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Testing Guidelines for Cognition and Emotion Research
Why do we need testing guidelines?
We were asked to develop a set of testing guidelines after a number of volunteers reported experiencing ill effects as a direct result of taking part in certain cognition and emotion experiments. The aim of this booklet is to provide guidelines that will help to minimise any distress to volunteers or to researchers carrying out the studies.
Contents
- Assessing the potential risks
- Risk management checklist
- Research using mood inductions, unpleasant IAPS pictures, invasive techniques and training in cognitive bias
- Potential problems and advice on what to do
- Appendices:
Assessing the potential risks
A formal risk assessment should be made prior to testing. A checklist is provided overleaf to assist in the assessment.
Lower risk studies will include those in which:
- healthy volunteers are recruited or volunteers who are deemed fit by the research team to take part in the study without undue distress being caused to participant or tester.
- neutral stimuli are used (e.g. normal range of cue words not all pleasant or unpleasant and none that under normal circumstances would be expected to produce an adverse reaction).
Higher risk studies will include those in which:
- participants are selected because they belong to a potentially vulnerable group (i.e. depressed/ anxious)
- inductions are used with the intention of inducing a potentially vulnerable state (e.g. negative mood induction)
- emotional stimuli are used (e.g. unpleasant IAPS pictures)
- researchers have consistently found that on previous occasions volunteers have become distressed with the tasks.
Special consideration: Inexperienced testers, new graduate students and new placement students should not be asked to run higher risk studies (or studies which could potentially fall into the high-risk category) without adequate training and support.
Training and support: It is the responsibility of supervisors or line managers to ensure that all research staff are fully competent in carrying out the tests and that strategies for dealing with potential problems have been outlined prior to testing.
'Buddy' system: New testers will be assigned a junior member of the cognition and emotion research team to act as a 'buddy'. The aim of the buddy system is to provide extra advice and support.
Contingency plan: If a proposed study falls into the high risk category, and panel members will be involved in the research, a brief contingency plan should be submitted to the panel office at the time the request is made for volunteers. The plan should provide details of what action will be taken to reduce the risk of distress to volunteers and to testers. The contingency plan must be agreed by the researcher and line manager or supervisor and signed by both parties. A sample contingency plan is provided in Appendix III.
Please note:
- All new members of the research group must find out from their supervisor/line manager if the research that they will be conducting is already covered by an existing ethics application.
- If their research is covered by an existing ethics application, then they must read the application and send a letter to the ethics committee stating that they agree to comply with all aspects of the application.
- If the study is not covered by an existing ethics application, then an application must be made under the guidance of the supervisor/line manager.
Risk management checklist
- Will the experiment use stimuli that could elicit a strong emotional reaction? (e.g. unpleasant IAPS pictures)
- Will the experiment use a negative mood induction?
- Will the experiment use any invasive techniques? (e.g. electrophysiology)
- Will potentially vulnerable (e.g. anxious or depressed) volunteers be asked to take part in tasks that might increase their vulnerable state?
If the answer to any of the items above is yes, you are required to send a letter to all potential volunteers explaining the nature of the experiment. The letter must be sent prior to recruiting volunteers over the telephone (see Appendix II for a sample letter).
Pre-test:
- If you believe that your study might cause undue distress, and your volunteers intend to drive to the unit to take part, you should ask if they would prefer to be collected prior to the study and taken home afterwards in the unit car.
- In the event of participants becoming distressed as a result of taking part in the research, what plan of action do you intend to take? (see sample contingency plan in Appendix III).
- If a clinical psychologist might be needed to provide back-up support (e.g. following an adverse reaction to a negative autobiographical mood induction), which clinician has agreed to act on your behalf?
- Have research-relevant assessments been made to check participants' suitability to take part? (e.g. mood check, claustrophobia check)
- If the study involves repeated use of keyboard or mouse, have any checks been made concerning repetitive strain injury or arthritis?
- If there is a possibility that participants may become upset during the test, have you got a box of tissues with you in the testing room?
Post-test:
A sample debriefing checklist can be found in Appendix IV
- Has the nature of the experiment been fully explained and was the participant given the opportunity to have any questions answered.
- What was the participant's reaction to the experiment? Was there anything about the experiment that they did not like? Will participants be given a feedback sheet to allow them to comment on their experience of taking part in the study?
- Is the participant's mood at its normal pre-testing level?
