Ethics and confidentiality for researchers
The BPSU and research teams involved in studies are unreservedly committed to ethical research. An understanding of ethics and confidentiality in BPSU studies is provided in:
If you are a patient or member of the public, please also read our Patient and public involvement pages.
Research Ethics Committees (REC)
- All BPSU studies must apply to a research ethics committee for approval. The research ethics committee is a group of health professionals, researchers and members of the public who discuss whether a study should go ahead. These committees have to consider the effect of a study on the people taking part and will not approve a study that is likely to be harmful or is considered not to be ethical.
- BPSU studies should apply through the IRAS system for ethics approval.
Ethics and Confidentiality Committee (section 251)
- BPSU studies need to collect a minimum of identifier information in order to find and remove any duplicate case reports. All BPSU studies must seek approval to collect data by showing that they will try to answer important research questions and aim to provide information to help improve children’s future health.
- BPSU studies need Section 251 approval from the National Information Governance Board's (NIGB) Ethics and Confidentiality Committee(ECC) .
- BPSU studies go through a fast track process of approval by the NIGB-ECC so there should be little delay. (Note: Section 251 exemption documentation can be submitted via the on-line IRAS system whilst preparing research ethics approval submission).
Specific advice regarding the ECC application procedure is available from the BPSU office. To make the application procedure easier the BPSU has produced templates which suggest appropriate text to explain BPSU procedures.
- Approved applications are placed on the Section 251 Register.
- Approved applications are renewed annually subject to NIGB-ECC review.
- The BPSU requires study applicants to detail the security measures they use to keep data secure and to protect patient confidentiality.