Requirements for ethics committee review for studies submitted to Implementation Science
Martin P Eccles1, Charles Weijer, Brian Mittman
1Institute of Health & Society, Baddiley-Clark Building, Newcastle upon Tyne, NE2 4AX, UK. martin.eccles@ncl.ac.uk
Implementation Science : IS
|April 2, 2011
Summary
Implementation Science now requires ethics review for all human subject research, including studies on healthcare providers. Proof of ethics committee approval or exemption is mandatory for both experimental and non-experimental studies.
Area of Science:
- Health Services Research
- Medical Ethics
- Scientific Publishing
Background:
- The necessity of ethics committee review for studies submitted to Implementation Science has been ambiguous.
- This ambiguity impacts researchers and the integrity of published work.
Purpose of the Study:
- To clarify and establish definitive requirements for ethics committee review in Implementation Science.
- To ensure ethical standards are met for all submitted research, regardless of design.
Main Methods:
- This editorial outlines the journal's updated policies on ethics review.
- Requirements apply to both experimental and non-experimental study designs.
Main Results:
- Studies meeting the definition of human subject research will require documented ethics review.
- This includes research involving healthcare providers.
Conclusions:
- Mandatory ethics review or documented exemption/waiver is now a prerequisite for publication.
- These updated requirements aim to uphold rigorous ethical standards in implementation science research.
Related Concept Videos
01:56Ethics in Research
Today, scientists agree that good research is ethical in nature and is guided by a basic respect for human dignity and safety. However, this has not always been the case. Modern researchers must demonstrate that the research they perform is ethically sound.
01:15Bioavailability Study Design: Healthy Subjects Versus Patients
Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
01:20Study Designs in Epidemiology
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
01:30Ethical Dilemmas II
Resolving an ethical dilemma in healthcare involves a systematic approach that considers every aspect of the issue, respecting both the patient's needs and values and the healthcare professional's ethical obligations. Here are potential steps to resolve an ethical dilemma:
01:15Bioequivalence Experimental Study Designs: Repeated Measures, Cross-Over, Carry-Over, and Latin Square Designs
Bioequivalence experimental study designs play a pivotal role in testing the effectiveness of various treatments. Key among these are the repeated measures, cross-over, carry-over, and Latin square designs. In the repeated measures design, each subject receives all treatments, allowing for temporal comparisons. This type of design is useful in reducing variability but requires careful planning to avoid bias.The cross-over design, an economical method, involves sequential administration of...