Human Participation

Participants should be fully informed about the purpose, methods and intended use of the research. They should be provided with sufficient information about the study to be able to make an appropriate decision about taking part. 

Typically, this information is provided in a Participant Information Sheet (PIS), but a member of the research team should also explain this information in a conversation with the potential participant. Additionally, participants should be given the opportunity to ask questions and have these answered satisfactorily. 

The information and level of detail that you provide in the PIS will depend on the nature of the  study. The document should include the following information as a minimum:

• the title of the project and the research aims
• details of who is carrying out the research 
• an invitation to participate in the study
• the terms for withdrawing from the study

A more detailed PIS should also address the following:

• what does taking part involve?
• what information will be collected and who will have access to the information collected?
• how will the data be used and stored during and after the study?
• any limitations of confidentiality (e.g. where researchers have a legal duty to report safety concerns)
• why has the participant been invited to take part? (What are the inclusion/exclusion criteria?)
• what are the possible benefits of taking part?
• what are the possible disadvantages and risks of taking part?
• what procedures are in place to minimise any disadvantages and risks?
• who is the sponsor and the data controller for the research?
• has the study received ethical approval?
• who should the participant contact for further information relating to the research?
• who should the participant contact to file a complaint?

For more tips on writing a PIS, see the HRA website. A number of Example Documents are also provided on the Ethics Toolkit.

Participants should take part voluntarily in the research, free from any coercion or undue influence. On receiving the information (and PIS) about the research study, potential participants should be allowed time to consider whether or not to take part and should be given the opportunity to discuss their potential participation with others if they wish to. Typically participants will sign a ‘Consent Form’*, (see Example consent form‌).  

As a minimum, the consent form should allow the participant to confirm each of the following, that they:

• have read the information seet, had the opportunity to consider the information and ask questions, and had their questions answered satisfactorily.
• understand their participation is voluntary, that they are free to withdraw at any time without giving any reason, without any penalty, and that they understand what will happen to any data collected prior to their withdrawal
• consent to their [anonymised/pseudonymised] research data being stored and used by others for future research
• understand their research data may be published as a report
• (If applicable) consent to the processing of their personal information for the purposes of the research study and that they consent to the retention of their personal information for [insert period time and purpose]
• agree to take part in the research project

Note that, in longitudinal research studies, consent may need to be obtained on more than one occasion.

Informed consent should also be taken from any staff or students who are participating in the study. 

The signature of an independent witness is also recommended for high-risk projects involving invasive procedures and / or vulnerable groups. 

*Providing written information is not always the best format to use. Instead of a PIS, other media e.g. a video, an audio recording, or a script to be read aloud by a researcher may be more appropriate. Similarly, instead of a written consent form, it may be more appropriate to use a recording device to record the obtaining of oral consent and have this witnessed. However, please be aware that providing written information and obtaining written consent is preferred. Therefore, where possible (i.e. where reading information and/or writing is not problematic), researchers should always provide a written information sheet and request written consent.

Researchers should always aim to conduct research studies for which participants are fully informed about the study before taking part.  However, sometimes providing participants with full information about the study is not possible, because doing so could significantly influence the outcome, and be at odds with the aims of the research. 

Whilst Newcastle University strongly encourages researchers to attain fully informed consent from all participants, the University’s Ethics Committees will consider applications for research where the only possible way to conduct the research involves deception/covert observation*. The researcher must clearly explain and justify the reasons for the lack of fully informed consent in their research ethics application. If there is an alternative way to investigate the research aims, which would allow participants to provide fully informed consent, this should be pursued instead. 

*Note observational research is only acceptable in situations where those observed would expect to be observed by strangers. 

Vulnerability may arise as a result of:

• age
• potential marginalisation
• financial circumstances
• disability
• being in an abusive relationship
• disadvantageous imbalance of power within personal/professional roles

Where research involves potentially vulnerable groups, researchers should make every effort to:

• attain fully informed and voluntary consent
• ensure participants have had the opportunity to discuss the research invitation with others
• develop methods of seeking consent that are appropriate

Other considerations:

Where researchers are in a position of authority/influence over potential participants, they must ensure that their relationship, for example, as a teacher or employer, does not influence any decision to take part. This also applies to participants who are staff and students at Newcastle University.

Where a payment is offered to participants for their taking part, the payment must not be used to induce participants to risk harm beyond that which they risk without payment in their normal life style.

