Research governance and ethics

Research Governance and Ethics (School of Applied Sciences)

The main purpose of the Schools Research Ethics and Integrity Committee (SREIC) is to ensure that all research carried out within the School of Applied Sciences is conducted to the highest possible ethical standards for research and to provide support to staff and students planning research projects. The review process is designed to ensure that researchers protect the health, the well-being, dignity, rights of research participants and the legitimate interests of other stakeholders.

It is essential that staff and post-graduate researchers gain the appropriate ethical approval for their research and that once approved, they comply with those terms of approval.

School Research Ethics and Integrity Committee (SREIC)

(1) Membership and Terms of Reference

Membership of the SREIC

Chair and Schools Research Integrity Champion: Prof Roger Phillips

Dean of School: Prof Michael Ginger

Designated Individual (DI) for HTA licence: Dr Nik Georgopoulos

Persons Designated (PD) for HTA licence: Dr Patrick McHugh (Pharmacy), Dr Hans Hennies (Biology), Prof Gordon Morris (Chemistry), Dr Anna Williams (Forensics)

Director of Post Graduate Education: Dr Dougie Clarke

Chair of GM Committee: Dr Tarja Kinnunen

Chemistry Representatives: Dr Esta Bostok

Biology and Geographical Sciences Representatives: Dr Hans Hennies

Pharmacy Representatives: Prof Zaheer Babar and Dr Hayley Gorton

Secretary: Jayne Amos

Quoracy

Chair of SREIC, at least one person’s designated (HTA) and representatives from a minimum of two departments.

(Reviewed and updated on 28^th January 2020)

Terms of Reference

To maintain the highest standards of rigour and integrity in all aspects of research.
To advise staff, students and postgraduate researchers within the School on ethical issues in research.
To ensure that research is conducted according to appropriate ethical, legal and professional frameworks, obligations and standards.
To refer research proposals that raise difficult ethical or legal considerations to the University Research Ethics and Integrity Committee (UREIC).
To provide an annual report to UREIC.
To support a research environment that is underpinned by a culture of integrity and based on good governance, best practice and support for the development of researchers.
To ensure that individuals who raise allegations of research misconduct are aware of the Universities procedures to deal with allegations of research misconduct.
To work together to strengthen the integrity of research and to reviewing progress regularly and openly.
To manage and ensure compliance with the Human Tissue Authority (HTA) Licence.

(Reviewed and updated on 25^th September 2019)

Reports to

School Research and Enterprise Committee, School Management Committee and the University Research Committee.

(2) Applying for Ethical Approval of your research.

Details of the application process for obtaining ethical approval for research, approval for use of human tissues in research, security sensitive research projects, the membership and terms of reference for the SREIC committee and links to University and National Codes of Conduct for Research Integrity are provided below.

Applying for internal and external ethical approval:

(i) Internal ethics approval for projects being led by researchers in the School:

Within the School of Applied Sciences, a diverse range of research is undertaken, much of which does not raise any ethical concerns. To accommodate this diversity in activity, the School employs a two-tier process based primarily upon the answer to the following question:

Does Your Proposed Research Project involve any of the following?

Human participants
Use and storage of human tissue
Medical research requiring NHS ethical / R&D approval
Use of animals (or tissues/fluids derived from animals)
Access to identifiable personal data for living individuals not already in the public domain
Increased danger of physical or psychological harm for researcher(s) or subject(s)
Raise any ethical issues associated with the use of genetically modified organisms
Research into security sensitive areas

If the answer is No, then fill in Form 1. This form is effectively a declaration by you that your research does not raise any ethical issues and that you take the responsibility of informing SREIC if your project subsequently develops into areas that will require ethical approval.

If you answer Yes to any of these questions, then fill in form 2. This form requires you to provide the committee with answers to specific questions and to provide additional documentation that supports your proposed study (patient information sheets, questionnaires etc) that are appended to form 2.

The submission and review process:

Both forms 1 and 2 are provided on the Schools UniShare site alongside instructions on how to submit these for ethical consideration. Form 1 submissions do not undergo review by the committee but these are automatically stored electronically. All Form 2 submissions will be sent directly to committee members for comments and a decision is usually reached within 4 weeks of submission. For projects that raise significant issues, the application will be placed on the agenda for the next SREIC meeting or it can be referred up to the University Research Committee (URC) for advice.

