Introduction
If you are a novice researcher or have competence in another discipline but are new to health research, the regulatory framework for health research may be challenging to navigate.
The following gives an overview of the legal and ethical standards for human participants, tissues, or data in health research, as well as links to where you may get further information.
What exactly is health research?
Any study that tries to enhance human health is considered health research. This includes, but is not limited to, the following:
- basic discovery science attempts to establish the essential knowledge basis and increase understanding of biological or other elements impacting human health (if you undertake basic research, we give guidelines when human samples or data about people are involved).
- Population-based studies that track the health of a large group of individuals, or a “cohort,” across time, generally for a number of years.
- Interventional studies, in which participants are randomly assigned to various treatments, such as those aimed at proving the safety and/or effectiveness of a ‘product’, such as a Clinical Trial of an Investigational Medicinal Product (CTIMP).
Whatever kind of health research you do, you may be subject to a variety of legal frameworks and regulatory restrictions.
Patient and public participation
It’s critical to think about how your study can best satisfy the requirements of individuals who will benefit from it. You may achieve this by asking individuals who have lived experience (such as your participants or patients, a group of people who are similar to them, or their caretakers) what is essential to them. Then you may include these viewpoints into your study from the start. People with lived experience may be involved informally via existing possibilities, such as asking questions about your study during clinic appointments, or officially through specific focus groups.
Researchers fresh to health research may be startled by the priorities identified as significant by individuals with lived experience.
More information on including patients and the general public in your study may be found on the co-production in research website, or if you are producing a product, on the EPSRC’s stakeholder engagement: Patients and the general public webpage. More information about public engagement in research may be found at the Health Research Authority (HRA), the regulator for research in the NHS in England.
Research permission
If you want to attract individuals to participate in your study, adequately informed, voluntary permission is the most probable option. Consent is essential in conducting ethical research and ensuring that study participants are treated equally and with respect. The consent procedure should assist prospective participants understand what participating in your study will imply for them, allowing them to make an educated decision about whether or not to participate (or not), and making them feel free to voice their desires.
In the MRC and HRA consent and patient information sheet preparation instructions, you may learn more about the ethical and legal concepts of consent, as well as how to organise and create documents to assist the consent process.
The MRC Ethics Series has information on incorporating particular groups in your study (for example, persons who cannot agree, children and young people).
Human participants in research is a wonderful research resource centre where you can learn more about UKRI’s expectations for incorporating people in research.
Consent is essential if you want to use or disclose identifiable data in your study. Consent, on the other hand, is unlikely to be your legal basis under GDPR. More information on legal bases may be found under Using data about individuals in research.
Consent is not the sole approach to guarantee that research is ethically and legally sound. There are ways for using human samples or data about individuals in research without their agreement. More information about this may be found at:
- The second page of our consent summary. This article investigates the legal exclusions that enable you to utilise human samples without permission when gaining consent is impractical.
- In the Using Information About People in Health Research Guide, ‘accessing identifiable information’ without permission is defined as ‘accessing identifiable information’.
Your local research institute
If you are a researcher at a university or the NHS, your local research office may provide you with further research guidance and assistance. This might be your’research governance’,’research integrity’,’research ethics’, or’sponsor’s’ office at a university, or your’research and development’ or a ‘R&D’ office in the NHS. Find out who they are and where they are, and contact them as soon as possible. They might be at another school or college if you are at a university.
Your local research office can clarify any permissions you will need for your study and connect you with individuals in your company who will play an important role in examining and supervising your research.
Before your study can begin, you may need to get permission from your research organisation. You should speak with your local research office as soon as possible to discover what permissions you may need, how to apply for them, and to address any potential concerns that your planned study may bring.
Your local research office may assist you on any study-related needs (such as legal or contractual requirements, indemnification, intellectual property, and so on). They can also help you with study design, arrange interactions with support departments, conduct peer review, and give advice on any research permission applications.
Typically, funding institutions need your research organisation to manage your award. You should contact your local research office as soon as possible to ensure that you submit complete costings for your grant application (including full economic costing where required).
Sponsorship
The UK policy framework for health and social care research has been adopted across the country. It specifies that any research conducted in the NHS or social care must be sponsored.
