Writing an Explanatory Statement Purpose The Explanatory Statement should by birdmandaddy

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									Writing an Explanatory Statement

Purpose
The Explanatory Statement should be designed so potential participants of
your research project can give informed consent to participate in the
project.

Do not mislead potential participants

Avoid misleading potential participants regarding the nature of the research
and its true purpose. For example, it is misleading to say that the research is
for a university project (such as a thesis) when it is linked with commercial
funding and the results will be used for marketing purposes. Such a situation
would expose the researcher to potential legal liability, so Explanatory
Statements need to be accurate. Another example is that researchers
need to be accurate when informing participants about the amount of time
participation in a survey or experiment will take. You may not, for example,
convey that the survey will only take a few minutes when it will take longer.

Keep to the approved research protocol

If a Student Investigator steps outside a procedure contained in the
Explanatory Statement and Research Protocol approved by BUHREC, then the
liability is on the student, not the Principal Investigator/Supervisor who is
unaware of this action (provided that the Principal Investigator has properly
instructed the student on the need for accuracy in complying with the
Explanatory Statement and Research Protocol). As a minimum requirement,
the student must be made aware of this document and of “How to write a
Consent Form”. If a researcher moves outside the protocol approved by
BUHREC, approval is automatically void and the project must cease
immediately.

Changes to the research protocol and Explanatory Statement after
BUHREC approval?

A Principal Investigator may change a protocol after first approval by sending
a request to the Ethics Officer of BUHREC detailing the specific matter
required to be changed. This request will be referred to the Committee for
approval at the next meeting provided that the request has been received by
the deadline for submissions. These dates are shown in the Application Form.
Unless a major change is involved that affects other responses on the form,
such requests will not require a new application form to be completed.

When are Explanatory Statements required?

Explanatory Statements are required for all projects under the BUHREC
application process including normal and template applications.
In addition to the Explanatory Statement, Consent Forms requiring
signatures of participants apply in specified cases. You need to check
whether your application requires a Consent Form by referring to the
Application Form and also “Writing a Consent Statement” for details. Note
that when written consent is required, this is best combined with the
Explanatory Statement in the one document, with two copies being signed by
both researcher and the participant and with one copy to be kept by each.




Who signs the Explanatory Statement?

The Principal Investigator/Supervisor, being the academic responsible for the
project (students are called Student Investigators) signs the Explanatory
Statement, together with the Student Investigators. In the case of external
applications; it must be signed by the employer and/or the operator of the
facility where the research will be conducted. The Explanatory Statement
may then be multiple copied for distribution to participants.


All Explanatory Statements must be written

All Bond Research Explanatory Statements must be on Bond
University Letterhead

Explanatory Statements must be on Bond University letterhead although
participants need not be given original letterhead. External applicants must
have their employer/facility letterhead and include Bond ethical paragraph.

CHECKLIST for students

The items listed below should be used as a guide as to what information is
required in the statement. This list is for students own reference and should
not be submitted with the application form.

Does your explanatory statement meet the following criteria:

  Clear identification of the University as the responsible institution (use
  Bond University letterhead)
  The short title of the project exactly as it appears on your BUHREC
  application form, name of chief investigator(s) and any other person who
  will have direct involvement with research subjects
  The BUHREC Project Number, issued to you by BUHREC prior to
  submission for ethical clearance
A statement of the purpose of the study, the inclusion and exclusion
criteria for participants and alternative treatments available (where
appropriate)
The amount of time the survey/experiment will take to complete
A description of the possible benefits for participants and/or society in
general
An outline of all methods or procedures involving the potential participant
An indication of the expectations of the potential participant: time involved,
level of inconvenience and/or discomfort and any payment, reward or
incentive offered
A list of all possible or reasonably foreseeable risks of harm or possible side
effects to the potential participant (outlining likely incidence and severity)
and contact details of someone who will answer any inquiries about the
research. Counselling telephone contact details where appropriate.
A statement about how you will discharge your responsibility to protect the
subjects’ rights to privacy.
A statement of where the records will be stored and details of access and
discard.
A clear statement that participation is voluntary, that subjects may
withdraw at any stage, or avoid answering questions which are felt to be
too personal or intrusive, and an assurance that this will not affect future
treatment.
An indication of whether participants will be informed of overall results, or
any which might affect them personally, and what debriefing procedures
are available (essential in all cases where permissible deception is
involved).
The name and phone number of someone who can be contacted in an
emergency or if the participant has any concerns (this must be a Bond
University work phone number)
The following University complaints clause:
 Should you have any complaint concerning the manner in which this
 research (project number) is conducted, please do not hesitate to contact
 Bond University Research Ethics Committee at the following address:

                  The Complaints Officer
                  Bond University Human Research Ethics
                  Committee
                  Building 7, Level 1
                  Bond University
                  Gold Coast, 4229
                  Telephone: (07) 5595 4194/Fax (07) 5595 1120
                  Email: buhrec@bond.edu.au

The signature of the Principal Investigator/Supervisor being an academic
employed by Bond University and Student Investigator(s) signature(s).
Is it written in language that potential participants could reasonably be
expected to understand?
  Is it free from coercive language or promises that cannot be kept and
  potentially misleading statements?




            DISPATCHED QUESTIONNAIRES TO BE COMPLETED BY THE
                            PARTICIPANT
                          (SAMPLE ONLY)
(Distribute photocopies to potential participants – use of original letterhead is
unnecessary)

Date:
Project Title: __________________________________________
(Exactly as it appears on your BUHREC Application Form)
Project Number: RO _ _ _ _

(a) Students:

___________________________________ (student name) is doing research
under the supervision of
Dr___________________________________________a_________________
______ (Assistant Professor/Associate Professor/Professor) in the Faculty of
______________________towards a _____________________ (eg Grad Dip,
BSc (Honours), MA etc) at Bond University. (This information must be
included, but you can vary the wording to suit your circumstances)

OR


(b) Staff: My name is Dr/Professor
__________________________________. I am employed at Bond University
and I teach and do research in the Faculty of
___________________________________, Department of
_________________________(if relevant, e.g. Psychology Department is in
the School of Humanities).

