All potential subjects must be provided with informed consent.
Make sure you cover all of the following issues/topics:
- The purpose of the study
- The procedures and duration of the study – include the amount of time needed for each subject
- Any possible risks or discomforts – if there are possible discomforts (i.e., interviewing a subject about a subject that might bring back discomforting memories) then a plan must be in place to respond to those discomforts – the plan must be noted in the document
- Benefits to the subject and/or society
- Confidentiality – explain how you plan to protect the anonymity of the subjects
- Voluntary participation – subjects must be informed that their participation is voluntary and that they can withdraw from the study at any time. If there are risks involved in just dropping out (i.e., a subject is taking medication and dropping out might cause unpleasant side effects) then a plan must be developed for those wanting to drop out and the subjects must be fully informed about the procedure.
- Questions: advise the subject that they have the right to ask questions about the study and their
participation. You should list your name – another’s name that they can contact if they have further
- Authorization – this includes the subject’s signature and the date of the signature. It should include a statement such as "your signature indicates that you have read all of the information provided above, and you have had all of your questions answered. Your signature indicates your willingness to participate in the study. You will also want to include the signature and date of the person obtaining the subject’s permission.
- This consent document can be presented in paragraph form, or you may choose to have separate headings for each of the areas described above.
Back to IRB home page