13 Research methods, statistics, critical review and evidence-based practice13.14 Research ethics
13.14.1 Research ethics and governance
3 min read
Written by Resident Doctor Committee · Published
New in the 2027 syllabus
The College added this topic for exams from January 2027.
Good research practice
Scientific validity is an ethical requirement in its own right. A badly designed study can place burdens on participants without answering a worthwhile question.
Participant welfare comes before scientific or organisational interests. Risks should be in proportion to the likely benefits and to the value of the knowledge the study is seeking.
Public involvement lets patients and service users help shape the research question, how the study is run and how the results are shared.
Who is responsible for what
Role or process | Main responsibility |
|---|---|
Sponsor | Takes responsibility for the arrangements to start, manage and fund the research |
Chief investigator | Leads the design and running of the project |
Research Ethics Committee | Gives an independent view on participants' rights and welfare and on whether the study is ethically acceptable |
Research governance | Covers responsibilities, legality, competence, quality and oversight |
Site arrangements | Establish whether the organisation can deliver the research properly |
Ethics review and organisational approval do different jobs. Having one does not automatically stand in for the other.
In the UK, health and social care research follows a common policy framework. Even so, the review and regulatory requirements for a particular study depend on the type of project and the jurisdiction it takes place in.
Work out the approval routes before the research begins. This includes any extra requirements that apply to medicines, devices, tissue or confidential information.
Consent and information
Informed consent is an ongoing process, not just a signature. People need information they can understand, a free choice and a chance to ask questions.
Capacity is specific to the decision being made. A psychiatric diagnosis or detention does not, on its own, show that someone cannot consent to research.
Adults who lack capacity can be included in research only with the relevant legal safeguards in place. These safeguards differ by jurisdiction and by type of research.
Withdrawal should be explained at the start. Tell participants what happens to data already collected, and about any limits on removing information once it has been anonymised.
Confidentiality means controlling who has access, handling data securely and keeping identifiable information to a minimum. Agreeing to take part in a study is separate from the legal basis for processing a person's data.
Transparency and integrity
Issue | Meaning |
|---|---|
Fabrication | Making up data or results |
Falsification | Manipulating research materials, processes or records so that the research is misrepresented |
Plagiarism | Presenting another person's work or ideas without proper acknowledgement |
Selective reporting | Holding back or emphasising findings depending on their direction or whether they are significant |
Competing interests include financial ties and relevant non-financial relationships. Reporting who funded the study, and what part the sponsor played, helps readers judge any possible influence.
Prospective registration and protocols: registering a study and setting out its protocol before it starts make undisclosed changes and missing results easier to spot.
An audit trail keeps records of data collection, decisions and analysis, so that others can check the reported findings.
Suspected misconduct should go through established institutional processes. These protect records and participants and allow a fair investigation.