- Are you giving participants an information sheet with a contact telephone number of the researcher on it to take away with? For previous studies using mood induction procedures, contact sheets have included the following wording: "We always try to ensure that when people leave the experiment, their mood has returned to normal. On rare occasions, people can find that their mood drops again after they have returned home. We do not expect this to happen but it is possible. If your low mood returns and you feel that your distress is due to the mood induction then call us on the telephone number below and we can discuss how best to help you."
What to do if participants become distressed as a result of taking part in the research:
- Sit and listen, and offer the participant a drink of tea or coffee.
- If necessary offer a confidential talk with a clinical psychologist.
- If the participant is unable to drive home, the unit policy is to drive the person home yourself in the unit car (you must see Anthea to complete the necessary forms). If this is not possible ask Jackie Harper or Pete Williams if they are willing to drive you and your volunteer to the participant's home. If all else fails, take the participant home in a taxi.
- Ask if the participant would mind if you called them later that day/the next day to check that they are OK.
Research using mood inductions, unpleasant IAPS pictures, invasive techniques and training in cognitive bias
The following guidelines have been adapted from the CBU policy on the use of mood inductions. The information regarding mood inductions can be found on the Intranet (see Homepage, go to Admin, see Testing).
- Any researcher proposing to carry out research involving mood inductions, unpleasant IAPS pictures, invasive techniques or training in cognitive bias should send an email/letter to the Director prior to testing to obtain consent.
- A covering letter must be sent to prospective volunteers indicating the nature of the research they are being invited to take part in (see Appendix II).
- A contingency plan must be submitted to the panel office describing what measures will be taken to reduce the risk of distress to volunteers and to testers, and what action will be taken if an individual does suffer as a result of the testing (see Appendix III).
- Volunteers must sign a written consent form before beginning the experiment (see Appendix I).
- If on the day of testing, the participant has changed their mind since agreeing to take part in the study and no longer wants to engage in the mood induction/view the IAPS pictures/be wired to the equipment, an alternative task must be made available for them to complete.
- Volunteers must be reminded that they are free to terminate the experiment at any point.
- Experimenters must ensure that volunteers' mood has returned to 'normal' (pre-testing level) before concluding the experimental session.
- Volunteers should not be asked to take part in other tests immediately following the experiment.
- A clinical psychologist should be approached and asked whether they would be prepared to talk to any participants who suffer an adverse reaction as a result of the experiment. This is not expected to happen but provision should be made in case it does occur. The discussion would take place at a time mutually convenient to the clinician and the volunteer.
Additional recommendations
- Scientists who are not clinically trained, but who wish to do mood induction research, must obtain guidance from someone experienced in the use of this technique. Guidance should cover screening of volunteers, implementation of the procedure and (most important of all) how to assess whether volunteers have returned to normal mood at the end of the experiment.
- The mood-state of volunteers must be screened before experiments using depression induction procedures, unpleasant IAPS pictures, invasive techniques or training in cognitive bias. Great care must be taken when testing volunteers scoring 14 or more on the Beck Depression Inventory, scoring above 8 on the HADS, and scoring 45 or more on the Spielberger Trait Anxiety Questionnaire. Only testers with suitable training should test volunteers with high depression or anxiety scores.
- As autobiographical mood inductions are more likely to lead to longer-term distress once the participant has returned home (compared with musical or film inductions) a negative autobiographical induction should not be used unless it forms an essential aspect of the study.
- Group mood induction should not take place unless a special case is made for it to the Ethical Committee.
Potential problems and advice on what to do
Participant care
Example 1: If a participant becomes distressed during the study....
If during an experiment (e.g. a study using an autobiographical memory task) a participant becomes distressed and begins to cry, testing should be curtailed. Sit tight, listen and make sympathetic noises if appropriate. Try to give the impression that their emotion is absolutely justified, they are normal, and you care that they are currently distressed. Give them time to recover. If it feels 'unfinished', ring the participant the next day to check they are OK. Provide feedback to the panel about the incident.
Example 2: If the participant's mood has not returned to normal after testing....
If after an experiment (e.g. a study using a negative mood induction) a participant's mood has not returned to pre-testing levels, explain that it is not unit policy to send participant's away from an experiment feeling unhappy. Take them to a quiet room, if possible, play them relaxing music/ a tape of mood enhancing sounds, offer them a drink, and allow them to sit and relax for a while. Give the participant an information sheet with a daytime contact number (see page 2). Should the participant's low mood return and they attribute it directly to the study, they can then telephone and discuss their feelings with the researcher. Provide feedback to the panel about the incident.
