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PESC Consent Form and Guidelines

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					                          MIDDLESEX UNIVERSITY
Obtaining Written Informed Consent - Psychology Guidelines

This document is intended as a guide to why researchers must obtain written
informed consent from participants before proceeding with their study.

See
http://www.bps.org.uk/document-download-area/document-
download$.cfm?file_uuid=F1C8E142-E935-EC00-75FD-519F1FDDEA5D&ext=pdf
for the BPS Guidelines for Conducting Research with Human Participants (August
2009)
and
http://www.bps.org.uk/document-download-area/document-
download$.cfm?file_uuid=E6917759-9799-434A-F313-9C35698E1864&ext=pdf
for the BPS Code of Ethics and Conduct (August 2009).

Conducting ethical research involves many stages and obtaining written informed
consent is the stage immediately prior to data collection. The purpose here is to
inform participants, prior to participation, about what they will be required to do during
the research project. This allows the participants to give informed consent about their
understanding of the nature of the task and the purpose of the project. Participants
should be assured that their data will be treated confidentially and anonymously.
However, they also need to be informed that their data may be used for the purpose
of publication, if there is such an intention.

It is important to bear in mind that participants have the right to decline taking part in
the study. This should be stated clearly on the consent form and participants’
attention should be drawn to the fact that they have the right to withdraw from the
study without any penalty at any stage. Moreover, participants need to be assured
that they will be given an opportunity to discuss the purpose and/or the procedure
with the researcher at the end of their involvement.

Although researchers often state the nature of participation in detail, they may have
to mislead the participants regarding the true purpose of the study, that is they
provide a cover story. This is often dictated by the research question but it is
nevertheless a form of deception - usually introduced to control for participant bias.
The following example may help clarify this point: Suppose a researcher is interested
in examining assertiveness in males and females under two conditions, namely,
same gender and mixed-gender groups. The participants are told that they will be
working on problem solving that requires team work. The concern here is that
knowing the true purpose of the study could influence participants’ behaviour in the
group. Under these circumstances, although withholding the true purpose of the
study would probably not influence participants’ decision to take part, one can
envisage that disclosing it prior to the study could have an impact on their behaviour.
It needs to be stressed here that inclusion of a cover story needs to be assessed by
an expert in the research field and by the ethics committee very carefully in deciding
whether the benefits of the procedure outweigh any risks to the participants. Under
such circumstances full debriefing (see A Guide to Debriefing document for details)
must be provided.

Finally, the aim is to provide an overview of the research project as honestly and as
sensitively as possible while the emphasis is on the procedure. Participants should
be made to feel that they can trust the researcher with their wellbeing before, during
and after their participation. Having obtained written informed consent provides
protection not just for the participant but also for the individual researcher and their
institution from future, unforeseeable problems related to the project.

A sample informed consent form is provided below, and you are welcome to adapt
this to your particular study. You must keep all your participants’ consent forms until
publication of the results of your study (PG students and staff). Undergraduate
student dissertations may be subjected to the university’s ethics audits hence it is
important that you keep your consent forms and data at least for 6 months after
graduation in a locked secure environment (see confidentiality guidelines).

In certain circumstances it is acceptable to obtain what is termed Implied Consent,
and when this is deemed appropriate a signed consent form for each participant is
NOT required. An example of where Implied Consent would be acceptable might be
a questionnaire study on an innocuous subject (for instance, attitudes towards
recycling, or congestion charging). In such circumstances, completion of a
questionnaire implies that the participant has understood what they are required to
do.

When might you consider Implied Consent?
When, and only when, the purpose of the study is self evident, there is no deception
whatsoever (including no ‘cover story’), the participants’ responses imply they have
given consent, and there is no likelihood of any questions causing offence or adverse
responses. Implied Consent therefore covers a very restricted range of studies.

What needs to be done?
A questionnaire study such as the ones outlined above would be appropriate for
Implied as opposed to Written Informed Consent. You would indicate this on the
ethical approval form.

You must include a short statement at the top of your research questionnaire which
clearly outlines its purpose in the language in which the questionnaire is written, and
which informs the participant (a) of their right to withdraw at any time without
providing any reason, (b) confidentiality, (c) possible publication of the results. You
might like to include a simple box which the participant can tick to indicate they have
understood this. Similarly, if you conduct your questionnaire study using the internet,
it is recommended that you include an option, at the end of the questionnaire,
allowing the participant to indicate that they are happy to submit their data.

What happens if my application for Implied Consent is turned down?
In all cases the decision of the Ethical Committee is final. Remember, the purpose of
ethical approval is protection of both participant and researcher. If there is any doubt
that one or both of these is not being held paramount, the Committee will determine
that full Written Informed Consent is required.

Consent with children younger than 16 years, clinical populations and
vulnerable adults
     For children aged ≤ 16 years, consent for participation must be obtained from
      their parents. Once children can read and write, the researcher may also
      collect ‘assent’ from the children themselves using an age-appropriate simple
      form.
     For clinical populations and vulnerable adults, the researcher must show to
      have carefully considered any issues concerning the ability of the participant
      to provide freely informed consent having understood what is required of
       them and why. It is recommended that a therapist may not be the person
       delivering information / debriefing and collecting consent from participants
       when these participants are her/his patients/clients.

Copy of signed consent to participants
When the research involves sensitive issues and/or clinical populations/vulnerable
participants, the researcher is advised to consider the possibility of leaving a copy of
the information sheet with signed consent (in one document) with the participant. The
researcher will also have to keep a signed consent sheet.

Cross-cultural studies
Please note that in some cultures name and signature are the same thing (e.g. in
Chinese). Information sheet and consent form may require some adjustments when
carrying out research with individuals from minority ethnic groups / within other
cultures – these need to be highlighted when submitting for ethical approval or
whenever the researcher becomes aware of significant alterations to the standard
procedures.
     NB this form needs to be adjusted when used in research with children


        Middlesex University School of Health and Social Sciences


                              Psychology Department


                            Written Informed Consent


Title of study and academic year: _________________________________________

Researcher:    _________________________________________________________

Supervisor (only for students): ____________________________________________


I have understood the details of the research as explained to me by the researcher, and
confirm that I have consented to act as a participant.

I have been given contact details for the researcher in the information sheet.

I understand that my participation is entirely voluntary, the data collected during the
research will not be identifiable, and I have the right to withdraw from the project at
any time without any obligation to explain my reasons for doing so.

I further understand that the data I provide may be used for analysis and subsequent
publication, and provide my consent that this might occur.



__________________________                            ___________________________
Print name                                            Sign Name
                         date: _________________________


To the participants: Data may be inspected by the Chair of the Psychology Ethics
panel and the Chair of the School of Social Sciences Ethics committee of Middlesex
University, if required by institutional audits about the correctness of procedures.
Although this would happen in strict confidentiality, please tick here if you do not
wish your data to be included in audits: ___________

				
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