Research ethics guidance

Download Case Study 1: Qualitative (PDF)

Analysis of demographics of a regional science festival audience and impact on participants’ science capital

Project description and aim:

A university hosts a regional science festival every year; the event is a key part of the institution’s public engagement activity. However, the event’s impact on the young people attending in terms of STEM (Science, Technology, Engineering and Mathematics) knowledge and perceptions of higher education is unclear. The university has initiated research/evaluation studies aimed at investigating the impact of this event on young peoples’ attitudes to science and higher education.

Methods: 

This mixed-methods research was conducted with three groups: school pupils, teachers and festival organisers. This case study focuses mainly on work with young people, as interviews with adults in professional roles provide fewer ethical challenges.

The young people in this research cohort were in Key Stage 2, aged 7–11. To gather their views, a group of researchers conducted online surveys with the school-registered children both before and after attending the festival. In addition, the researchers conducted a series of focus groups with young people in their schools to gain a deeper understanding of their views on science and education and how these were impacted by their visit to the science festival.

Key ethical considerations:

The children attended the science festival independently of the study; thus, ethical scrutiny focused on the study instruments (survey, interviews and focus groups). The study itself was considered low risk as it focused on what the pupils thought of the festival, what they had enjoyed and whether anything had made them think about what they might like to do in the future. All these areas were thought to be the kinds of discussions that children may have had at school as a result of attending the festival with their teacher. There was an additional time demand on pupils for completing the survey, being interviewed or taking part in a focus group. Care was taken to minimise this time, and the study was conducted in a way that reduced disruption to the pupils’ education. The study met the criteria of an ‘audit’; nevertheless, given that it would be reported in general terms to the science festival’s stakeholders, and potentially reported in academic publications, a standard process was used for ethical consent and care was taken to anonymise data for dissemination.

Schools were initially approached for institutional consent to conduct the study with their pupils at school. This included briefing teachers on how to support pupils and parents in giving or withholding informed consent.

The first and most significant issue to note is the importance of ensuring that parents and young people had clarity about what participation in the study involved and that they were able to give informed consent.

Written consent was sought only from parents. Due to the demographics of the area from which this research cohort was drawn, the researchers anticipated that some parents might have a first language other than English, and others might have low levels of literacy. It was important, therefore, to provide project documentation written in simple language and to achieve a suitable balance between the desire for simplicity and the need to fully explain the ethical considerations to participants.

The survey was conducted by the teacher in the classroom, and pupils were reminded that they did not have to answer every question.

Consent from child participants for the online survey was gathered through their submission of the survey. Here, given the power imbalance between pupils and teachers, the key consideration was ensuring that pupils were free to decide not to participate. The researchers ensured that the teacher made it clear to pupils that they could refuse to take part for any reason, or without giving a reason, and this was written in clear English at the beginning of the survey. Verbal active consent was sought from participants. The researchers also asked the teacher to ensure that an alternative activity was available for non-participants, to avoid classroom management issues.

For the focus groups, the researchers recorded oral consent at the beginning of the session and afforded participants the opportunity to leave and return to the classroom. The interviews and focus groups were conducted in public spaces around the school (e.g. the school library) and were audio-recorded on a password-protected, encrypted recording device. The recording was transferred to the university’s secure OneDrive as an encrypted, password-protected file. The researcher/evaluator was skilled at conducting interviews and focus groups with children and had an enhanced safeguarding check. Children and parents were given one week to withdraw from the interviews. Withdrawal from the survey or the focus group was not possible after the post-festival survey. Interviews and focus group recordings were transcribed and anonymised. After the post-festival survey had been completed, the pupil’s identities were permanently deleted from the survey results.

Ensuring that both young people and researchers were comfortable during the focus groups was important. However, several unforeseen logistical challenges arose that the researchers had to address by improvisation; it would have been beneficial to have planned for these.

In one example, during a focus group, the supervising teacher had to leave the room unexpectedly; during their absence, some participants became slightly disruptive, which impacted the comfort of others. In another incident, a young participant who was not a native speaker of English struggled to understand the researcher’s questions. The difficulty was resolved by a bilingual pupil translating the questions and responses. Advance consideration of these types of situation might have brought a better outcome.

