Research Ethics Application Guidance Notes

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These notes are provided to help you prepare and complete the forms required for a research ethics application to the School of Psychology Research Ethics Committee. The application form has been structured to lead you through the main issues to be considered when evaluating the ethical implications of your research. These are not rules and the Psychology Research Committee reserves the right to consider any aspect relevant to maintaining ethical standards in research. By their very nature psychological experiments are different and require different considerations. As such there is no single correct response to each question. Rather the nature of responses will depend on the individual study.

• Research Ethics Application Form
• Guidance for Research Protocol
• Guidance for Schools Research Information Sheet
• Application for Criminal Record Check
• Animal Research Information Sheet
• Guidance for Participant Information Sheet
• Participant Consent Form

General notes

You must complete the form in full and in typescript. Failure to fully complete the form may delay the process of considering your application. Not all questions may be relevant, if they are not answer with N/A. Do NOT leave questions blank. Ensure you provide all the necessary information required for your application. The front of the application form contains a list of necessary information. Do not change the formatting or structure of the form.

When complete the application must be submitted to The General Office, School of Psychology, Queenâ??s University, Belfast, BT7 1NN and clearly marked RESEARCH ETHICS APPLICATION.

Your research may not begin until you have received notification from the School of Psychology Research Ethics Committee.

Research Ethics Application Form

Applicant Information

A1 Project Title:

This should be a concise description of your proposed study. Avoid terms such as "An experiment to" , "A study of".

A2 Researcher(s):

Please give level UG(1,2 or 3)

MSc, PhD, Staff

List the names of all researchers, include their current status, e.g. Yr2 UG, PhD, etc.

A3 Supervisor for UG/PG students:

For undergraduate and postgraduate students you must give the name of your supervisor. S/he applies for ethical approval on your behalf and both you and your supervisor will be informed of the decision of the committee.

A4 Address, tel. and email for correspondence:

UG/PG projects should use

their Supervisor's address

Give full postal address, telephone numbers and email address. For undergraduate and postgraduate students you must give the details for your supervisor.

A5 Proposed Start date:

Give the date you are proposing to start the research. Note you must not commence the research until ethical approval has been granted.

A6 Duration of project:

How long will the project last?

A7 Where will the research be undertaken?:

Provide the details and address(es) of where it is proposed to undertake the research.

A8 List roles of individuals undertaking this research:

Name Role Qualifications

Provide a list of all individuals involved in the research, what their role is and their qualifications. If individuals are to be appointed, indicate this by AN OTHER but fill in details of their role and proposed qualifications.

Declaration

This must be signed by the researchers, and for UG and PG their supervisor

Research project

(A complete research protocol should be attached to this application. See Guidance notes)

B1 What is(are) your research question(s)?:

You should succinctly state what your main research question(s) is.

B2 Outline, briefly, the background to the research:

Provide a short statement as to the background of the research. If it replicates previous studies state why this is necessary. This should be readable and understandable to individuals with no knowledge of the area.

B3 Outline, briefly, the methods and analysis you intend to use:

This section should identify the key variables of your study and main methods to be used. Information should be provided on the research design (e.g. questionnaire, interview, observation, experimental-give type]..), the procedure (between subjects, randomised control trial..). Justification for the number of participants is required. You should outline the main analysis that will be undertaken. This section should be understandable without reference to the full protocol.

B4a Does this study involve any deception or with-holding information? Yes : No

If yes, why is this necessary? how does this conform to the BPS Code of Conduct

Principles for Deception (Section 4 page 9 Revised Code of Conduct)

The BPS code acknowledges that "It may be impossible to study some psychological processes without withholding information about the true object of the study or deliberately misleading the participants" [4.3]. If you intend to use deception, provide explicit details of why it is necessary, how its use conforms to that required by the BPS and what has been done to minimise this potential risk. The BPS code states "misleading of participants is unacceptable if the participants are typically likely to object or show unease once debriefed" [4.1]. Further the code recommends "Intentional deception of the participants over the purpose and general nature of the investigation should be avoided whenever possible"[4.2]. If deception is to be used it must be fully justified.

B4b Does this study involve any physical risk to participants? Yes : No

If yes, why is this necessary? how has this been minimised?

If yes, provide explicit details of why it is necessary that you use this particular procedure and what has been done to minimise this potential risk.

B4c Does this study involve any psychological risk (e.g. cause upset, worry, stress, fatigue, feelings of being demeaned? Yes : No

If yes, why is this necessary? how has this been minimised?

