cures Act. Further testing across more institutions and annual exercises leveraging the application of data exchange over a blockchain infrastructure are recommended actions for determining the feasibility of this approach during a public health emergency and broaden the understanding of technical requirements for multisite data extraction. The FDA's RAPID (Real-Time Application for Portable Interactive Devices) program, in collaboration with Discovery, the Critical Care Research Network's PREP (Program for Resilience and Emergency Preparedness), identified the technical and legal challenges and requirements for rapid data exchange to a government entity using the FDA blockchain infrastructure.

Assembling the Career Firefighter Health Study cohort: A methods overview.

Studies of World Trade Center (WTC)-exposed rescue/recovery workers report the increased occurrence of health conditions after work at the WTC disaster site. However, the extent to which these associations are due to WTC exposure is unclear, in part due to the lack of suitable comparison groups. Accordingly, we identified a previously assembled National Institute for Occupational Safety and Health (NIOSH) cohort of career firefighters from three US cities (n = 29,992). Here, we document the challenges in establishing this non-WTC-exposed firefighter cohort for the goal of tracking and comparing cancer and chronic health conditions in WTC-exposed and non-WTC-exposed firefighters. Follow-up process included institutional review board applications, data use agreements, state cancer registry linkages and vital status determination for the NIOSH firefighter cohort. After completion of these steps, we undertook outreach to the three original city fire departments and union officials, before contact tracing and direct recruitment of 14,566 living firefighters to complete a confidential health survey. We staggered recruitment efforts by the city, using letters, postcards, emails, videos, and telephone outreach. Participants who completed the survey received $10. A total of 4962 of 14,566 alive firefighters responded to the baseline survey (34.1% response rate). Respondents were older and more likely to be non-Hispanic white than nonrespondents. We provide an overview of the process for the first survey to collect information on physical and mental health conditions among US firefighters. The data collected will have an important impact on studies of WTC rescue/recovery work, firefighting, and related health conditions.

920 Annual research boot camp: Ob/Gyn fellows demonstrate knowledge retention

While research is a central component of Ob/Gyn fellowships, a 2015 national survey of fellowship directors identified deficiencies in fellow knowledge of research projects, statistical analysis (SA) and manuscript preparation. We sought to investigate retention in knowledge of study design (SD) and research methods among Ob/Gyn fellows 1 year after implementation of a focused weeklong research curriculum. We designed and implemented a weeklong curriculum in 2019 focused on promoting baseline research knowledge. A total of 10 fellows from 4 subspecialty training programs in Ob/Gyn, including Maternal-Fetal Medicine, participated. Topics included SD, sample size calculation, grant writing, institutional review board applications, SA, and results presentation. Time was allotted for review of institutional research opportunities (IRO). Fellows were also tasked with proposing a new research idea to a faculty group. In both 2019 and 2020, fellows completed a 20-question pre/post research knowledge test as well as a survey rating their improvement in understanding of a variety of research topics. 2019 and 2020 results were compared using paired Wilcoxon signed rank sum tests. The mean research knowledge pre-test scores were 11.3±2.8 (2019) and 15.5±3.2 (2020). Pre-test scores increased significantly from 2019 to 2020 (+4.3±1.6; p=0.01). There was no significant difference in the 2019 post-test score and 2020 pre-test score (p=0.18), demonstrating knowledge retention over a 1-year period. Fellows reported improvement in understanding of all topics, but SD and IRO rated particularly highly. All fellows developed new research ideas or collaborations and felt more prepared to complete their thesis projects. A weeklong research boot camp resulted in significant retention of knowledge of research related topics over one year. This curriculum could be introduced in other institutions or broadened nationally to promote lasting research knowledge among Ob/Gyn fellows.