The researchers also had to ensure that schools, as gatekeeper organisations, understood what was involved for staff and pupils participating in the research project. If research is conducted on the premises of an organisation, it is common practice that consent be obtained from a member of the senior leadership. Due to the school’s responsibility for the children’s welfare, Senior Leadership Team (SLT) consent to the study was sought and obtained. Consent was also obtained from SLT to approach teachers as participants; this was needed because the study was directly linked to their employment in the school.

The researcher/evaluator conducted a post-study debriefing session online with the teacher to discuss any issues that might have emerged.

Scientific limitations and recommendations for future research: 

• Ensure that information sheets are accessible to adults with low levels of literacy and to non-English speakers, while still conveying key messages about the purpose and methods of the survey and what consent entails.
• When interviewing/surveying primary school children, prepare a simple explanation about what you are doing and what will happen to the data they provide.
• When teachers are involved in administering surveys, ensure that power imbalances are taken into consideration and pupils know that they are free to withdraw. Make sure they can withdraw without feeling uncomfortable and without this creating classroom management issues.
• When visiting schools to conduct research, discuss SLT expectations of what the event will involve, ensuring it aligns with your own understanding, including:
  • expectations around supervision of the session by staff
  • practicalities, such as whether some children involved may likely have limited English.
• Consider whether consent from organisations, such as schools, needs to be sought for the study to go ahead.

Download Case Study 2: Cluster randomised controlled trial (PDF)

A cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of higher education/career interventions with Level 3 students from low Index of Multiple Deprivation (IMD) areas

Project description and aim:

Heads of year in further education colleges have a key role in guiding students and, as research has indicated, a strong commitment to raising aspirations. It was unclear whether an intervention based on cognitive behavioural therapy (CBT) principles led by these teachers could improve the likelihood of their students applying for a higer education course. Thus, this study aimed to evaluate the effectiveness and cost-effectiveness of a targeted advice intervention provided by further education heads of year in the nine months before university applications were made.

This study was designed as a cluster randomised, multi-centre, controlled trial. The participants were students aged 16 and older, taking courses that could lead to higher education and in the lower two quintile areas according to the IMD. The study was conducted in 15 local authority areas of the UK between March 2014 and December 2015. After stratification by local authority, further education colleges were randomly allocated to group A (training and delivery of the intervention at the beginning of the study) or B (training and delivery nine months later, i.e. to the next student cohort). The allocation used computerised random number generation in blocks of five. Each further education college recruited five students, with both groups followed up for nine months.

Methods:

The intervention consisted of four systematic, structured, face-to-face consultations with the head of year, covering the student’s assessment scores and aspirations, the process of applying for a higher education place, including how to choose a course, possible career possibilities and outcomes for the student. It also provided an opportunity to discuss possible barriers to the student applying for an higher education course. The consultation plans were informed by CBT but were not therapeutic in style or content.

The primary outcomes were self-reported beliefs about the likelihood of applying to higher education (assessed at six months using the 12-item TICCCL [Trowsdale Indices of Confidence in Competence, Creativity and Learning]) vs actual application to higher education. Secondary outcomes were strong future career narratives, an understanding of possible future educational paths, and the cost-effectiveness of the intervention compared with usual advice. Although blinding was not possible for either teachers or students, the assessment of outcomes was conducted by researchers blind to group allocation.

Key ethical considerations: 

Three key ethical issues were identified in this study: informing students and further education college staff and gaining their consent, addressing the unequal treatment of intervention and control groups, and the possible harm caused by over-raising students’ aspirations.

The project team worked hard to develop a series of information sheets and a video for students and further education college staff. The project coordinator also had online conversations with key senior members of the further education colleges involved, including the head of year, covering the nature of the project in more detail and the inclusion criteria for selecting students. The team also provided support documents for teachers to use in introducing and discussing the project with potential student participants. All student-facing material was piloted for intelligibility for 16-year-old students.

Further education college leaders were asked for consent to conduct the study in their college. Heads of year and students were asked for their consent to be involved. As all students were over 16 years of age, they were deemed competent to give their consent, and parental consent was not sought. However, a short information sheet was given to student participants to hand to their parents. This invited parents to contact the college or the research team if they had any concerns.

While the key purpose of the study was to find out whether the intervention had any impact on students’ applications for higher education courses, there was anecdotal/intuitive belief amongst further education staff that the intervention would be beneficial to their Continuing Professional Development and Learning (CPDL). The design was, therefore, costed to include CPDL and support materials for the control group further education colleges to use in the following year. Given that the intervention had implications in terms of demanding time from students and further education college staff, there was no clear evidence that it would be beneficial and, after ethical scrutiny, it was agreed that a principle of equipoise existed between the two arms of the randomised controlled trial (RCT).

