JMIR Research Protocols is a scientific journal dedicated to publishing study protocols in the fields of digital health and eHealth. It provides a platform for researchers to outline their study designs and methodologies before data collection begins. This pre-publication of research plans helps to foster openness and enhance the rigor of scientific inquiry in these rapidly advancing areas.
Understanding JMIR Research Protocols
JMIR Research Protocols was established to promote transparency and reproducibility in health research. Publishing a protocol prior to study commencement counteracts publication bias, where only positive outcomes are reported. It also prevents selective outcome reporting, ensuring all pre-specified outcomes are disclosed. This commitment to open science strengthens the credibility of research findings.
The journal provides a time-stamped record of research intentions. This record allows researchers to demonstrate adherence to their original design and helps others understand the planned methodology. For digital health interventions, where rapid technological advancements often occur, clearly documented protocols become significant for tracking research progress and ensuring methodological soundness. The journal supports open science, encouraging the sharing of research plans to build a transparent and collaborative research environment.
Types of Protocols Published
JMIR Research Protocols accepts study designs and methodologies focused on digital health, mobile health (mHealth), telehealth, and other eHealth interventions. The journal publishes protocols for randomized controlled trials to evaluate new digital health tools. It also covers observational studies, including cohort and case-control designs, investigating patterns and associations related to digital health use.
Epidemiological studies examining the prevalence and impact of digital health interventions on populations are also within scope. The journal welcomes qualitative studies exploring user experiences and perceptions of digital health technologies, and mixed-methods studies combining quantitative and qualitative approaches. Feasibility studies and pilot studies, which assess an intervention’s practicality and initial potential before a larger trial, are frequently published. Examples of interventions covered include mobile applications for chronic disease management, web-based platforms for mental health support, wearable devices for health monitoring, and telehealth systems for remote consultations.
Essential Components of a Research Protocol
A research protocol submitted to JMIR Research Protocols requires several components for clarity and comprehensiveness. The protocol begins with a background and rationale section, articulating the existing knowledge gap and explaining why the study is necessary. This section details the public health problem or research question the study aims to address. The study objectives or aims clearly state what the research intends to achieve, often broken down into primary and secondary outcomes.
The methods section outlines the study design, such as a randomized controlled trial or a cohort study. It specifies the participant population, including inclusion and exclusion criteria, and describes recruitment strategies. A description of the intervention, including its components, delivery method, and duration, is provided, especially for digital health interventions. Outcome measures are defined, along with plans for data collection, including instruments and procedures, and the statistical or qualitative data analysis plans.
Ethical considerations are a mandatory part of the protocol, documenting approval from an Institutional Review Board (IRB) or Research Ethics Committee (REC) and outlining the informed consent process. A dissemination plan describes how findings will be shared with the scientific community and the public, often including peer-reviewed publications and conference presentations. For clinical trials, registration in a public registry, such as ClinicalTrials.gov, is required prior to or concurrent with protocol submission. Adherence to established reporting guidelines, such as the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement for clinical trials, is encouraged to ensure all pertinent information is included.
The Publication Journey
Publishing a research protocol in JMIR Research Protocols involves several stages, beginning with pre-submission preparations. Researchers ensure their study protocol has received ethical approval from their institutional review board or equivalent committee before submission. For interventional studies, particularly clinical trials, registration with a public trial registry is a prerequisite, providing a unique identifier and a publicly accessible record of the study plan. These steps confirm that the research adheres to ethical standards and promotes transparency from the outset.
The submission process is conducted through the journal’s online manuscript management system. Authors upload their protocol document along with any supplementary materials, such as consent forms or data collection instruments. The system guides authors through providing metadata, including author information, keywords, and abstract, which helps in the efficient processing and indexing. The peer-review process for protocols focuses on the methodological rigor, scientific rationale, and ethical considerations of the study. Reviewers assess the clarity of the research questions, the appropriateness of the design, the feasibility of the intervention, and the soundness of the data analysis plan.
After peer review, authors receive feedback that may require revisions to their protocol. This iterative process of revision and resubmission ensures the protocol meets the journal’s standards before acceptance. Once accepted, the protocol is published, providing a time-stamped, citable record of the study design. Publishing a protocol offers several benefits, including early feedback from peer reviewers, increased visibility for the research team, and the potential to attract collaborators. This public record helps mitigate publication bias by committing researchers to report all pre-specified outcomes, enhancing the integrity and reproducibility of research in digital health.