Policy for non-clinical research involving human participants

This policy is intended to cover all research projects which will include the observation or collection of personal data from humans but will not involve any clinical/clinically related activities. It includes research involving the use of human tissue. It is aimed at:

Researchers who are planning to carry out non-clinical research involving human participants;

• Research supervisors
• Ethics committees considering whether to grant ethics approval for a Research Project

This policy sets out the following:

• Fundamental principles underpinning research
• The relevant research governance committees
• Procedures that researchers should follow to obtain ethics approval
• Important considerations for different types of research project
• Responsibilities of researchers.

Researchers must consider all of the above when planning a research project.

Definitions used in this policy can be found in Appendix 1.

1.  Definition of Research

The key source of reference for determining whether an activity is or is not research is the Frascati Manual. The Frascati definition of research and development is summarised below:

“Research and experimental development (R&D) comprise creative and systematic work undertaken in order to increase the stock of knowledge - including knowledge of humankind, culture and society - and to devise new applications of available knowledge.”

“The term R&D covers three types of activity: basic research, applied research and experimental development. Basic research is experimental or theoretical work undertaken primarily to acquire new knowledge of the underlying foundations of phenomena and observable facts, without any particular application or use in view. Applied research is original investigation undertaken in order to acquire new knowledge. It is, however, directed primarily towards a specific practical aim or objective. Experimental development is systematic work, drawing on knowledge gained from research, practical experience, and producing additional knowledge, which is directed to producing new products or processes or to improving existing products or processes.”

Further information can be found in the Guidance for Researchers for Checklist 1.

2.  Fundamental Principles Underpinning Research

All research involving human participants, their tissue or data requires approval by a research ethics committee.

Research ethics is important in order to:

• Protect participants and researchers from harm
• Preserve the rights and dignity of participants
• Create a culture of mutual respect and trust between participants and researchers
• Provide reassurance to participants, the wider public and funders regarding the ethical conduct of research
• Maintain the integrity and reputation of the researchers and host institution(s)

3.  . Research Governance

There are two main types of research ethics committee that are responsible for review and ethical approval of Research Projects. These are:

• The University Research Ethics Committee (UREC)
• School Research Ethics Committees (SRECs)

UREC

UREC provides oversight, monitoring and guidance to the School Research Ethics Committees. SRECs report directly to UREC. UREC reports to the Research Governance and Policy Sub-Committee.

SRECs

SRECs oversee the ethical review and approval of non-clinical research involving human participants proposed by staff and students. SRECs are responsible for maintaining ethical standards of practice in order to protect participants and researchers from harm, preserve participants’ rights, and ensure public trust in the conduct of research at the University. SRECs have responsibility for maintaining and disseminating information about good ethical practice.

4.  Ethical Approval for a Research Project

Requirement to obtain approval before commencing research

A researcher must not start gathering data until they have received approval in writing from the Convener of the SREC for a project to go ahead.

Failure to follow the University’s ethical review and approval procedures, as referred to in this Policy, including conducting a Research Project without ethical approval, may result in disciplinary action being taken by the University against a researcher. There are separate discipline procedures for students and for staff. The Code of Policy and Procedures for Investigating and Resolving Allegations of Misconduct in Research states that research misconduct includes ‘conduct which seriously deviates from accepted ethical standards in research’ (section 2.1). A finding that someone has committed research misconduct could lead to the initiation of formal disciplinary proceedings (section 4.6).

Review and approval procedure

The application procedure described on the Non-clinical research ethics web pages should be followed when seeking ethical review and approval for a research project.

Applicants should hear back from reviewers within 3 weeks of submission of their application, but reviews may take longer during busy times

Requesting an extension or an amendment to a project

Ethical approval of a project is based solely on the information received and reviewed by the relevant ethics committee at the time of application (including any revisions made following feedback from reviewers). Researchers who wish to make changes to approved studies must submit a post-approval request for an extension or amendment to the relevant SREC.

5.  Specific Categories of Research Projects

There are some categories of Research Project which may require extra consideration by researchers when planning and/or carrying out their research. These include, but are not limited to:

• Research conducted overseas
• Research involving secondary data including social media data and other data available on the internet
• Research involving human tissue
• Security-sensitive research

Research conducted overseas

If a researcher is planning an overseas Research Project a specific approval process that must be followed which includes obtaining local ethics approval in the country where the Research Project is to take place.

