Research involving NHS patients, staff, premises, resources (pharmacy, radiology or laboratories) or data/tissue in England is required to go through the HRA’s approval process. Royal Holloway provides sponsorship for these projects rather than ethical review.

If you are unsure as to whether you require NHS REC approval, the HRA have created a decision tool, and a student-specific research toolkit. If you do require NHS REC approval you will need to complete an application using the Integrated Research Application System (IRAS). The HRA provides detailed guidance on the process and how to apply, which you should read carefully before submitting an application. The guidance also contains a link through to IRAS and a bite-size eLearning module. Please note that part of the process will involve the confirmation with the NHS trust of the capacity and capability to complete the project.

NHS REC review

NHS Research Ethics Committees (RECs) review research applications and give an opinion about whether the research is ethical. For most applicants to the HRA, the NHS REC review forms part of the overall HRA Approval process. For some projects that do not require HRA Approval NHS REC review may still be required.

Royal Holloway Sponsorship

The HRA stipulates for its approval process that research should have a sponsor, taking on overall responsibility for proportionate, effective arrangements to be in place to set up, run and report a research project, including the financial indemnity for a project. To acquire sponsorship from Royal Holloway, email your HRA ethics documents plus a completed Royal Holloway confirmation form (students / staff) to ethics@rhul.ac.uk (signed off by your Supervisor if you are a PhD researcher, and Departmental Director of Research if you are Staff). Confirmation of sponsorship will be returned in the form of an email. Please note that for clinical trials of investigational medicinal products (CTIMPs) there are additional legal duties, and sponsorship must be approved by a 'legal representative' of the College.

If amendments need to be made to a research project, Royal Holloway will need to again confirm sponsorship of the amended project. Please email the updated project documents, plus a newly signed confirmation form, to ethics@rhul.ac.uk.

Research passports

If you require a research passport, contact the doctoral school if you are a PhD researcher, and HR if you are Staff.

Doctorate in Clinical Psychology (DClinPsy)

For students undertaking work with the NHS for the Doctorate in Clinical Psychology (DClinPsy), sponsorship is signed off by the programme’s Research Director. (Please note, for research for the DClinPsy not involving the NHS, applications are to be submitted through Royal Holloway’s research ethics review process. Please see Applying for Ethical Review - Postgraduate Research Students and Staff, below).

Research by Undergraduates and Postgraduate Taught students is reviewed at the Department and School level. Please discuss with your Module Convener or Supervisor who will direct you to the processes within your Departments or Schools. The College has provided a template ethics application form to facilitate the review of Undergraduate and Postgraduate Taught research ethics but please consult with your supervisor to see if there are any specific School or Department procedures.

Postgraduate Research and Staff projects are reviewed by the College Research Ethics Committee through an online research ethics form (guidance on completing the form here - VPN required). After entering the system there are three pathways for receiving approval:

Self Assessment

When you enter Royal Holloway’s Online Ethics System you will be faced with a series of questions. If, for instance, your project does not involve human participants, animals, or have an impact on cultures, heritage, or the environment, you may be given the choice of completing a ‘Self-assessment’ review, and no further action will be needed. ‘Self-assessment’ applications are usually for research that are limited to literature analyses or theoretical research.

Please do remember the importance of honesty and rigour in the Concordat to Support Research Integrity, and how research misconduct has consequences for the integrity of your research, of Royal Holloway, and research more generally. If in any doubt, it may be best to err on the side of caution with your answers.

Full Review

Having answered questions in such a way that takes your project beyond Self-assessment, you will then be presented with a further set of tick-box questions and text boxes. If you tick boxes that indicate the presence of risks, please use the text boxes to explain these risks and the strategies you are putting in place to mitigate them. For guidance on how to identify and mitigate risks, please see the next heading below on Guidance.

Depending upon the nature of your research, you may need to upload additional documents. Please see the below header for further details. Once you have completed this form and uploaded your documents, you will be given the option to either submit their application for full review by Royal Holloway’s Research Ethics Committee, or stating you wish to 'self-certify' your project. If you decide to take your project to Full Review, your project will be reviewed by:

• Royal Holloway’s Research Ethics Officer
  • Identifying whether there are any obvious ommissions, whether supplementary documents should be provided, and whether there is enough content for peer reviewers to undertake a review.
• One or two members of academic staff from your Department, School, or cognate discipline (depending upon the risk level of your project)
  • Reviewing and either providing feedback to improve the application or passing to Chair-delegate for final approval
• Chair-delegate of the College Research Ethics Committee.
  • Reviewing and either providing feedback or giving the project ethics committee approval.

