How trials are regulated
Regulation around research is tight. Research trials and studies are strictly regulated to try to make them ethical and safe. Generally speaking, the rules are there to ensure that every phase of a trial or study is run safely, ethically and with the full consent of everyone taking part.
- Under the law, researchers must ensure that you fully understand the objectives of the research, along with any risks and inconveniences you may experience, when you take part. This is called informed consent.
- They must give you this information and provide a point of contact so you can find out more when you need to.
These rules form part of the Medicines for Human Use (Clinical Trials) Regulations 2004. For more information on what else you might want to find out before a research study starts, see our section on how to take part which includes some helpful questions to ask.
In addition, before a research study for a new medicine can take place:
- Experts must review the science on which the research is based
- The researchers must secure funding for the study
- An organisation, such as a hospital or research institute, must agree to provide a home base for the study. A recognised ethics committee must review and approve the research study and allow it to proceed. You can read more about these in the section below.
The Medicines and Healthcare Products Regulatory Agency (MHRA) also inspects sites where trials take place, to make sure they're conducted in line with good clinical practice.
How trials are approved
Healthcare research studies go through a rigorous process before they are approved:
Each site that wants to take part in the study has a check called a Site Specific Assessment (SSA) which makes sure the site has the staff, equipment and expertise to carry out the research.
An overall plan for the research study and all its phases is called a protocol. It should be approved by a group of researchers who are not involved in the study. This approval is called an independent scientific review or peer review.
An independent research ethics committee will review the protocol. This committee is responsible for looking after your rights, safety, dignity and wellbeing when you take part in research. It can also decide whether or not the study can go ahead. The committee checks a number of things, including:
- The potential benefits are likely to outweigh the side effects
- Patient information is clear and satisfactory
- Any expected effects are clearly written into the protocol and patient facing information
- People will be recruited for the study in an appropriate way.
It will also look at paperwork relating to the study and may ask for changes before it gives the go-ahead. This may include the patient information sheet and the consent form, as well as the protocol.
Researchers aren’t allowed to change the protocol without telling the ethics committee. The ethics committee can stop a trial at any time if it has any concerns about the welfare of people taking part.
All research taking place in the NHS in England and Wales also requires approval from the Health Research Authority. This ensures that health and social care research involving participants is ethically reviewed and approved. They ensure studies comply with relevant legislation and guidelines (such as Clinical Trials Regulations, the Human Tissue Act and the Data Protection Act) as well as a number of other areas of national policy and governance.
In certain cases, the research study may require approval from other groups. For example, a study involving treatments that expose people to radiation would need a certificate from a specialist committee.
In a research study that tests a medicine or medical device, the MHRA must review and approve the study, and issue a Clinical Trial Authorisation (CTA).
When a research study produces a large amount of information over several years, a data monitoring committee will be involved. Such studies will have early warning systems that help identify whether the benefits of a treatment are so good, or the risks so high, that the study should be stopped early. The role of the committee is to review the data and make this decision.
How trials are funded
Many different types of organisation support healthcare research. These include:
- The NHS
- The Medical Research Council and Government departments or agencies
- Drug companies
All health and care research studies, no matter who funds them, are checked and monitored in similar ways to make sure that the people who take part are protected. Each study also has a sponsor who is responsible for the conduct of the research. The sponsor may be the organisation funding the study or the institution hosting the research, for example, a university.
Many of these organisations involve patients to help decide what research studies will be conducted in the future. It is essential that research takes into account the needs and interests of the people it is trying to help.
Specialists are often aware of gaps in knowledge about diagnosis and treatment but patients and their families may also see aspects of care that need further research.
The James Lind Alliance (JLA) is a non-profit making initiative established in 2004. It brings patients, carers and clinicians together in Priority Setting Partnerships (PSPs) to identify and prioritise the top 10 unanswered questions for particular areas of health and care.
The aim of this is to make sure that health research funders are aware of the greatest research needs, as identified by the people who are most affected in their everyday lives.