Example 3: If a participant reports feeling adverse effects a week or more after testing....
If, after taking part in a high-risk study (e.g. research using unpleasant IAPS pictures), a participant reports having intrusive thoughts about the stimuli they were presented with, listen to the individual's concerns, and talk to them about their experience. If they remain unhappy, invite them to discuss their concerns with the nominated clinician. Provide feedback to the panel about the incident. Follow-up the complaint 2-3 weeks later with a telephone call to see how the participant is feeling.
Example 4: If a participant faints or becomes ill during testing....
Before you begin testing, check which members of staff are first aid qualified, which are situated nearest to your testing space and whether they are willing to be called upon should the need arise. If a volunteer does become ill during testing let the panel managers know about the incident. Follow-up with a telephone call the next day to see how the participant is feeling.
Researcher support
Example 1: Dealing with distressed participants...
If the researcher suspects that a participant is becoming unduly distressed by the experiment, then testing should be curtailed. After measures have been taken to deal with the participant's distress (see above), the tester should discuss the incident with their line manager or supervisor. This debriefing for the tester should aim to provide reassurance and advice about the way the incident was handled, as well as advice on what further action should be taken.
Example 2: If repetitive testing leads to tester-distress....
If repeated testing using emotional stimuli (e.g. unpleasant IAPS) causes distress for the tester, or an incident with a participant has created 'emotional wear-and-tear', the tester should seek out their 'buddy' or their line manager/supervisor to discuss the problem. This debriefing for the tester should aim to provide reassurance and advice. If it is the material that is causing particular problems, the issue should be raised with the line manager. They should discuss ways in which to alleviate distress to the tester (e.g. by waiting outside the room during critical parts of the experiment) and if necessary, revise the experiment. The tester should be given as much time and emotional support as they require. Testing should only continue when the tester feels confident to do so.
Example 3: Working outside normal hours or working alone outside the unit....
Junior staff/ students should avoid working alone outside the unit, if possible. All staff testing outside the unit should register their whereabouts, contact details and expected return time with their line manager, their 'buddy' or with reception staff before they leave. They should take a unit mobile phone and inform their line manager/'buddy'/reception when they return. Junior staff/ students should also avoid testing participants in the unit outside normal working hours. If testing outside office hours proves essential, arrangements should be made to make sure that an experienced member of the group is present in the building, who can provide assistance should it be needed. All staff working out of hours should sign in to register their presence.
appendices
Appendix I
Sample Consent Form No. 1
Consent Form
This session will involve some simple psychological tasks (description of the tasks....mention stimuli e.g. IAPS, negative texts). This task will last for approximately ....... (time to be entered appropriately for each study) .....minutes.
Please tell the experimenter at any time if you do not wish to continue. Your participation is entirely voluntary and you are free to withdraw at any time.
All data and results relating to you will be totally confidential, will not be revealed to anyone outside the research team, and will be kept securely in accordance with the Data Protection Act. Your help with this research is very much appreciated. Please complete the following consent:
NAME:
I have read the above description of the research and understand that my participation is voluntary and I am free to withdraw at any time.
I CONSENT TO TAKE PART IN THE RESEARCH
Signed: Date:
Sample Consent Form No. 2 (mood induction research)
Consent of volunteer to take part in the study.
I (Name in block capitals) .....................................................................................
of (Address) ..............................................................................................................................
give my consent to take part in the research project entitled...(title of study). I understand that it involves a neutral or negative mood induction, that will be voluntarily induced and that any negative mood will only last for a brief period. I acknowledge that ...(the researcher) has explained to me the purpose of the research and that I have had the opportunity to ask questions relating to the study. I understand that I may withdraw at any stage. I also understand that the information that I give will not be made available to any persons beyond the research team and that it will be kept securely in accordance with the Data Protection Act.
Signed: ................................................................... Date: .................................
Researcher:
I confirm that I have explained the nature of the study to the volunteer and that he/she has
been given the opportunity to discuss any queries.
Signed: .............................................................. Date: .....................................
Printed Name (Block Capitals) ........................................
Appendix II
Sample letter no. 1 (example used is for a mood induction study)
Dear ...................
