University Research Ethics Committee

ETHICS REVIEW
APPLICATION FORM
To be used for School or University level review
Please append all relevant and supporting documentation to this project application form when submitting
for School level (SREC) or University (UREC) review. Text boxes will expand as required and all language
used to explain or justify the application should be comprehensible to a lay person.
Application form and all associated documents should be submitted electronically.
Submission deadline dates for UREC can be found on the UREC webpage.

Section 1: APPLICATION DETAILS

1.1 PROJECT AND DATES

Title The influence of pain on problem solving ability

Date of 24/01/2022
submission

Start date 28/02/2022

End date 06/03/2023

1.2 APPLICANT DETAILS

Chief Dr Katherine Finlay

Investigator

Please note that an undergraduate or postgraduate student cannot be a named Chief Investigator for research ethics purposes.
The supervisor must be declared as Chief Investigator.

Is the project being carried out in whole or in part to support a student degree?

☒ Yes ☐ Undergraduate ☐ Masters ☒ PhD

☐ No

School Psychology & Clinical Language Sciences

Department CINN

Email katherine.finlay@reading.ac.uk

Telephone 0 118 378 8523

Name: School Position Email

All other
Applicants Dr Wiebke Gandhi Psychology & Postdoctoral w.gandhi@reading.ac.uk
Clinical Language Research Fellow
Sciences

Dr Richard Harrison Psychology & Research Associate rich.harrison@reading.ac.uk

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 Clinical Language
Sciences

Jacqui Bernarde Psychology & Postgraduate j.bernarde@pgr.reading.ac.uk

Clinical Language Research Student
Sciences

Brendan Williams Psychology & Research Fellow b.williams3@reading.ac.uk

Clinical Language
Sciences

Megan Gompels Psychology & Undergraduate M.A.M.Gompels@student.reading.ac.uk

Clinical Language Student
Sciences

1.3 WHAT REVIEW IS NEEDED?

Please tick the appropriate box below to confirm which review your ethics application requires.

Please tick all that apply.

☒ School Level Review (SREC) ☐ External (for example, HRA)

☒ University Research Ethics Committee Review (UREC)

Projects expected to require review by the University Research Ethics Committee (for example; research involving NHS patients,
research involving potential for distress to participants) must be reviewed by the Chair of the School Ethics Committee or the Head
of School before submission to UREC. For further information see Section 16 of the UREC Guidance.

1.4 EXTERNAL RESEARCH ETHICS COMMITTEES

Please provide details of other external research ethics committees from whom a favourable ethics opinion will be required (for
example; HRA REC)

Name of Committee Date of submission / approval Reference Status

N/A Click here to enter a Click here to enter

date. text.

1.5 PROJECT SUBMISSION DECLARATION

On behalf of my co-applicants and myself,

 I confirm that to the best of my knowledge I have made known all information relevant to the appropriate Research Ethics
Committee and I undertake to inform the Committee(s) of any such information which subsequently becomes available
whether before or after the research has begun
 I understand that it is a legal requirement that both staff and students undergo Disclosure and Barring Service checks
when in a position of trust (for example; when working with children or vulnerable adults)
 I confirm that if this project is an intervention study, a list of names and contact details of the participants in this project
will be compiled and that this, together with a copy of the Consent Form, will be retained within the School for as long as
necessary.
 I confirm that I have given due consideration to equality and diversity in the management, design and conduct of the
research project.
 (For Chemistry, Food & Pharmacy (CFP) only) I confirm the Internal Review has been undertaken by Click here to
enter text. and I have made the changes requested.

SIGNED, CHIEF INVESTIGATOR

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 13/01/2022

Where required by the School’s Research Ethics Procedures, this ethics application should be signed off by the appropriate person
to confirm the School Body are content for this application to be reviewed by UREC.

Chemistry, Food & Pharmacy – will require sign off from: Chair of SREC, Head of Department and School Ethics Administrator –
insert rows below as required.

SIGNED, AUTHORISING SIGNATORY

Signature: Position: Date:

Choose an item. Click here to enter a date.

Choose an item. Click here to enter a date.

Choose an item. Click here to enter a date.

Choose an item. Click here to enter a date.

Section 2: PROJECT DETAILS

2.1 LAY SUMMARY

Please provide a summary of the project in plain English that can be understood by a non-specialist audience, which includes a
description of the background of the study (existing knowledge), the questions the project will address, the methods to be used and
the key ethical issues.

Please note the lay summary should not contain references and be no more than 500 words.

Learned helplessness occurs when an individual fails to learn how to escape an aversive stimulus e.g. pain, after a
period of uncontrollability, i.e., there is nothing they do can stop the aversive stimulus from occurring. Later, when
their actions are able to stop the aversive stimulus from occurring, they may give up even trying to stop it as they
have learned that their actions have no response. This is defined as learned helplessness.