Studies may unintentionally increase psychological risk, you must carefully consider the implications of your study for the participants. If you have answered yes then you must provide explicit details of why it is necessary that you use this particular procedure and what has been done to minimise this potential risk.

B4d Does this study involve any social risk (e.g. loss of status, privacy, reputation)? Yes : No

If yes ,why is this necessary? how has this been minimised?

Studies may unintentionally increase social risk, you must carefully consider the implications of your study for the participants. If you have answered yes then you must provide explicit details of why it is necessary that you use this particular procedure and what has been done to minimise this potential risk.

B4e Does this study require participants to disclose information of a sensitive or personal nature? Yes : No

If yes, why is this necessary? how has the procedure been adapted to minimise any feeling of distress at providing this information?

You must carefully consider the implications of providing sensitive information and the means of its collection. For example, questionnaires administered in a lecture theatre with individuals sitting on top of one another is not the best way to collect information of a personal or sensitive nature, nor is it likely to elicit this information accurately. If your research involves collection of such data then you must provide information of how this is to be collected and how privacy and confidentiality will be preserved.

B4f Are there any other risks different from those encountered in everyday life Yes : No

If yes, why are they necessary, how is their potential effect minimised?

There may be risks not covered above which need to be addressed. Do so here, stating why it is necessary for this procedure and what has been done to reduce any potential risk.

B5 How will confidentiality of participants and their responses be assured?

It is expected that all information will be confidential to the researchers and individually identifiable data not available. State how this will be done. If you intend to deviate from above then reasons must be given as to why this is necessary.

B6 If observational research is to be undertaken without prior consent, describe the situation and how privacy and individual confidentiality will be preserved.

Some research involves unobtrusive observation of naturalistic situations where it is not possible to inform participants or gain consent prior to the observations. In these situations you need to state how the privacy and individual confidentiality will be preserved.

B7 How will participants be debriefed?

If no debriefing is planned say why not.

If deception or withholding of information is central to the study a debriefing session is essential to the procedure. For all experiments some debriefing is required. Provide explicit information on how subjects will be debriefed after the experiment. If written information is to be provided a copy of this must be included with the application.

B8 Is permission required from any other source before commencing the research, e.g. from School, Hospital Yes : No

If yes, state from where and what has/is been done to obtained this. Relevant permissions should be included - checklist 10

If the research is being undertaken off the QUB site then permission(s) may be required from wherever the research is to be undertaken. The advent of Research Governance has unfortunately introduced many layers of permission required before research may proceed. Approval of the School of Psychology Research Ethics Committee does not confer these permissions. If your research involves Schools you require permission from Psychology's 'Schools Research Liaison Officer' before approaching the School. You must list here what other permissions are needed and include any supporting information under item 10 of this application procedure.

Participant Information

C1 What participants will be used in the study

Students at QUB Yes : No

Normal adults (outside QUB) Yes : No

Persons 15 and under Yes : No

Persons with specific medical conditions Yes : No

Persons whose ability to consent to the study is compromised Yes : No

Prisoners Yes : No

Animals Yes : No

Circle what category(ies) of participant you will be using

C2 How many will be used?

Give numbers in each group, including any controls. How will participants be included or excluded - give criteria.

Provide the numbers required, what the potential drop out rate will be. If there are specific criteria for participant inclusion or exclusion you should provide details here.

C3 How will participants be recruited?

Include a copy of any advert to be used to recruit participants (checklist 10)

Provide information about how you intend to recruit your participant pool.

C4 What, if any, is the relationship between investigators and participants (e.g. fellow students, club members, family, friends, etc)?

State the relationship, if any, between you and your participants. Address the participants' perception of power, e.g. will you be seen as their 'superior' and hence the participants are more likely to conform. With you as their supervisor will they be less likely to withdraw for fear of adverse consequences? What will be done to overcome this?

C5 What information will be given to participants?

Include copies of written information. If information is provided verbally say what is provided and why this is done verbally?

It is expected that participants will receive written information. If this is not the case justify this decision. Further information is provided on Guidance for Participant Information.

C6 How will participants give consent? Written : Verbal

It is expected consent will be written, if not why not? Include a copies of the consent form

It is expected that participants will provide written consent If this is not the case justify this decision and provide a copy of the words to be used. Further information is provided in Guidance for Participant Consent.

