This policy is currently under review
HRB researchers and Host Institutions in receipt of HRB funding awards have a duty to adhere to the highest ethical standards when conducting research.
All researchers and Host Institutions must ensure that, before the research commences and during the full award period, all the necessary ethical, legal and regulatory requirements in order to conduct the research are met, and all the necessary licences and approvals have been obtained.
Overall responsibility for ensuring that all HRB-funded research is subject to appropriate ethics review and monitoring lies with the Host Institution. Host institutions should have clear, transparent and effective procedures for ethics review and governance, and appropriate mechanisms for monitoring the operation of Research Ethics Committees (RECs) and the decisions they take in relation to HRB-funded research.
Research involving human participants or biomaterials, including clinical trials and interventions
Ethical approval is required for all research work funded by the HRB that involves human participants or human material (including tissue). Applicants are responsible for ensuring that all necessary approvals are in place prior to the start of the research.
HRB researchers should allow sufficient time to obtain ethical approval from the relevant research ethics committee and/or competent authority (i.e. Health Product Regulatory Authority (“HPRA”) approval as notification of such approvals must be submitted to the HRB before the initiation of the award. It is suggested that these are sought in parallel to the submission of the application to the HRB. The HRB will require notification that relevant ethical and regulatory approval has been granted prior to any work that requires such approvals commencing.
In the event that the competent authority (i.e. Health Product Regulatory Authority (“HPRA”) or a research ethics committee requires amendments that substantially affect the research question, methodology, trial duration or costs to the extent that the project is no longer the same as that approved for funding by the HRB, the HI of the award must notify the HRB.
In 2001 the European Union adopted the EU Clinical Trials Directive (2001/20/EC) as a framework for good management in trials of medicines for human use. The subsequent Irish regulations, Clinical Trials on Medicinal Products for Human Use) Regulations, 2004, SI No 190 of 2004, became law in 2004. In 2020, the way clinical trials are conducted will undergo another major change when the new EU Clinical Trial Regulation, (EU) No 536/2014, comes into application. The regulations are intended to protect the rights, safety and well-being of research participants and to simplify and harmonise regulatory processes. They apply to trials designed to generate information on the efficacy or safety of medicines.
The HRB Policy on Clinical Trials and Interventions Governance sets out the requirements for Host Institutions before, during and after the conduct of clinical trials to ensure adherence to good research governance, including on ethics and scientific quality of research. See https://www.hrb.ie/funding/funding-schemes/before-you-apply/all-grant-policies/hrb-policy-on-clinical-trials-and-interventions-governance/.
If any part of the clinical trial will be subcontracted to a third party, the HI must ensure that they have a formal contract/agreement in place before they start work.
To ensure that the processing of personal data for the purposes of health research is compliant with General Data Protection Regulation (“GDPR”) and the Health Research Regulation 2018 (S.I No.314 of 2018), researchers should seek project specific advice from their institutional Data Protection Officer.
The Health Research Regulations provide for suitable and specific measures for data processing for health research, including the requirement for ethical approval as an appropriate governance structure. The Health Research Regulations further require that explicit consent is a safeguard that must be obtained. Prior to obtaining explicit consent, Principal Investigators should submit consent and patient information to their relevant ethics committees for review and approval to ensure explicit consent can be adequately achieved and in compliance with the Health Research Regulations.
In this regard, Principal Investigators should also consider:
- the consent guidance set out by the HSE
- the HSE National Policy for Consent in Health and Social Care Research (PDF), and
- guidance from the Department of Health on information principles for informed consent (PDF).
Please note the HSE National Consent Policy (PDF) should be considered for all other health and social care interventions which are not part of a research process.
Research involving animals
Research involving animals helps to enhance our understanding of human, animal and environmental health and biology. It raises many complex issues for example, ethics, animal welfare, transparency, reproducibility and translation. All HRB research involving animal use is conducted in accordance with Irish law and ethically approved.
