Guidelines for application to the Department of Psychology and Counselling Research Ethics Committee (DREC) For undergraduates, Graduate Diploma and Masters degree students enrolled at the University of Greenwich Application to the Departmental Research Ethics Committee (Department of Psychology and Counselling, University of Greenwich) All students undertaking a research project will need to apply for approval by the Department Research Ethics Approval (DREC). This includes all projects where there is some collection of data. This includes data from individuals outside the Department, other students, colleagues or the student themselves. Projects involving extended literature searches or document analysis do not need to apply. Students studying at doctorate level will need to apply to the University Research Ethics Committee (UREC). Details of how to apply to UREC are available on the University of Greenwich website. Students may not collect data until approval from DREC is obtained. In most courses, there will be a deadline for this application to DREC. Please refer to the handbook on your course covering the research project. These handbooks should include these dates. All work must be handed to the student supervisor for initial scrutiny prior to submitting to DREC. The student’s supervisor has a responsibility to ensure that the project complies with ethical standards, before it is passed to the DREC and has to sign the forms. The DREC is run in line with BPS ‘Guidelines for minimum standards of ethical approval in psychological research’ (BPS, 2004) or those outlined by the BACP (in the case of the MSc Therapeutic Counselling students) .These are used in conjunction with professional standards, University guidelines (including Health and Safety) and Department guidelines on ‘Research with children and vulnerable adults’. DREC membership includes members of the Psychology and Counselling Department and at least two members of staff external to the Department. The DREC at the University of Greenwich meets approximately every two months. Occasionally, more frequent meetings are arranged to facilitate the approval of student projects. Meetings are also organised so that they occur approximately two weeks after the hand –in deadlines. This gives time for proposals to be checked and sent to a member of the committee for more detailed examination. Each proposal is scrutinised by a member of the committee who will complete a checklist, similar to that included at the end of this document. Each proposal will be discussed within the committee and a decision made on whether the study can be approved. If there are specific concerns about a proposal, another member of the committee or the chair will also look at it. Any outstanding issues may be referred to UREC. A list of decisions made by DREC will be passed on to the UREC. 1 What needs to be included in the application To facilitate the process, applications should be submitted with the documents in the following order. 1. The ethical approval form 2. The risk assessment form 3. A copy of the research proposal 4. Copies of the questionnaires that will be used, or the topic guide in the case of an interview, or other relevant materials used in other types of design 5. A copy of an advert or materials to be used in recruitment 6. A letter of consent from any other organisation involved 7. The consent form for participants 8. The information sheet for participants 9. The debriefing form for participants The ethical approval form must be signed and dated by the student and by their supervisor prior to submission. The supervisor’s signature is needed in order to ensure that the supervisor has seen the proposal and agreed to the contents. The student and their supervisor must also sign the risk assessment form. Incomplete or unsigned projects will be returned to the student supervisor and will not be submitted to the committee. This will cause a delay as the project will not be able to be assessed until the next committee meeting. Participants It is unlikely that any project involving vulnerable participants will be approved. These are not appropriate areas for conducting research by students. It is not appropriate for any project at this level to cause distress to participants or have the potential to do so. In addition, projects should not include patient groups. Any research on these groups needs to be sent to a NHS research ethics committee. This is not only a time consuming process but they are unlikely to agree to review a student proposal. Research involving children under 18 This is permissible but needs a number of additional safeguards. Students are required to successfully undertake a Criminal Records Bureau check and to be fully acquainted and adhere to the departmental guidelines on research with children and vulnerable adults (see Web CT for these guidelines). It is generally advisable to use adult participants, where possible. Materials to be included Ethical approval form (available on Web CT . This should be included in the folder relating to projects or your year of study). Apart from filling up the form, students are asked to give a brief summary of their project as part of the ethical approval form. This is essential for DREC committee reviewers so that they can understand the design and nature of the study, without reading the research proposal. It should not be necessary for committee members to have to read the research proposal to 2 approve the project. However, it is important to include the proposal in case the committee members wish to obtain further clarification about the study or to judge whether students have fully understood the ethical implication. The summary of the project included in the ethical approval form should include the following:Title of project, purpose and rationale How the participants will be recruited Inclusion or exclusion criteria- how will the researcher ensure that vulnerable participants are excluded. Sample size Dates when the project will start and be completed Where the study will be carried out Study design and materials to be used Consent , debriefing issues and how participants can withdraw if they so wish Confidentiality and anonymity issues How the data will be analysed Other relevant ethical issues The risk assessment form This can also be downloaded from webct from the same area as the ethics approval form. The risk assessment form needs to be