Some research studies require extensive information documents due to the procedures and/or known or anticipated risks.
The informed consent process begins at the recruitment stage and continues through to step of providing appreciation and feedback on the study findings.
A few special considerations are:
- web-surveys;
- interviews;
- alternate ways of recording consent such as written, verbal, and implied;
- legal obligations to report.
Web-surveys
Web-based questionnaire studies introduce different requirements to ensure anonymity of participants such as: the site will not collect any information that could potentially identify participants (such as IP addresses or machine identifiers).
Interviews
Some types of interview studies cannot provide anonymity due to the nature of the research such as a oral history. In some studies attribution may enhance the research while anonymity would detract from it.
Consent
Once a potential participant has read the information letter and has had an opportunity to ask any questions related to the study and receive satisfactory responses, they should requested to sign a consent form that states they have read the information in the letter and agree to participate in the research.
For some groups (e.g., ethnic, cultural) or situations the information letter contents may be presented verbally.
If a project involves an anonymous questionnaire a consent form is not necessary since consent is implied by the participant completing and returning the questionnaire.
Legal obligations to report
For studies where there is a possibility that a researcher may learn that a participant may do harm to his/herself or another, then the information letter should reflect the researcher's legal obligations and should include an exception clause to the confidentiality of data statement.
For example: "All information you provide will be kept confidential except as required under law".
If the project involves school children then the statement could be "In cases where researchers believe that a student may need protection from harm, researchers must by law report this information to authorities."
Guide for research participants in seeking information about a study
The following set of questions can be used as a guide for research participants in seeking information about a study.
These questions can also serve as an outline for the type of information to be provided to a research participant during the informed consent process.
In addition, these questions can be used in the development of an Information Letter with Question and Answer format. Also, refer to the checklist for creating an information letter and consent form (DOC) .
- Who is conducting this study?
- What is the purpose of this study?
- What is expected of me as a research participant in this study?
- Will there be any direct benefits to me as a participant in this study?
- Will there be any benefits to others from conducting this study?
- What are the possible risks to me if I decide to participate?
- What will be done to protect me against these risks?
- How much of my time will the study take and how many sessions will there be?
- Will there be any penalty to me if I don’t want to be in this study?
- Can I begin the study and then later decide I want to drop out?
- How do I say I don’t want to continue?
- Will I be paid for participating or will I receive any other type of remuneration?
- What happens to this if I drop out of the study?
- How will my privacy be protected?
- Will anyone be able to tell if I am participant in this study?
- What will happen to the information I provide during this study?
- Will the information I provide remain confidential?
- Who do I call if I have questions about the study?
- Who do I call if I have any comments or comments about my participation in the study either now or later?
- Additional Questions for Certain Studies
- Who is sponsoring this study?
- What kind of questions will I be asked?
- Can I decline answering any of the question if I want?
- Where will the study be conducted?