Similar to comparative effectiveness research, outcomes research is designed to identify ways to improve quality of life through the study of treatment results, risks, and benefits. Originally driven forward by the desire to reduce the increasing cost of medical care, the ultimate goal is to assist physicians in making informed decisions about patient care and the overall quality of care provided. Outcome based research extends the scope of research beyond biomedical measures and endpoints, taking the patient's experiences into consideration.
Most commonly, outcomes research studies involve development of instruments such as quality-of-life surveys or tools for evaluation. The procedures used include internet surveys, focus groups and telephone interviews.
IS IRB REVIEW NEEDED FOR OUTCOMES STUDIES?
In most cases the research clearly includes additional interaction with healthy or patient participants, likely making them human subjects.
WHAT ARE THE MAJOR ISSUES IN IRB REVIEW OF OUTCOMES RESEARCH?
The areas that are often inadequately developed include:
- Methods used to recruit, inform and gain consent
- Simple methods of documenting consent or seeking waiver of some elements
- Subject privacy in focus groups and response to questions of a sensitive nature
- Confidentiality and data security
E&I has extensive experience in the review of outcomes research, as well as the appropriate application of regulation and identification of projects not needing IRB review. Please feel free to contact our office for more information.
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