completed to ensure that the student has considered all risks involved in the study, this includes risks to participants, people identified by participants (where applicable) and the student themselves. It is also important to ensure that the student has put in place procedures to reduce these risks. The risks may be physical safety and that is why it is important to know about the location. It is also important that consents are obtained when the study takes place in other organisations. Students need to consider their own safety as well as the safety of participants. The student also needs to consider whether the study may cause anxiety or distress, including performance anxiety in tests. This includes participants, or anyone else connected with the study, including the student researcher themselves. Procedures in place to reduce these risks must be stated. A copy of the research proposal Projects should only be submitted to DREC after the final design has been agreed with the supervisor. If projects are changed after DREC approval, they need to be re-submitted. Copies of the questionnaires that will be used, or the topic guide in the case of an interview, or other relevant materials used in other types of design If the study uses questionnaires, these need to be submitted. If the study uses an interview format, a topic guide should be included. All other materials, such as those used in experimental designs, should be submitted (for example, printed versions of stimulus materials or images). Personal codes to enable participants to withdraw data should be attached to these materials. 3 A copy of an advert or materials to be used in recruitment Participants need to know what the study is about and be fully aware of what they will be required to do. Any inclusion or exclusion criteria should be included to avoid time wasting or distress to participants. A letter of consent from any other organisation involved If participants are recruited from any outside organisation, this can only be done with a letter of consent from that organisation. In addition, if a project takes place within the premises of another organisation, a letter of consent must be obtained. The consent form for participants The consent form should include some detail of the study (for example, one or two sentences) not just the title. Participants should be made aware that participation is voluntary and that they can withdraw at any time. They also need to be told the procedures that are in place to enable withdrawal. This should include the date up to which they can withdraw (normally up to the time of data analysis). Participants should be given the opportunity not to answer any question that they do not wish to, or take part in any specific part of the study. Generally, it is advised that participants give their initials rather than signing (in case of loss of consent forms). It is not necessary to have a witness or for the researcher to sign. The use of initials is particularly important when the study includes sensitive information, such as alcohol use. Consent forms must not be attached to other materials or stored with them. They should not include personal codes or any identifying data such as age, gender etc. The information sheet for participants This should outline the study. It should also give information regarding confidentiality, anonymity, where the data will be stored and when it will be destroyed (alternatively, these can be given on the consent form). The debriefing form for participants This form is taken away by participants after they have finished. It is where they should make a note of their personal code in case they wish to withdraw. This sheet generally has 4 functions: a) to give feedback about the study and what it is about ( in more fuller detail). This is particularly important, if there is any deception involved or details not fully explained initially. If references are to be included in this section (and these are not always necessary), these need to be introduced. b) To give participants the contact details of the researcher and procedures for withdrawal. It is generally advisable not to give the home address of the researcher or personal mobile telephone numbers, where possible. 4 c) To give participants the contact details of the supervisor of the project (if they have any concerns about the project or the way in which it was conducted) d) To give participants, who may be distressed, worried or anxious after taking part, details of relevant support organisations. It is very important when giving details of support organisation that they are appropriate and relevant (for example, the Samaritans are probably not appropriate for most studies). Local support organisations should not be included unless permission has been obtained. If participants are other students, it may be appropriate to include the university counselling service. The debriefing sheet may also contain information on storage and when the information will be destroyed. It may also include information according to whether the participant can access any report on the findings. Outcome of applications to DREC- category of approval In the week following a DREC committee meeting, projects will be normally handed back to the project supervisors. Project supervisors will be responsible for contacting the student and handing the project back to them. It is therefore important for students to keep in contact with their supervisors to find out the outcome. Projects will be returned from the ethics committee with a category of approval. Category 1- approval without conditions. Applicants may proceed with data collection. This will be clearly stated by the letter sent to the supervisor which will be passed onto the student. Category 2 - approval, subject to minor changes being made and agreed by the supervisor The letter will state that the project was given conditional ethical approval and that the student will need to make some changes or provide additional information before they start their project. The letter will specify what changes need to be made or additions. These changes need to be made and then re-submitted to the project supervisor. If the supervisor is satisfied that the changes made are appropriate, they will sign a slip indicating their approval. One copy of this slip will be given to the student, the other will be returned to the secretary of the committee. The student can then proceed after receiving this slip. Category 3 - approval, subject to more major changes being made and agreed by the chair of DREC. This category of approval is given when more substantial changes are necessary. The letter will state that the project was given conditional ethical approval, however, the student will need to make substantial changes and/or give additional information. The letter will also specify what changes need to made or additions. These changes need to be made and resubmitted to the project supervisor. The supervisor will return these to the chair of the ethics committee for approval. If these changes are appropriate, the chair will sign the ethical approval forms and a slip indicating their approval. One copy of this slip will be given to the supervisor to pass on to student, the other will be returned to the secretary of the committee. 