INFORMATION SHEET
Guideline:
Require 8 elements be included :
1) Purpose and duration of participation
2) Risks
3) Alternatives
4) Benefits
5) Confidentiality of records
6) Compensation for injuries
7) Person to contact for answers to questions
8) Voluntariness and right to withdraw
_____________________________________________________________________________
Research Title :
Introduction
Introduce the research
You are invited to participate in a research study. Before participating in this study, it is important
that you take time to read and understand the information in this Information Sheet.
Purpose of Study
Introduce the subject to the potential participant.
Write a short description explaining in the purpose of the study. Explain in lay-person terms which
should be about Standard 6 – Form 4 level. Do not use scientific jargon or abbreviations. There is no
need to detail the theory of the topic. Do NOT include references.
This section should be 2-3 paragraphs.
What will the study involve?
Explain study procedures in simple terms.
Detail out :
• Randomisation (if any)
• Data collection eg. BP measurement, questionnaire,
• Visit schedule & duration of time commitment eg 30 minutes for questionnaire, 3 monthly
clinic visits for 1 year etc.
• Blood – amount and number of times.
Risks and Benefits:
Detail the possible benefits to the participant in the study. If there is not likely to be any benefit, this
should be declared. The benefit is related to the study and not financial gains unless they are normal
volunteers asked to test out medication eg Phase 1 trial.
Detail out risk of procedures including those related to surgery etc. These may be rated as minor
(discomfort or inconvenience), moderate or high. Also indicate rescue procedures should
participants develop adverse events.
Do you have to take part?
Participants do not have to take part, it is voluntary
Explain about signing the consent form and that they get to keep a copy.
Explain alternatives and option to withdraw.
Indicate the researcher may also remove the patient from the study
Data & Confidentiality
A statement of anonymity / confidentiality is required.
State the need to break confidentiality if required by law eg potential suicide or injury to others.
Payment and compensation
Indicate study sponsor and payment if any eg travel allowance. Indicate compensation for injury
related to the study.
EXAMPLE
Research Title:
Control of shivering during spinal anaesthesia : Prophylactic ketamine or tramadol in urological and
lower limb orthopaedic surgery in UKM Medical Centre
Introduction:
You are invited to participate in a research study. Before participating in this study, it is important
that you take time to read and understand the information in this Information Sheet.
Purpose of Study:
Shivering that occurs associated with spinal anaesthesia is relatively common. It may lead to an
unpleasant experience and may be stressful for the patient. Corrective measures can be taken to
prevent shivering. These may include the use of blankets, warm air circulation to the patients and
drugs. Several drugs are in use to prevent shivering. These include tramadol, ketamine and
paracetamol among others. We are not sure which drug is the best prevention of shivering . The aim
of this study is to compare the effectiveness of ketamine versus tramadol in the prevention of
shivering during spinal anaesthesia.
What will the study involve?
You are about to undergo surgery with spinal anesthesia. This involves introduction of a needle into
the spine and an anesthetic drug will be given through the needle. This will result in numbness of
your abdomen for the surgery.
After introduction of spinal anaesthesia, patients with be randomly chosen to be given one of the
two drugs either ketamine or tramadol. The drug will be given as injection through the vein prior to
surgery. The incidence and severity of shivering will be recorded during the operation.
Risks and Benefits:
There is unlikely to be a direct benefit for you in participating in this study. The drugs given may or
may not help to reduce shivering during your surgery. However, your participation could help us
improve on the prevention of shivering in future patients.
The risk of this study is mainly due to spinal anesthesia which include low blood pressure, headache,
vomiting and back pain. The study drugs are given in low doses and are unlikely to cause side-effects
such as increased in blood pressure, palpitations and nausea. Should you get any problems, we will
give you medication to make you feel better.
Do you have to take part?
Participation in this study is voluntary. If you agree to take part, then you will be asked to sign the
“Informed Consent Form”. You will be given a copy of the form and this Information Sheet.
Your treatment is not affected if you decide not to participant in this study. You will undergo surgery
under spinal anaesthesia as usual and you anaesthetist may or may not give you medication to
prevent shivering.
Should you decide to participate, you can still withdraw from the study without penalty. Your data
will not be used and will be discarded. The researcher may also remove you from the study for a
variety of reason. In this event, you will not be penalised or lose your rights as a patient.
Data & Confidentiality:
The data from this study will be made into a report which may be published. Access to the data is
only by the research team and the REC UKM. The data will be reported in a collective manner with
no reference to an
individual. Hence your identity will be kept confidential.
Payment and compensation:
You do not have to pay nor will you be paid to participate in this study. You do have to pay for the
usual hospital charges.
This study is being conducted with a UKM Research Grant. You will be given a sum of RM xxx as
travel reimbursement for this study. Should you develop complications related to the study, then
you will be compensated accordingly.
Who can I ask about the study?
If you have any questions, you can direct them to the research team. You can also contact the REC
UKM for clarifications.
Research Team REC UKM
Dr XXX
Department of Anaesthesiology
UKMMC
Phone Number : 03-9145 XXXX
Mobile : 012-XXX XXXX