5. Ethics and approvals - MRC

Contents

5.2 Human participants in research

5.2.1 Regulations and guidance

The MRC expects all work involving human participants to be undertaken in accordance with its policies and guidance.

These include:

  • Research regulation and ethics – MRC position (2005)
  • MRC Guidelines for Management of Global Health Trials (2017)
  • Good Research Practice: Principles and Guidelines (2012)
  • Human Tissue and Biological Samples for Use in Medical Research (2001): Operational and Ethical Guidelines (2015)
  • Human material derived from the nervous system (2003)
  • Medical Research Involving Children (2004)
  • Medical research involving adults who cannot consent (2007)
  • Personal Information in Medical Research (2000)
  • Research Involving Human Participants in Developing Societies (2004)
    Framework on the feedback of health-related findings in research (2014)

All these publications can be accessed in the publications section of our website.

The MRC Regulatory Support Centre (RSC) provides support and guidance for those conducting research with human participants, their tissues or data.

Adequate information should be included in each proposal to enable the MRC to evaluate any physical or psychological hazard to which participants may be exposed. Each proposal should specify the number, sex, age range and state of health of the human participants. Applicants will also need to indicate how informed consent will be obtained and whether the participants are, for example, patients, healthy volunteers or individuals in a control cohort.

Payments to healthy volunteers participating in research are allowable, provided that the payment is to reimburse expenses or compensate for time and inconvenience, and is not at a level that would constitute an inducement for people to take part in studies.

Independent ethics committee approval is required for research that involves human participants (whether patients or healthy volunteers); their data or tissues. There may be cases where this review must be made by an NHS Research Ethics Committee (NHS REC). For further guidance on when NHS REC approval is required please see go to the Determine which review body approvals are required pages of the Health Research Authority (HRA) website. Proportionate review is also available for studies which present minimal risk or burden to participants.

If the study is testing the safety or efficacy of a medicinal product, it is likely that this will fall under the scope of the UK Medicines for Human Use (Clinical Trials) Regulations 2004, regulated by Medicines and Healthcare products Regulatory Agency (MHRA). More information on the types of studies that fall under these Regulations and practical help on implementing the requirements (including the requirements of a Clinical Trial Authorisation (CTA) application) can be found on the Clinical Trials Toolkit. Guidance on risk-proportionate approaches to the management and monitoring of clinical trials is provided in the MRC/DH/MHRA Joint Project document (see Appendix 2). For details of the risk-adapted approach to Clinical Trial Authorisations, please see Submitting a Notification for a trial on the MHRA website.

For investigations that involve NHS patients, their data, tissues or NHS resources; NHS R&D management permission is required from all relevant NHS organisations for research. For further guidance please the MRC Data and Tissues Tool Kit.

If the investigation is to take place within an organisation such as a factory, school or service establishment, applicants may be asked to provide evidence of relevant approvals from the appropriate authorities.

Approvals for the research detailed in an MRC grant proposal must be granted by the appropriate bodies before any work can commence. Institutions, applicants and grant holders have absolute responsibility for ensuring that the necessary approvals are granted for the research considered by the MRC and that no research requiring approvals is initiated until they are in place.

The MRC reserves the right to refuse to make an award on ethical grounds alone, even if the agreement of an independent ethics committee has been obtained.

Applicants must ensure that the appropriate approvals are in place before that aspect of the research can start with the MRC.

5.2.2 Research involving human participants in developing countries

Applications involving research with human participants in developing countries may have additional ethical implications that should be considered in developing the research protocol. Any partnership between the UK and research organisations in a developing country is expected to be fair and ethical. See J Dodson. (2017) Building Partnerships of Equals. UK Collaborative on Development Science (PDF 4.7MB).

Research involving human participants requires approval from an independent ethics committee in the UK; ethical review should also be sought from an independent ethics committee in any developing country in which there are study participants.

In the ‘ethical implications’ section of the application form, applicants should describe any ethical implications relevant to their proposal and confirm that these are being addressed. The following is a list of ethical considerations that might arise when designing and conducting research in developing countries. If any of these are relevant to the research and not discussed elsewhere in the proposal, then confirm these issues are being addressed. It is not necessary to make a statement about issues that are not relevant to the proposal.

