Health research aims to answer questions and provide new knowledge and understanding about various conditions. This involves testing new approaches, treatments and medicines.
For this reason, there is a variable degree of risk for research participants, depending on the type of research. To manage this risk, research carried out in the UK is highly regulated in order to protect participants and to ensure those involved are treated with respect at all times.
Before you take part, it’s important to understand how research is prioritised, approved and regulated.
Regulation around research is the same across England, Wales, Scotland and Northern Ireland.
Is it a priority?
Before any research goes ahead, we must first decide if the research is a priority.
The James Lind Alliance (JLA) is a non-profit making initiative that brings patients, carers and clinicians together to identify and prioritise the top 10 unanswered questions for particular areas of health and care.
Their aim is to make sure that health research funders know about the greatest research needs, as identified by the people who are most affected in their everyday lives. This helps prioritise all research.
Who approves health research?
An overall plan for the research study is called a protocol. Before a study can start, the protocol needs to 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.
All research taking place in the NHS in England and Wales also requires approval from the Health Research Authority (HRA). They are responsible for the coordination of regulation relating to health research and ensure studies comply with relevant legislation and guidelines (such as Clinical Trials Regulations, the Human Tissue Act and the General Data Protection Regulation) as well as a number of other areas of national policy and governance. An independent research ethics committee will also review the protocol.
Research Ethics committees (RECs)
This committee is responsible for looking after the volunteer’s rights, safety, dignity and wellbeing when they take part in the research. It can also decide whether or not the study can go ahead. The committee checks a number of key elements and ensures that:
- potential benefits are likely to outweigh the side effects
- participant information is clear and satisfactory
- any expected side effects are clearly described
- people will be recruited for the study in an appropriate way
- the paperwork relating to the study is comprehensive - this may include the participant information sheet, consent form and the protocol. Changes may be required before the committee gives it the go-ahead.
Researchers are not 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.
Medicines and Healthcare Products Regulatory Agency (MHRA)
The Medicines and Healthcare Products Regulatory Agency (MHRA) inspects the places where research studies take place, to make sure they are conducted in line with Good Clinical Practice. Be Part of Research only lists studies that have received these approvals.
Site Specific Assessment
Each site that wants to take part in the study undergoes a check called a Site Specific Assessment (SSA). This check ensures the site has the necessary staff, equipment and expertise to carry out the research.
Specialist approval
In certain cases, the research study may require additional approval from other groups. For example, a study involving treatments that expose people to radiation would also need a certificate from a specialist committee.
Sponsors and funders
Sponsors
A sponsor takes legal responsibility for the conduct of the research. They may be:
- An NHS trust
- Charities
- Pharmaceutical companies ie private healthcare or research companies
- UK Research and Innovation and other government departments
The sponsor is not the same as the funder, although some organisations are both. This decision on which sponsor is appointed is based on a number of reasons that might include what resources are available i.e money and logistics.
Funders
A funder is the organisation responsible for paying for the study. They may be:
- An NHS trust
- Charities
- Pharmaceutical companies ie private healthcare or research companies
- UK Research and Innovation and other government departments
You can find out who the sponsor is on each study page on this site.
How research is regulated
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.
As safety is a key consideration throughout, these regulatory groups maintain an interest in the progress of the project. The MHRA, in particular, may inspect a study to ensure that everything is being done in accordance with the law and with applicable regulations.
In order to learn how studies are regulated, they are grouped into two distinct types:
1. Research studies that involve testing new medicines
Research studies for new medicines are also known as Clinical Trials of a Medicinal Product (CTIMP). Before a research study for a new medicine can start it must have the following in place:
- Experts must review the science on which the research is based. The research team will put together their protocol. The protocol 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.
- Once this has taken place, the plan will go to the ethics committee. The researchers must then 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.
- The drug being investigated is made in line with high quality standards.
- Researchers are not 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.
2. Other studies that involve testing treatments, therapies and non-medicinal products (Non CTIMP)
Research studies for all other healthcare treatments do not fall under the same strictly regulated processes as medicines, but they do still require most of the documentation and follow most of the same procedures.
Other healthcare treatments might include diet programmes, imaging like x-rays or MRI scans, testing a new medical device, for example cardiac stents or new types of ventilators. These are classified as ‘non-CTIMPs.’
- Experts must review the science on which the research is based. The research team will put together their protocol.
- The protocol 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.
- Once this has taken place, the plan will go to the ethics committee
- The researchers must then 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.
Changes to the protocol
If any changes are to be made to the plan (protocol) that was originally approved, that change must also be submitted for further approval to all the groups mentioned and cannot be implemented until such approvals have been obtained. At the end of the study, the groups also expect to be notified.
Staff
All staff involved in running research studies, such as doctors, nurses, trial managers, and pharmacists, must be trained in running research.
Everyone involved in the research team is trained in the principles of Good Clinical Practice, which covers the appropriate rules and regulations on how to carry out and manage research.
The aim of all of these rules and regulations is simple. They are there to remind researchers that their work must always have 3 aims: safety, quality and respect.
Long research studies
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 treatment are so good, or the risks so high, that the study should be stopped early.
The Research Ethics committee will review the data and make this decision.
Interested in learning more about research?
There are some key pages across this site which can help you understand more about health and care research.
Visit the links below to find out more about what happens on a study, giving consent to take part and common questions.
