[YOUR INSTITUTIONAL LETTERHEAD]
Please do not submit consent forms on the WHO letter head
[Name of Principle Investigator]
[Informed Consent Form for _____________________]
Name the group of individuals for whom this consent is written.
Explanation
Example
[Name of Principal Investigator]
[Name of Organization]
[Name of Sponsor]
[Name of Proposal and version]
This Informed Consent Form has two parts:
Information Sheet (to share information about the research with you)
Certificate of Consent (for signatures if you agree to take part)
You will be given a copy of the full Informed Consent Form
PART I: Information Sheet
Introduction
Briefly state who you are and explain that you are inviting them to participate in the research you are
doing.
Explanation
Example
Purpose
Explain in lay terms why you are doing the research.
Explanation
Example
Type of Research Intervention
Briefly state the type of intervention that will be undertaken.
Explanation
Example
Participant selection
State why this participant has been chosen for this research.
Explanation
Example
Page 1 of 5
Voluntary Participation
Indicate clearly that they can choose to participate or not. State, only if it is applicable, that they will still
receive all the services they usually do whether they choose to participate or not.
Explanation
Example
Information on the Trial Drug [Name of Drug]
Include this section only if the protocol is for a clinical trial
1) give the phase of the trial and explain what that means. Explain to the participant why you are
comparing or testing the drugs.
2) provide as much information as is appropriate and understandable about the drug such as its
manufacturer or location of manufacture and the reason for its development.
3) explain the known experience with this drug
4) explain comprehensively all the known side-effects/toxicity of this drug, as well as the adverse effects
of all the other medicines that are being used in the trial
Example
Procedures and Protocol
Describe or explain the exact procedures that will be followed on a step-by-step basis, the tests that will
be done, and any drugs that will be given. Explain from the outset what some of the more unfamiliar
procedures involve (placebo, randomization, biopsy, etc.) Indicate which procedure is routine and which
is experimental or research.
Explanation
In this template, this section has been divided into two: firstly, an explanation of unfamiliar procedures
and, secondly, a description of process.
A. Unfamiliar Procedures
This section should be included if there may be procedures which are not familiar to the participant.
If the protocol is for a clinical trial:
1) involving randomization or blinding, the participants should be told what that means and what chance
they have of getting which drug (i.e. one in four chances of getting the test drug).
Example
2) involving an inactive drug or placebo, it is important to ensure that the participants understand what is
meant by a placebo or inactive drug.
Example
3) which may necessitate a rescue medicine, then provide information about the rescue medicine or
treatment such as what it is and the criterion for its use.
Explanation
Example
Page 2 of 5
If the protocol is for clinical research:
Firstly, explain that there are standards/guidelines that will be followed for the treatment of their
condition. Secondly, if as part of the research a biopsy will be taken, or surgery carried out, then explain
whether it will be under local anesthesia, sedation or general anesthesia, and what sort of symptoms and
side effects the participant should expect under each category.
Example
For any clinical study (if relevant)
If blood samples are to be taken explain how many times and how much, in a language that the person
understands. It may, for example, be inappropriate to tell a tribal villager that blood equal to a wine-glass
full will be taken but it may be very appropriate to use pictures or other props to illustrate the procedure if
it is unfamiliar.
If the samples are to be used only for this research, then explicitly mention here that the biological
samples obtained during this research procedure will be used only for this research, and will be destroyed
after ____ years, when the research is completed.
Explanation
Example
B. Description of the Process
Describe to the participant what will happen on a step-by-step basis.
Explanation
Example
Duration
Include a statement about the time commitments of the research for the participant including both the
duration of the research and follow-up, if relevant.
Example
Side Effects
Potential participants should be told if there are any known or anticipated side effects and what will
happen in the event of a side effect or an unexpected event.
Example
Risks
Explain and describe any possible or anticipated risks. Describe the level of care that will be available in
the event that harm does occur, who will provide it, and who will pay for it.
Explanation
Example
Discomforts
Explain and describe the type and source of any anticipated discomforts that are in addition to the side
effects and risks discussed above.
Example
Page 3 of 5
Benefits
Mention only those activities that will be actual benefits and not those to which they are entitled
regardless of participation.
Explanation
Example
Incentives
State clearly what you will provide the participants with as a result of their participation. WHO does not
encourage incentives. However, it recommends that reimbursements for expenses incurred as a result of
participation in the research be provided.
Explanation
Example
Confidentiality
Explain how the research team will maintain the confidentiality of data, especially with respect to the
information about the participant which would otherwise be known only to the physician but would now
be available to the entire research team.
Explanation
Example
Sharing the Results
Where it is relevant, your plan for sharing the information with the participants should be provided.
Explanation
Example
Right to Refuse or Withdraw
This is a reconfirmation that participation is voluntary and includes the right to withdraw.
Explanation
Example
Alternatives to Participating
Include this section only if the study involves administration of investigational drugs or use of new
therapeutic procedures. It is important to explain and describe the established standard treatment.
Example
Who to Contact
Provide the name and contact information of someone who is involved, informed and accessible (a local
person who can actually be contacted. State also that the proposal has been approved and how.
Example
This proposal has been reviewed and approved by [name of the local IRB], which is a committee
whose task it is to make sure that research participants are protected from harm. If you wish to
find about more about the IRB, contact [name, address, and telephone number.])
Page 4 of 5
PART II: Certificate of Consent
This section can be written in the first person. It should include a few brief statements about the research
and be followed by a statement similar to the one in bold below. If the participant is illiterate but gives
oral consent, a witness must sign. A researcher or the person going over the informed consent must sign
each consent.
Explanation
Example
I have read the foregoing information, or it has been read to me. I have had the opportunity to ask
questions about it and any questions that I have asked have been answered to my satisfaction. I
consent voluntarily to participate as a participant in this research and understand that I have the right
to withdraw from the research at any time without in any way affecting my medical care.
Print Name of Participant__________________
Signature of Participant ___________________
Date ___________________________
Day/month/year
If illiterate
A literate witness must sign (if possible, this person should be selected by the participant and should have
no connection to the research team).
I have witnessed the accurate reading of the consent form to the potential participant, and the
individual has had the opportunity to ask questions. I confirm that the individual has given consent
freely.
Print name of witness_____________________
AND
Thumb print of participant
Signature of witness ______________________
Date ________________________
Day/month/year
I have accurately read or witnessed the accurate reading of the consent form to the potential
participant, and the individual has had the opportunity to ask questions. I confirm that the individual
has given consent freely.
Print Name of Researcher________________________
Signature of Researcher _________________________
Date ___________________________
Day/month/year
A copy of this Informed Consent Form has been provided to participant _____ (initialled by the
researcher/assistant)
Page 5 of 5