Finally, there was a risk that engaging in this additional intervention might unrealistically raise the aspirations and expectations of the students in the intervention group. This was discussed with further education staff in the preliminary conversation about inclusion criteria. The participating students needed to be capable of successfully applying to an higher education course, and the intervention conversations were to be challenging but realistic in their evaluation of career/educational aspirations and goals.

Scientific limitations and recommendations for future research:

It is essential to identify and avoid bias in research, but issues with sources of bias may have occurred in this research. For example, the teachers providing the intervention were responsible both for selecting students and entering the data collected onto the electronic template; both tasks are possible sources of bias. The overall population included more males than females (p < 0.01).

However, none of these issues was deemed sufficient to conclude that the study would not provide valuable scientific evidence about career/higher education interventions.

Download Case Study 3: Qualitative and quantitative (PDF)

Evaluating the impact of different academic support schemes for first-year students

Project description and aim:

The university has a centrally managed and funded Student Academic Support scheme which promotes peer support of first-year undergraduate students by second- and third-year undergraduates. The scheme is not compulsory, and several departments across the university have their own approaches to peer academic support for first-year students that have emerged historically in the development of the university and its departments. The study was designed to assess the impact of the centrally managed scheme and two other departmental schemes on the academic development of first-year students.

This is a form of service evaluation, in that it is primarily concerned with improving the university’s support for its students, but the study’s conclusions and details of the data obtained will be circulated widely in the university and beyond. Should the study show one scheme to have a greater impact on student retention, progression or grades, this would directly affect the university’s policy. It was also clear that the evidence developed had potential implications for other universities and should be disseminated via conferences and publications.

Methods:

The study had a mixed-methods design and included three elements:

1. Statistical analysis of the retention, progression and overall grade for all first-year students in relation to their level of attendance and the academic support offered to students by their department and also examined in relation to Index of Multiple Deprivation (IMD) score for home address, gender and whether students commuted or lived in student accommodation.
2. Audio-recorded focus groups (of a random sample of first-year students in each of the three types of support scheme) were held for: (1) non-attendees at support sessions; (2) occasional attendees (<33% attendance); (3) regular attendees (33–66% attendance) and high attendees (>66%), with 9–11 students in each of the 12 focus groups.
3. Interviews with second- and third-year students who were peer supporters on each of the three schemes.

The researchers also gathered background information about the schemes that were publicly available within the university, including minutes of planning meetings and any formal notes made by members of staff.

Key ethical considerations:

The three elements outlined above each brought ethical concerns.

Firstly, a central team could conduct the statistical analysis anonymously if attendance at academic support sessions were recorded directly in the same way as attendance at lectures and seminars. This required a change in the way data was collected but avoided the need to manually add attendance to the database (which would have required knowledge of students’ names). Further, it was realised that it could be possible to de-anonymise data collected for small course sizes. After investigation, it was concluded that de-anonymisation was unlikely to be possible in course cohorts greater than 50. A margin of error was built in, and courses of fewer than 60 students were excluded from parts of the analysis. It was judged that this part of the study carried a very low risk and, as it was anonymous, did not require ethical consent from students.

The second element – the focus groups – was considered to present a higher level of risk and multiple ethical challenges, including:

• the need to identify students to contact them
• the potential harm of discussing academic needs and support, especially with students who had not attended or attended very few sessions
• the need to audio-record, transcribe and then quote students in reports
• the lack of confidentiality given by a focus group compared with interviews or questionnaires.

The team decided that the student’s voice was necessary for the study and that collective discussion in groups, segmented by attendance level and the support scheme available, was also methodologically the most desirable way of gathering data. The team decided that course teams should put a short video on their virtual learning environment and show it in an all-course lecture. This video gave details of the study, explained that the evaluation team might be in touch via university email and confirmed that students would not be disadvantaged if they did not agree to take part in the study.

Course leaders were briefed on how to support unsure students. The study team contacted potential participants, and course teams did not know who had been invited or whether they had consented or refused. A random sample of students was approached with an information sheet and consent form, and given the day and time of the focus group. These meetings were scheduled over lunch when there were no lectures; lunch was provided, as were travel expenses for commuting students who were not on campus that day. Participants were also given a university travel mug and a voucher for a hot drink by way of a thank you.

