Sample Informed Consent Form For Qualitative Studies (Page 5 of 8) in pdf

Risks

Explain and describe any risks that you anticipate or that are possible. The risks depend upon the nature

and type of qualitative intervention, and should be, as usual, tailored to the specific issue and situation.

(If the discussion is on sensitive and personal issues e.g. reproductive and sexual health, personal habits

etc. then an example of text could be something like "We are asking you to share with us some very

personal and confidential information, and you may feel uncomfortable talking about some of the topics.

You do not have to answer any question or take part in the discussion/interview/survey if you don't wish

to do so, and that is also fine. You do not have to give us any reason for not responding to any question,

or for refusing to take part in the interview"

OR If for example, the discussion is on opinions on government policies and community beliefs, and in

general no personal information is sought, then the text under risks could read something like "There is

a risk that you may share some personal or confidential information by chance, or that you may feel

uncomfortable talking about some of the topics. However, we do not wish for this to happen. You do not

have to answer any question or take part in the discussion/interview/survey if you feel the question(s) are

too personal or if talking about them makes you uncomfortable.)

Benefits

Benefits may be divided into benefits to the individual, benefits to the community in which the

individual resides, and benefits to society as a whole as a result of finding an answer to the research

question. Mention only those activities that will be actual benefits and not those to which they are

entitled regardless of participation.

(Example: There will be no direct benefit to you, but your participation is likely to help us find out more

about how to prevent and treat malaria in your community).

Reimbursements

State clearly what you will provide the participants with as a result of their participation. WHO does not

encourage incentives beyond reimbursements for expenses incurred as a result of participation in the

research. These may include, for example, travel costs and reimbursement for time lost. The amount

should be determined within the host country context.

Example: You will not be provided any incentive to take part in the research. However, we will give you

[provide a figure, if money is involved] for your time, and travel expense (if applicable).

 Examples of question to elucidate understanding: Can you tell me if you have

understood correctly the benefits that you will have if you take part in the study? Do

you know if the study will pay for your travel costs and time lost, and do you know

how much you will be reimbursed? Do you have any other questions?

Confidentiality

Explain how the research team will maintain the confidentiality of data with respect to both information

about the participant and information that the participant shares. Outline any limits to confidentiality.

Inform the participant that because something out of the ordinary is being done through research, any

individual taking part in the research is likely to be more easily identified by members of the community

and therefore more likely to be stigmatized. If the research is sensitive and/or involves participants who

are highly vulnerable - research concerning violence against women for example - explain to the

participant any extra precautions you will take to ensure safety and anonymity.

(Example: The research being done in the community may draw attention and if you participate you may

be asked questions by other people in the community. We will not be sharing information about you to

anyone outside of the research team. The information that we collect from this research project will be

kept private. Any information about you will have a number on it instead of your name. Only the

researchers will know what your number is and we will lock that information up with a lock and key. It

will not be shared with or given to anyone except [name who will have access to the information, such as

research sponsors, DSMB board, your clinician, etc])

Page 5 of 8

Sample Informed Consent Form For Qualitative Studies Page 5

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