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FAILSAFE Fungal Antimicrobial Resistance Innovations for Low & Middle Income Countries: Solutions & Access For Everyone

Ethics

Use of Human Samples or Data

FAILSAFE expects all research involving human participants to be undertaken in accordance with MRC policies and guidance. These include:  

  • Good Research Practice (2012)  
  • Medical research involving adults who cannot consent (2007)  
  • Medical Research Involving Children (2004) 
  • Human Tissue and Biological Samples for Use in Research (2014)  
  • Personal Information in Medical Research (2000).  

Independent Research Ethics Committee approval is required for research that involves human participants (whether patients or healthy volunteers) or records. Such approval is also required for certain studies of human tissues.  

In the case of social science research, FAILSAFE recommends that award holders follow the ESRC Framework for Research Ethics (revised 2015) which highlights the responsibility of the research organisation for ensuring that the research is subject to appropriate ethics review.  

Research involving human participants in developing societies presents specific ethical challenges and the MRC guidelines Research Involving Human Participants in Developing Societies must be followed.  

Award holders whose research involves the removal, use or storage of human tissue as specified in the relevant legislation must:  

  • Comply with the appropriate legislation, i.e. the Human Tissue Act 2004 and/or the Human Tissue (Scotland) Act 2006  
  • Follow the relevant standards and Codes of Practice issued by the Human Tissue Authority (HTA) (the MRC Regulatory Support Centre has summarised these). 
  • Follow the MRC guidance detailed in Human Tissue and Biological Samples for Use in medical Research (2014).  

For research taking place outside the UK, in addition to UK guidelines, local national guidelines and international best practice must be followed. All legal requirements for the import/export of biological materials must be adhered to. The lead applicant is responsible for ensuring that co-applicants adhere to all relevant ethics requirements.

Use of Animals

FAILSAFE supports the principles of the 3Rs (Replacement, Reduction and Refinement). Award holders are expected to abide by the core principles set out in the cross-funder guidance ‘Responsibility in the use of animals in bioscience research: Expectations of the major research councils and charitable funding bodies’ and GC2 of the RCUK Terms and Conditions. If the research involves the use of animals (rodents, rabbits, sheep, goats, pigs, cattle xenopus) overseas, rather than in the UK, you should also complete the appropriate additional questions on the use of [species] overseas’ forms, and submit it with your application.  

The standards and principles of the Animals (Scientific Procedures) Act 1986 must be observed. All FAILSAFE awards are made on the absolute condition that no work that is controlled by the Act will begin until the necessary licences have been obtained from the Home Office (or equivalent body if work is outside the UK). When animals are purchased from commercial suppliers, in-country suppliers should be used wherever possible, to minimise the risk of suffering during transport. All research involving non-human primates must comply with the NC3Rs Guidelines: Primate accommodation, care and use. The lead applicant is responsible for ensuring that co-applicants adhere to all relevant ethics requirements. 

Genetically Modified Organisms (GMO)

National regulations and international best practice must be followed. Researchers who carry out genetic modification should be familiar with the legislative requirements and with the Scientific Advisory Committee on Genetic Modification (Contained Use) guidance. 

Dangerous Pathogens

Research organisations accommodating projects involving the use of dangerous pathogens must comply with appropriate local and national regulations and safeguarding.  

The Nagoya Protocol

The Nagoya Protocol is an international agreement that implements the access and benefit sharing obligations of the Convention on Biological Diversity.

The Protocol is designed to provide a legal framework for the access to and utilisation of genetic resources and associated traditional knowledge from overseas while ensuring the fair and equitable sharing of benefits arising out of the utilisation of said resources with the original provider country.

Genetic resources means any material of plant, animal, microbial or other origin containing functional units of heredity (e.g. genes and DNA) which is of actual or potential value. This also includes derivatives of genetic resources e.g proteins, lipids and enzymes. The Protocol does not apply to human genetic resources.

Traditional knowledge refers to knowledge, know-how and practice of indigenous and local communities relevant for the utilisation of the genetic resources accessed under the protocol.

Compliance with the Protocol has been implemented in EU and UK law: Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (EU) 511/2014 (click here for more details) and The Nagoya Protocol (Compliance) Regulations 2015 (click here for more details).

What to do

Researchers have a legal duty to comply with the Protocol obligations and to ensure that the correct contracts, permissions and benefit sharing agreements in place before importing material covered by the Nagoya Protocol. Researchers intending to use genetic materials sourced from overseas need to establish if these fall under the scope of the Nagoya Protocol.

The Protocol only applies to genetic resources accessed from a country that abides to the Nagoya Protocol and that has ABS legislation: Check the list of countries on the Access and Benefit-Sharing Clearing-House website.

The Protocol applies to researchers who acquire genetic resources directly from the country of origin, AND those who procure them indirectly from third parties.

The protocol does not apply to:

  • Human genetic resources
  • Genetic resources already governed by specialist treaties or agreements (e.g. the International Treaty on Plant Genetic Resources for Food and Agriculture)

If you think your resources are within the scope of the Nagoya Protocol, you may need to apply for Prior Informed Consent from the provider country:

Prior Informed Consent (PIC): Users must obtain PIC from the country where the genetic resource is located. PIC refers to permission granted by the competent national authority of a provider country to a user before accessing genetic resources. PIC ensures that users are aware of the terms and conditions for accessing and using genetic resources. It is essentially a licence from a branch of the local government allowing the collection of samples containing a genetic resource.

Mutually Agreed Terms (MAT): Along with PIC, users and providers negotiate and agree upon the terms and conditions for access and use of genetic resources. These terms are established through Mutually Agreed Terms (MAT). MAT ensures transparency, fairness, and respect for the rights of the provider country or community. A MAT is an agreement setting out how any benefits derived from use of the samples will be shared with the provider country.

For more information about The Nagoya Protocol please see: Regulations: Nagoya Protocol on access and benefit sharing (ABS) – GOV.UK (www.gov.uk) and Guidance on the UK Access and Benefit Sharing Regulations (publishing.service.gov.uk)