Below is a fictitious ethics application for psychological research. The application contains deliberate flaws, which are identified and discussed in the feedback underneath. Why not see if you can spot the flaws as you read through?
Ethics Application Form for Non-Invasive Research on Healthy Adults:
SECTION B – PROJECT DETAILS
B1 Summary of Research
It is particularly important to provide sufficient detail of the research protocol and the measures that will be used, to enable evaluation of the application on ethical grounds. It is also important to clearly demonstrate that the proposed measures are ‘innocuous’ and fall within PaLS Ethics remit.
Please provide a brief summary of the project/programme of research including
• Participants and recruitment
• Procedure (including whether face-to-face or online study)
• Examples of measures (tests, questionnaires, interviews etc.) as per RD guidelines
NB When providing examples of each measure you plan to use, please select the most emotive/distressing examples so that the Ethics Chair can judge the potential for causing any distress.
Proposed Research: The research programme will examine how discomfort impacts on decision making. We know that many factors can impact on optimal decision making, such as the amount of information available, time pressures etc. However, little is known about how discomfort effects decision making. Furthermore, most decision making studies do not relate to challenging real-world situations where rapid difficult decision might need to be taken. The background demographics and personality of the users will also likely impact on decision making ability.
Our aim is to examine how discomfort impacts on decision making in real-world situations and in relation to personality and demographic factors.
Participants: We will test UCL students, but also to go beyond standard student populations and we will recruit members of public in public places such as local hospitals, bars, schools and underground stations. We will use leaflets presented to people to aid recruitment.
Procedure: Participants will be tested on a number of judgement tasks, perceptual (line lengths), emotional (which emotion are the people displaying). We will conduct experiments both in the lab at computers but also in London’s streets, using actors to play out scenarios (such as witnessing an altercation) to test decision making. To maintain ecological validity participants will not be informed these are actors. Discomfort will be applied by a range of methods including making the participants wear a lead-lined jacket to weigh them down, placing their left-hand in an ice-cold bucket of water for 30 minutes and calibrated electrical shocks to their ear-lobes. Participants will be filmed throughout the experimental period after they have consented to allow us to analyse facial expressions and body posture of the participants.
Participants demographics data will be collected via online forms. This data will include age, gender, sexual orientation, ethnic background, family income, medical history etc.
Using the Aware App for smart phones we will collect data on participants GPS, and app use on their mobile phone to study their travel and other activities.
Measures: Performance on the decision making tasks will be used to measure decision-making. App data will be used to characterise individual differences.
Example Measures: Correct judgements, distance travelled per day, visits to the gym. Self-rated discomfort from electrical shocks.
B2 Will the results be disseminated outside the standard academic outlets? Yes.
If you answered ‘yes’, please specify: To comply with the Open Science Framework (https://osf.io) we will create a permanent open access website for participants to see the data collected on themselves, and let them explore their data in relation to their friend’s data who have also participated and for other scientists to analyse.
B3 Please outline any ethical issues that might arise from the proposed study and explain how they will be addressed.
Discomfort from our interventions can be distressing. If participants report being distressed by the discomfort-causing interventions, we will suggest they take a 10 minute break before carrying on. When they have asked for 3 or more breaks we will terminate the experiment immediately.
SECTION C – PARTICIPANT DETAILS
C1 Participants to be studied
Number of volunteers: 500
Upper age limit: 94
Lower age limit: 5
Will payment or any other incentive (e.g. a gift voucher or free services) be made to any research participant? Yes. We will pay participants £5 per hour for the testing, with a £10 top up for exceptional performance. Participants who agree to provide a blood sample will receive an extra £100 amazon voucher.
(i) Describe how potential participants will be identified: By whether they stop to collect a leaflet
(ii) Describe how potential participants will be approached and recruited: Face to face and via emails
C4 Will the participants participate on a fully voluntary basis? Yes
Will UCL students be involved as participants in the research project? Yes
Will any form of deception be used that raises ethical issues? If so, please explain. Because the word ‘discomfort’ will likely put people off participating, we will not mention this in the flyer but discuss this in person when the participant arrives at the testing location and we will offer them the chance to leave the experiment without taking part.
C6 Will you provide a full debriefing to the participants? No.
If ‘No’, please explain why below. Because we do not want people to share the nature of the experiment we will not be telling participants about the reasons for the manipulations.
Thank you for completing this ethics application. Based on the information you have provided, we are not currently in a position to approve the application. Below you will find a summary of feedback which identifies 5 key areas of concern, with recommended amendments where appropriate. If you have any questions, please do not hesitate to contact us.
- Age of Participants:
- Children under the age of 16 are considered a vulnerable population, therefore a high-risk ethics application would be required to conduct research on them (this current application is for research on healthy adults). We recommend that, unless it is essential for the value of your research, you exclude children under the age of 18 from your study. (Note also that any research involving children would likely require guardian consent, see the APA Handbook of Ethics in Psychology, Vol. 2, C16, p345).
- The upper age limit of 94 years increases the likelihood that participants are from vulnerable populations, such as those with physical or mental ill health. We recommend that, unless it is essential for the value of your research, you exclude adults over the age of 65 from your study. If you chose to include older adults, we would deem the study high-risk due to the nature of your procedure.
- Exclusion Criteria: Your application does not mention the use of exclusion criteria. This application is for research on healthy adults, and therefore you would need exclusion criteria that ensure participants are adults in good physical and mental health.
