Apply for Ethical Approval
1. All Undergraduate and Taught Masters research projects are reviewed at local School level. Students should liaise with their supervisors regarding this process. Please refer to the following documents:
2. For all other research projects that require ethical approval, you must submit the appropriate application form to REC at firstname.lastname@example.org. Please refer to the Calendar of REC meetings (.pdf) for details on submission deadlines and review process.
How to Apply
- Ensure that the application is fully completed with all supplementary materials included (recruitment materials, participant information sheet, informed consent, permission letters, etc. Incomplete applications will be not be reviewed, but will be returned for completion, which may delay their review.
- Avoid technical jargon and insider terminology, as REC members come from various academic and non-academic backgrounds.
- Ensure that the entire application, but especially the materials intended for distribution to participants, are free of spelling and grammar errors, and proofread for readability, clarity and accuracy.
The full application, including any accompanying documentation, should be submitted to email@example.com as one single electronic document.
Types of REC submissions
The appropriate type of application depends on a combination of risk assessment, the specific population to be researched, and the research methods to be used. The researcher, supervisor and research team (as applicable) should carry out an ethical assessment of their project to determine which form should be used. [flowchart] If the appropriate submission type remains unclear, advice can be sought from the REC by email. The REC application should include a brief justification for final decision reached. The REC review will include an evaluation of this justification and may ask for one of the other types to be used if the ethical assessment is deemed to be inappropriate. In this event, the reasons why resubmissions is being sought will be provided.
The following descriptions provide some guidance on the types of research projects which should be submitted for notification, expedited review or full committee review. The guidelines are broad because the ethical issues involved in specific research projects will be determined by their details. Examples are provided in each category, but these are not an exhaustive list of the projects falling into each category.
Not all research requires an application to REC. Such exempted research would be projects that do not involve animals or humans as participants or subjects. This includes:
- Research on publicly available information or records, such as: political speeches or debates; newspapers; opinion pieces; open-source qualitative data; company mission statements, etc.
- Projects involving assessment or audit of standard practice, such as clinical audit or assessment of teaching practice. The focus of exempted projects should be on-going practice or learning.
The boundary between audit and research is not clear-cut, especially if the intention is to publish the results of such studies. Researchers should evaluate whether journals in their field will expect such projects to have received formal ethical approval.
The notification form is to approve relatively low-risk research involving human participants, primarily using social science methodologies in which any personal information collected is not of a sensitive nature.
Examples of projects suitable for submission under this category include:
- Anonymous surveys in which the topic itself is not likely to elicit significant difficulties for the participants, such as: anonymous internet surveys (e.g. Survey Monkey), street questioning.
- Observation (without audio or visual recording) of public settings where privacy would not normally be expected, such as observing people on streets or at sports events.
- Research carrying no risks beyond those of everyday life (as experienced by the intended participant population), such as asking people’s opinions about products or services; asking students about educational experiences; monitoring the impact of daily activities.
- Interviews with public figures, professionals or others in their professional capacity regarding their professional activities.
- Analysis of data (e.g. health records) which have had all identifying information removed by the data holder and been provided to the researcher in accordance with data protection legislation.
- Collection of biological samples which are anonymised and do not require invasive techniques (e.g. hair, nails).
The expedited review process uses the full REC application form which is reviewed by a REC sub-group. This type of submission would apply to studies where, although information of a sensitive or personal nature may be sought, the risks to participants are considered moderate. When applying for expedited review, the researcher must consider the level of risk associated with the study and a justification must be provided to REC for why this level of review is sought. The level of risk may be influenced by the following factors: the vulnerability of the research group; the methods used; and the nature of the research itself.
Examples of projects suitable for submission under this category include:
- Research involving specified, REC pre-approved invasive techniques such as blood collection where standardised protocols, necessary training and appropriate supervision are in place. Many invasive techniques are not covered by such protocols.
- Research in which participants’ personal viewpoints, attitudes or beliefs are collected and participants are identifiable; or where sensitive questions are asked that could lead participants to have strong reactions, either in the long or short term; or where private information is collected.
- Certain types of research involving vulnerable groups or children where private information is not being collected and the topic is not sensitive. Such research should be unlikely to influence or affect the participants physically, socially, psychologically or spiritually. Examples could include asking people with intellectual disability for their views on a new product being developed for people with their condition, or asking children about an educational programme.