(ii) Ethical approval for research led by collaborators in external institutions:

As a School, we encourage multidisciplinary research and this often requires working with external institutions. If partners in other institutions are leading the project, they may already have ethical approval for certain aspects of the proposed project. In this case, Form 2 still needs to be completed but details of the partners ethical approval need to be appended to the form as evidence that the proposed work has obtained the necessary approval by other institutions. SREIC will take this into account and focus on work that is to be specifically conducted within the School of Applied Sciences.

(iii) Ethical approval for research involving the NHS:

Projects that involve work with the NHS will require Health Research Authority (HRA) approval through the Integrated Research Application System (IRAS). Details of what is involved in obtaining HRA approval can be found at the HRA website.

All projects will also need approval by SREIC but it is important to state that approval by SREIC without HRA approval does not allow you to conduct research in the NHS.

Please note that the law regarding data protection has changed. GDPR came into being on 25th May 2018. Please ensure that you understand your obligations in terms of obtaining and processing personal data. This link has some useful information and advice.

(3) Research involving the use of human tissues:

The University of Huddersfield has a license (number 12641) for the storage of human tissue for the purposes of research, which satisfies all requirements under the Human Tissue Authority (HTA) regulations. Professor Liz Towns-Andrews is the Corporate License Holder and the Designated Individual (DI) and Persons Designated (PD) are listed in the SREIC membership section. Under Section 18 of the Human Tissue Act 2005, the DI has the legal duty to ensure that statutory and regulatory requirements are met and the PDs assist the DI in ensuring compliance with HTA standards.

All research involving human tissue samples at the University must be approved by the SREIC (by completion of form 2 as stated above). Staff wishing to conduct research involving human tissue must liaise directly with the DI at all stages of the process to ensure compliance with the guidelines provided regarding storage of human tissue. Failure to do so will constitute research misconduct.

What is considered human tissue?

The Human Tissue Authority provides a list of 'relevant material'. This list is not intended as exhaustive or exclusive, but is intended to provide guidance in respect of a number of materials that might be considered relevant material. As a general rule 'relevant material' is anything that contains viable human cells.

University of Huddersfield Procedures

Before human tissue research storage is undertaken

Every researcher whose work involves the storage of human tissue must have previously read and understood the School’s HTA policy document and discuss the work with the DI or appropriate PD in the relevant area of the School. There will also be a requirement that each researcher completes the MRC online training course (see Training and Development section below) and sends the certificate of completion to the DI that will be kept on file. This will ensure that every investigator will have fully familiarized themselves with the legal framework regarding storage of human tissue and compliance with the HTA regulations.

Human tissue log

All human tissue stored at the University has to be logged in the Human Tissue Log. To get access to this, please contact the DI and provide them with the following details:

The ethics committee approval for the project
Your name
Full project title
Project number

How to store your human tissue at the University

Human tissue samples must be stored in the designated freezers / fridges in your Faculty. The samples should be clearly identified as being human tissue using specific labels, including the required information. For information on containers to be used, labeling of boxes and tubes containing human tissue, please liaise with the DI.

Disposal of human tissue

Please read the HTA Code of Practice 5: Disposal (PDF 1.3 MB). It is the relevant researcher’s responsibility to record when a relevant sample is no longer stored in the premises and to dispose that tissue via clinical waste disposal procedures in the School of Applied Sciences. The DI will provide details of disposal using clinical waste bins in the School of Applied Sciences.

End of project

At the end of your project you will need to notify the DI that the project has ended and that no human tissue relating to this project is held in the premises.

(4) Security sensitive research:

Staff have to declare if their research falls under the definition of ‘security sensitive research. Security sensitive research includes research that is:

Commissioned by or on behalf of the military or the intelligence services
Commissioned under an EU security call
Involves acquisition of security clearances
Concerns terrorist or extreme groups

Please familiarise yourself with the UK guidance on security sensitive research https://www.universitiesuk.ac.uk/policy-and-analysis/reports/Documents/2012/oversight-of-security-sensitive-research-material.pdf before commencing your research project.

If your research falls under the criteria described above, the chair of SREIC will issue you with a form to complete which defines exactly what is involved in the proposed research. The chair of SREIC will then take this to University Research Ethics and Integrity Committee (UREIC) and Research and Enterprise and upon approval, details will be sent to Computing and Library Services (CLS) who will set up IT facilities for data storage and access.

