EBP Week 12

• The first step in the research process is determining the general type of research being conducted, classifying it as human subjects, animal, or non-human subjects research.
• Mandatory IRB approval is required for any research study involving human subjects, including submitting a detailed application outlining research design, participant recruitment, outcome measurements, and potential risks/benefits
• Informed consent, consisting of a document explaining the study to participants, who must agree, is a critical component of the IRB review
• The goal of the IRB is to ensure the ethical conduct of research, address ethical questions, minimize risks to participants, ensure confidentiality while considering a broader purpose.

Human Subjects Research

• Human subjects research involves living individuals from whom data or biospecimens are obtained, used, or analyzed through interaction or intervention
• Includes studies where private or identifiable information is obtained, used, generated, or analyzed from living individuals
• IRB exemptions are possible for some studies under this definition

IRB Evaluation Examples

• Simple studies with minimal ethical considerations undergo IRB review to ensure proper procedures, confidentiality, and outcome metrics
• Complex research involving significant ethical and safety concerns necessitates in-depth IRB review, often involving medical ethicists and specialists
• IRB Decisions and Approval: Requests for more information, modifications, approval or rejection will follow a review
• Research cannot begin until formal IRB approval is received, usually in a letter specifying the approval period (usually 1-3 years).
• Researchers can not begin recruiting participants until after IRB approval is granted
• A key aspect of informed consent is the participant's right to withdraw from the study at any time without penalty.
• The rigor of IRBs can vary significantly between institutions and even within the same institution.

Pre-Registration of Research

• Pre-registering the study protocol on a public website like clinicaltrials.gov is often required
• It is especially necessary for federally funded research, clinical trials, and systematic reviews
• Pre-registration involves publicly declaring the study's design, participants, procedures, and primary outcomes before data collection begins
• Main purposes are to provide public information about clinical trials and to enhance research integrity by preventing researchers from retrospectively changing their intentions or methods if the results are not as expected

Animal Model Research

• Animal research involves using animals to benefit human health, raising significant ethical concerns
• They can be valuable for studying processes over shorter lifespans or in situations where it is difficult or unethical to conduct long-term or invasive studies in humans
• Animal model literature can provide insights when human clinical trials are lacking, flawed, or unavailable, offering preliminary opinions on treatments.
• Findings from animal models to humans may have translational challenges stemming from species differences in metabolism and physiology

Dissemination of Research

• The final stage of the research process after data collection and analysis involves sharing the findings with the broader scientific community and potentially the public.

Conference & Peer Review Presentations

• A platform for researchers to present their work through poster or podium presentations
• A conference presentation typically requires submitting an abstract, which is reviewed by a committee for acceptance.
• Publishing in peer-reviewed journals undergoes a rigorous process of scrutiny by experts in the field and is often considered the ultimate goal of research.
• Researchers choose journals based on factors like the journal's scope, readership interest, and perceived prestige (often measured by impact factor)
• Peer review is a quality control mechanism, but it is not infallible due to human error and bias.

Pre-prints & Predatory Journals

• Pre-print servers allow rapid dissemination by making research publicly available online before formal peer review, lacking the quality control of peer review
• Predatory journals are unethical publications that prioritize profit over rigorous peer review and scientific integrity
• Identifying predatory journals is crucial

Key Terms

• Research Question: The first step in a research study, defining what the study aims to ask and how it will be answered.
• Outcome Metrics: Measurements used to answer the research question.
• Study Design: The plan for how the research question will be answered.
• IRB Exempt Studies: Certain types of research involving human subjects that do not require full IRB approval.
• Dissemination of Research: The process of sharing the findings of a completed research study.
• Peer Review Paper: An article published in a scholarly journal that has undergone a thorough quality control process where experts (peers) in the field review the research before publication.
• Journal Acceptance Rate: The percentage of submitted research articles that are accepted for publication in a journal.
• Preprint: A copy of an article that is planned for peer review publication made public on a preprint server before formal journal publication.