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What is clinical research?
Clinical research plays an important role in all our lives, as it seeks to provide new knowledge and understanding about various health conditions. It is key to finding better ways of preventing, diagnosing, and treating disease and other health conditions by testing new approaches, treatments, and medicines. A clinical trial is a type of clinical research that evaluates the impact that an intervention, such as new medicine, medical device, or therapy has on health outcomes.
Clinical research allows researchers to:
- diagnose diseases earlier or more accurately
- develop safe and effective life-changing treatments
- prevent people from developing conditions in future
- provide new approaches to existing clinical practices
- ensure everyone has a better quality of life
What is Boots' role in clinical research?
With 175 years’ experience in healthcare, Boots ambition is to continue to advance healthcare for future generations to come by conducting and contributing to clinical research. We want to improve health conditions for all by supporting the research conducted into certain conditions and empower individuals to live better lives.
We work with a variety of organisations including the National Institute of Health and Care Research, the NHS, charities, academic institutions (i.e., universities), and companies in the life sciences sector (i.e., pharmaceutical companies) to support clinical research.
We support the inclusion of clinical research by providing customers with details of relevant clinical research opportunities through email, letters, in-store and online updates. We also support through conducting elements of a study within our stores. Our involvement depends on the research requirements and is always undertaken by trained healthcare professionals and pharmacists.
Boots are a trusted brand with 175 years of experience who have invaluable insights, clinical expertise, and an extensive footprint to support recruitment, retention, and decentralised services for research. If you are looking for a partner to support the successful delivery of your research ambition, please contact clinicalresearch@boots.co.uk
Why consider clinical research at Boots?
Participating in clinical research
- To access new treatments for yourself or your dependents
- To help others now and in the future
- To take an active role in your health and the health of others
How do I participate in clinical research?
Participating in clinical research typically involves finding relevant opportunities for you. Read below to explore our current clinical research opportunities, which we are currently offering at Boots. You can also find clinical research opportunities by consulting with your doctor or another healthcare professional (i.e., pharmacists) or through other research institutions (i.e., Universities). Clinical research can take place in a variety of places – including hospitals, GP surgeries and community pharmacies like Boots.
Before participating in a research opportunity, inclusion and exclusion criteria will be used to make certain the research is suitable for you as a participant. You will then be able to ask any questions you may have to ensure the opportunity is right for you, before you provide informed consent to participate.
Boots may reach out to you by email or post to inform you of relevant clinical research opportunities you may be interested in. Opportunities may also be presented in store, or on our App and website, including on this page.
Who can take part in clinical research?
Anyone can participate in research; people of all ages (including children), who are healthy or have existing health conditions. The UK population is made up of a wide range of communities and individuals with different identities, such as sex, race, ethnicity, and sexual orientation. For clinical research to benefit all, it must represent all.
Different people may experience the same condition to different effects. When research includes a diverse population, the outcomes improve healthcare and provides a better representation of everyone. Inclusion of a diverse range of people in research is critical to reduce biases, stop inequalities and promote health equity.
Information regarding the use of your data is found here in our Privacy Policy. We are committed to using and protecting your data in accordance with the Data Protection Act 2018 and UK General Data Protection Regulation (GDPR). Data used for communications regarding clinical research will be processed under legitimate interest. For more information on legitimate interest, please see the Information Commissioner’s Office (ICO) guidance here.
A sponsor (a pharmaceutical company, the NHS, academic institution, or healthcare organisation) may approach Boots with defined criteria of who they would like to participate in their clinical research. The criteria may include information such as age, geographic location, whether they have any health conditions and any medication they are taking. Boots will lawfully process your data under legitimate interest to identify whether the clinical research may be suitable for you against the criteria the sponsor provided, using Advantage Card and/or prescription databases. If the clinical research may be suitable for you, you may receive an email and/or letter informing you of the research.
Boots will not share your data with any third parties. If you wish to take part in clinical research, you will be responsible for providing your information directly to the relevant third party (managing the clinical research study) as part of the sign-up process.
If you choose to take part in any clinical research, the associated researchers will collect information as part of the study and that information will be held securely by them in accordance with Data Protection Regulations. Any information that is collected about you will be treated as confidential. For any further information, contact the relevant researcher(s) directly.
You may unsubscribe by selecting the unsubscribe link at the bottom of an email you have received, or you may contact Boots Customer Service Centre by emailing boots.customercare_team@boots.co.uk or by phoning 0345 070 8090.
Patient safety is of upmost importance to Boots. There are a number of different safeguards in place to ensure the safety of participants taking part in clinical research. This includes:
- The regulatory and independent ethics approval process to ensure the research is authorised
- Adherence to the inclusion and exclusion criteria to ensure the research is suitable for you
- Strict adherence to the protocol to ensure the research is conducted as safely as possible
- Transparency about the benefits and any associated risks before signing up for research
- Regular monitoring during and after the research by medical/research professionals
- Comprehensive training of all personnel involved in the research
- Strict adherence to the Data Protection Act 2018 and UK GDPR including confidentiality
- Inspections by regulatory bodies and audits of the research are conducted to ensure it meets the principles of Good Clinical Practice and other regulations
- Research Site assessments (i.e., at Boots stores) to ensure it is fit for purpose with the necessary facilities to conduct research.
