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Frequently Asked Questions

Guidance for Researchers working with human participants, tissue and data.

 

1. Does your study involve the use of human participants, their tissue and/or data?
 
2. Does the research project involve the investigation of the safety or efficacy of a medicine/foodstuff/placebo in humans?
 
3. Does the research project involve patients, clients, staff or carers of an NHS Trust or Social Care Organisation?
 
4. Has the funding body stated that they require a Sponsor to be identified for the project?
 
5. Will the University act as Sponsor for my study?
 
6. Does your project fall within the definition of Clinical Research as given by the MRC? This section also includes the definition of a randomized clinical trial.
 
7. Does my study need peer review?
 
8. Which Committee do you need to send your project to for ethical approval?
 
9. I am collaborating with other organisations on a study, who is responsible for obtaining the ethics approval?

 
1. Does your study involve the use of human participants, their tissue and/or data?

If yes then you will require ethical approval.

2. Does the research project involve the investigation of the safety or efficacy of a medicine/foodstuff/placebo in humans?

If yes, it is highly likely that it falls within the “Medicines for Human Use (Clinical Trials) Regulations 2004” and you will need to gain a Clinical Trials Authorisation from the MHRA via their application form .

A Sponsor is required and the registration costs depends upon the type of trial, registration costs which will need to be funded by the project.

To help clarify the scope of the regulations, below is an extract from the MHRA website defining what the regulations are primarily concerned with. In addition there is a useful algorithm pdf file to help determine applicability.

The Regulations only apply to trials of medicinal products. These are substances or combinations of substances which either prevent or treat disease in human beings or are administered to human beings with a view to making a medical diagnosis or to restore, correct or modify physiological functions in humans.

3. Does the research project involve patients, clients, staff or carers of an NHS Trust or Social Care Organisation?

If yes, the project falls within the scope of the “Research Governance Framework for Health and Social Care (2nd edition),” and a Sponsor is required. You will need to get approval from the relevant NHS Trust(s) or Social Care Organisation Research Management Office(s) before starting the research project.

In addition, you and all other staff working on the project who have access to any NHS or Social Care patients or patient identifiable information will need to hold honorary or substantive contracts with the NHS Trust(s). If you or any other staff who may be working on the project do not hold such honorary contracts, you will need to request them through the Trust(s) Research Management Offices or Human Resources departments.

4. Has the funding body stated that they require a Sponsor to be identified for the project?

Research concerned with the protection and promotion of public health, research undertaken in or by the Department of Health, its non-Departmental Public Bodies and the NHS, and research undertaken by or within social care agencies, including clinical and non clinical research; research undertaken by NHS or social care staff using resources of health and social care organisations; and any research undertaken by industry, charities, research councils and universities within the health and social care systems that might have an impact on the quality of those services, requires a Sponsor to be indentified.

Many research charities and other funding bodies are now insisting on a Sponsor for each research project regardless of the nature of the work. Where appropriate, the University will generally act as Sponsor for those studies designed and management by University employees, more information can be found on the University's Sponsorship Principles web page.

5. Will the University act as Sponsor for my study?

The University's Sponsorship Principles outline the circumstances under which Warwick would normally be willing to accept the role of Sponsor.

It is important to note that if the University declines to be the Sponsor for your project and you have not identified an acceptable alternative Sponsor, under no circumstances can you do the work through the University or use University Staff, equipment, facilities or laboratories in the project.

6. Does my project fall within the definition of Clinical Research as given by the MRC?

In order to ensure that you are adequately insured for the research you undertake the University has decided to adopt the broadest definition of clinical research as provided by the MRC.

Clinical research:

Research based on humans and designed to answer questions about health and disease. In addition to direct examination of individual patients and populations, it includes the study of biological samples and personal data deriving from the individuals concerned. It also includes research on volunters, or on populations of apparently healthy individuals, where such study relates to a disease process being investigated.

More specifically, this means that research defined as clinical should encompass at least one of the following categories:

Human participation: studies which require face-to-face contact with patients and/or healthy human participants and may involve use of patient records as a concomitant eg, a clinical trial

Records based studies: studies which require access to personal data on health or lifestyle without involving face-to-face contact with any people eg, epidemiological studies, health economic studies, public health interventions, health services research and meta-analyses – information may be obtained by telephone, postal questionnaires/surveys or electronic/manual data retrieval.

Clinical samples: studies which involve laboratory studies on human material which are specifically designed to understand or treat a disease/disorder. However, basic biomedical research of remote relevance to a disease/disorder, such as the use of immortalised human cell lines in model biological systems, is excluded.

Technology development for clinical use: development or adaptation of technologies for diagnosis or therapy, eg, instrument development for diagnostic or surgical use; development of new techniques, such as photodynamic therapy, for clinical use.

If your project is Clinical, for insurance purposes also we need to know whether or not it is invasive (involves manipulation, issue of drugs or devices or surgery to patients) to ensure we have appropriate cover.

Definition of a randomized controlled trial:(RCT) A study in which people are allocated at random (by chance alone) to receive one of several clinical interventions. One of these interventions is the standard of comparison or control. The control may be a standard practice, a placebo ("sugar pill"), or no intervention at all. Someone who takes part in a randomized controlled trial (RCT) is called a participant or subject. RCTs seek to measure and compare the outcomes after the participants receive the interventions. Because the outcomes are measured, RCTs are quantitative studies.

In sum, RCTs are quantitative, comparative, controlled experiments in which investigators study two or more interventions in a series of individuals who receive them in random order. The RCT is one of the simplest and most powerful tools in clinical research.

7. Does my study need peer review?

It is good practice that all projects should receive some form of peer review. As a minimum, this will generally be needed for all projects that require ethical approval.

For projects that involve applications to funding bodies, such as research councils and charities, you can assume that the application process includes peer review.

If you need a peer review and are unsure as to how to acquire one you should ask your Head of Department in the first instance.

8. Which Committee do you need to send your project to for ethical approval?

You can use the Ethical Review Decision Making Tool to determine which ethics committee your study will need to be sent to. Our Research Ethics committees web pages also provide further information on the remit of each the committee.

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9. I am collaborating with other organisations on a study, who is responsible for obtaining the ethics approval?

If a Sponsor has been identified for the Study, it will be the Sponsor's responsibility to obtain appropriate ethical approval. The Sponsor is responsible for implementing good governance standards and adhering to regulations, not just in one institution but also across the whole spectrum of organisations involved throughout the course of the study.

It is expected that the organisation employing the Chief Investigator, designing the protocol and/or managing the project would act as Sponsor, depending on the nature of the project more than one Sponsor may be identified.

For some types of project e.g. EU projects, organisations may need to apply for ethics approval in their country for the portion of work they are undertaking.

You should contact you RIS Departmental Officer for advise on sponsorship and ethical approval.