For more information, including details of the procedure to be followed, researchers should refer to Approval of International Collaborative Research Projects – Guidance for Researchers and School Research Ethics Committees.

Research involving secondary data including social media data and other data available on the internet

Secondary data are data that have already been collected for some other purpose. Some secondary data are publicly available, e.g. from social networking services. Data available on the internet are likely to have been collected and made available using consent processes based on a lower ethical standard than that appropriate for research. It cannot be assumed that secondary data will have the appropriate consent for new uses of the data for research purposes. In addition, the copyright might be owned by the platform the data are hosted on, requiring permission to use the data to be obtained.

Research based on secondary data should consider the possibility of harm to data subjects and whether steps to mitigate risk are required, even where these data are anonymous. Where data are combined or added to by the researcher, the risk of re-identification should be carefully evaluated.

New uses (further processing) of personal data must be fair, lawful and transparent. Researchers must comply with obligations to document all processing of personal data.

More information can be found in the University’s Data Protection and Research – Guidance, the Information Commissioner’s Office website and the Additional Guidance for Researchers on Data Management. If a researcher requires any specific advice about secondary data they should contact Information Governance by emailing them at dataprotection@dundee.ac.uk.

Research involving human tissue

If a Research Project involves the use of anonymised tissue and associated data from NHS patients that is surplus to diagnostic and surgical requirements and will be obtained from a tissue bank, a researcher should obtain ethical approval through the Tayside Biorepository.

If a Research Project involves the use of human tissue from healthy volunteers then researchers should refer to the Procedure for Best Practice in Ethical Review and Approval of Research Projects Involving the Use of Human Tissue from Healthy Volunteers.

Researchers should refer to the Policy for the use of Human Tissue.

Security-sensitive research

Security-sensitive research (whether or not involving human participants) will require ethical approval and should be referred to the Convener of the University Research Ethics Committee (UREC) in the first instance.

6.  Responsibilities of Researchers

To consider and comply with Data Protection Laws including the rights of data subjects

Data protection is about ensuring people can trust you to use their data fairly and responsibly2 . The University is trusted by various people and organisations to keep and process their personal data and it is important that this is done properly and in accordance with applicable law.

The University must comply with relevant data protection laws, including the Data Protection Act 2018 and the UK General Data Protection Regulation (UK GDPR) i.e. “Data Protection Laws”. Data protection in the UK is regulated by the Information Commissioner’s Office (ICO).

The University has a Data Protection Policy and several Data Protection Standard Operating Procedures (SOPs) which are set out on the University’s Data protection website. These include a SOP for Data Sharing which must be followed before providing, sharing or receiving personal data and entering into data protection agreements with third parties.

Under the Data Protection Laws, data subjects (which includes research participants) have various rights with regards to their personal information, including the right to be informed about the collection and the use of their personal data. These are set out on the University’s website covering individual rights under the General Data Protection Regulation.

Further information about data protection can be found in the University’s Data Protection and Research guidance and on the ICO’s website.

Respect for participants

All participants must be treated with respect and dignity paying due regard to participants’ protected characteristics3 as well as other aspects such as social and cultural norms.

As an example, respect is one of four ethical principles underpinning the British Psychological Society’s (BPS) Code of Ethics and Conduct (2021). Respect and dignity are considered to be related in this document:

“Respect for dignity recognises the inherent worth of all human beings, regardless of perceived or real differences in social status, ethnic origin, gender, capacities, or any other such group-based characteristics. This inherent worth means that all human beings are worthy of equal moral consideration” (BPS, 2021, p.6).

Researchers should refer to the following University Policy: Dignity at Work and Study Policy and Procedures (Harassment and Bullying).

Confidentiality

Researchers must ensure that all research data and its sources remain confidential unless participants have consented to their disclosure. In the latter case, researchers must ensure that plans have been made for storage and access to the data (see also ‘Data Management’ below).

Subject to the requirements of Data Protection Laws, information obtained about a participant during an investigation is confidential unless otherwise agreed in advance. In particular, identifiable personal information should only be conveyed to others within the legal framework and with the permission of the participant. It is the researcher’s responsibility to familiarise themselves with the current legal requirements on storage and access to personal data.