Both the UK policy framework and the UK clinical trials legislation describe the role of the sponsor. Sponsors guarantee that suitable systems for managing health research are in place. Please read sponsorship in the Clinical Trials Toolkit for further information on the function of the sponsor under UK clinical trial rules.
Sponsorship obligations may be divided across institutions (for example, a university and an NHS entity), and some functions might be outsourced to the chief investigator. In such cases, any allocation of tasks should be agreed upon.
Sponsorship of an investigational medicinal product (CTIMP) clinical study is a statutory responsibility that should be formalised in a legal contract (read more about contracts and agreements in the Clinical Trials Toolkit). Be aware that small-scale proof-of-concept studies, early human safety trials of prospective pharmaceutical items, vaccine trials, gene therapy trials, and cell therapy trials are likely to come within the clinical trials rules.
If you are an MRC-funded researcher, you may discover MRC sponsorship criteria on the following pages:
- Policy of the Medical Research Council on the UK Policy Framework for Health and Social Care Research
- The MRC’s policy on clinical trials regulation
Because securing a sponsor might take time, it is critical to identify the sponsor early in the research phase. In most circumstances, the sponsor will be a research organisation, often the employer of the study’s primary researcher. The main researcher must request funding from the research organisation.
You might also consult with other specialists.
Statistician
A statistician may assist you in the following ways:
- create your research
- choose acceptable outcome metrics
- justify the size of your sample
- create a research data analysis strategy
- process and organise gathered data
If your research is minimal in scope and not intended to give direct and conclusive evidence to induce a change in practise, a formal power estimate may not be required. You should, however, be able to explain your recommended sample size.
Departments of collaboration and support
If your research involves assistance from others, such as NHS departments (such as pharmacy or radiology), analytical labs, or academic colleagues, you should think about how you will work with them. To guarantee the effective execution of your research, you will need the full assistance of any collaborator or support department. Early engagement will ensure that any difficulties are discovered and resolved prior to the finalisation of your protocol or plan. At this point, you should also evaluate potential finance difficulties. Technical Assurance is being adopted throughout the UK to make it easier to apply for help from pharmacy or radiology inside the NHS. Depending on how it is administered, there may be a price for Technical Assurance review.
You may need to formalise your partnerships with a legal contract at times (for example, a service agreement, material transfer agreement, data sharing agreement, confidentiality agreement, and so on). If this applies to your research, you should consult with your local research office.
Ethical clearance
All studies involving human subjects need the approval of a research ethics committee (REC). The primary investigator (or main researcher on the project) is in charge of obtaining this review.
RECs exist to safeguard research participants’ rights, safety, dignity, and well-being. As a result, they will assess factors such as the fairness of the research population, the hardship on participants, and the duty of confidence.
In the United Kingdom, ethical review is often requested from the principal researcher’s university or from one of the HRA’s NHS RECs. Certain kinds of research need NHS REC approval.
Other permits or permissions may be required in addition to ethical clearance before your study may begin. What you will need will be determined by your study and the scope of your inquiry.
You may also need the assistance of a sponsor. Find out more about’sponsorship’ at your nearest research office.
Any necessary approvals or permits must be obtained before your study may begin. They are not required to be in place before applying for financing.
Resources to assist you in applying for an ethical review
We’ve included the information below to assist you understand what research ethics committees will look for in ethics review submissions. Many of the materials listed below assist with the HRA’s REC review process. The ethical issues highlighted in these materials, however, may also apply to applications to other RECs.
The Economic and Social Research Council’s (ESRC) research ethics guidelines also includes helpful materials to help you think about ethical concerns (for example, an example research ethics beginning checklist).
Check to see whether you need an NHS REC review.
Not every research undertaken in the United Kingdom needs NHS REC approval. The HRA and MRC decision tool may assist you in determining whether or not you need NHS REC review.
Even if you do not need NHS REC review, you may require review by another REC. If you work at a university, for example, you may need university REC review (in accordance with local rules).
You may also need additional research clearances. Any clearances that you may want may be obtained through your local research office.