Staff in central academic support had been briefed about the study and any student who was negatively affected by the focus group conversation was directed to their offices. Participants were assured of confidentiality from the study team and reminded of their right to withdraw at any point until the end of the focus group. In the focus group, participants gave themselves pseudonyms and referred to each other using these names during the session. The study team did not record the real names of participants. Transcriptions and notes were, therefore, pseudonymised at the point of data collection.

The third element of the study was deemed of lower risk. All second- and third-year students involved as peer supporters received from their scheme coordinators an information sheet outlining what was involved in the study. They were invited to email a member of the study team to arrange a mutually convenient time to meet on campus for an interview and were sent a consent form to complete. The interviews took place over a hot drink and vegan cake and lasted around 30 minutes, focusing on what those students thought the first-year students had gained from the support sessions. The interviewer was experienced and monitored for any indication of discomfort or distress. However, none was evident. Following the interview, the participant was sent a thank you email, a voucher for a hot drink on campus and a reminder they had a further 48 hours to withdraw from the study.

The background documents used in the study were publicly available to all university members and had been redacted to remove any personal information. It was therefore decided that these documents could be used without further consent from their authors.

Scientific limitations and recommendations for future research:

The anonymity of participants’ personal information should be protected even when the main source of information is pre-collected data. Especially when a large statistical analysis is involved, de-anonymising samples can be difficult or impossible. An alternative approach should be considered if this is the case.

When identifying and approaching students in educational settings, the power dynamic between students and teachers can trigger ethical issues. For example, in this case, the course convenors were in a position to support and inform about the project, but were not required to approach or invite students. Thus, students did not feel they had to participate in the focus group because of the power relations between them and their teacher (e.g. for fear of losing marks if the course convenor were their examiner). Conversely, the course team did not know which students were involved in the project. The participants’ identities were further protected by not exposing their choices to non-investigators.

Download Case Study 4: Large scale quantitative study (PDF)

Education outcomes

Project description and aim:

This quantitative study involves an outreach programme for primary and secondary school students in Lancashire. The participating schools asked all students (with consent forms) to complete an annual attitude survey. This research aims to identify any key points in the education journey where certain attitudes may be linked to higher education progression and whether any specific type of activity helps shift such attitudes.

The research team for this project has a partnership with six secondary schools and eight of their feeder primary schools, as part of a School University Network (SUN). The team delivers a programme of activities including, but not limited to, workshops, masterclasses, campus visits, mentoring programmes, residentials and subject-specific enrichment activities.

In this study, the researchers use pre-collected student demographic data with questionnaire data that assesses students’ attitudes towards higher education. The three main areas that the researchers wish to investigate in this project are:

1. Whether there are links between certain widening participation (WP) indicators set by the Office for Students (OfS) (e.g. first in the family to study at university or living in a low higher education participation neighbourhood) and attitudes toward higher education.
2. Whether a change in attitudes can be linked with certain activities to assess which are more effective, e.g. are mentoring programmes more or less effective than academic enrichment?
3. Whether certain attitudes are linked to progression by cross-referencing survey responses with higher education progression.

Methods:

The researchers are collecting data on the students to assess whether they meet the WP criteria and tracking them using the Higher Education Access Tracker (HEAT). Researchers can then analyse whether certain attitudes correlate to demographic data and track changes in attitudes linked to the activities in which students have participated. In the long term, they will be able to track these changes over time and eventually use the HEAT tracker to identify whether the students go on to study in higher education.

All parents/carers and students over the age of 13 years are given a Data Privacy Notice. In this research, the lawful basis for processing the data for evaluation and monitoring is a public task. Parents/carers and students can object to their data being processed and stored in this way at any time. If students/parents consent to participation in the research, the researchers will link the data and use it for research purposes. If parents complete a reply slip about the SUN programme but do not consent to the research, the student can still take part in the programme activities, but the researchers cannot use their data for research.

To monitor and evaluate this programme, the researchers use the HEAT database. This tracker provides the following information:

• Anonymised KS4 attainment data
• Anonymised KS5 attainment data
• HE progressions data
• Graduate outcome data.