C7 If individuals are unable to give consent, e.g. through age or incapacity how will consent be obtained?

State exactly how consent will be obtained and what will be done to ensure the safety of participants in these situations.

C8 Are there any medical conditions which increase participants' risk when undertaking the study? Yes : No

If yes, how will this information be obtained?

Some studies may increase risk if the participant has a specific medical condition, e.g. stress studies and patients with cardiac disease. Consider those factors that may increase risk of participants who take part in the study. How will these factors be identified. If these are not part of the exclusion criteria, why not and justify their inclusion of such participants in the study.

C9 Do participants have the right to withdraw from the research at any time Yes : No

How and when are participants informed of this?

The answer here is yes, it is unlikely approval will be granted if this is not the case. State how participants will be informed of their right to withdraw.

C10 What will happen if participants wish to withdraw?

State what procedures will be followed if a participant wishes to withdraw from the study, including what happens to data already collected.

C11a Will confidentiality of information be preserved? Yes : No

It is expected that all information will be treated with the utmost confidence.

C11b What steps will be taken to ensure this?

State how individual identifying information will be removed from the data collection.

C11c Where will data be stored?

It is expected that raw data will be held by the PI or for UG research the supervisor must hold the information. For PG research a copy will held by the Supervisor. The Supervisor must provide information about how this information will be secured. Information should be provided about how the information will be stored, e.g. paper records, computer files, etc.

C11d Who will have access to this data?

It is expected that only the researchers will have access to this data. If it is intended that others may have access, explicit consent for this access must be obtained from the participant at the time of the research study.

C11e Where will consent forms be stored?

Consent forms are stored separately from the data and are usually held in the School of Psychology's Research Registry. If you wish to deviate from this explicit reasons must be given.

C11f Will individually identifiable information be given to third parties or available through publications, etc.

If yes, state why this is necessary and demonstrate participants are aware of this.

If individually identifiable information is to be presented or used in publications explicit consent must be obtained from the participant. You must justify why this is necessary.

C12 Is any payment provided to participants? Yes : No

If yes, how much? what for? and why is this necessary?

Provide details of how much and the reason for this. Provide a statement why this is necessary. It is not usual to pay people for participating in research but their expenses incurred in doing so may be re-imbursed.

Administration of Substances to Participants

D1a Will you be administering any substances to participants? Yes : No

If, as part of your study, you are giving participants any substances, e.g. drugs, alcohol, food, exposure to odours, etc. indicate yes.

D1b Will you be asking participants to refrain from taking any substance they would usually take? Yes : No

If, as part of your study, you are asking participants to refrain from taking any substances they would normally eat, drink or take, e.g. food, drugs, cigarettes, etc., indicate yes.

D2 If you have answered yes to either of the above questions provide the following information for each substance to be administered or withheld: a) substance, b) amount to be administered or withheld, c) desired effect, d) possible side effects, e) what will be done to minimise risks.

If you are administering any substances to participants or requiring them to refrain from taking particular substances you must provide full information on this. This must include what the substance is and how much you are administering, dose, duration or how much is being withheld, dose, duration. You should provide details of what the desired effect of the administration or withholding of substances is, state how long this will last and what if anything will be done to reverse the effect. You should indicate what, if anything, will be done to ensure the participant's safety whilst 'under the influence' of the substance or its absence. You should detail any possible side affects arising from your procedure and what will be done to minimise these.

Administration of Questionnaires/Tests to Participants

E1 Will you be administering any questionnaires/tests to participants? Yes : No

If you are administering questionnaires to participants indicate yes

E2 If yes to E1 list the questionnaires/tests you will be using below. For each questionnaire/test state: a) title, b) reference if published, or if unpublished provide copies of the questionnaire with the application, c) purpose of the questionnaire.

For each questionnaire/test you are using you must provide the title. If it is a published questionnaire/test provide reference details, if it is unpublished provide copies of the questionnaire as required (see checklist). You should state the purpose of the questionnaire, what information is the questionnaire designed to gather.

Guidance for Research Protocol

This should be prepared under the following headings

Aim of project

This should be a brief succinct statement of the purpose of the project and its intended outcome(s).

Background (not required for UG research)

This should provide the background to the research. What has been done previously and why this research is necessary.

Methods

This section should provide a full description of the methods that will be used in the research.

Participants:

Detail your participants for the study

Apparatus:

Outline the facilities and equipment that will be used in the study.