This study aims to develop a task that causes symptoms of learned helplessness in healthy participants in response
to pain. Symptoms of learned helplessness include: poor performance on the task following the uncontrollable period
(defined as slower performance or less correct responses), giving up and not attempting to complete the task
following the uncontrollable period and more negative mood once the task portion of the study is complete. The task
will be based on reversal learning, whereby participants learn how to stop pain by performing a task correctly. The
rules of the task change every once in a while, requiring people to adapt in their behaviour. And eventually there will
be a period when it is impossible for participants to give the correct response. It is expected that this period will
cause symptoms of learned helplessness. After this period where it is impossible for participants to select a correct
response, the rules will change again and it will be possible for them to select a correct response. It is expected that
participants who are vulnerable to learned helplessness will not attempt to perform the correct responses after going
through the period of uncontrollability.

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 Participants will be asked to complete some self-reported questionnaires, some of which will assess aspects of their
mental health such as depression and anxiety. This is necessary for the analysis where we will be interested in if
there are individual differences in the experience of learned helplessness of people who for example, score higher
on the depression questionnaire.

Ethical Issues
Thermal stimulation stimulus will be utilised for the purpose of acting as an aversive stimulus. The experimental
protocols that utilise this thermal stimulus will be conducted by trained students and members of staff. The device
used for stimulation has built-in hardware and software restrictions to prevent harm or burns from occurring. The
protocol is initiated via preliminary testing to determine individual threshold and tolerance levels of each patient.
Lastly, every patient is free to withdraw from study interventions at any point, and is informed of this verbally and via
the written information sheets and consent forms.

It may be frustrating for participants to experience the part of the task where their actions have no response on the
pain stimulus, which some participants may find slightly distressing. Participants will be fully debriefed after the
experiment and will be told that there was a period where their actions had no response over the pain stimulus.

2.2 PRIMARY RESEARCH QUESTION

Please detail the primary research question this project will answer.

Due to the limited research currently available in this area, this study aims to develop a behavioural paradigm of
induced learned helplessness using pain as an aversive stimulus

2.3 SECONDARY RESEARCH QUESTION(S)

Please detail any secondary research question(s) this project will answer.

To explore individual differences of learned helplessness i.e., are certain people more susceptible to experience
learned helplessness (e.g., those who score greater on measures of depression?)
An additional benefit will be the development of a paradigm that will be useful in future research.

2.4 DESIGN AND PROCEDURE

Please describe concisely what the study will involve, how many times and in what order, for your participants and the procedures
and methodology to be used.

Note: Any questionnaires or interview scripts should be appended to this application.

Participants who meet the inclusion criteria will be invited to take part in the study. After informed consent has been
obtained, capsaicin cream will be placed on a small area of the participant’s forearm. Whilst waiting for the cream to
take effect, participants will be asked to complete the following questionnaires (copies found in appendix): Positive
and Negative Affect Schedule (PANAS) and State Trait Anxiety Inventory – State (STAI-S).

Participants’ pain tolerance will be established using the Medoc PATHWAY system by placing the thermode on the
participant’s arm where the capsaicin cream was placed. A temperature that is painful but not unbearable for
participants will be established. Participants will be asked to complete a task on the computer, whilst the thermode is
placed on their forearm. The task involves them selecting the correct medicine bottle out of 3 options. The first set of
15 trials is designed so that participants learn which medicine bottle is the correct one. Once the correct bottle has
been selected, participants will be rewarded with a reduction in temperature in the thermode on their forearm. If
participants choose incorrectly then the painful temperature will still be administered. After 15 trials, the rules will
change and participants will have to work out what the correct bottle is. After these 15 trials, participants will go
through 50 trials where it is impossible for them to select a correct medicine bottle, i.e. participants have no control
over their pain. After these trials, there will be another set of 15 trials where it will be possible for participants to
select the correct medicine bottle and reduce their pain.

Participants will be asked to complete the following self-report questionnaires (copies found in the appendix):
PANAS, STAI-S, Locus of Control Scale, Connor-Davidson Resilience Scale 10 item (CD-RISC-10), BIS/BAS, Pain
Catastrophising Scale (PCS), Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder (GAD-7).

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 Participants who have a score of 10 or greater on the PHQ-9, and/or who do not answer “not at all” to question 9 of
the PHQ-9 relating to self-harm/suicidal ideation, will be contacted on the same day by one of the researchers.
Participants who have a score of 10 or greater on the GAD-7 will be contacted on the same day by one of the
researchers.