- Research which requires some inconvenience or minimal time commitment from participants rather than extensive burdens or time commitments.
- This category may be suitable for some, but not all, research projects involving participants in a dependant relationship with the researcher, such as professionals and patients; supervisors and employees; educators and students. Due account must be taken of how potential conflicts of interest will be addressed. The nature of the relationship, or the level of risk, may require that some projects of this type have full committee review.
- Projects involving deception of the form that participants are not given a complete list of the objectives in a direct and straightforward manner, such as research requiring that the subject be naïve to some aspects of the research so that their participation can be as authentic as possible.
- Research involving previously collected human tissues which are no longer identified but for which consent for research was not originally obtained.
Full committee review is intended for research that involves risks to participants which are greater than those found in everyday life. These may be of a physiological, psychological or social nature. Most projects involving vulnerable groups of participants will be included here.
Please note that any study involving animal subjects must undergo full committee review. Applicants should contact the Bio-Resource Advisory Group (firstname.lastname@example.org) in the first instance, as there is an internal review meeting to be undertaken with them before any application is submitted to REC.
Examples of projects suitable for submission for full committee review include:
- Physically invasive research other than projects involving pre-approved techniques that follow standardised protocols.
- Research using qualitative methods to investigate highly sensitive topics or those likely to illicit highly personal information, such as those involving significant relationships, suicide, trauma, sexuality or potentially unethical or illegal behaviour. Topics at risk of leading to stigmatisation or discrimination are also included here.
- Research involving vulnerable groups where the participants are placed at higher than everyday risk. Such research requires careful ethical evaluation as increased vulnerability sometimes increases the risk of harm to participants or generates additional types of harm. However, precise definitions of vulnerability are not universally agreed and research involving vulnerable groups raises different degrees of risk. For example, a project asking abuse survivors about their experience of abuse raises different levels of risk compared to asking the same people about issues unrelated to abuse. Such factors should be discussed clearly in the REC application.
- Research where the information obtained may have immediate and/or long-term legal, economic or social consequences for participants.
- Projects with a strong likelihood of identifying illegal activities, even if those committing such acts cannot be identified (such as some internet-based research).
- Research projects where participants are in a dependant relationship with the researcher and where the research process or its findings may negatively impact the participants.
- Projects involving surveillance and recording of people without their consent.
- Projects involving inducements or payments to participate that go beyond travel reimbursement or small expressions of gratitude. The concern is that these could be seen as enticing some people to accept greater risks then they might otherwise be willing to accept.
- Projects involving deception of the form where participants are provided false or misleading information; or where participants might experience guilt or other distress when the true nature of the research is revealed; or where the research topic is sensitive or the participants vulnerable.
- Projects that put participants or researchers in harm’s way.
- Research involving children that might provoke psychological discomfort or distress. Researchers working with children should be aware of child protection guidelines and conduct research involving children to the highest ethical standards. Children protection guidelines in relation to research were published in April 2012 and should be complied with. Researchers involving children should remain current in their knowledge of such responsibilities.
- Research involving other participants who cannot give full consent themselves, such as people with some types of intellectual disabilities, or patients who are not competent to consent.
- Research involving the collection of human tissues for research purposes.Research involving ethically controversial tissues such as human embryos, human foetuses or tissues from aborted human foetuses.
REC Submission Forms
- Notification Form for Low-Risk Projects (last updated Jan 2016)
- Expedited and Full Review - Application for approval of a project involving Human Participants (last updated Apr 2016)
Please note that if your research requires approval from the Biological Safety Committee, this approval should be in place prior to REC submission. Please refer to the BSC submission forms and associated documentation on the Faculty webpage.
All IMB applicants must contact BRAG in the first instance, as there is an internal review meeting to be undertaken with them before any application can be submitted to the REC. Further details available from the BRAG Chair - email@example.com
What happens next?
The committee will review your application at their next meeting. If you have submitted an application for Full Review (High-risk application), it will be reviewed at next full committee meeting (please note the dates in the calendar). The REC secretary will communicate with you regarding the results of your application, or if any further information is needed.
Your application may be approved outright, approved with minor revisions, or recommended for resubmission. If minor revisions are required, you must usually submit the revised application within a week of the notification of the result.