Please note researchers working with vulnerable groups may need to undergo a Disclosure & Barring Service (DBS) check. For further information, please contact Newcastle University’s Human Resources team.

16 years and older: In clinical practice, young people aged 16 years and above are able to give their own consent. 

Younger children: Where the potential participants are younger children (i.e. under 16 years), Newcastle University expects researchers to make every effort to inform children about the research study. This is by talking to them about the study and using age-appropriate language and participant information sheets. Children should be asked if they want to participate in the research and, where possible, should provide their consent to do so. Researchers must also fully inform the children’s parents/guardians about the study, provide them with a PIS and ask them to provide their consent for their child’s participation.

Infants: Researchers must fully inform the infant’s parents/guardians about the study, provide them with a PIS and ask them to provide their consent for their child’s participation.

The HRA provides some example documentation.   

Please note researchers working with children will need to undergo a Disclosure & Barring Service (DBS) check. For further information, please contact Newcastle University’s Human Resources team.

The Mental Capacity Act (2005) is an Act of Parliament of the UK, applying to England and Wales. It provides a legal framework for making decision on behalf of adults (defined in this case as 16 years and above) who lack the capacity to make decisions.

Section 2 (1&2) of the Act defines a person who lacks capacity as follows:

• a person lacks capacity in relation to a matter if at the material time he is unable to make a decision for himself in relation to the matter because of an impairment of, or a disturbance in the functioning of, the mind or brain
• it does not matter whether the impairment or disturbance is permanent or temporary

A person’s lack of capacity may be due to various reasons including, for example, dementia, mental illness, learning disability, brain damage, intoxication.

The researcher is responsible for deciding whether a potential participant has the capacity to consent for themselves, and is able to consult other care professionals, if appropriate.  In order to assess capacity, the researcher must consider:

• is there an impairment of, or disturbance to, the functioning of the mind or brain?
• if so, is the impairment or disturbance sufficient that the person is unable to make the decision to consent?

Research that involves recruitment of adults who lack the capacity to consent must undergo approval through an NHS or Social Care REC (see NHS & Social Care). 

Researchers may require permission from a gatekeeper to acquire initial or continued access to potential participants. A gatekeeper is an individual/organisation that controls the initial or continued access to an individual or group of individuals. 

Examples of situations in which researchers may require a gatekeeper to access a potential participant include research involving:

• employees recruited through their employer (gatekeeper = employer)
• NHS service users recruited through an NHS service provider (gatekeeper = NHS service provider)
• social care service users recruited through a social care provider (gatekeeper = social care provider)
• children recruited through their school (gatekeeper = school head)
• minority groups recruited through their community centres (gatekeepers = community centres)

If a researcher intends to access participants by using a gatekeeper, the researcher must acquire the necessary permission and consent from the gatekeeper to approach the potential participants. Researchers will still need to fully inform potential participants about the research and acquire their voluntary consent.   

It is strongly recommended that researchers acquire fully informed written consent from all participants. However, for questionnaires where personal data, sensitive data and/or confidential data are not collected, implied consent may be sufficient. In this case, prior to completing the questionnaire, participants should be fully informed about the study (see 'Informing participants' section above). Within this information it should be stated that consent for using their data for the specified purposes is implied from their participation.  

In addition to obtaining ethical approval, colleagues and students conducting security sensitive research should also ensure that they follow the University's Prevent Guidance. Researchers should:

Complete Prevent training: All colleagues are expected to complete the mandatory e-learning programme via the University's Learning Management System (internal login required). Further online training is available to colleagues and students via the Home Office website. 

Not use their personal or work laptop to access security sensitive materials online: Contact a member of the Prevent Team or IT Helpdesk to arrange access to a University PC or laptop which can be used for this purpose.  

Not store any security sensitive materials on their personal or work laptop: Contact the University's Research Data Service for advice on developing an appropriate Research Data Management Plan.  

Consider their own mental health and wellbeing: Students can access support through the University's dedicated counselling service.  Staff can access support through the Colleague Health and Wellbeing Hub (internal login required).

Refer to the UUK Report on Oversight of Security Sensitive Research Material in UK Universities for further best practice guidance.  

The global pandemic had an impact on how we collect data for research. Some communication technologies offer new opportunities to conduct qualitative research.

For example, Zoom, Microsoft Teams, Skype and Google Hangout allow researchers to conduct interviews using videoconferencing platforms.