The researchers collect the following data and store it on HEAT along with information about the activities in which the students have participated:

• Name
• Date of birth
• Email address (if available)
• Postcode
• Gender
• Ethnicity
• Whether anyone in their family has gone to university.

In addition to the above data, the researchers also collect data on whether students are eligible for pupil premium funding as a proxy for household income, whether students are young carers, whether they have experience of care and whether they have a disability. These are some of the criteria the researchers use to assess whether students are eligible for the WP activities. This data will not be stored on HEAT, but is held on a spreadsheet on a secure server.

The researchers collect information about students’ attitudes towards higher education annually, through a questionnaire completed at school.

Key ethical considerations: 

Initial school consent was gained as part of the arrangements for running the outreach programme with the schools.

Given the age of the participants, parental consent is required as well as pupils’ consent. As data collection is via questionnaire, pupils’ consent can be recorded through its submission. The questionnaire indicated the purpose of the study and each head of year had emphasised to pupils their right not to complete the questionnaire. Teachers were also briefed on the right of a pupil not to complete the questionnaire and the need to provide alternative activities.

Parental consent was more difficult to obtain, for two reasons. Firstly, the essential content on the information sheet was extensive and potentially off-putting to parents. The risks of the study and the time commitment required from pupils are both very low, and the questionnaire will be conducted in school time. The information letters covered both GDPR requirements – that this study was being completed on a public task basis – and the ethical requirement to obtain consent. This complexity in messages and wording made the letters difficult to follow especially for those for whom English is a second language.

The second issue was that, for some pupils taking part in the programme from less advantaged households, parents were less likely to return completed consent forms. It would have been potentially more inclusive to assume consent or to allow pupils to consent without parental consent. However, given the age of the participants, neither of these options was ethically justifiable.

All pupils were permitted to take part in the outreach events, regardless of whether they or their parent(s) gave consent for the study.

Scientific limitations and recommendations for future research:

Guidance around ethics, and the ability for schools to take an opt-out approach rather than requiring opt-in consent from parents, would ensure that more students can engage in WP interventions and that they are proportionally represented in evaluation and research results.

Guidance around and consideration of research designs should be more inclusive in the ethical collection of data from pupils from disadvantaged backgrounds.

Download Case Study 5: Randomised controlled trial (PDF)

The impact of summer schools on widening participation in higher education

Project description and aim: 

In 2019, the Education Policy Institute (EPI) and TASO conducted an evidence review of pre-entry interventions for higher education by assessing the benefit of summer schools in boosting higher education enrolment rates. The evidence review suggested that attendance at summer schools was correlated with increased aspiration and confidence related to higher education; however, this evidence is correlational rather than causal. There is a lack of evidence definitively showing that summer schools are an effective intervention, particularly in increasing enrolment rates in higher education for disadvantaged and underrepresented groups. To build a causal evidence base for summer schools, a group of researchers initiated a randomised controlled trial (RCT) in collaboration with eight partner higher education providers to evaluate the impact of summer schools on aspirations and attitudes related to higher education and on higher education enrolment rates.

Methods:

This project involved eight partner higher education providers (HEPs) in England. Four HEPs ran summer schools for students under the age of 16 (Years 9 and 10) and four HEPs ran summer schools for students over the age of 16 (Year 12). Applicants to each summer school were given participant information sheets that explained that the summer school they were applying to was part of a research project and what this entailed. At this point, applicants could choose whether they wanted to participate in the research project and were told that their decision would have no impact on whether they would be awarded a summer school place or not. All applicants meeting the summer school eligibility criteria (widening participation criteria) were randomly allocated to either the intervention group (they received a place) or the control group (they did not receive a place). This was possible because both summer schools were oversubscribed and, therefore, had more applicants than places available. Before and after the summer school, both intervention and control group students were asked to complete a survey on their attitudes and aspirations regarding higher education. In the long term, the researchers used the Higher Education Access Tracker (HEAT) to track whether applicants later enrolled in higher education.

Key ethical considerations:

The eight partner HEPs included students from different age groups. The four HEPs targeting students under the age of 16 gave students the option to opt out of the study. Students and/or their parents/carers had to complete an opt-out form within two weeks if they did not want to participate in the research. It was deemed that these students were old enough to make their own decision; however, their parents could support the decision if required. The opt-out process was deemed ethical because all students would be required to give full consent at the point where their data was being collected, that is when they completed the questionnaire.

