BSREC will need to see a fully complete application form and any relevant supporting documents including: information leaflets, consent forms, questionnaires, interview schedules/topic guides, invitation emails, leaflets, posters and any other participant facing documents relevant to the project. As of October 2018 there is no requirement to submit a protocol with the BSREC application. Please note where protocols are submitted to accompany the application, the application will be reviewed based on the information provided in the application form. Please do not answer questions with 'see protocol'.
This is fine, the questionnaire can be submitted later on as an amendment to the project once it has been developed.
No- it is not mandatory to use the BSREC templates available, but it is strongly recommended that you refer to these for guidance on what to include in each document.
BSREC requires evidence that your Supervisor has reviewed and approved the application before it can be sent for review. If it is not possible for the application form to be physically signed by your Supervisor, then an email in lieu of this can be accepted, from the Supervisor’s Warwick email address.
No- Committee review is determined by the Faculty in which you are based, not by the type of research. The only exception to this, is for projects that involve the NHS, which will be reviewed by BSREC, regardless of where the applicant is based.
The application needs to provide enough detail so that another researcher could pick up the protocol and carry out the project without needing to ask any questions. The more detail provided will reduce the number of queries the committee may have about the project. This also needs to be clear and written in a lay manner so that a non-specialist in the field can understand the study. Technical terms should be avoided where possible.
No- questionnaires are considered self-consenting so it is not necessary for participants to complete a separate consent form. Instead a statement should be included in the introduction to the survey to state that by completing the survey, participants are consenting for their data to be used in the study. An information leaflet should still be provided to explain what the study is about, and what will happen to the data etc. but this can be built into the introduction and doesn’t need to be a separate document. It should be clear to participants how they can withdraw from the study if they change their mind.
Personal data refers to data which relate to a living individual who can be identified:
- from those data, or
- from those data and other information which is in the possession of, or is likely to come into the possession of, the data controller, and includes any expression of opinion about the individual and any indication of the intentions of the data controller or any other person in respect of the individual. Further guidance from the Information Commissioner’s Office can be found here.
Pseudonymised data means replacing any identifying characteristics of data with a value which does not allow the data subject to be directly identified. This is different to anonymous data and only offers limited protection, as it still allows identification by an indirect means. It is therefore still classed as personal data and should follow the same guidance.
Anonymisation is the process of removing personally identifiable information from data sets so that an individual cannot be identified by the remaining data set. Simply redacting an individual’s name does not necessarily make the data anonymous. There is still a risk of indirect re-identification if the data set could be linked to a data subject by age, postcode, medical condition or job title. The more information included in each data set, the greater the risk of identification when combined. Small data sets and specific characteristics e.g. ethnicity or gender may also increase the chance of identifying individuals. The Information Commissioner’s Office guidance on the principles of anonymising data can be found here.
Whilst blacking out eyes of photographs or digitally blurring images can distort features, it is entirely possible that a subject could still be identified by friends or family. Since complete anonymity of faces is almost impossible to achieve, informed consent should always be sought from participants. Applicants should be aware of ensuring anonymity where this may not be possible.
Not necessarily. It would be the responsibility of the researcher receiving the data to check with their organisation on the ethical review requirements for secondary analysis of previously collected data. However, before any research data is sent to a third party, it is your responsibility to note the terms in which this data was originally collected. This should be detailed in the research protocol and relates to what the purpose the data was originally collected for (i.e. was this limited to use for research purposes), the consent given for the data collection (i.e. was it specified that the data would not be shared with third parties) and in what format the data will be transferred (i.e. anonymised, identifiable). You do not need individual consent to share anonymous research data with a third party but you must make sure there is no chance any individuals can be identified from the data set. Please contact R&IS to discuss data sharing agreements before any data is transferred out of the University. To use research data for commercial purposes, please contact Warwick Ventures.
Participants need to be aware that they can withdraw from a study at any time without giving a reason but it needs to be clear how they do this. For online surveys participants can change their mind at any time by closing the browser. It must be made clear that once responses have been submitted, it will not be possible to withdraw data from the study as responses are anonymous and it will not be possible to identify individual responses.
The University recommends using Qualtrics or Bristol Online Surveys to distribute online surveys/questionnaires. These tools have been approved by the University’s Information Governance team as secure for hosting data. Please note Survey Monkey is not currently a University approved service.
Opt-out consent is permissible in certain projects where the participants are not considered vulnerable or the study is not investigating a sensitive/intrusive topic. The process must be clearly detailed in the protocol and justification for why this is considered appropriate should be provided.
No. All research agreements/contracts should be signed off by an appropriate individual on behalf of the University, not the researcher or the supervisor. Please contact R&IS for guidance.
It depends on the age of the children and also their competency. Good practice would be to also obtain consent from the parents as well but this depends on the nature of the study. The approach taken should be appropriate, detailed and justified in the research protocol. The ESRC provides further guidance on this.
Yes- the current contact for complaints is the Head of Research Governance/Deputy Director of Research & Impact Services. Contact details can be found in the BSREC template Information leaflet.
No- the application needs to detail exactly how you will ensure compliance with the data protection regulations/principles and how you will will mitigate any risk of accidental disclosure of data, especially where this is personal or special category data. The application form asks specific questions about this.
University policy is that research data should be reviewed after 10 years to see if the data needs to be retained or can be deleted. This applies to research data which would be necessary to back up publications resulting from the data if the published results were challenged. Similarly, consent forms should be retained for this period of time in case of a challenge. Consent forms should be stored separately to research data.
For student projects or projects where the results will not be published, research data can be deleted as soon as it is no longer required. This will often be after the student has completed their course and the final grade is given.
Yes- a small token as a ‘thank you’ can be offered to research participants but this must be appropriate and proportionate to the amount of time/level of involvement required from the participant in the study. Payments must not be excessive so that they could be seen as a bribe or to coerce people into taking part in a study. Vouchers are generally considered more appropriate than cash rewards. The chance to be included in a prize draw is also another common incentive used in research. See further guidance from the Heath Research Authority .
Social media can be used as a method of recruitment but consideration should be given to who’s account will be used to advertise the study, how this will be done, and where the advertisement will be placed. The advertisement text used will need to be reviewed by BSREC. Permissions must be sought from the administrator of any specific groups targeted, before posting any recruitment materials.
24. Do posts on social media count as publicly available data?
No- quotes and opinions posted on social media do not count as publicly available data, and should not be used for research purposes without permission/consent from the individual, regardless of privacy settings. Studies gathering information this way must also be subject to ethical review by BSREC.
Yes- this is for audit purposes, and so it is easy to keep track of documents should amendments be required to the study as it progresses. It also makes sure that the study team are using the correct and latest version of information leaflets and consent forms etc.
There are multiple acceptable approaches to gaining electronic consent. This may be advisable when research is being conducted remotely and where there will be no opportunity for participants to physically sign consent forms. Recording verbal consent using an Information and Data Compliance (IDC) approved platform is one option. Asking participants to print a consent form, sign it, scan it, and return it is another option. Using 'e-consent' signatures is another option. The HRA and MHRA have published useful guidance on this topic which can be accessed here.
You should first consider whether it is necessary to collect this personal data. If it is not required for your research, in keeping with the principle of data minimisation, it would be best practice to not collect gender data. However, if this is required information you should allow a free text response where possible, the give respondents the opportunity to most accurately describe their gender. If a free text option is not possible (for example if you require a discrete set of data points), the following set of response options should be used:.
- Prefer not to say
Further guidance can be found on the University's Equality, Diversity and Inclusion web pages.