At the moment we are running an experiment to look at ... (e.g. how sad moods may affect our daily lives and, in particular, how they may make a difference to the way we find solutions to simple problems). The aim is to ... (e.g. gain a greater understanding of depressed moods). The experiment takes about ... hours to complete. Volunteers are asked to ... (describe tasks).
As we are looking at sad moods, when volunteers have reached a certain point in the experiment, we ask them to try and lower their mood a little. We use a tried and tested method to do this .... (briefly explain method). It takes quite an effort to get into the sad mood and the effects of the mood induction wear off very quickly but it does give us a short period of time to look at how sad moods may influence our lives.
As the experiment involves a sad mood induction, it is unreasonable to ask people who have recently been feeling depressed to come along and take part. So if you have felt extremely low for more than three months at any time in the last year or have been feeling particularly down in the past week or two then I would recommend that you do not volunteer. I must also mention that, even if you agree to take part, if you decide during the experiment that you do not want to continue, you are allowed to stop and will still receive your payment.
I will give you a telephone call within the next two weeks to find out if you are interested in taking part. I look forward to speaking to you.
Yours sincerely
...........................
Sample letter no. 2 (example used is for a study measuring responses during picture viewing or word imaging. Here the letter requires a response)
Dear PANEL MEMBER
As one of our panel volunteers at the Cognition and Brain Sciences Unit we would like to invite you to take part in a study we are currently running. We are writing in advance and not simply telephoning because this study has some extra requirements.
Firstly, you will have to view pictures, which differ in their emotional content (how pleasant, unpleasant or arousing they are). The unpleasant pictures may contain scenes of trauma and violence such as bodies or weapons. Each picture is shown for 6 seconds. Although these pictures have been used in many previous studies some people may find them distressing and might prefer not to take part.
Secondly the experiment involves measuring the various bodily changes which occur in response to such pictures. Specifically we will record the magnitude of your eye blink (i.e. how much the muscle contracts) following a sudden noise, the changes in your heart rate, and the small differences in the amount of sweat produced on the surface of your hand. In order to do this we have to place three different types of recording sensors on your body. Understandably, some people may prefer not to undergo this. Details of the placement of sensors are as follows:
- The Electromyogram (EMG) requires two sensors that will be attached to the face below the right eye. This will measure the force of the eyeblink.
- The Electrocardiogram (ECG) uses sensors placed on the wrists and ankle. This will measure your heart rate.
- The conductive skin ratio (CSR) sensors will be applied to the undersides of two fingers. This determines slight changes in the amount of perspiration on your fingers. The measurement involves passing an unnoticeable current across your fingers. The current is so small that it will be below your sensitivity threshold and you will not be able to detect it.
Finally, during the experiment, from time to time we will present a brief (1/20th of a second) pulse of noise through earphones. Although short this noise is loud and is intended to make you startle or jump slightly. You may not wish to participate if you suffer from abnormal sensitivity (or insensitivity) to noise, or if you think you may experience adverse effects for any other reason.
After completing the main experiment described above, all participants will be asked to complete some questionnaires like those used in many of our other studies. These involve answering questions both about how you are feeling right now, and how you generally feel.
The experiment will take approximately 70 minutes and overall should be no more than 1 1/2 hrs.
Please complete and sign the enclosed form to indicate whether you would be willing to take part in this study, and return it in the freepost envelope provided (no stamp required). If you are agreeable we will then phone within the next few weeks to arrange a convenient time. If we do not hear from you we may phone to ask whether you are willing to participate. If you do not wish to be contacted again, please be sure to return the form to let us know.
As with all studies at the CBU you should feel free to change your mind and withdraw at any time.
Yours sincerely
---------------------------------------------------------------------------------------------------------------------
Measuring responses during Picture Viewing or Word Imaging
Please complete this form indicating whether or not you would be willing to take part in this study, and return it in the freepost envelope provided.
I.................................................................. (PLEASE PRINT YOUR NAME)
have read the description of the study on measuring responses during Picture Viewing or Word Imaging.
I would prefer not to take part in this study .................
I am willing to be contacted with regards to taking part .................
I can be telephoned on ......................................................................(daytime),
Or alternatively on............................................................................(evenings)
If you have an email address, please list it here:..................................................
Signature: ................................................. Date: ........................
Appendix III
Sample contingency plan: (Template provided is for use in studies using negative mood inductions or unpleasant IAPS pictures)
Title of Study............................................................
We ............................................................................. (names of researcher and
line manager/supervisor) confirm that the following steps will be taken to reduce the risk of distress being caused to volunteers or to members of the research team administering the tests.