- Recruitment Methods: We recommend you do not recruit in schools or hospitals, which have a greater number of individuals from vulnerable populations such as children and those with physical and mental ill health. We also recommend you do not recruit in bars, where potential participants are more likely to be under the influence of alcohol, influencing their decision to take part.
- Any compensation offered should not lure participants into procedures that they would otherwise avoid or not be eligible for. We suggest that a £100 voucher is sufficient to do this, and that this value should be decreased. (Please also see ‘Participant Distress’ for comments on the blood sample procedure to which this relates).
- It is unclear what is meant by ‘exceptional performance’ in section C2. Please provide further information.
- During Recruitment: Whilst it is sometimes appropriate to use deception for methodological purposes, such as when knowledge of the research purpose would influence the psychological processes under study, the stated use of deception in this study to increase recruitment rates is not appropriate. Participants must be made aware that the study involves discomfort in the initial recruitment stage.
- Witnessing Altercations: We suggest you consider whether this deception of not informing participants that they are witnessing actors is essential, since witnessing altercations between known actors is likely sufficient to cause discomfort. If you choose to use deception, participants should be fully debriefed that the people they witnessed were actors. This should happen as soon as possible, rather than only at the end of the study. (Please also see ‘Participant Distress’ for comments on conducting this in public).
- Discomfort-Inducing Interventions: Research which could induce psychological stress, anxiety or humiliation, or cause more than minimal pain is considered high-risk, and would therefore require a high-risk application.
- It is important to ensure that the discomfort induced by interventions is not unreasonable. For example, we suggest that the level of discomfort likely to be induced by having one’s hand submerged in ice-cold water for 30 minutes is unreasonable. We suggest significantly shortening the time to 30 seconds. We would also recommend using standard weights in place of lead (which is poisonous to humans).
- It is important to ensure that the discomfort is not unreasonable for all participants. For example, the level of discomfort induced by a heavy jacket may differ depending on participant stature. Ideally, participants should have the ability to test increasing levels of discomfort and be given the choice as to how much discomfort they wish to endure, up to a maximum, reasonable amount.
- Please provide full details of all interventions (e.g. electric shocks, witnessing altercations etc.) that each participant will be subjected to, and in what timeframe this will take place, so that the Ethics Committee can adequately assess whether discomfort is reasonable or unreasonable.
- Blood Sample: This is an invasive procedure and therefore outside the bounds of this application. It also involves access to biological information. A high-risk application would therefore be required. We recommend you do not take blood samples unless essential for the value of your research.
- Acting Out Altercations in Public: We request more information on the altercations to assess whether distress induced for the participant is reasonable (see above), but we also recommend this is not carried out in public. This is likely to induce distress in members of the public, who will not have provided informed consent or be provided with a debrief.
- Termination: Participants must know that they are able to exit (not only pause) the study at any time without penalty.
Debriefing: It is important to provide appropriate debriefing to participants.
- This should include an explanation of the study aims. If you wish to ensure that participants do not share information about the study with others, we recommend that you specifically request this of them.
- The debriefing should also include actions to eliminate potential harmful after-effects on participation. For example, if you are inducing some discomfort in participants, you should seek to actively restore comfort. We recommend you also provide contact details with which participants can seek further support.
Participant Data: Though you have included a Data Protection Registration Number, we ask that you request approval from the Data Protection Team for this specific study, particularly in light of the new GDPR guidelines. We must advise that the study, in its current form, is unlikely to be approved due to the following concerns:
- Collection of participant data without a clear rationale: Overall, we suggest that the amount of participant data being collected is very large, and much of it does not have obvious application to the research question. We understand you wish to account for individual differences, but it is currently unclear why individual differences would be relevant to all the data items you propose to collect. All data collected must serve a clear purpose.
- Examples of collecting sensitive personal data without a clear rationale: Special category personal data includes collection of sexual orientation, ethnic background, medical history, and biological information (e.g. blood sample). Such data should only be collected when there is clear rationale. Based on the information currently provided, it is unclear why such data would be relevant to the research question, and we suggest that you do not collect it. See the ‘Sensitive Personal Data’ section on UCL’s Data Protection website for more information.
- Examples of collecting personal data without a clear rationale: Personal data includes any data from which a living individual can be directly or indirectly identified, for example video footage. Personal data should be anonymised such that it is not possible to identify individuals from the data collected. We recommend not collecting any personal data that is not essential for the research.
- Time period of data collection: The time period over which participant data (such as the video footage or app data) is collected should be the minimum necessary for the research, and must be made clear to participants prior to consent being sought. It is currently unclear over what time periods this data will be collected.
- Sharing of non-anonymised data: Personal data should be anonymised as much as possible. Informed participant consent would need to be sought in order to carry out the suggested sharing of non-anonymised data on the Open Science Framework (OSF) platform. Participants should be given the opportunity to review all data stored about them before it is shared, and to withdraw any data they wish to. Note that anonymised data would still be OSF compliant (see their guidelines here). We would strongly recommend that data is fully anonymised before it is shared, including removal of indirectly identifiable information such as GPS information.
You may find the following resources useful when amending your application:
- The new, GDPR-compliant templates for the Participant Information Sheet and Consent Form. These provide more guidance on data protection and ethical considerations (download and open in MS Word).
- The Information Commissioner’s Office Anonymisation Code of Practise
- The British Psychological Society’s Code of Human Research Ethics
- The APA Handbook of Ethics in Psychology, Volume 2, Chapter 16