Supporting the Human Research Review Process
The purpose of the scientific review process is to support the human research review process, including IRB review, by ensuring that human research conducted at BIDMC meets the highest level of scientific merit and design. To accomplish this goal, scientific reviewers representing the many clinical disciplines and the diverse human subject research portfolio at BIDMC are appointed to perform a scientific review of human research studies.
Scientific Review Requirements
Scientific review is required of all research proposals prior to CCI submission. The Scientific Review Officer for the PI's department is required to review the entire Protocol and complete the Scientific Review Officer (SRO) Form. Proposals will not be accepted without the signed SRO Form.
In their review, Scientific Reviewer Officers (SRO) specifically evaluate whether or not the following criteria have been met:
- There is adequate merit to justify using human research subjects;
- Confirm that there is no other method to investigate this question that would not require the use of human subjects;
- The risk/benefit ratio is favorable;
- Risks to subjects have been minimized by employing sound scientific design, and to the extent possible employ procedures that subjects would undergo as part of their regular care;
- Potential risks have been accurately and fully described in the IRB application and consent form;
- The data and safety monitoring plan is adequate given the risk level of the study;
- The study design adequate to answer the scientific question posed;
- There is a reasonable likelihood the PI will be able to meet her/his enrollment goal.
SROs can require investigators to revise their submissions if they find the submission to inadequately address the points above, before giving their approval. In some cases the SRO may feel that additional reviewers, perhaps from other disciplines, are required to adequately complete the scientific review of a research study.