Procedure:

This must explicitly state what participants will undergo when taking part in the research. It should include information on duration of participation. How the participant's responses will be recorded should be stated (questionnaire, filming via video, etc.). How this information will be stored should be stated.

Analysis:

The key dependent and independent variables used and obtained in the research must be stated. How the data are to be analysed should be discussed.

References where appropriate

Guidance for Schools Research Information Sheet

This is required for all research that proposes to use Schools and their pupils for their research. You MUST NOT contact the School until approval has been given by the School's Research Liaison Officer.

S1 Project Title:

This should be a concise description of your proposed study.

S2 Researcher(s):

Please give level UG(1,2 or 3)

MSc, PhD, Staff

List the names of all researchers, include their current status, e.g. Yr2 UG, PhD, etc.

S3 Supervisor for UG/PG students:

For undergraduate and postgraduate students you must give the name of your supervisor. S/he applies for permission to use the School on your behalf and will be informed of the decision of the committee.

S4 Address, Tel and email for correspondence:

UG/PG projects should use

their Supervisor's address

Give full postal address, telephone numbers and email address. For undergraduate and postgraduate students you must give the details for your supervisor.

S5 Proposed Start date:

Give the date you are proposing to start the research.

S6 Duration

How long will the project last?

S7 Proposed School at which research is to be undertaken

Provide the details and address(es) of the School(s) where it is proposed to undertake the research.

S8 How much time will be required of each student participating in the research?

You must provide details of how much time pupils will spend on the research and on how many occasions. How will pupils be tested, individually or groups - provide information on size of group.

S9 How many students and what year?

Provide details of the number of students required, their ages and any special characteristics

S10 Why has this School been chosen?

Indicate why this School has been chosen, i.e. what characteristics are important. It may not be possible for you to use this School and this information may enable alternatives to be found.

S11 What are the selection criteria for students to participate in the study?

What are the inclusion or exclusion criteria for participants to be enrolled in the study.

S12 Do you have a relationship with the School?

Do you have a connection with the School, e.g. former pupil, parent relation works there, etc.

Application for Criminal Record Check

For some research, e.g. working with children, it is required that you have a Police check to ensure you have no criminal convictions relevant to the research. Separate forms is required for this and must be submitted via Prof. Peter Hepper, School of Psychology, General Office. These forms may be downloaded from www.psych.qub.ac.uk/ethics.

Animal Research Information Sheet

Z1 Project Title:

This should be a concise description of your proposed study. Avoid terms such as "An experiment to" , "A study of".

Z2 Researcher(s):

Please give level UG(1,2 or 3)

MSc, PhD, Staff

List the names of all researchers, include their current status, e.g. Yr2 UG, PhD, etc.

Z3 Supervisor for UG/PG students:

For undergraduate and postgraduate students you must give the name of your supervisor. S/he applies for permission to use the School on your behalf and will be informed of the decision of the committee.

Z4 Address, Tel and email for correspondence:

UG/PG projects should use their Supervisor's address

Give full postal address, telephone numbers and email address. For undergraduate and postgraduate students you must give the details for your supervisor.

Z5 Proposed Start date:

Give the date you are proposing to start the research.

Z6 Duration

How long will the project last?

Z7 Where will the research be undertaken?

Provide the details and address(es) of the location(s) where it is proposed to undertake the research.

Z8 Does the research require a license Yes : No

Most animal research requires a License under the Animal Procedures (1986) Act.

If yes

Z8a Who is the Project license holder?

Provide details of who holds the project license for this research.

Z8b What is the Project license number?

Provide the project license number.

If no

Z8c Why not?

Provide details of why this research does not need a license.

Z9 Is the research is to be undertaken outside a licensed facility Yes : No

If yes, why?

Provide details of why the research is being undertaken outside of licensed facilities.

Guidance notes for Participant Information Sheet

The following gives a brief outline of the material that should be included in the Participant Information Sheet.

General points

The information should be provided to participants in any readily accessible way, using language that they will understand. Avoid subject specific terminology or technical language.

The information should be printed on approved School of Psychology headed paper and contain the names of the researchers and contact information.

The aim of the Participant Information Sheet is to provide the individual taking part in the study with information on what they are participating in, what will be done to them and what risks (if any) there are. It must also make clear that participation is voluntary and they may withdraw at any time with no consequences. Finally information should be provided as regards the confidentiality (or otherwise) of their participation and information provided.