The process takes three weeks, though this can take longer if substantial edits are required for a project to receive approval.

Self Certify

In contrast, a self-certified project resembles the ‘Self-assessment’ route in that it is not taken to reviewers. If you choose to ‘self certify’ your project you can commence your project immediately. Self-certified projects should be of a very high standard, should be extremely detailed in their descriptions of the risks involved, have effective strategies in place for mitigating risks, and have all the required additional documentation in place if necessary. If you have any doubt about the quality of your strategies for mitigating the risks involved with your research or the documents that you are going to use then it is strongly suggested that your take your project to full review. Please also note that in order to comply with Royal Holloway's commitment to the concordat to support research integrity, ‘self certify’ projects are subject to audits by the Research Ethics Committee, and if your project is identified as one that is not robust enough then the Committee may reach out to you to ask you to revise your aspects of your research after it has potentially already commenced.

In addition to your ethics application, you may need to upload certain additional documents, depending upon your research project. If you choose to self certify your project, it is expected that you will provide these documents.

Participant Documents

• Participant Recruitment Material (Letter/Email/Social Media Post - template here)
• Participant Information Sheet (template here - please note that Royal Holloway requires as mandatory that the GDPR statement at the end of the document is included)
• Participant Consent Form (template here)
• Participant Debrief Form (for projects that may cause distress to participants during or after involvement)
• Questionnaires / Question lists (if applicable)

If you are working with research participants, you will need to upload participant documents. These provide evidence that you are adhering to the principle of being honest with your research participants and not exploiting them. In particular, evidence that you are pursuing informed consent from your participants. There may be situations when deception is necessary for a project. In these cases, we would need to see that full disclosure is present at the debriefing stage.

Data Management Plan

A data management plan will be needed to be uploaded to your application if you will be working with data such as 'identifiable data' and 'special category' Data, under GDPR. This could be for working with participants or for working with secondary data about people (see the national Information Commissioner's Office (ICO) webpages for more information on what constitutes this kind of data). To create a data management plan document, Royal Holloway recommends DMPOnline (registration required). This tool breaks down the elements of a data management plan through prompting questions, and gives you the option to produce a word document of your plan at the end that you can then upload to the ethics online system. The research data management team can also provide more detailed advice about more complex data protection questions (dataprotection@royalholloway.ac.uk).

Link to College Data management

Link to College guidance on GDPR

Data Sharing Agreement

Data sharing agreements might be needed for secondary data analyses (more on these below), and if your research data (including consent forms) is managed by a third party during the undertaking of your research.

Risk Assessment Plan (Lab-based and Fieldwork)

If you are conducting lab-based research or fieldwork (both in the UK or internationally), please upload a risk assessment plan that has been discussed with and signed off by your Department or School-based Health and Safety Co-Ordinator.

If you plan on analysing a dataset that includes data about people and which has already been collated:

• Did the individuals provide informed consent for the initial collection of the data?
• Are your research questions close to those raised for the initial collection of data? Is it reasonable to assume that the individuals that the data belongs to would have agreed to your research questions?
• How has the dataset been managed? Has it been managed in a secure fashion?
• Are data access agreements in place for accessing and using this data? (If so, please attach these.)
• Could anyone (including the research/s) link the data back to an individual or individuals? If this is a possibility, please explain how the associated ethical issues will be addressed:

Please note, secondary data analyses are not a means of bypassing Royal Holloway's policy that it does not provide retrospective approval for research that has already taken place.

Royal Holloway Guidance

Human Tissue Act Guidance

Approved Mitigation Protocols

In October 2021 Royal Holloway's Research Ethics Committee approved the implementation of a mitigation protocol in which opt-out informed consent when working with children in schools or other childcare settings could be deemed appropriate. The committee is actively investigating whether other approved mitigation protocols may help to provide clearer guidance for researchers when conducting research that raises more complex considerations for research ethics.

AMP01 Parent-Guardian Opt-Out Consent Protocol for Research in Schools and Other Childcare Settings

To request an amendment, please complete this amendment request form and email to ethics@rhul.ac.uk. This document should clearly detail each proposed change and why these changes have been proposed.