NHS RECs’ mandates and membership
Standard operating procedures for RECs give valuable insight into the responsibilities of NHS RECs. While the majority of the material focuses on the methods and procedures that drive NHS REC review, there are parts that attempt to offer NHS REC members with an awareness of different forms of research. For instance, ‘Background – what are stem cells’.
In terms of membership, lay people make up at least one-third of an NHS REC committee. Furthermore, there is no assurance that any professional members will be experts in your scientific field. All of this indicates that it is critical to write your application for ethical review in ordinary language.
On the HRA website, you may learn more about applying to a REC.
Documents required for the NHS REC review
You will need to provide a variety of papers to support your application in addition to answering the questions in the Integrated Research Application System (IRAS). The following papers are often needed for NHS REC review:
- procedure for investigation
- Forms of permission and participant information sheets
- CV synopsis for the Chief Investigator
- Proof of insurance or indemnification (only for non-NHS sponsors).
Depending on the research, more papers may be necessary. IRAS presents a selection of documents that may be useful for your research. Make careful to include all’mandatory’ papers.
Writing your application in layman’s terms
As previously stated, at least one-third of NHS REC members are lay. As a result, drafting your application in simple English (in language understandable by members of the public who are not professionals in your subject) should make your ethical review go more smoothly.
The HRA’s tools for writing plain language research summaries and the plain language summaries e-learning session are intended to assist you in writing a research summary. The e-learning material is available on Centric Cortex (see ‘HRA eLearning for NHS REC members is relevant for applicants’ below).
However, the ‘generic principles’ may be used more broadly to assist you in writing for a lay readership.
Obtaining consent and creating participant information sheets
Outlining how you will get informed permission from participants, as well as the papers that will support this, are critical components of your application. The consent and participant information guidelines provided by the HRA and MRC includes examples and templates to help with the consent process.
The HRA has implemented a new participant information policy as part of its Think Ethics project (13 June 2022). According to the guideline, all participant information must fulfil a quantifiable criteria before being examined by an NHS REC.
In addition, while writing participant information, researchers will need to collaborate with individuals who have relevant lived experience.
Findings relating to health (or clinical significance)
Researchers must decide on a plan for communicating any health-related results to individual donors. The Wellcome Trust and MRC framework on the feedback of health-related results in research provides guidance on what to consider when building such a plan.
Inclusion, diversity, and equality
It is critical to consider diversity and inclusion while planning clinical research.
Clinical trial populations, according to research, may not usually represent the heterogeneous community in which a medication would be administered. This may result in experimental advantages or difficulties not transferring well to real-world implementation.
This is accompanied with a 15-minute e-learning programme (INCLUDE E&D – eLearning). This e-learning material may be found on Centric Cortex, which is linked to below in the ‘HRA eLearning for NHS REC members is relevant for applicants’ section.
CTIMPs, medical devices, and diagnostic research
You should now use IRAS for combined review to apply for NHS REC review of a clinical trial of an investigational medical product (CTIMP) (or a combination trial of an IMP and an investigational medical device).
When completing your application, please careful to read the guidelines in the grey boxes, since these fields indicate what information you must include.
If you are submitting an application for NHS REC evaluation of a medical device (including software), you will find helpful resources on HRA’s medical devices and software applications page.
To apply for NHS REC evaluation of a clinical trial for a medical device, you must complete standard IRAS. Use the green ‘i’ buttons beside each question to see what information is requested.
You may find information on preparing and submitting applications for ethical review in IRAS, in addition to question-specific guidance.
Applicants may benefit from HRA eLearning for NHS REC members
There are several e-learning courses available in the HRA Learning Management System (Centric Cortex). Some of them are designed specifically for REC members so that they may assist you in seeing research through their eyes and considering the ethical implications of your own study.
To access the HRA’s e-learning programmes, you must first create a free account if you do not already have one.
Once signed into Centric Cortex, the links below will take you straight to the course. To begin any of these courses, click the ‘enrol’ and ‘launch’ buttons (or’retake’ and ‘launch’ if you’ve already completed the module).
