Regulating doctors, ensuring good medical practice

Good practice in research: Good research design and practice

  1. 7.  You must make sure that research is based on a properly developed protocol that has been approved by a research ethics committee.7 It must be prepared according to good practice guidance given by government and other research and professional bodies.
  2. 8.  You must make sure that the safety, dignity and wellbeing of participants take precedence over the development of treatments and the furthering of knowledge.8
  3. 9.  You must make sure that foreseeable risks to participants are kept as low as possible. In addition, you must be satisfied that:
  • the anticipated benefits to participants outweigh the foreseeable risks, or

  • the foreseeable risks to participants are minimal if the research only has the potential to benefit others more generally.

  1. 10.  You must make sure that decisions at all stages of research, especially for recruitment, are free from discrimination9 and respect participants’ equality and diversity. You should take all reasonable steps to make sure that people eligible to participate in a project are given equal access to take part and the opportunity to benefit from the research. Where appropriate, you should use patient and public involvement groups at all stages of the project to help make sure that the research is well designed and conducted.
  2. 11.  You should make sure that details of a research project are registered on an eligible, publicly available database that is kept updated, where such a database exists.
  3. 12.  You should be satisfied that appropriate monitoring systems are in place to make sure research is being carried out in accordance with the law and good practice.
  4. 13.  You must keep your knowledge and skills up to date. If you lead a research team, you must make sure that all members of the team have the necessary skills, experience, training and support to carry out their research responsibilities as effectively as possible.
  5. 14.  You should make sure that commercial and other interests do not stop or adversely affect the completion of research. If you are concerned about this you should follow the guidance on raising your concerns in paragraph 19. 

Footnotes:

7. Research ethics committees (RECs) have a responsibility to safeguard the rights, safety, dignity and wellbeing of people participating in research. They review applications for research and give opinions about the proposed participant involvement and whether the research is ethical. Guidance on whether research requires ethical review under either the law or the policy of the UK health departments can be found on the National Research Ethics Service website.

8. The Declaration of Helsinki states that ‘The benefits, risks, burdens and effectiveness of a new intervention must be tested against those of the best current proven intervention, except in the following circumstance. The use of placebo, or no treatment, is acceptable in studies where no current proven intervention exists or where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive the placebo or no treatment will not be subject to any risk of serious or irreversible harm. Extreme care must be taken to avoid abuse of this option.’(World Medical Association Declaration of Helsinki, 2008)

9. Restricting research participants to subgroups of the population that may be defined, for example, by age, gender, ethnicity or sexual orientation, for legitimate methodological reasons does not constitute discrimination.