5 The student can then proceed with data collection after receiving this slip. If, however, the changes are not adequate and the Chair of the committee still has concerns, the project may be re-submitted to the next meeting of DREC for the committee’s approval. Category 4 - not approved. This category is given when the committee have concerns about the proposal and are not willing to approve it unless substantial revisions are made or a new subject area is chosen. The letter will state that the project was not approved by the Departmental Research Ethics Committee because it does not meet the requirements. The reasons for this decision will be attached to this letter. For this category, a resubmission is necessary. If substantial changes are made, these need to be resubmitted to the committee, together with the initial proposal, the reasons for the project not being approved by DREC, and details of the changes made. However, if a completely different topic area is re-submitted, it will not be necessary to submit the old one. Conditions that need to be met prior to approval by DREC Below are a list of some of the more common reasons why approval is not given by DREC. It may be helpful to work through this list prior to submission. Students doing this are more likely to receive approval for their projects and to have to make subsequent changes. Involvement of external agencies If external agencies are involved in this project- a letter (or similar) is needed with their consent If this study involves the NHS- it would need NHS ethical approval (unadvisable because of the delay and difficulties in obtaining approval) Ethical approval form Form should be complete Most projects might precipitate distress/ worry/ performance anxiety in participants. The appropriate box should be ticked. There needs to be sufficient detail on who may be excluded and how this will be done (to ensure that vulnerable participants are excluded) The form needs to be signed by researcher The form needs to be signed by supervisor There should be a summary of the project The sample size should be stated The project start or end date should be given The risk assessment form Form should be complete Form should be clearly worded without errors Most projects might precipitate distress/ worry in participants. The procedures in place to support participants need to be stated Some projects might present some risk to the researcher. The procedures in place to support participants need to be stated The form needs to be signed by researcher The form needs to be signed by supervisor 6 The consent form This project should have a consent form The consent form should include a little detail of what is being studied (just a sentence or two- or well worded title) The consent form should be complete, clearly worded without errors Initials of participants are more appropriate than names Participation must be voluntary, the participant also needs to be given the opportunity not to answer every question The participant needs to be given the opportunity to withdraw at any stage Information for participation form There should be an information for participants form This form should include detail of what is being studied The detail of the study needs to be written so that it does not cause distress/ concern The form should be clearly written with no mistakes Debriefing form If participants are asked to provide a personal code, they need to be given the opportunity to make a note of it on this form(as they take it away with them) The form should be clearly written with no mistakes Participants should be advised that if they are distressed by participating in the study, they should consider contacting one of the support organisations provided on the form. The support organisations listed must be appropriate for the sample The support organisations that are listed should be national ones rather than local ones (unless prior permission has been obtained). Exception: university services if sample is university students Participants should be given the opportunity to withdraw and given instructions on how to do this and deadline date Participants should be advised that if they have any queries, they can contact the researcher or their supervisor. They also need to be given contact details of researcher and name of their supervisor and contact details. Mobile phone numbers or personal contact details (apart from university email) are not to be included, where possible – this could increase risk to researcher Any references included in the debriefing form need to be introduced- so the participant has a clear idea about what is included Advert / recruitment The advert / email to participants should be included The advert/ email needs to include information about the precise nature of the study, including exclusion or inclusion criteria Questionnaires/ interview The personal code needs to be added to the interview/ questionnaires so that the material can be withdrawn if the participant requests it Questionnaires or an interview topic guide should be included The questionnaires/ interview topic guide must be complete without errors Storage/ when destroyed You need to include details regarding storage of data and when it will be destroyed 7 Involvement of children Project involves children under 18, evidence of CRB check is needed Arrangements regarding children’s consent need to be in place and stated Arrangements regarding parental consent need to be in place and stated Consent forms should be appropriate for their intended audience- for example, children or parents. 8