A number of features of these technologies, such as automatic transcription, along with their cost-effectiveness, data management features, and security options are potentially appealing to qualitative researchers. These technologies can be more convenient for the research participants, too. A recent research that explored the feasibility and acceptability of using Zoom to collect qualitative interview data shows that most participants found their interview experience as highly satisfactory. They generally rated Zoom above alternative interviewing mediums such as face-to-face, telephone, and other videoconferencing services (Archibald et al 2019).

Before conducting online interviews the researchers should consider carefully whether the topic is appropriate for an online interview. For example, if the interview is on a sensitive or intrusive topic, conducting an online interview might not be the best approach.

The videoconferencing tools allow the researchers to video record the interaction in a specific drive or Cloud. Video recording is not a common practice during the face-to-face interviews, unless the research is designed that way, and the researcher has a particular reason for making a video of the session. Arguably, making a video of someone is more intrusive than recording their voice, and protecting that data also involves more risk (eg facial recognition technologies can easily match someone’s face with their personal identity). Hence, it is preferable to use phone rather than Zoom, to discuss strictly confidential or sensitive topics.

Even if the interview topic is not sensitive, it is important to obtain consent from the participants to record their video. Some participants may not be aware of the fact that the research does not necessarily require a video recording. The researcher should communicate this openly with the participant and remind the participant that turning off the video camera would not affect the quality of the research.

Most video conferencing software allows you or the participant to disable the camera. The participants can also be reminded that they can cover the camera with a cloth or a piece of paper. It is also worth reminding them at the start of the interaction that the session is being recorded. 

In summary, the participants should be aware of the fact that giving an interview using a videoconferencing software does not necessarily involve being audio/video recorded. The Participant Consent forms should include an explicit statement consenting to interview via the named platform (eg Zoom) and to the audio (and video, if necessary) recording of the conversation.

Data recorded from remote or online interactions with participants should be transferred as soon as possible from the recording location (eg Zoom Cloud) to a password protected folder. The original file in the recording location should be deleted once it is transferred. The researchers should also keep in mind that some video conferencing software deletes the files automatically (eg Zoom deletes the files in 30 days). 

Dr Ilke Turkmendag

Senior Lecturer, Newcastle Law School

References

Archibald MM, Ambagtsheer RC, Casey MG, Lawless M. Using Zoom Videoconferencing for Qualitative Data Collection: Perceptions and Experiences of Researchers and Participants. International Journal of Qualitative Methods. January 2019. doi:10.1177/1609406919874596

Researchers must inform participants of their right to withdraw from the research study at any time, without giving any reason, without any penalty (and irrespective of whether or not payment or other inducement has been offered). 

Researchers must inform participants of what will happen to any data collected from the participant prior to their withdrawal of consent.  Participants have a right to request that their data be destroyed, but where research data is anonymised it can no longer be identified to be excluded. Accordingly, participants need to be informed if any research data provided by them, prior to any withdrawal, will be excluded/included.

Researchers must protect the privacy of research participants and the confidentiality of their personal information. 

Participants must be informed of any limits to their privacy/confidentiality, and their consent for using their personal information must be attained.    

Researchers should also consider whether their research could potentially lead to any circumstances in which they might be required to divulge information to legal or other authorities. If so, the limits of confidentiality should be clearly specified in the PIS:

'We [the researchers] will generally not disclose the information you [the participant] provide without your consent, but there may be circumstances where we have to because we have a legal requirement to do so (for example, under statute or a court order) and/or we have an overriding duty to the public (for example, the information concerns the commission of a criminal offence or relates to life-threatening circumstances)'. 

Research within the workplace: Researchers should be aware of the possible existence of any confidentiality clauses in employment contracts. Researchers may require consent from employers for any information given by employees within the workplace, during the course of their employment.

Research with children: Researchers working with children should be familiar with the relevant child protection act 1989 for England and Wales, and consider what actions they would take in the event of a disclosure of child abuse. 

Research should be worthwhile and provide value that outweighs any risk or harm to participants and/or researchers.  

Researchers must:

• adequately asses the potential risks of their research study
• consider how these will be best managed to ensure that they are avoided/minimised

The information below provides a guide to the types of risks that research studies can pose, examples of the risks and of ways to manage them.This is not an exhaustive list, and so researchers will need to carefully consider any other risks their research study may pose. 

If you have further examples that could be beneficial to other researchers, please contact res.policy@ncl.ac.uk so that these can be added to the table.