2.5 LOCATION

Please describe where the research will take place.

The research will take place in CINN at the University of Reading.

Please state whether an appropriate risk assessment/ local review has been undertaken.

☒ Yes
☐ No
☐ Not required

Note:
- Ensure specific risk assessments have been undertaken for non-University locations (for example; schools or participant homes).
Please consult either your School Ethics Contact or UREC for guidance.

If the project is to take place in Hugh Sinclair Unit of Human Nutrition, it must be reviewed by the Research Nurses and the Hugh
Sinclair Manager also informed that the ethics application is being submitted for the study.’ Signatures are required below.

Hugh Sinclair Manager Click here to enter a date.

Research Nurse Click here to enter a date.

Click here to enter text.

2.6 FUNDING

Is the research supported by funding from a research council or other external source (for example; charities, businesses)?

☐ Yes
☒ No

If “yes”, please,

(a) Give details of the funding body;

Click here to enter text.

(b) Confirm if the funder specifically stipulates review by the University Research Ethics Committee.

☐ Yes
☐ No

2.7 ETHICAL ISSUES

Please summarise the main ethical issues, including harms and risks, arising from your study and explain how you have addressed
them.

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 Pain induction ethical implications

The study involves inducing pain using a thermal stimulus. Only trained students/staff will be conducting the study
using the thermal stimulus and will be following an experimental protocol. The device used for stimulation has built-in
hardware and software restrictions to prevent harm or burns from occurring. The protocol is initiated via preliminary
testing to determine individual threshold and tolerance levels of each patient, to ensure that the temperature is not
beyond their tolerance level. Participants are freely able to life their arm off of the thermal stimulus at any time and
will be informed of this before the experiment begins. Lastly, every participant is free to withdraw from study
interventions at any point, and is informed of this verbally and via the written information sheets and consent forms.

Deception ethical implications

It may be frustrating for participants to experience the part of the task where their actions have no response on the
pain stimulus, which some participants may find slightly distressing. Participants will be fully debriefed after the
experiment and will be told that there was a period where their actions had no response over the pain stimulus, as
they may be feeling frustrated over their poor performance during this period. Participants will be informed that this
was a necessary part of the procedure to induce feelings of helplessness.

2.8 DECEPTION

Will the research involve any element of intentional deception (for example; providing false or misleading information about the
study)?

☒ Yes
☐ No

If “yes”, please justify and append a description of the debriefing procedure.

Participants will be deceived in the third set of trials of the task, as they will not be informed that there is no
possibility for them to choose a correct response. This is necessary to induce learned helplessness, as a period of
uncontrollability is necessary for learned helplessness to occur.

2.9 PAYMENT
Will research participants receive any payments, reimbursement of expenses or any other benefits or incentives for taking part in
this research?

☒ Yes
☐ No

If “yes”, please specify and justify the amount.

Participants will be offered the choice of receiving £10 for their participation or 1.5 SONA credits

2.10 DATA PROTECTION

This section is required for applications reviewed at School (SREC) level only.

For applications reviewed at UREC level, do not complete this section. Move onto section 2.11.

What steps will be taken to ensure appropriate secure handling of personal data? Give comprehensive details on the collection,
retention, sharing and disposal of participant personal data.

Personal data means any data relating to a participant who could potentially be identified. It includes pseudonymised data capable
of being linked to a participant through a unique code number.

For guidance on data protection please, see the Data Protection for Researchers Guidance document.

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 Click here to enter text.

2.11 DATA MANAGEMENT PLAN

Requirement for applications to be submitted to UREC, only.

Applications submitted to UREC must be accompanied by a Data Management Plan (document available via link).

Please append the Data Management Plan.

☐ N/A, application not to be submitted to UREC

☒ Yes, appended*

*Please note; as the Data Management Plan is appended there is no requirement to complete section 2.10 Data Protection.

2.12 DATA PROTECTION IMPACT ASSESSMENT (DPIA)

Will the research involve any activity that requires a Data Protection Impact Assessment (DPIA)?

☐ Yes
☒ No

If “yes”, please append the “Pre-Screening Questionnaire for Data Protection Impact Assessment”.

Please note; the Pre-Screening Questionnaire for a DPIA is only accessible with staff credentials and the Chief Investigator is
responsible for its completion.

2.13 INFORMED CONSENT

a. Will you obtain informed consent from, or on behalf of, research participants?

☒ Yes (go to question b)

☐ No (go to question c)

b. If “yes”, please describe the process by which they will be informed about the nature of the study and the process by
which you will obtain consent.

c. If “no”, you are not obtaining consent, please explain why (for example; ‘opt-out’ methodology without the acquisition of
consent)?