Should you require changes to any supplementary documents (information sheets, consent forms, debrief sheets) please provide a copy of each document in .docx format with track changes enabled. This will make it much easier for the reviewer to identify the amendments being requested and how they change the documents.

Approval must be received prior to the commencement or continuation of the project. Amendments are distinguished between Minor and Major Amendments. Minor amendments are reviewed approved by the Research Ethics Officer and can take up to a week. If the Research Ethics Officer decides that an amendment request constitutes a Major Amendment, it will need to be reviewed and approved by the Chair of the REC, who are given three weeks to review.

Minor Amendments (Approved by Research Ethics Officer within Three Working-Days Timeframe)

• Amendment to research methods that mean that the project operates at the same or lower level of risk
• Minor textual errors, e.g. correcting errors, updating contact points, minor clarifications
• changes in funding arrangements
• changes to contact details for the chief/principal investigator or other study staff
• extension of the study beyond the period specified in the application form
• changes to the research team (excluding the Principal Investigator), subject to confirmation of additional researchers having undertaken appropriate training in research ethics

Major Amendments (Approved by Committee within Three Week Timeframe)

• changes to the design or methodology of the study, or to background information affecting its academic value (including addition of participants);
• changes to the procedures undertaken by, or other requirements expected of, participants (including any change relating to the safety or physical or mental integrity of participants, or to the risk/benefit assessment for the study)
• significant changes to study documentation such as protocol, participant information sheets, consent forms, questionnaires, letters of invitation, information sheets for relatives or carers
• appointment of a new chief/principal investigator
• change of territory for international studies
• temporary halt of a study to protect participants from harm (or resulting from a concern or complaint made), and the planned restart of a study following a temporary halt
• any other significant change to the terms of the REC application

Please submit your amendment request by emailing it to ethics@rhul.ac.uk.

Professional Guidelines

In grant application forms funders are increasingly requesting information about the ethical considerations of a research prokect. This can be difficult at such an early stage. Projects can change, albeit in very subtle ways, between writing a grant application and being awarded with funds. Moreover, the word count for outlining a project's research ethics can be very short.

Try to avoid making general claims that your project is ethically sound, that there are no real ethical issues, or that you are an experienced, ethical researcher. Instead, focus on the process. Your experience may inform how you mitigate a risk (experience of a location, working with vulnerable adults, etc.), but as with research ethics applications, focus on specific risks and specific mitigations for those risks.

Three specific considerations when writing your ethics statement:

1. Funder guidance:

• Does the funder have any requirements, stated in either the documentation for the funding opportunity, or the funder’s more general terms and conditions?

2. The essential ethical considerations of the research, and potentially how to mitigate them:

• Familiarise yourself with key risks, as outlined in the ethics application process at Royal Holloway, and established mitigations. 

3. Evidence a commitment to submitting the research for review by the College’s Research Ethics Committee:

• To summarise the ethics section, state that you have identified what you think are the key ethical issues and the ways in which you will mitigate them, but that you will take your project to Royal Holloway’s Research Ethics Committee to finalise.

Royal Holloway has access to an interactive training programme provided by Epiguem, accessible via Moodle (login credentials required).

In addition there are recordings of the following sessions:

Royal Holloway's Research Ethics Committee (REC) is responsible for overseeing all research ethics matters for research at Royal Holloway and is accountable to the College Council.

The REC is chaired by the Senior Vice-Principle (for Research), who has overall responsibility for research ethics and integrity at the College. The Chair provides the final stage of decision making and ethical approval on behalf of the REC.

The REC is serviced by the Research and Innovation team. For detailed queries about the Committee structure for overseeing research ethics and integrity at Royal Holloway, please contact ethics@rhul.ac.uk.

Royal Holloway's Research Ethics Policy

Royal Holloway’s commitment to research integrity

Other Research Related Policy Documents

Lockdown measures in England and international travel restrictions have now eased, but Covid-19 remains a challenge for ensuring the health, welfare and safety of students, staff, collaborators, and research participants. The College continues to recommend that research be conducted remotely if possible, but when research needs to be conducted in person, please consult:

• The College's guidance on the Practical implications of Covid-19 restrictions
• Your research with your Departmental or School-based Health and Safety Co-ordinator.

Updated 20-Aug-2021