Table 1.

Review domains specified by the HRA

1. Social or scientific value; scientific design and conduct of the study (including involvement of patients, service users and the public, in the design, management, and undertaking of the research).

2. Recruitment arrangements and access to health information, and fair research participant selection

3. Favourable risk benefit ratio; anticipated benefits/risks for research participants (present and future)

4. Care and protection of research participants; respect for potential and enrolled research participants’ welfare & dignity

5. Informed consent process and the adequacy and completeness of research participant information

6. Suitability of the applicant and supporting staff

7. Independent review

8. Suitability of supporting information

9. Other general comments

10. Consider and confirm the suitability of the summary of the study