The information sheet is part of the consent process and must be given to participants prior to signing of the consent form

Although there is no one participant information form that covers all research the following points should be covered in any form produced for your research.

1. Study title

This should be self explanatory to a lay person

2. Invite participation

The opening paragraph should make it clear your participant(s) is being invited to participate and it is voluntary. You should also state who you are.

3. Aim of the Study

The aim of the study should be given. Information as regards the purpose of the study should be given.

4. Participation is voluntary

It needs to be made clear that participation is voluntary and that the individual may withdraw at any time with no adverse consequences.

5. What will the participant experience, what will happen to them in the study

The form should explicitly state what will happen to the participant. How long s/he will be required for, what they will do in the study? what risks the are, if any, how s/he will be required to change her/his lifestyle to participate if appropriate, e.g. refrain from smoking for a period, etc., etc. After reading this the participant should know exactly what is required of them and what they will be doing in the study.

6. Participation is confidential

The form should state how confidential the information is, what it will be used for and whether any individually identifiable information will be available. Also, if the data is to be used by others this needs to be indicated.

7. Special factors

If there are any special factors that the participants should be aware of that may increase their risk by participating, e.g. allergies in taste/odour research, etc., these must be clearly stated.

Participant Consent Form

It is essential that participants provide informed consent prior to beginning the study. This consent is required to be recorded and stored. To provide informed consent participants must be provided with information on the study (see Participant information sheet).

Participants 15 and under

If the research involves individuals 15 or under, consent to participate in the study must be obtained from the child's parent or legal guardian. In these cases the parent or guardian signs the form on behalf of the child. Full explanations must be provided to the parent or guardian. However it is important not to forget the child and although formal consent is provided by another, it is good practice to fully inform the child of the research in a manner appropriate to their age.

Participants unable to provide informed consent

If the research involves individuals unable to provide informed consent, e.g. through mental disability, learning difficulty, legislative restriction, consent must be obtained from a relative or individual with legal/medical responsibility for the care and welfare of the individual. The relationship of the individual providing consent for the participant must be explicitly stated. Particular care must be taken to respect and preserve the dignity of these individuals in research studies.

Research with children in Schools

For research undertaken with children in Schools or other establishments written permission must be obtained from the School Head or individual with responsibility for the children. In addition to this consent from the child's parent or legal guardian must be obtained. Best practice is to use an opt-in process. Here a child may only participate in the research if specific written permission has been provided by the parent. In exceptional circumstances it may be possible to use an opt-out procedure where parents actively withdraw a child from the study by signing a declaration that they do not wish their child to participate. This may be used where the research is unlikely to raise any ethical problems. In these circumstances the School Head or other individual with legal responsibility for the child must sign a statement agreeing to act in loco parentis and opt the child in. The child should also agree to participate where possible.

Preparing a Consent form

This should be written in clear language.

The form must be printed on approved School of Psychology paper (this is available on-line see http://www.psych.qub.ac.uk/ethics)

The completed forms must be stored separately from data and confidentially.

Although there is no single form that covers all research the following should be included as appropriate. Statements should be individually numbered and participants should initial each statement as well as signing the completed form.

The form should begin with the:

• Title of Study
• Name of participant
• Address of participant
• Essential
• Statement that the participant agrees to participate in this research.
• Statement that this agreement is of the participants own free will.
• Statement that the participant has had the opportunity to ask any questions they wish.
• Statement that the participant may withdraw from the study at any time, without giving a reason and with no adverse consequences.
• Statement that the participant has been given full information about the study (Participant Information Sheet).
• Statement that the participant has been given contact information for the researchers.
• Statement regarding the confidentiality of the information provided.

Optional (depending on nature of research)

• Statement that participant agrees for researchers to have access to other records (medical, School)

The forms should be signed by the participant or individual giving consent if the participant is unable to do so.

The form must be witnessed by the researcher.

To ensure anonymity the participants research number or code should be included on the form.

A copy of the form should be given to the participant, if using participants from other settings, e.g. Hospital, School, a copy of the form should be provided for their notes.

Questionnaire studies

A separate consent sheet may not be necessary for questionnaire studies. The front page of the questionnaire should make clear what the questionnaire assesses, what participation involves, that it is not compulsory to complete the questionnaire or individual questions, and the confidentiality of the responses. A statement should be included on the front page that indicates that by completing and returning the questionnaire the participant has consented to participate in the study.

• Download an example participant consent form