Researchers must appraise themselves of the limits of confidentiality from a legal perspective. Where they possess evidence pertaining to a legal case as a result of their research, they could be issued with a court order which would compel them to produce documents or to give evidence at a hearing or trial. Researchers must make the limits of confidentiality clear to participants. This should be conveyed in the Participant Information Sheet (PIS). The participant is required to indicate their informed consent either through signing a consent form or by another means (e.g. recorded verbal consent). In providing informed consent they are indicating that they have read the PIS and agree to take part in the study.

Safety and wellbeing of Participants and Researchers

Researchers should familiarise themselves with the University’s health and safety policy. They should also refer to university guidance on travel within the UK and overseas. A risk assessment should be completed if the research incurs a risk of injury or ill-health above the level of risk prevalent in daily living.

Researchers must keep in mind the safety of their participants, especially when working with vulnerable groups, and ensure that taking part in a study does not increase the likelihood of participants coming to any harm, either psychological or physical. At all times participants must not be exposed to unnecessary risks. If there is any possibility that participants might experience some distress or discomfort, then appropriate procedures for dealing with the distress or discomfort must be in place (e.g. referral to appropriate counselling services). Researchers must provide contact details for participants should they have delayed reactions to taking part in the study or wish to find out more about the study later.

Researchers have a responsibility to monitor participants in case of any unforeseen reactions to the study. Such monitoring is particularly important if deception has been involved. In the course of the research, a researcher may obtain evidence of psychological or physical problems of which a participant is, apparently, unaware. In such a case, the researcher has a responsibility to inform the participant as not doing so may impact upon the participant's future wellbeing. If the issue is serious and the researcher is not qualified to offer assistance, the appropriate source of professional advice or help should be sought and/or recommended.

Researchers must complete the relevant sections of Form A or Form B on risks of harm to researchers and participants when preparing their application.

Safeguarding

Researchers are required to ensure that they understand what their safeguarding responsibilities are. This includes being familiar with the University’s Safeguarding Policy, the Safeguarding Guidance for researchers and any other relevant policies and procedures. More information can be found on the University’s Safeguarding web pages.

Reporting criminal activity and other safeguarding concerns

Researchers should raise safeguarding concerns in line with the University’s Safeguarding Protocol. The recommended way to raise a concern is by completing the online Raising a Concern Form. If a researcher has been the victim of a crime or they have witnessed one during a Research Project which is based in the UK, the matter should be reported to the police. If a criminal matter arises when a researcher is not in the UK, for example, they are carrying out research overseas, then they should carefully consider who the matter should be reported to. For example, in certain circumstances, contacting the local police force may result in more harm being caused, and it may be better to report the matter to the University via the Raising a Concern Form in the first instance.

If a researcher requires advice about a safeguarding concern they should contact the Safeguarding Advisory Group by e-mailing: safeguarding@dundee.ac.uk.

Deception

Deception is where the researcher deliberately withholds information from or provides false information to potential participants about the true nature and purpose of the research. Intentional deception of participants about the purpose and general nature of the Research Project must be avoided whenever possible. However, deception may be necessary in exceptional circumstances to preserve the integrity of the research because the participants’ behaviour could be influenced by knowledge of the true nature of the research project. When applying for ethics review, researchers must provide a full explanation of why there is no alternative to the deception. They should ensure that participants will not experience undue distress and outline the steps to be taken to mitigate distress when the deception is subsequently revealed. The nature of and reasons for the deception must be fully disclosed to participants as soon as is reasonably possible, and participants must then have the opportunity to withdraw their data if they wish.

Recruitment using social media

Social media is increasingly regarded as an effective recruitment tool, which is growing in popularity, notably for historically hard-to-reach populations. UREC has developed guidance for researchers planning to use social media for recruitment. The aim of this guidance is to facilitate the use of social media in ways that are ethically and legally appropriate.

The casual and immediate nature of some social media interactions does not negate the requirement of the researcher to explain the basis of the proposed research and how the data will be captured, stored and processed. Consent must still be recorded, although this may be completed at the stage of recruitment onto the study.