Please append all relevant participant facing information documentation for participants, parents or guardians. Please note, age-
appropriate information sheets must be supplied for all participants wherever possible, including children. Assent should be
obtained from children, under 16 years, in addition to the consent required from parents, guardians or carers.

Participants will become aware of the study through emails sent out to university students and staff. The emails will
include a poster which will also be posted on social media. Written informed consent will be obtained by the lead
researcher prior to the study beginning, using the consent form in the appendices. Participants will be informed they
can remove their arm from the painful stimulus at any time by simply lifting their arm from the stimulus. They will also
be informed they can choose to stop the study at any time.

2.14 GENOTYPING

Are you intending to genotype the participants?

☐ Yes
☒ No

If “yes”, which genotypes will be determined?

Click here to enter text.

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Section 3: PARTICIPANT DETAILS

3.1 PARTICIPANT NUMBER

How many participants do you plan to recruit?

Please briefly explain why the number is appropriate to answer the study’s research question(s).

A previous learned helplessness study conducted by one of the applicants (Dr Wiebke Gandhi) was used to
determine an appropriate sample size. This study had a correlation of r=0.34, which corresponds to a Cohen’s
f=0.362 (f2=0.131). Based on this effect, the following G-Power analysis was conducted to calculate the sample size
needed to detect the anticipated effects for the present study:

To allow for potential technical failures, we would like to request an additional 15% of participants  to be recruited
for the study. This would equal a total N of 71+11=82 participants. 

3.2 PARTICIPANT CHARACTERISATION

What age-range of participants will you recruit?

Participants over the age of 18 years

Please list the principal inclusion and exclusion criteria.

Inclusion:

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 Participant is willing and able to give informed consent for participation in the study.
Participants aged 18 years or above.

Exclusion:

Any illness causing chronic pain

Diabetes or circulation disorders
Experiencing physical pain at time of study
• Communication difficulty due to language barriers
• Any other significant disease or disorder which, in the opinion of the recruiting physician, may put either the
participants at risk because of participation in the study, or may influence the result of the study, or the participant's
ability to participate

3.3 RECRUITMENT

Please describe the recruitment process and append any advertising if used.

An email will be sent out to university staff and students which gives details of the study and will ask for
participants.

3.4 NHS AND SOCIAL SERVICES INVOLVEMENT

Will participants be recruited because of their status as NHS patients or Social Services clients, or identified through those
services’ records?

☐ Yes
☒ No

If “yes”, please give details of current status of the HRA REC review.

Click here to enter text.

Will the study involve adult participants unable to consent for themselves as defined by the Mental Capacity Act 2005 or other
vulnerable adults?

☐ Yes
☒ No

If “yes”, please detail the associated procedures as set out in the HRA REC application.

Click here to enter text.

CHECKLIST
1. The Application form has the appropriate signatories Yes
2.The Participant Information Sheet includes a statement to the effect that the project Yes
has been reviewed by the appropriate Research Ethics Committee and has been
given a favourable ethical opinion for conduct.

3. The Participant Information Sheet contains the relevant Data Protection Yes
information.

4. Where minors (under 18) and vulnerable adults are involved in the study/research,
please confirm that all investigators have obtained a full enhanced DBS (Disclosure Not Applicable
and Barring Service check). Please select ‘Not applicable’ if this does not apply to
your research.

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 5. EITHER a) The proposed research will not generate any information about the health of participants; ☐

OR b) If the research could reveal adverse information regarding the health of participants, their
consent to pass information on to their GP will be included in the consent form and in this
☐
circumstance I will inform the participant and their GP, providing a copy of the relevant
details to each and identifying by date of birth.

OR c) I have explained within the application why (b) above is not appropriate. ☒

6. EITHER a) The proposed research does not involve children under the age of 5; ☒

OR b) My Head of School (or authorised responsible person) has given details of the proposed ☐
research to the University’s insurance officer.

7. EITHER a) The proposed research does not involve the taking of blood samples: ☒

OR b) For anyone whose proximity to the blood samples brings a risk of Hepatitis B, ☐
documentary evidence of immunity prior to the risk of exposure will be retained by the Head
of School or authorised responsible person.

8. EITHER a) The proposed research does not involve the storage of human tissue, as defined by the ☒
Human Tissue Act 2004;

OR b) I have explained within the application how the requirements of the Human Tissue Act ☐
2004 will be met.

9. EITHER a) The proposed research does not involve the use of ionising radiation; ☒

OR b) I am aware the proposed research will require HRA REC review. ☐

VERSION CONTROL
VERSION KEEPER REVIEWED APPROVED BY APPROVAL DATE

1.5 UREC Annually UREC September 2021

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