Issues to consider when applying for ethical approval

Working with People
We want to know that the safety, wellbeing, and dignity of research participants is assured, that the applicant is aware of any possible ethical issues in carrying out the research and that steps have been taken to ensure that best practice is followed. We also draw your attention to the section below entitled ‘recruiting participants’. It is very important that people are aware that you respect their confidentiality and that, where possible, rigorous steps will be taken to preserve anonymity.

Working with Children

You must ensure that there is a real need to involve children in the research and be able to justify this to the Committee. Anyone under 16 years of age is classed as a child. You must check and comply with any legal requirements, such as vetting procedures for working with children, before you proceed with such work. The responsibility for checking and complying with such legal requirements is yours. However, the Committee may ask for evidence of compliance.

Please note that research involving children always requires written consent from parents, guardians or those in loco parentis (i.e., individuals legally permitted to provide consent other than a parent or guardian, e.g., a teacher). If the research involves a school, consent must usually be obtained from the principal of the school as well as a parent or guardian.

Where consent is given by parents, guardians or those in loco parentis, it is still important to try and obtain consent from the child after you have provided age-appropriate information about the study. Older children would normally be expected to give their consent in the same way as adults. Where children are younger and are capable of understanding, the researcher should explain to the child that what they are doing is entirely voluntary and that they can refuse to take part if they wish. Appropriate briefing and/or debriefing should therefore always be part of the investigation.

Researchers should also be aware of any possible implications or consequences that their research could have on participants' school or family life.

Researchers should also be aware of the possible need for indemnity insurance with respect to any investigation involving schools, schoolchildren, and/or their parents.

Working with Vulnerable Adults

You must ensure that there is a real need to involve potentially vulnerable adults, for example those with severe learning disabilities, and be able to justify this to the Committee. You must have familiarised yourself with the relevant legal position, where it is intended to conduct research with adults who may not be able to give a legally valid consent to take part in research.

Where the proposed research participant is in a dependent relationship to the researcher (for example, where the research participant is a student) the researcher must make it clear that a decision to take part or not to take part in the project will in no way affect the individual's relationship with the researcher, and the researcher must ensure that this is the case.

Where the proposed research participant is in custody the researcher must make it clear that a decision to take in the project or not will in no way affect the individual's situation, and the researcher must ensure that this is the case.

Working with People Engaged in Illegal Activities
Before starting a project that will involve research with persons engaged in potentially illegal activities you need to consider under what circumstances you might be legally required to divulge information about your research participants. You need specifically to consider when to anonymise your research data. You also need to consider under what circumstances you might become implicated in the illegal activities and how you will ensure that this does not happen.

Recruiting Participants
The doctrine of valid consent operates here. Participants should enter into the research freely and willingly and know and understand what they are agreeing to when they take part. They should be told that they have the right to withdraw from the research at any time. Wherever possible, anonymity and confidentiality should be maintained (see the section entitled ‘Providing Information to Participants’).

The validity of consent depends on many factors associated with the specific research situation. Where possible written consent should be obtained from research participants. However, in certain cases it may be unnecessary, inappropriate or unfeasible to seek written consent. For example, in cases where questionnaires are administered that do not include probing questions and where a front sheet clearly describes what is going to be asked, it can be assumes that the act of accepting the questionnaire implies consent by the respondent. There may be other situations too where provision of an information sheet would be sufficient.

For example, in cases where the research presents no more than minimal risk of harm to participants, involves no procedures for which written consent is normally required outside of the research context, or where oral consent may better protect the interests of the participants.

Where written consent is not sought, the researcher must still ensure that the research participants are given sufficient time to read the information about the research, and hold a record demonstrating oral consent. Please note that the validity of consent mainly depends on the adequacy of the explanation to the participant before a decision is made to participate in the research, and not merely on the acquisition of a signature.
Appropriate written consent should always be obtained when working with vulnerable groups (see the sections entitles ‘working with children’, ‘working with vulnerable adults’, and ‘working with people engaged in illegal activities’).

Research Using the Internet and Electronic Recruiting

Electronic recruiting (e.g., via email or the Internet) is acceptable within the following limitations:

  • Any mailing to an identifiable group of people (e.g. to all of the students in a School or a class) should be brief and succinctly explain the nature of the research and the criteria for participation;
  • None of recipients should be identifiable by their name, email address or any other information. In practice this means that invitations should only be send via a mailing list or that all recipients are ‘bind copied’ (BC) when sending out the invitation;
  • It should be clearly indicated at the beginning of the invitation that it is a request for help from an academic researcher;
  • If the reader of the e-mail is interested in participating then he or she should be asked to contact the researcher directly (not a group reply), or referred to a web page where the research information is located;
  • The number of electronic invitations to the same person(s) must be kept to a minimum. In practice this means that no multiple invitations or reminders should be send to the same person(s);
  • The Cardiff University Information Services Postmaster must be asked for permission to send e-mails to University group addresses.

Providing Information to Participants
By far the greatest number of amendments that School Research Ethics Committees ask to be made concern the information that will be given to participants. You must take time over this aspect to ensure that you explain properly what you are asking participants to do and what the possible implications of the research are, so that participants can make a proper decision for themselves whether they wish to take part.

You must clearly explain the following matters in terms that an ordinary person, rather than a specialist in your field, can understand:

  • That you are inviting them to take part in a research project;
  • Who you are – a student/your role in the University ;
  • The nature, risks (if any), benefits (if any), duration and purpose of the research project. This must include clear information about what the participant will be asked to do, where the research will be carried out, any risks to the participant’s health and safety and the steps that will be taken to minimise those risks;
  • That participation in the project is entirely voluntary;
  • By whom the project is funded;
  • What the information gathered is intended to be used for, including whether it is intended to publish the results;
  • The arrangements concerning confidentiality of, and access to, information about the research participant;
  • How the research participant can obtain further information about the project (such as by the provision of work contact numbers/email for the researcher; home contact numbers should never be given nor should university office numbers be given where the researcher is a student);
  • Whom the research participant can contact if they are concerned about any aspect of how the research was conducted. This would normally be the Chair of the School Research Ethics Committee.

You should give the research participant a copy of the information sheet to keep.

If the study design necessitates some deliberate deception (e.g., in an experiment), then after the experiment is finished participants should be told the purpose of the experiment and why information was withheld or why they were misled.