Record keeping

Researchers are required to maintain consistent records of their processes. This includes information such as research design documentation and ethics approval paperwork. Records must be of a standard that would allow public scrutiny whilst protecting confidentiality and sensitive information. Data protection legislation (2018) requires ‘an effective audit trail of how and when consent was given’ by research participants. Records of consent must be maintained by the researcher to be used as evidence if challenged. They can be stored electronically in a University recommended cloud facility or in secure facilities e.g. filing cabinets. Please see the following for further information:

• More detailed guidance on GDPR for research staff 
• More detailed guidance on Records Management

Data management

Data management is the administrative process of collecting, organising, analysing, sharing, and storing research data during the research lifecycle. It is necessary to keep data safe, maximise data’s re-use potential and support longer-term preservation. Staff and postgraduate research students are required to complete a data management plan for proposed projects - the Library and Learning Centre (LLC) has a guide on Data Management Planning.

Where personal data and special category (sensitive personal) data are collected for research, processing of data must be documented to ensure compliance with the Data Protection Laws.

This includes keeping a record of:

• all correspondence with participants including consent
• safeguards in place to protect personal data

Research publication and research data publication

Any publication of research data has the expectation that individuals cannot be identified. Particular care is required in the publication of personally identifiable biometric data such as facial images, fingerprints, dental records, DNA sequences, skin features, characteristic behaviour patterns or other unique human biological data. Research data of this type must not be held in publicly accessible databases without the participant’s explicit consent, even when no other data identifiers are linked. This research data may be held securely in a Biobank with access controlled and available to registered and trusted researchers only.

Further guidance is available at the following links:

• University of Dundee Policy to Govern the Management of Research Data
• University guidance on Research Data Management
• University of Dundee Data Protection and Research – Guidance
• University of Dundee Data Protection web pages
• University of Dundee Policy to Govern the Publication of Research

Competence

The researcher(s) must be competent and qualified to carry out the research. Student applicants should indicate that they are conducting research under supervision. Staff undertaking research should ensure they have the relevant knowledge and skills. If they do not consider themselves competent in all aspects of the research they should seek further training before the research commences.

Protecting Vulnerable Groups (PVG)

Researchers working with children and/or protected adults in Scotland will need to apply to Disclosure Scotland for membership of the Protecting Vulnerable Groups (PVG) scheme. For research conducted in England and Wales, researchers should use the Disclosure and Barring Service (DBS). In Northern Ireland, AccessNI should be used. Researchers conducting research overseas should refer to Approval of International Collaborative Research Projects – Guidance for Researchers and School Research Ethics Committees.

Insurance

The University carries a range of insurances to protect itself and its staff and students. These include Professional Negligence, Public Liability, Business Travel/Personal Accident and Material Damage / Business Interruption. Researchers should consult the document Research and Insurance.

7.  Other Relevant policies, Procedures and Codes of Practice

There are a number of policy documents and codes of practice within the Policy Roadmap which are particularly relevant for researchers including:

Policy Check 3: Code of Good Practice in Research

Policy Check 7: Policy for the use of Human Tissue

Policy Check 10: Policy to Govern the Management of Research Data

Policy Check 12: Health and Safety

Policy Check 13: Data Protection and Records Management

In addition, researchers should refer to the following University policy: Dignity at Work and Study Policy and Procedures (Harassment and Bullying).

 

Document information

Policy number	RGPSC_230711_PNCRHP_v1
Date Approved	11 July 2023
Date for Renewal	July 2028 or as required

Appendix 1: Definitions Used in the Policy

Clinical Research	There are a range of projects which fall within the overarching category of healthcare or social care research ‘in or through the NHS’. Please refer to Checklist 1: Does the project require ethical approval?
Data Protection Laws	means all applicable laws and regulatory requirements relating to privacy and the protection of personal data including, without limitation, the United Kingdom’s Data Protection Act 2018 and any statutory modification or re-enactment thereof and the UK GDPR.
Information Governance	means the University’s Information Governance Team.
Informed Consent	means the procedure by which potential participants can reach a truly informed decision about whether or not to participate in the research. In order for Informed Consent to be considered valid, the Participant must be competent and the consent must be given voluntarily.
Non-clinical Research	means studies which do not fall under the category of clinical research which involves the collection and analysis of data from or about human beings. Please refer to Checklist 1: Does the project require ethical approval?
Participant	means any individual who has consented to take part in a Research Project.
Researcher	means any person involved in a Research Project.
Security-sensitive Research	means research which involves “viewing or otherwise accessing via the internet documents or records containing information which is likely to be useful to a person committing or preparing an act of terrorism” (Universities UK, 2019, p.4).
UK GDPR	means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data (as transposed into UK legislation).