(5) Research Integrity

Concordat to Support Research Integrity

The University of Huddersfield subscribes to the principles outlined in the Concordat to Support Research Integrity and is committed to excellence in all aspects of research. The concordat sets out 5 main commitments:

Maintaining the highest standards of rigour and integrity in all aspects of research.
Ensuring that research is conducted according to appropriate ethical, legal, and professional frameworks, obligations and standards.
Supporting a research environment that is underpinned by a culture of integrity and based on good governance, best practice and support for the development of researchers.
Using transparent, robust and fair processes to deal with allegations of research misconduct should they arise.
Working together to strengthen the integrity of research and to review progress regularly and openly.

Full details of the Concordat to Support Research Integrity

Research Misconduct

The Universities policies on reporting and investigating cases of research misconduct are available online

A common source of academic misconduct allegations centers on authorship on research papers and further guidance on this issue is provided below.

Guidance on the Authorship of Papers

An important part of any students or academics research is the publication of their work in good quality journals. There are no universally accepted standards for assigning authorship and principles, customs and practices differ significantly from one discipline to another. The specific rules that govern who should and should not be included as an author on a paper are provided by the journal you are planning to submit to.

In general terms however, an author is an individual judged to have made a substantial intellectual or practical contribution to a publication and who agrees to be accountable for that contribution. This would normally include anyone who has:

Made a significant contribution to the conception or design of the project or the acquisition, analysis, or interpretation of data for the work; AND/OR
Drafted the work or reviewed/revised it critically for important intellectual content.

Anyone listed as an author on a paper should approve the final version of the paper and accept responsibility for ensuring that he or she is familiar with its contents and can identify his or her contribution to it.

Individuals who contributed to the work, but whose contributions were not of sufficient magnitude to be listed as authors should be properly acknowledged, usually in an acknowledgements section.

Authors should be careful to ensure fair and proper acknowledgement of contributions from individuals who have not been listed as an author and make sure that acknowledgements fully reflect the level of the input of the contributor.

As an example, papers submitted to Life Science focused journals typically adhere to the International Committee of Medical Journal Editors (ICMJE) guidelines. These state that authorship be based on the following 4 criteria:

Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
Drafting the work or revising it critically for important intellectual content; AND
Final approval of the version to be published; AND
Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

All those designated as authors should meet all four criteria for authorship, and all who meet the four criteria should be identified as authors.

Contributors who meet fewer than all 4 of the above criteria for authorship should not be listed as authors, but they should be acknowledged. Examples of activities that alone (without other contributions) do not qualify a contributor for authorship are acquisition of funding; general supervision of a research group or general administrative support; and writing assistance, technical editing, language editing, and proofreading.

Additional general guidance on authorship is provided by the following groups:

Council of Science Editors, White Paper on Publication Ethics– A paper designed to offer general guidance across the sciences.
The Committee on Publication Ethics– COPE provides advice to publishers and editors on publication ethics and has produced a Code of Conduct for journal editors and guidelines on handling authorship dispute

(6) Guidance on Intellectual Property

Where research has generated results that require intellectual property (IP) protection, conversations must be had with (i) the School (Dean and Associate Dean for Research) and (ii) Research and Enterprise as soon as possible. The issues surrounding inventorship and ownership are complex and require discussion in the School and the University prior to submission. Please also consult the Universities policy on Intellectual Property for further information.

(7) Training and Development

The University will offer training and briefing sessions, co-ordinated and facilitated by the Research and Enterprise Office in collaboration with the Staff Development Office.

The University through the provision of guidance notes will provide guidance and support and web-based resources that can be accessed via links on the Research and Enterprise webpages or Brightspace as appropriate.

All new members of staff are required to meet with the Chair of SREIC as soon as they start in post. This constitutes a formal component of the induction process, the purpose of which is to inform new members of staff about the University’s and School’s policies on Research Integrity and Ethics. If the new member of staff is likely to use human tissue, he/she must meet with the Designated Individual (DI) who will introduce and go through the School’s procedures for compliance with the HTA licence. The staff member will also be required to complete an online training package to ensure understanding of the HTA legal framework.

All new postgraduate research students will be required to attend presentations on research integrity and ethics as part of their induction process. These sessions will be delivered by the Chair of SREIC and where appropriate, the DI.

The training offered by the School through our induction process and human tissue usage procedures is sufficiently flexible to provide subject or discipline specific guidance and training. Links to other professional bodies in the major subject disciplines of Biology, Chemistry and Pharmacy are provided below.

MRC

RCUK

UKRIO

Human Tissue Authority and code of practice 9 (research)

Royal Pharmaceutical Society