Observational Research
An observational study is one where researchers either collect information from participants prospectively or review data that was already collected. In these studies, no intervention is given.
An observational study is one where researchers either collect information from participants prospectively or review data that was already collected. In these studies, no intervention is given.
In observational research, typically researchers follow participants over a long period of time. The three most common study designs for observational studies are cohort studies, case-control studies, and cross-sectional studies.
The main sub-types of observational studies include:
- Natural History Studies: Researchers observe a cohort of participants over a long period.
- Secondary Research Studies: Researchers use existing data or biospecimens that were previously collected for a different purpose.
- Repository Studies: These involve only the collection and storage or maintenance of identifiable private information or identifiable biospecimens for secondary research.
When conducting observational studies, it's important to include some of the same information required for interventional studies. However, make sure to clearly distinguish between clinically driven care and research (e.g., systematic research interventions or collection of secondary data during clinical care). Remember that human subjects regulations apply only to research and not to the practice of medicine.
Research: means "an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships.)" (Belmont Report)
The practice of medicine: "refers to interventions that are designed solely to enhance the wellbeing of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals." (Belmont Report)
Observational Protocol Templates
For developing an observational research protocol, there are three templates you should use:
- Natural History/Observational Study Protocol Template: For studies where you observe a cohort of participants over a long period. Additionally, there is specific guidance for writing a Natural History study, which you can find linked below.
Protocol Template For Natural History/Observational Trials
Related documents
- Repository Protocol Template: For studies that involve the collection and storage or maintenance of identifiable private information or identifiable biospecimens for secondary research.
Protocol Template For Repositories Only
- Secondary Research Protocol Template: For studies that use existing data or biospecimens previously collected for a different purpose.
Protocol Template For Secondary Research With Biospecimens, Data And/Or Medical Records Only
These templates and guidance documents will help you organize your research and ensure it meets all necessary requirements.
Related Resources
Regulatory Considerations in Natural History Studies
Presented by Jonathan Green
Research vs Practice: Separating church from state in NIH protocols
Presented by Jonathan Green