(Please note that none of the examples below are based on real research
projects. They are invented to illustrate the sorts of things, which need to be
included if you are using particular types of research techniques and
participants. Use the most appropriate alternative as a pattern for your
explanatory statement and adjust it to suit your research.)

EXAMPLE 1

The aim of this research is to gain a better understanding of the health needs
of the Koori community. I hope that it will provide information, which will
help the Koori community to lobby government for better health care.
I am seeking members of the Koori community and health professionals
providing services to the Koori community who are willing to complete a
questionnaire and return it anonymously in a stamped, self-addressed
envelope. Completing the questionnaire should take 30-60 minutes and can
be done at home at your convenience. It should be returned in the stamped,
self-addressed envelope provided by ________.

No findings, which could identify any individual participant, will be published.
The anonymity of your participation is assured by our procedure, in which the
questionnaires are anonymous and only the combined results of all
participants will be published.

You do not have to return the questionnaire. If you do return the
questionnaire, you do not need to answer every question. If you are having
trouble understanding any of the questions, you are welcome to ring me on
___________ (not home phone number) and I will try to help you. If you
need to make an STD call, you can give me your phone number and ask me
to call you back. If you have to leave a message on my answering machine,
you can just tell me your first name if you wish.

OR

EXAMPLE 2

The aim of this research is to evaluate the effectiveness of a new method of
teaching mathematics for year 9. I am one of the year 9 teachers at
your/your child’s school. I hope that it will make learning mathematics more
enjoyable and effective for students.

I am looking for students in year 9 maths classes who are willing to fill out a
questionnaire at the beginning and end of term 3, which asks about their
opinions about maths, and complete a diary each week during term 3 which
talks about their experiences during maths that week. The questionnaires
should take about 30 minutes to complete and will be done during a lunch
hour during the first and last weeks of term, and the diaries will take 5-10
minutes a week. They will be done in class time. All students will complete
the diaries as they are part of the process of reviewing the week’s work in the
subject, but diaries from students who are not participating in the research
will not be included in the research data.

No findings which could identify any individual participant will be published.
Since data must be stored for five years according to university regulations,
your child will be asked to invent a code name which will be put on both
questionnaires and all diaries. They will be collected and processed by one of
the other year 9 maths teachers so that your child’s teacher will only see
his/her class results and will therefore not be able to identify any student’s
work by their handwriting.
If you agree to have your child take part, you can withdraw at any time by
writing to the teacher who collects the papers using your child’s code name.
Your child may also choose not to answer some of the questions. Since all
class members will be doing all the work and all written material is coded, no
child will be disadvantaged or punished for not having their work included in
the research findings.

OR

EXAMPLE 3

The aim of this research is to see if there is a relationship between separation
of children from their parents in the early years of life and body image in the
teenage years. I hope that it will add to the field of knowledge in the area of
body image. This is important because poor body image can lead to low self
esteem, depression and poor school results in teenagers.

I am looking for students aged 13-17 years and their parents. Students will
be asked to fill out questionnaires which ask how they see themselves, how
they feel about their bodies and how this affects their relationship with other
people. Parents will be asked to complete a questionnaire about how often
the child was separated from them before s/he began school and how long
these separations lasted.

The student questionnaires will take approximately 30 minutes to complete
and will be done at lunch time under the supervision of the researcher and
the classroom teacher. Parent questionnaires will also take about 30 minutes
to complete, will be done at home and returned to the school in the envelope
provided. It is possible that some children may find some of the questions
upsetting. Should a child become upset while completing the questionnaire,
s/he should discontinue working on the questionnaire and will be offered the
opportunity to talk to the school guidance counsellor. It is also possible that
some students may answer the questionnaire in such a way as to raise
concerns that they may be suffering from depression. If this happens, the
principal will be notified within 24 hours and will take appropriate action.

No findings which could identify any individual participant will be published.
Your family’s anonymity will be protected by our procedure in which names
are removed from all questionnaires and replaced by code numbers. Only my
supervisor and I will have access to this data which will be stored for five
years as prescribed by the university regulations.

If you agree to participate you may withdraw your consent at any time.
Parents may do this by simply not returning the questionnaire or by notifying
me by phone or in writing. Students may with draw by submitting a blank
questionnaire, or by notifying me by phone or in writing. Parents and
students can also return questionnaires with some questions left unanswered.
  Not participating in the research will not disadvantage you/your child in any
  way.


  The following information must be included in your explanatory statement.

  If you have any queries or would like to be informed of the aggregate
  research finding, please contact:
  Name of Student Investigator
         _____________________Signature___________________

  Name     of  Principal Investigator/Supervisor_______________________
  Signature___________________
  Telephone ________________ (This must be a university or work
  address/telephone/fax not a personal contact number)
  Fax _______________________ (This must be a university or work
  address/telephone/fax not a personal contact number)
  Address: School of __________________, Bond University 4229.


Should you have any complaint concerning the manner in which this research is conducted,
please do not hesitate to contact Bond University Human Research Ethics Committee, quoting
the Project Number (above):

                  The Complaints Officer
                  Bond University Human Research Ethics Committee
                  Building 7, Level 1
                  Bond University
                  Gold Coast, 4229.
                  Telephone (07) 5595 4194 Fax (07) 5595 1120
                  E-Mail buhrec@bond.edu.au

								
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