Requirements Analysis and Design of IRB System

Institutional review boards (IRB) are established by institutions to protect (human) research subjects from abuse. Researchers are thus required to apply and obtain IRB ap- proval for any research initiative that involves human subjects. Currently, most USA institutions use paper-based or partially automated approaches for IRB application, review, and approval processes. This can be cumbersome, error-prone and usually add unnecessary workloads to researchers. Moreover, paper- based approaches can delay or reduce research output, especially during collaborative research projects if researchers are from different institutions. Web-based information systems can be developed and used to streamline IRB application and approval processes. Before such web-based systems can be developed, the requirements of the system have to be analyzed and designed. However, requirements analysis and design are usually very tedious and expensive project, which may discourage some institutions from implementing systems to support IRB processes. The aim of this paper is to contribute a set of requirements and systems models that can be customized and re-used, by other institutions, to develop IRB Systems. Accordingly, we provide the following models, use case, feature tree model, and network diagram. In addition, we discussed our experiences and systems analysis principles we adopt to make this project a success. We believe that the experiences we share and the models we provide in this paper can inform practice and advance the knowledge of web-based information systems development. Re-using existing requirements and designs can also help to reduce the amount of time and cost required to develop similar systems.

Indigenous Research Ethics Requirements: An Examination of Six Tribal Institutional Review Board Applications and Processes in the United States.

Tribal Institutional Review Boards (TIRBs) in the United States assert their rights within sovereign nations by developing ethical research processes that align with tribal values to protect indigenous knowledge systems and their community from cultural appropriation, exploitation, misuse, and harm. We reviewed six TIRB applications and processes to gain a better understanding about their requirements and research ethics. We located 48 activated and deactivated TIRBs in a database, mapped them in relation to tribal reservation lands, and then conducted in-depth content analysis. Our analysis demonstrates the importance of building relationships, becoming fully acquainted with the TIRB's operating environment before seeking research approval, and issues related to tribal data management practices.

Assessing and investigating clinicians' research interests: Lessons on expanding practices and data collection in a large practice research network.

Conducted in naturalistic settings, practice-oriented research (POR) is aimed at building stronger connections between the science and practice of psychotherapy. Promoting the principles of POR, this article has 2 aims: (a) presenting the results of a survey assessing the interests of members of a large practice research network in topics that could guide future research conducted as part of clinical routine, and (b) describing difficulties in implementing a study in line with such interests. Despite the significant interest in and perceived clinical significance of two relationship constructs (alliance and countertransference), there were unique obstacles faced in their empirical investigation within an already operationally functional practice research network. Challenges in this process included resource-related difficulties (such as changes in staff and the time required to set up the study and administer the measures), logistics-related issues, and effectively incorporating the assessment procedure into an existing clinical system. The article also describes strategies to address these obstacles, with differing degrees of success, including the role of a "local champion" at each site, the importance of a personal/professional relationship between the researcher and participating centers, as well as the pragmatic assistance to sites during the preparation, coordination, and implementation process (e.g., providing templates and feedback on institutional review board applications, and technological assistance on how to incorporate the measures into existing center software). The article concludes with general recommendations and future directions for POR. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Thinking/writing within and outside the IRB box

Prompted by shared discussions about our doctoral research, this paper focuses on two tensions we identified when applying to our university’s Institutional Review Board (IRB). The first tension relates to our discomfort with the assumptions about research participants as articulated in the IRB application. We detail how one of us sought to work with/in but also outside of the constraints we discuss. The second tension takes us into a more experimental space. We write ‘outside’ of the IRB boxes as a form of critique, but also as a way to produce more affirmative ways of thinking about what else can be thought and done within university IRB structures. We focus in particular on the ways that “data” is contained within IRB boxes. We conclude by offering some additional questions that this process of thinking/writing together have generated.

Characteristics of Successful Internal Medicine Resident Research Projects: Predictors of Journal Publication Versus Abstract Presentation.

To identify the characteristics of successful research projects at an internal medicine residency program with an established research curriculum. The authors collected data about all research projects initiated by or involving medicine residents from 2006 to 2013 at Baystate Medical Center, using departmental files and institutional review board applications. Resident and mentor characteristics were determined using personnel files and Medline searches. Using multivariable models, the authors identified predictors of successful completion of projects using adjusted prevalence ratios (PRs). The primary outcome was manuscript publication, and secondary outcome was publication or regional/national presentation. Finally, residents were surveyed to identify barriers and/or factors contributing to project completion. Ninety-four research projects were identified: 52 (55.3%) projects achieved the primary outcome and 72 (76.5%) met the secondary outcome, with overlap between categories. Most study designs were cross-sectional (41; 43.6%) or retrospective cohort (30; 31.9%). After adjustment, utilization of the epidemiology/biostatistical core (PR = 2.09; 95% CI: 1.36, 3.21), established publication record of resident (PR = 1.54; 95% CI: 1.14, 2.07), and resident with U.S. medical education (PR = 1.39; 95% CI: 1.02, 1.90) were associated with successful project completion. Mentor publication record (PR = 3.13) did not retain significance because of small sample size. Most respondents (65%) cited "lack of time" as a major project barrier. Programs seeking to increase resident publications should consider an institutional epidemiology/biostatistical core, made available to all residency research projects, and residents should choose experienced mentors with a track record of publications.