HRB researchers and Host Institution must ensure that, before the research commences and for the full award duration, all the necessary ethical, legal and regulatory requirements in order to conduct the research are met, and all the necessary licences and approvals have been obtained. HRB researchers are expected to follow the highest standards of animal welfare. HRB will require notification that relevant regulatory requirements have been met prior to any work involving animal use commencing.
The European Union Directive 2010/63/EU on the protection of animals used for scientific purposes was issued to ensure harmonised standards of animal welfare across the EU, whilst maintaining Europe’s place as a world leader in scientific research. This legislation was transposed into Irish law in December 2012 by SI No 543 of 2012 and is implemented by the Health Products Regulatory Authority (HPRA), the competent authority in Ireland responsible for the protection of animals used for scientific purposes.
It is important to ensure the principles embedded in the legal text are implemented in practice. In particular, the Directive imposes a clear and explicit obligation on licensed researchers to ensure that the opportunities for reduction, replacement and refinement of animal involvement (See principles of the 3Rs - Replacement, Reduction and Refinement) are intrinsic to their work. Researchers are expected to adhere to the general principles and best practice outlined in the guidance provided by the HPRA and are advised to consult the ARRIVE guidelines (Animal Research: Reporting In Vivo Experiments) produced by the UK National Centre for the Replacement, Refinement & Reduction of Animals in Research (NC3Rs).
The HRB has worked with Science Europe and other like-minded funders and stakeholders across Europe to reaffirm its commitment to ensuring responsible research involving animals.
Research Using Human Embryonic Stem Cells
Pending legislation from the Department of Health governing assisted human reproduction and associated research, the HRB is not in a position to fund research using human embryonic stem cells.
Key International Guidance on Ethics in Research
The need for the ethical scrutiny of research has influenced the development of guidelines, exemplified by the successive versions of the World Medical Association’s international code on research ethics, the Declaration of Helsinki (1964). With particular relevance to this briefing, the 1975 amendment of the Declaration required the submission of clinical trial protocols to an independent commission, and the regular use of ethics reviews.
- World Medical Association, Declaration of Helsinki: Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects. Adopted by the 18th World Medical Assembly, Helsinki, Finland, June 1964. Amended by the 29th World Medical Assembly, Tokyo, Japan, October 1975; the 35th World Medical Assembly, Venice, Italy, October 1983; the 41st World Medical Assembly, Hong Kong, September 1989; and the 48th General Assembly, Somerset West, Republic of South Africa, October 1996. See https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects/
- Council for International Organizations of Medical Sciences (CIOMS), in collaboration with the World Health Organization (WHO). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva 1993. See https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
- EU Clinical Trials Directive (2001/20/EC). See https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-/dir_2001_20/dir_2001_20_en.pdf
- S.I. No. 190/2004 - European Communities (Clinical Trials on Medicinal Products For Human Use) Regulations, 2004. See http://www.irishstatutebook.ie/eli/2004/si/190/made/en
- REGULATION (EU) No 536/2014 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. Seehttps://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf
- Guideline for good clinical practice E6(R2) EMA/CHMP/ICH/135/1995. See http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002874.pdf
- The National Centre for the Replacement, Refinement and Reduction of Animals in Research. The ARRIVE (Animal Research: Reporting of In Vivo Experiments) guidelines. Originally published in PLOS Biology, June 2010. See https://www.nc3rs.org.uk/arrive-guidelines
- Department of Health. General Scheme of the Assisted Human Reproduction Bill 2017. See https://assets.gov.ie/19004/d250693cb05d44e2b2c45d7cf26614d3.pdf
- European Commission High-Level Exert group on Artificial Intelligence. Ethics Guidelines for Trustworthy AI. Seehttps://ec.europa.eu/digital-single-market/en/news/ethics-guidelines-trustworthy-ai
- European Commission. Ethics and Data Protection. This document has been drafted by a panel of experts at the request of the European Commission and aims at raising awareness in the scientific community, and in particular with beneficiaries of EU research and innovation projects. It does not constitute official EU guidance. See https://ec.europa.eu/research/participants/data/ref/h2020/grants_manual/hi/ethics/h2020_hi_ethics-data-protection_en.pdf