At this point, opt-out was chosen to allow students and parents not to be involved, but to avoid narrowing the pool of potential participants, as good coverage across the entire participant population is essential to ensure that analysis and findings from the data are accurate, unbiased and representative. If the researchers were to ask pupils and parents for fully informed consent at this point, only the most engaged pupils and parents, who actively take steps to opt-in would be included. The researchers would miss the overall story of differential education trends, because data under the opt-in model would reflect only a small, selective portion of the population.

For the four HEPs targeting students over the age of 16, opt-in consent was used at the initial application stage. Consent was not required from parents as the students were over 16. As part of their application to the summer school, students were required to read the participant information sheet and tick a box if they were happy to participate in the research.

Regardless of whether consent was given, all applicants were part of the randomisation process described above which decided their place on the summer school; however, those applicants who chose not to participate in the project were not tracked after the project or contacted to complete any surveys.

Full information was provided to students at the beginning of each survey and its submission was deemed active consent. Given the low risks of the survey and the relatively short time required for completion, consent from students, regardless of age, was deemed sufficient.

Explicit consent from students was also gained to track their future application(s) to higher education.

Scientific limitations and recommendations for future research: 

Some of the partner HEPs used local partner schools to recruit for their summer schools. These schools were only involved in the project via a third party and were not, therefore, directly engaged with the researchers. This posed difficulties for the researchers and the HEPs, who did not know whether students or parents had been fully informed about the nature of the project or whether the parental opt-out form was completed by parents or a school-based gatekeeper. However, as the core ethical consent was concerned with the submission of the survey and this did not require parental consent, it was not seen as ethically problematic.

The data for this research was gained from two sources and consent was gained in different ways for each. This led to some individual students’ data being only partial. For instance, applicants could decide to participate in the research project, which meant they could be contacted to complete surveys; however, they separately gave consent (or not) to have their long-term data tracked by HEPs using the HEAT database. Thus, in some cases, the researchers had permission to use the student data in the research project but did not have permission to track using HEAT. Conversely, some students did not agree to take part in the research project, but individual HEPs were able to track higher education enrolment using HEAT.

In future iterations of the project, it would be simpler to gain consent to use both sets of data at the same time.

Legally, pupil data can be tracked using the HEAT database on a ‘public task’ basis; therefore, the HEPs and researchers did not require legal consent from students. However, ethically, they ensured that all students were informed of the data tracking and linkage, and the purpose of these activities, as part of the project.

The navigation checklists provide a ‘way in’ to the guidance document. These will be particularly useful for early-career researchers/evaluators or those exploring new methodologies. Each checklist consists of a series of questions that researchers/evaluators should consider when designing their study. Each question in the checklist directs the user to the appropriate section of the guidance document to support their considerations. Three navigation documents are included. Checklist 1 is intended to support early-career researchers/evaluators in studies that are designed using the ‘standard approach’ to research ethics. Checklist 2 is concerned primarily with qualitative research studies and Checklist 3 with larger, primarily quantitative, studies.

• Navigation Chart 1: for research following standard processes (PDF)
• Navigation Chart 2: Does your research/evaluation need further ethical scrutiny? (PDF)
• Navigation Chart 3: Large-scale quantitative studies (PDF)

These resources are free to download and aim to support you in various stages of the research ethics process.

(This accompanies Core Document, Sections E, F, and G)

The informed consent process requires that prospective participants, and/or their legal guardians/advocates, are provided with sufficient information about a research project to make a knowledgeable decision about whether or not they want to take part. Consent forms can be provided together with the information sheet but consent should not be sought until after the participant has read and had time to consider all the information provided.

This template is designed primarily for those doing qualitative interviews with adults from non-vulnerable populations and dealing with non-sensitive topics, or children where parental consent is also being sought. The points listed on the template below are for illustration only. You may alter the wording to suit your project as you see fit. For example, the form would be different in the case of focus groups or quantitative research. If conducting research with vulnerable populations and/or sensitive topics, please see template 4 and 5 for further details.

A consent form is not simply about a person giving you permission to involve them in research/evaluation, it is an agreement between the researcher/evaluator and the participant outlining the roles and responsibilities they are taking towards one another throughout the whole of the process. The researcher/evaluator should retain one copy of the consent form signed by both themselves and the participant. The participant should also be given a copy of the consent form as a record of what they have signed up to.