If your research includes gene editing, specifically CRISPR-Cas9 technology, two movies geared towards REC members may be of interest. The first video by Dr. Annie Etuk presents an overview in plain English. CRISPR-Cas9 genome editing: clinical applications provides excellent ideas for what to include in your application concerning risk and risk reduction when using CRISPR-Cas9 in a clinical environment. The relevant segment begins at 7:45.
If you are seeking for ethical assessment of a research tissue bank, the module How to Ethically assessment a Research Tissue Bank, especially the section on ‘Ethical Issues’ (pages 6 to 15), may be of interest.
Human Tissue – eLearning research may potentially be of interest. You may filter the course by audience type, such as ‘REC’. We also provide advice on how to use human samples in research and human tissue e-learning.
There are additional ethical issues if your study will involve people under the age of 18. Consent Assent Dissent provides a seven-minute introduction to this language. You may also be interested in the MRC and ESRC guidelines for incorporating children in research.
Stem cells
Various types of stem cells will need various considerations. This review article discusses some of the ethical problems of various types of stem cells.
UK Research and Innovation has released a brochure that is designed for young people but addresses the ethical considerations surrounding stem cell research quite effectively and provides insight into widespread societal concerns.
In ‘Annex H’ of the standard operating procedures for RECs, there is also information on applying for ethical review of stem cell treatments.
Artificial intelligence (AI) and data-driven technologies
When building data-driven technology for the healthcare industry, you must consider any ethical considerations that may emerge as a result of its usage.
A good practise guide for digital and data-driven health innovations is intended to assist entrepreneurs and researchers in understanding what the NHS expects from the technology purchased for its services. Section 1 is titled ‘How to Operate Ethically,’ and it introduces the Data Ethics Framework.
When it comes to ethics and AI, the World Health Organisation publication Ethics and governance of artificial intelligence for health is an excellent place to start.
Research in health and social care, especially NHS research
The UK policy framework for health and social care research establishes good practise standards for research conducted in the NHS and social care throughout the UK (or Health and Social Care (HSC) in Northern Ireland).
If you are a student, the Health Research Authority’s (HRA) student research toolbox may help you understand what you can and cannot undertake in terms of NHS research.
If you do not have a clinical job within the NHS, it may be beneficial to identify a local care practitioner to engage with you on your study.
If your study will include NHS facilities, patients, or personnel, you should get guidance from the NHS as soon as possible. You may seek guidance from your local NHS research and development office or, if necessary, one of the national research support agencies listed below:
- Clinical Research Network of the National Institute for Health and Care Research in England
- Wales Health and Care Research
- The Clinical Research Network of Northern Ireland
- NHS Scotland Research
Your local NHS research and development office or one of the national research support agencies may help you determine the viability of your study, such as:
- (NHS DigiTrials can assist with identifying eligible patient groups and possible trial venues in England)
- availability of any research support services, such as pharmacy, laboratory, and radiology services in your area. (If you are applying for NHS pharmacy or radiology assistance, you may find further information on Technical Assurance.)
- all expenses connected with doing your study in the NHS. If you are applying for funding, the MRC offers information about NHS expenses.
Approvals and sponsorship
All study involving the NHS (or the HSC in Northern Ireland) must be sponsored. More information regarding sponsorship is available at your local research office.
Aside from sponsorship, a variety of clearances may be required before your study may begin. For NHS-related research, you will require ethical clearance from an NHS research ethics council as well as NHS or HSC research and development authorisation. You may need more. What permissions you will need, as well as any other regulatory requirements, will be determined by your study and what it will entail.
If you are an academic looking to engage with the NHS, an honorary research contract may be required. If necessary, NHS research and development departments may assist you in obtaining the necessary papers. This procedure may be time-consuming, so getting started as soon as possible is recommended. The Research Passport is being used throughout the UK to make it easier to apply for honorary research contracts at different NHS agencies.
We also provide more tips on:
- Using personal data in research
- the use of human material in research
- creating medical equipment, diagnostics, software, artificial intelligence technologies, clinical trials, and sophisticated medicines
If you are building an app or other technology with a medical purpose, it may be classified as a medical device, please visit developing healthcare items.