  1. Research approvals: Applicants should confirm that they have sought or are seeking appropriate ethics review and any other relevant approvals, in the UK and in any other countries involved. For further information about the requirements for ethics review, please see Research Involving Human Participants in Developing Societies (Specific consideration 7).
  2. Vulnerable groups: Applicants should state whether any participants will be from vulnerable groups, justify their involvement and briefly clarify how the study design takes account of their needs. Examples of vulnerable groups might include children, prisoners, victims of violence, military conscripts, individuals lacking capacity, or disadvantaged by poverty or gender.
  3. Informed consent: Applicants should indicate if there are specific considerations in relation to consent influencing their proposal, for example, providing information to participants whose language has no written form, or seeking consent from community leaders as well as participants when this is expected.
  4. Managing participant care: Applicants should state whether, in the design of the research, they have considered the risks of any intervention, the standard of care to be offered to participants (including controls) during the research, continuing care after the research ends, or ancillary care.
  5. Information Management: Describe how participant confidentiality and data security will be managed, including transfer outside the developing country or sharing data in a registry. All relevant information formats should be considered, including conversations, medical consultations, written data, images, sample analyses, and research outputs. Research data management should be described in the Data Management Plan, however specific issues can also be highlighted in the ‘ethical implications’ section of the application form.
  6. Management of biosamples/biobanks: If a proposal involves the collection or use of biosamples, then applicants should confirm that they will comply with local developing country (or UK) codes of practice or legal requirements. For example, this may influence arrangements for transfer of biosamples outside the developing country for analysis.
  7. Adverse impacts of the research: Applicants should consider the wider impact of the research, negative as well as positive, on participants and communities and state how this will be managed. For example, this may include engagement with local stakeholders to ensure that the outputs of the research are used to benefit the local population and reduce inequity or discrimination.
  8. Public / Community engagement (PCE in the developing countries): Applicants are encouraged to involve community and patient advocate groups in designing and conducting the research to increase the acceptability of the study and its findings. If preliminary engagement work has been undertaken or there are plans for future engagement, this should be stated. If all public engagement activities have taken (or will take) place only in the UK, then applicants should demonstrate that these are relevant to the developing country’s participant population and that consideration has been given to capacity-building in developing countries.

5.2.3 Use of human tissue

Applicants whose proposed research involves the use of human tissue or use of human tissue to treat patients as specified in the relevant legislation must confirm in their proposal that they will comply with the appropriate legislation and follow the relevant Codes of Practice issued by the Human Tissue Authority (HTA).

For further guidance please see the MRC Data and Tissues Tool Kit – Which approvals are needed? and HTA licence.

Applicants whose proposed research involves the use of human foetal tissue, or non-foetal products of conception, (eg amniotic fluids, umbilical cord, placenta or membranes) should follow the guidance set out in relevant Codes of Practice issued by the HTA (in particular see paragraphs 157-161 in the Code of Practice on Consent).

Research involving gametes and embryos is subject to regulation by the Human Fertilisation and Embryology Authority (HFEA) and researchers must ensure that they adhere to the relevant guidance. For further details please see the MRC Data and Tissues Tool Kit – HFEA licence.

Cell lines and embryonic stem cell lines fall within the regulatory remit of the HTA by virtue of the Human Tissue (Quality and Safety for Human Application) Regulations 2007, which regulates the processing, storage and distribution of stem cell lines for human application. Both the HFEA and the MHRA also have a regulatory remit in respect of cell lines and embryonic stem cell lines. A position statement on regulating human embryonic stem cell lines has been issued by the HTA, HFEA and MHRA which provides guidance on the relevant regulatory remits. More information on the regulatory routes for conducting human stem cell research in the UK can be found on the UK Stem Cell Tool Kit.

A letter of support must be attached to the application if human tissue will be sourced from a public or collaborator’s resource eg brain bank (even if from the PI’s RO), or from a separate RO.

See the list of materials considered to be ‘relevant material’ under the Human Tissue Act 2004.

5.2.4 Xenotransplantation

Applicants must therefore seek relevant approvals and confirm in their proposal that they will follow the DH guidance and, if applicable, comply with the ATMP regulations. For further guidance please see the MRC Experimental Medicine Tool Kit – Xenotransplantation.

5.2.5 Use of radioactive medicinal products in humans

Applicants, whose proposed research requires the administration of radioactive medicinal products (including in- vivo neutron activation analysis in humans), should follow the guidance issued by the Administration of Radioactive Substances Advisory Committee (ARSAC) and seek the relevant approvals as appropriate. Please note that ARSAC is currently moving to a more integrated process with the Health Research Authority (HRA) that will remove the requirement for additional ‘research certificate’ applications. For further details please see the HRA website.

5.2.6 Genetic modification

The Genetically Modified Organisms (Contained Use) Regulations 2000 (GMO (CU)) as amended by the Genetically Modified Organisms (Contained Use) (Amendment) Regulations in 2002, 2005 and 2010 require laboratories that intend to carry out genetic modification to assess the risks of all activities and make sure that any necessary controls are put in place. Further information about the legislation and relevant approvals required is available on the Health and Safety Executive (HSE) website.

Last updated: 17 August 2021

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