Good practice in research: Protecting participants from harm

1. 15.  You must stop research where the results indicate that participants are at risk of significant harm or, in research involving treatment required by a patient, where no benefit can be expected.
2. 16.  You must report adverse findings as soon as possible to the affected participants, to those responsible for their medical care, to the research ethics committee, and to the research sponsor¹⁰ or primary funder where relevant. You must make sure that bodies responsible for protecting the public, for example, the Medicines and Healthcare products Regulatory Agency, are informed.¹¹
3. 17.  You should make sure that participants are not encouraged to volunteer more frequently than is advisable or against their best interests. You should make sure that nobody takes part repeatedly in research projects if it might lead to a risk of significant harm to them. You should make sure that any necessary safeguards are in place to protect anybody who may be vulnerable to pressure to take part in research. You must follow our guidance in paragraphs 21-22 of Consent to research on involving vulnerable adults in research.
4. 18.  If a participant is involved in investigations that may contribute to a cumulative long-term risk of harm, for example, radiation from X-rays or radioactive substances, you must consider any previous exposure to the risk and make sure that a record is kept about their participation.¹²
5. 19.  If you have good reason to believe that participants are at risk of significant harm by taking part in research or by the behaviour of anyone conducting research, you must report your concerns to an appropriate person in your employing or contracting body. If you remain concerned you should inform the research ethics committee and the research sponsor or primary funder. You should follow the guidance in Raising concerns about patient safety¹³ if you are not sure when or how to raise concerns.
6. 20.  If you are responsible for acting on concerns raised by colleagues, you must make sure that reporting procedures are in place and that staff are aware of them. If a concern is brought to your attention you must take appropriate action promptly and professionally.¹⁴