Permissions for NHS and HSC research and development
If your study includes NHS (or HSC in Northern Ireland) buildings, patients, or personnel, you will require necessary NHS or HSC research and development clearances. The review procedure varies somewhat throughout the United Kingdom. For example, if your lead NHS site is in England or Wales, you should apply for HRA clearance (Health and Care Research Wales (HCRW approval) in Wales), NHS research and development permission if led from Scotland, and HSC research and development permission if led from Northern Ireland.
Because cross-border research is coordinated across the four countries, if your study is led from Scotland or Northern Ireland and includes NHS sites in England or Wales, you do not need to apply for HRA or HCRW authorisation individually. You just need to apply for NHS or HSC R&D clearance in the lead country, and if accepted, HRA and HCRW authorisation will be provided for the English or Welsh facilities.
The UK local information pack is the UK-wide process for establishing your research at NHS or HSC institutions.
You do not need to complete the UK local information pack for a single site study with an NHS or HSC sponsor if that single site is also the sponsor of your research.
If this is not the case, each NHS or HSC entity must consent to participate in your study. To accomplish this, they must acquire the UK local information pack and affirm that they have the capacity and competence to participate in your study. The sponsor is responsible for disseminating the UK local information pack, however this may be outsourced. More information on distributing the UK local information pack may be found on IRAS.
If your study includes the NHS, you may find further information on the NHS and HSC research and development clearance procedure on the IRAS support website.
Using IRAS to apply for approvals
You may apply for a variety of research approvals via IRAS.
The combined review service for clinical trials combines evaluation by the MHRA and the NHS research ethics committee, as part of a new section of IRAS.
The online IRAS tutorial explains how to utilise IRAS. It is intended to assist people who request for approvals as well as those who examine or sign off on projects. If you are new to IRAS, you may find the information for new users useful.
We also provide advice on how to seek for ethical clearance.
Transparency in research
If people will be involved in your study, you should think about how you can be open at all phases of the process. You should ask queries like:
- There you will register your research after it is authorised so that everyone can see what is going on
- how your research participants will learn about the findings of your study
- if the study findings will be expressed in an understandable manner
More information is available under the HRA’s policy on research openness.
More information about sharing the findings of your research may be found under ‘dissemination of findings’ at the end of study and archiving section.
Study completion and archiving
When your research concludes, you must inform your sponsor and any review bodies that initially authorised it.
The Health Research Authority (HRA) offers advice on how to conclude your study.
Funders will also expect a final report at the conclusion of the project. Final reports are often expected in a particular format and under certain time constraints. They are also likely to include some financial reporting.
Documenting study findings
It is critical to save research data for the long term for many reasons:
- to encourage repeatability and open research (essential for transparency)
- to give an audit trail or record of your organization’s research
- to make future research possibilities possible by exchanging data or samples
According to clinical trials laws, clinical trials of investigational medical products (CTIMPs) must be stored. The Clinical Trials Toolkit has further information about archiving.
The MRC Regulatory Support Centre retention framework may be used to guide retention decisions for research data and associated material.
Findings dissemination
Your study results should be disseminated in a timely and suitable manner (for example, through a peer-reviewed publication or by presenting at scientific gatherings).
The HRA gives further recommendations on research dissemination.
The HRA’s plain language summaries e-learning programme and tools for creating a plain language summary of your research results may assist you in drafting a research report in lay language. The e-learning is available on HRA’s Centric Cortex system. This system is accessible once you have created a free account.
When publishing your study, make sure you are aware of any grant restrictions. Any research publications funded by the government must generally be published open access. The UKRI open access policy is also included in the UKRI advice on publishing your research. Your organization’s open access financing sources will vary. You may address this with your local research office.
The EQUATOR network seeks to enhance the quality of published health research by encouraging transparent and accurate reporting and expanding the adoption of strong reporting criteria (such as ARRIVE, STROBE, CONSORT, and others).
If you feel your study has commercial potential, universities, the NHS, and funders all have technology transfer departments that may assist guarantee your discovery is sufficiently secured before it is widely distributed.
Meta Title: Health Research: Exploring its Impact and Benefits
Meta Description: Gain a deeper understanding of the significance of health research in this enlightening blog post. Explore the impact and importance of ongoing health research.