- For more information, refer to the research team, their website and any documentation provided on the clinical research.
All clinical trials are regulated, and each study must obtain independent ethics approval. Boots have a strict process of assessing clinical research requests and will only take part if the research has been ethically approved. Research cannot begin until all relevant permissions and approvals have been obtained, as detailed below.
Clinical trials are highly regulated to protect participants and to ensure those involved are always treated with respect. Before you take part, it’s important to understand how research is approved and regulated. Regulation is the same across England, Wales, Scotland, and Northern Ireland for new medicines and medical devices.
A protocol details the objectives, rationale, design, methodology and end-to-end process of a clinical trial. It outlines the plan for the research which must safeguard participants and answer the research aims. Before research 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.
Following this, the Sponsor must apply for regulatory permission and ethics approval to proceed by completing an application using the Integrated Research Application System (IRAS).
The Medicines and Healthcare products Regulatory Agency (MHRA) (a government agency who regulates, reviews, and approves research) is the regulatory authority for clinical trials of new medicines and medical devices. The MHRA must provide permission to proceed; without this authorisation, the trial will not go ahead.
Once the MHRA has provided permission to proceed, the trial must be ethically approved. Independent research ethics committees are responsible for protecting and promoting the interests of participants in research by ensuring their rights, safety and wellbeing are maintained. They are responsible for ensuring research complies with relevant legislation and guidance, as well as reviewing the protocol. All research must be approved by an independent ethics committee, otherwise the study will not go ahead, or they can stop a trial at any time if the committee has any concerns. The protocol cannot change without re-approval by the MHRA and independent ethics committee.
Once a trial has regulatory and ethics approval, conduct of the trial can start. There are strict regulations and guidelines in place to monitor the trial to ensure it is safe for participants and to confirm compliance to Good Clinical Practice (international guidelines which must be followed to conduct clinical research) and other relevant standards.
All clinical trials are tested in various stages, known as ‘phases’. Typically, there are four separate phases: Phase I, Phase II, Phase III and Phase IV (also known as Phase 1, Phase 2, Phase 3 and Phase 4). For a clinical trial to progress to the next stage, the medicine or treatment must be well tolerated with minimal side effects. Each phase is highly regulated and the trial is monitored at all times. If there are any safety concerns, the trial may not continue to minimise risks and protect participants.
It is important to note that new medicines and treatments are tested in laboratories before being tested on people.
Phase 1 trials involve a small number of healthy people who will be the first volunteers for the new medicine or treatment. This will be to evaluate its safety by closely monitoring any side effects and reviewing what the right dose may be.
Phase 2 trials involve a small-medium group of people (healthy and/or with existing health conditions) to evaluate whether the medicine or treatment works as expected, whether it’s safe and monitor whether there are any side effects.
Phases 3 trials involve a large number of people (healthy and/or with existing health conditions) and are designed to assess how the treatment works, compared with existing treatments or a placebo (a safe substance with no effect). They also continue to assess side effects and risks. This is the last phase before a medicine may be licensed by the Medicines and Health products Regulatory Agency (MHRA) if it has met the required safety standards.
Phase 4 trials are carried out on medicines which have a marketing license (approved and available on prescription by the MHRA) to continue to monitor its effectiveness and whether it can be used for other purposes.
For the purposes of clinical research, Boots do not undertake laboratory or Phase I trials but may support Phase II, Phase III and Phase IV clinical trials by informing individuals of these research opportunities or by trained healthcare professionals delivering elements of the trial in selected Boots stores.
Before you participate in clinical research, you must provide consent. This will usually be written consent, but it may be verbal. For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision.
For consent to be voluntary, the decision must not be influenced by any other person.
For consent to be informed, a person must be provided with sufficient information before deciding whether to participate or not. A member of the research team or a healthcare professional (i.e., Pharmacist) will explain the research in detail, including its purpose, how long the research will last for, what participation entails, any benefits, any associated risks or side effects, and key contact details. You should be able to ask further questions or seek more information if required to help your decision. You may wish to discuss participation with others, such as relatives or friends.
To make an informed decision, a person must have capacity to understand the information provided to you. Consent is usually provided by the participant but for children under the age of 16, a parent or legal guardian may be required to give consent on a child’s behalf.
It is important to know that consent can be withdrawn at any time. You can decide to withdraw from clinical research, with or without a reason.
This depends on the clinical research study and may vary. Most clinical research relies on volunteers to participate. Some clinical research may reimburse travel expenses. You should refer to the research team, their website and any documentation provided for more information.
Clinical research may be funded by several different sponsors including the government (i.e., the National Institute of Health and Care Research), the NHS, charities, academic institutions (i.e., universities), and companies in the life sciences sector (i.e., pharmaceutical companies).
This depends on the clinical research study and will vary. You should be informed of this information as part of the sign-up and informed consent process. Refer to the research team, their website and any documentation provided for more information.
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