- A covering letter will be sent to volunteers explaining what is involved in the study and why we are carrying out the research
- When participants are recruited over the telephone the nature of the study and the task requirements will be explained again and they will have an opportunity to ask questions.
- For IAPS only: On the day of testing, before starting the tasks, participants will be shown examples of the kinds of IAPS pictures they might see during the experiment. The tester will be able to choose to wait outside the testing room while the participant engages in the IAPS task if they wish to do so.
- An alternative task will be available that could be used if the participants decides that they do not want to engage in the set tasks.
- It will be made clear to participants that they can end the testing session at any point if they do not want to continue, without forfeiting their payment.
- Visual analogue scales will be used to assess pre- and post-test happiness, despondency and anxiety. At the end of the study participants will be debriefed. They will be asked how they are feeling and whether or not they feel their mood is at / has returned to normal levels.
- If participant's mood has not returned to normal they will be taken out of the testing room and seated in an appropriately quiet space, offered a drink, played relaxing music and given the opportunity to talk about how they are feeling.
- Participants will be given a contact number before they leave.
- In the unlikely event that the participant does not feel happy to drive home then they will be driven home by a member of staff. A and B have already been approached and have been asked if they would be prepared to do this should they be available.
- Person C has been approached and asked whether they would act as the nominated clinician for this project. They have agreed to talk to any distressed volunteers at a mutually convenient time, should the need arise.
Signed ......................... (researcher) ........................ (line manager/supervisor)
Date ............................
Appendix IV
Sample debriefing checklist (kindly provided by Jenny Yiend and Becky Lee)
For All Participants
Ensure the nature of the experiment is explained
Explain the purpose of the study and what the participant's contribution is.
Ascertain the participant's reaction to the experiment
Questions to be asked:
"What did you think of the experiment?"
"Was there anything about the experiment that you didn't like?"
"Did you experience any adverse effects, for example concerning how you feel?"
Check current mood status
Ask the participant about their feelings at this moment, whether or not they feel their mood is at / has returned to normal levels. End the session if all is well, otherwise continue with the steps below.
Additional measures, in case of distress
Provide a safe space
Participant's should be offered a drink and in a peaceful environment in which to relax, to allow any adverse effects to dissipate. A member of the research team should remain with them or in the vicinity for as long as needed.
Offer a confidential consultation with a clinical psychologist
If the participant remains upset or wishes to talk at length then offer the chance to speak with a nominated clinical psychologist, at a time that is mutually convenient.
Ensure Safe transport home and further follow up if necessary
Consider participant's suitability to drive and arrange alternative transport (e.g. staff member- see page 2) if necessary. Offer follow-up telephone calls, as appropriate.
Appendix V
Checklist for use when testing outside the unit (Kindly provided by Jill Keene)
| Preparation | 1 | Decide on tests to use | |
| 2 | Read papers/instructions relevant to tests/ask for guidance as appropriate | ||
| 3 | Practise tests which are new/unfamiliar on self or others | ||
| 4 | Make appointment(s) (Avoid early Monday morning - traffic/collecting money - and Wednesday LTS, Thursday ABC if possible) | ||
| 5 | Ask for instructions to patient's house | ||
| 6 | Print map(s) from UK streetmap/multimap on web | ||
| 7 | Book unit car (as far in advance as possible) | ||
| 8 | If testing someone for the first time, make sure someone from CBU is available to come with you | ||
| Week before | 9 | Email Reception with details and mobile number (see Anthea's guidelines) | |
| Day before | 10 | Telephone participant to confirm meeting. | |
| 11 | Assemble book tests/questionnaires, etc. and decide on order. Check supply of response sheets for each test | ||
| Before setting out | 12 | Check material e.g. computer, response box, speakers etc Check patient's address and telephone number. Take map, pad and pen(s) | |
| 13 | Collect book and keys for unit car from Workshop, collect unit mobile phone | ||
| On return | 14 | Tell Reception/line manager/supervisor. Return unit car keys to Workshop |
General:
- Smart appearance - no jeans
- Need to appear confident and professional
- Even if it is the first time you have carried out a particular test, try not to say so.
- If there are problems with the computer, speakers, etc., if can't fix quickly, leave and do something else. (If there is another tester, ask them either to fix computer or administer another test while you fix the computer.)
- Check whether person being tested is happy to carry on, needs a break, as appropriate.