Ethical Considerations in Research: The Brain & Mind Series (Part 5 – Ethics)

Ethical Considerations in Research

Part 5 of the Brain & Mind Series

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This is a review of a fictitious Ethics Application for an assignment. It touches upon key ethical issues faced by researchers when designing psychological experiments. The discussion fully identifies problems and suggests alternative approaches/modifications where applicable. 

Ethics Assessment

Below is Fictitious Ethics Application for Teaching on the UCL MSc in Psychological Sciences

Ethics Application Form for Non-Invasive Research on Healthy Adults

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
• Background
• Aims
• Participants and recruitment
• Procedure (including whether face-to-face or online study)
• Measures
• 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 No
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

C2 Payment

Will payment or any other incentive (e.g. a gift voucher or free services) be made to any research participant?
Yes No

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.

C3 Recruitment
(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 No

Will UCL students be involved as participants in the research project? Yes No

C5 Deception
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? Yes No x
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.

Section 1: Overview

Unfortunately, the incorrect form has been filled out. Based on the current research design, the high risk ethical application form will need to be completed instead. This is because it involves vulnerable groups, invasive interventions, sensitive topics, and deception (see Section 3). Please see procedures for further details. If you decide all of these aspects can be removed from your design, then the current form is fine.

Overall, the ethics application does not convincingly demonstrate that the experiment is inflicting the least harm possible to participants, or that the level of risk is necessary. Typically, the risk of harm participants are subject to should not exceed that encountered in everyday life, unless proportionate to the potential societal benefits (BPS, 2014). While this research is concerning the effect of discomfort on decision-making and so there is inherent risk in the design, the level of risk need not exceed that encountered in everyday life.

Section 2: Initial Action Points (applicable to either form)

  • The declaration for the principal researcher will need to be signed and dated, and all researchers involved will need to be listed. If this involves lone work, the potential risks to the researcher need to be considered and precautionary measures put in place.
  • When describing the procedure, a timeline would be helpful or a clearer description of what the participant will be asked to do, in what order, and for how long. It also needs to be made clear that the experiment will only commence after participants have provided informed consent, what the test environments are, and that participants will still receive any benefits offered even if they wish to withdraw. Similarly, benefits should not be contingent upon performance or what participants provide (see below). All participants should instead receive the same benefit.

“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.”

  • The proposed end date is before the start date – this of course will need changing.
  • Throughout this application clear rationale for desired methods, and potential ethical issues have not been exhaustively raised (see section 3).

Section 3: Risks

Please consider whether the following listed aspects are an essential part of your design (see guidebook for further assistance), and if so how you will obviate, minimise or manage the potential risks imposed by these aspects using the guidance provided. All listed aspects below involve more than minimal risk (see p.13 in the BPS, 2014). You are referred to section 4 of this document throughout because this section provides guidance concerning what to do if you wish to retain the aspects of your design listed below.

Aspects with More Than Minimal Risk

  1. You plan to recruit participants with a lower age limit of 5 (i.e. you plan to include children aged under 16), an upper age limit of 95 (i.e. you plan to include the elderly), and you plan to recruit participants from hospitals and schools. Additionally, you plan to recruit from bars where individuals may be inebriated. For these reasons, you will likely recruit participants that are lacking capacity or are in a dependent or unequal relationship that thus can be considered vulnerable according to the BPS (2014). As a result, it is advised that you:
    • Obviate risk by increasing your lower age limit to 16 years of age and lowering your upper age limit to 59 years of age, so that participants are neither children nor elderly. Only recruit participants via posters or leaflets around your university (i.e. not in bars, hospitals or underground stations) or using well-established online recruitment platforms, ensuring that you include all recruitment text in your next ethics application.
    • Alternatively, if you chose to recruit participants from hospitals you will need to provide evidence of having received external permission from the NHS or the hospital for using patients and staff (e.g. through the National Research Ethics Service). Similarly, you will need to obtain permission from organisations (e.g. schools, pubs, TFL). Parental/guardian consent will be needed for anyone aged under 16 years. Lastly, exclusion criteria need to be covered in depth (e.g. to exclude those with learning disabilities and with mental health diagnoses). Also see section 4.

2. You plan on collecting personal and sensitive data

“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.”

