Guidelines for Minimum Standards of Ethical Approval in

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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.
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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
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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.
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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.
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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.
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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
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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
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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.
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