• Research ethics content form template 4 (ODT)
• Research ethics consent form template 5 (ODT)

Participant information sheet guidelines 1

(This accompanies the Core Document, Sections C, E, and F)

The informed consent process requires that prospective participants, and/or their legal guardians/advocates, are provided with sufficient information about a research project to make a knowledgeable decision about whether or not they want to take part.

Participant Information Sheets (PIS) are an important part of the informed consent process. This document provides a basic template for researchers when designing information sheets for their research/evaluation projects. The following is a suggested template for participant information sheets. You should adjust and populate the template to suit your project and intended audience. Use clear, simple English at all times and avoid abbreviations and acronyms.

Whilst the PIS does not need to be in written form, and alternatives, such as video, may be appropriate, it does need to be clear to potential participants. If you are planning to use a video format, then it ought to follow the same structure as a written PIS.

This template is designed primarily for those doing qualitative interviews with adults or children (where parental consent is also required) from non-vulnerable populations and dealing with non-sensitive topics. You will need to adapt the different sections and information if doing focus groups or structured interviews. If conducting research with vulnerable populations and/or sensitive topics, please see participant information sheet guidelines and template 2 for further details.

PIS template 1 (ODT)

Participant information sheet guidelines 2

(This accompanies the Core Document, Section E, F, and G)

This document provides guidance and a template for those conducting research with vulnerable populations or involving sensitive topics, and those conducting focus groups or structured interviews. For more information about participant information sheets and basic templates, please consult simplified participant sheet guidelines and template 1.

General information

For most adults, information is normally provided on a sheet that they can take time to read and consider. However, the procedures will sometimes need to be customised, for example when researchers work with children or people who have learning disabilities, cognitive impairments, low levels of literacy or do not speak English fluently. If no special provision is made for these participants, then they are effectively being excluded from the study, and this must be stated in the research proposal and a justification given.

The design of the information sheet must reflect the research study and be accessible to the intended participants. For example, an information sheet for a complex study, or one that carries potential risks (such as discussion of personal information or family background) will need to be relatively detailed, while an information sheet for children may use graphics or photographs rather than just text.

When working with children or vulnerable adults, you may need to produce two versions of the information sheet: one which is accessible to the participants and one intended for the legal guardian (parent, guardian or caregiver). The two versions must be aligned in terms of content and provide sufficient information, in appropriate detail, such that consent is fully informed.

It is important to ensure that participants are able to ask further questions and are provided with details about where they can find further appropriate information on the specific research area. This applies throughout the research process, even after the information sheet has been read and consent has been obtained.

Working with children

In the UK, people under the age of 18 (16 in Scotland) are classified as children. However, researchers should not assume that all children are vulnerable and incapable of providing consent because of their age. Children under the age of 16 can be capable of making decisions for themselves.

As a consequence of the 1985 Gillick Case, medical practitioners refer to ‘Gillick competency’ to denote when a child is able to understand the proposed treatment and to make an informed choice in their best interests. While not yet tested in law, researchers have adopted the same approach and will normally seek consent from both parents/guardians and a child who is deemed Gillick competent. There is no set age for Gillick competency; it depends upon the maturity and understanding of the individual.

While consent can be sought from a child who is deemed Gillick competent, it is normally in the best interests of the child not to proceed with participation unless consent has also been given by their legal guardian. However, in some circumstances, the researcher may decide that parents do not need to be informed and/or do not need to consent. Such cases must be justified robustly and are considered by the research ethics committee on a case-by-case basis.

Accessibility for all 

You may need to make provision for participants who are not fluent in the language of the information sheet and consider how to deal with challenges such as low levels of literacy. For example, you may choose to have information sheets translated into other relevant languages and/or use translators when seeking consent. Rather than relying solely on a written format, information may be also delivered verbally, perhaps as a video.

Such provisions need to be factored into the study design and approved by the research ethics committee prior to recruitment. Given the ethical requirement for fairness and justice in recruitment, the decision to make no provision for these participants must be stated in the research proposal and a justification given.

• PIS template 2 (DOCX)
• PIS template 3 (DOCX)

This webinar is an opportunity to hear about TASO’s research ethics guidance, produced by TASO and the University of Central Lancashire.

This is a full recording of the webinar session, which was presented in four sections:

• Introduction to TASO
• Background to research ethics guidance
• Tour of the research ethics guidance
• Q&A with the audience