Is Color and Light Therapy an Effective Complementary Therapy for Oncology Patients? An Analysis of One Practitioner's Anecdotal Experiences

Background: Color and light therapy has its roots in ancient medicine, although historical and medical implications have not been fully documented. Knowledge about the therapeutic value of color and light therapy has informed both ancient and contemporary medicine. This paper will discuss the author's experiences working with oncology patients using color and light therapy called colorpuncture and includes a preliminary analysis of its efficacy based on participants' reports and the practitioner's notes. Treatment sessions were offered at the now defunct Wellness Community in Boca Raton, Florida, a cancer support organization. The author studied colorpuncture founded by Peter Mandel, ND, a scientist and naturopathic healer who is the Director of the Mandel Clinic in Bruchsal, Germany. Materials and Methods: Educational lectures on the history of light therapy and application of colored light were provided for all interested participants who attended several educational presentations. All participants were invited to receive sessions without charge and were shown the acu-light therapy device used in treatments. All participants signed up for treatment sessions without committing to any specific treatment frequency. Sessions were held at the Wellness Community during 2004–2005. No Institutional Review Board application was filed, and permission was granted by the Clinical Director. All participants were given contact information to report adverse reactions or to share information with their physicians. Participants filled out surveys and completed reports that were sent to the practitioner. Each session lasted 45–60 minutes, and all participants received appropriate color and light therapy applications that addressed their individual health concerns. Participants were informed that all of their responses would be recorded and would be anonymous for any future publication. Results/Conclusion: Participants were treated with the application of colored light called colorpuncture for common oncology problems, including gastrointestinal problems, sleeplessness, anemia, balance difficulties, nausea, loss of appetite, depression, and so on. This noninvasive integrative medicine therapy was often described by patients as both “painless” and “relaxing.” Initial analysis based on participants' reports indicated that color and light has proven to be effective (anecdotally) in the reduction of common problems that people with cancer experience, including side effects from radiation and chemotherapy treatments: nausea, vomiting, anemia, pain (in general), and port pain (in particular). The author intends to conduct future research through a controlled trial to gather data on the efficacy of this integrative therapy utilizing her own technique called spectra-immunology™, which included the application of colored light therapies with energetic therapies.

Practical Tips for Ethical Data Sharing

This Tutorial provides practical dos and don’ts for sharing research data in ways that are effective, ethical, and compliant with the federal Common Rule. I first consider best practices for prospectively incorporating data-sharing plans into research, discussing what to say—and what not to say—in consent forms and institutional review board applications, tools for data de-identification and how to think about the risks of re-identification, and what to consider when selecting a data repository. Turning to data that have already been collected, I discuss the ethical and regulatory issues raised by sharing data when the consent form either was silent about data sharing or explicitly promised participants that the data would not be shared. Finally, I discuss ethical issues in sharing “public” data.

Effects of Regulatory Support Services on Institutional Review Board Turnaround Times.

We evaluated how regulatory support services provided by University of Illinois at Chicago's Center for Clinical and Translational Science may reduce Institutional Review Board (IRB) turnaround times. IRB applications were categorized by receipt of any regulatory support and amount of support received. Turnaround time included total turnaround time, time for IRB review, and time for investigators to modify protocols. There were no differences in any turnaround times for supported versus nonsupported applications. However, for supported applications, those receiving more intensive support had total turnaround times 16.0 days ( SE 7.62, p < .05) faster than those receiving less intensive support. Receiving higher regulatory support may be associated with faster approval of IRB submissions.

Lack of efficacy of topical timolol for cutaneous telangiectasias in patients with hereditary hemorrhagic telangiectasia: Results of a pilot study

Lack of efficacy of topical timolol for cutaneous telangiectasias in patients with hereditary hemorrhagic telangiectasia: Results of a pilot study