…therefore it is advisable to:

  • Obviate risk by not collecting this information at all.
  • Alternatively, collect as little sensitive data as possible, by only including that which is directly relevant to your research question(s) or that may act as a confounding variable. Also, you will need to seek NHS ethical approval if using medical history (see approval guidance). Alongside this, collecting data on participant’s GPS, and app use is not advisable because this increases the risk of participants being identified. If you deem this necessary, you will likely seek permission to use this data both from the participant and the web service provider. Please see this data guide, internet-mediated research guide, and section 4 below for guidance.

3. Three aspects of the proposed research involve deception (only the first is acknowledged as deception)…

“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.”

“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.”

“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.”

…. therefore it is advisable to:

Debrief participants as fully as possible (non-optional) and…

  • Obviate risk by informing participants that the experiment may involve some level of discomfort and thus not deceiving them. Given that you are planning on telling participants that the experiment involves this in the test location, it is perhaps best to disclose this in the recruitment details. Inform participants that the scenarios are played by actors.
  • Alternatively, ensure that both aspects are discussed in the Ethics Application under deception. Also see section 4.

4. There is a risk that the planned research could “induce psychological stress, anxiety or humiliation or cause more than minimal pain” (BPS, 2014, p. 14) and involves invasive interventions that would not usually be encountered in daily life…

“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.”

… therefore it is advisable to:

Describe how you will ensure that the potential harmful after-effects are removed (e.g. by providing participants with contact details for mental health support or by inducing a positive mood). As well as…

  • Minimise risk by choosing non-intrusive forms of inducing discomfort (e.g. merely putting their hand in an ice-cold bucket of water and not weighing them down or giving them electric shocks). Ideally, methods for inducing discomfort should align with events one might ordinarily encounter in everyday life. Consider reducing the time participants are asked to put their hand in ice water to the minimum required for the participant to feel discomfort. Also, avoid carrying out discomfort-inducing methods in front of the public to reduce the likelihood of participants feeling stressed or humiliated (see also section 1: Respect, of the Code of Ethics and Conduct, 2018).
  • Alternatively, consider the least risky, least intrusive and quickest method for inducing the discomfort required. Also see section 4 below.

5. There is a risk that the planned research could “…have an adverse impact on employment or social standing” (BPS, 2014, p. 14) because it involves making decisions in public, being subject to tasks that could be humiliating (e.g. being weighed down and experiencing electric shocks) and currently allows anyone to access identifiable data on participants (e.g. performance on judgements tasks etc.). Therefore, it is advisable to:

Keep all data strictly confidential (this is non-optional) and…

  • Obviate risk by conducting all experimentation in private (e.g. labs).
  • Alternatively, if you require a naturalistic environment, consider one that has restricted access so that the public can’t watch the experiment without the participant’s consent. Also see section 4 below.

6. There is a risk that the proposed research may cause the participant to label themselves (e.g. ‘I am weird’). This is because you plan on allowing participants to explore their data in relation to friend’s data, which will include performance on judgement tasks and discomfort rating, such that participants may construe they are abnormal if their ratings/performance is different from others.

Therefore, ensure data is kept confidential (non-optional), and…

  • Obviate risk by ensuring participants are not told the scores they have obtained or whether they are in the normal range.
  • Alternatively, see section 4. Given that this is not an integral aspect of the design however, I would remove it entirely.

7. The proposed research also poses more than minimal risk because it involves “…the collection of human tissue, blood or other biological samples.” (BPS, 2014, p. 14). Therefore, I recommend that you:

  • Obviate risk by not collecting blood samples at all.
  • Alternatively, see section 4.

Section 4: General Course of Action for Aspects with More than Minimal Risk

If you do deem any above-mentioned aspects necessary, you will need to demonstrate on the ethics application that you have assessed “…these risks for their probability and severity, and put in place measures to obviate, minimise and manage such risks.” (BPS, 2014, p. 12). You will also need to justify desired methods in your next application. Currently, while you may have gone through this process, it is necessary to lay it out on the ethics application. You will also need to submit “…a detailed case outlining the cost-benefit analysis and the risk management protocol” (BPS, 2014, p. 14) to the research ethics committee.

Word count – 1499 (excluding quotations from the Ethics Application)

References

The British Psychological Society (BPS). (2014). Code of Human Research Ethics (2nd ed.). Retrieved from https://www.bps.org.uk/news-and-policy/bps-code-human-research-ethics-2nd-edition-2014

The British Psychological Society (BPS). (2018). Code of Ethics and Conduct. Retrieved from https://www.bps.org.uk/news-and-policy/bps-code-ethics-and-conduct

 

 

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