Although exempt research is exempt from some of the federal regulations, in most cases of interaction with participants, a consent process is indicated. It’s important to understand that even though consent may not be documented with a signature, as is the case with much of exempt research, consent is still being obtained. For example, when a consent script that contains basic elements of consent is used for a phone survey, the participant may choose whether or not to proceed with the survey based on the information provided. That is consent; it is not implied.
Written and script forms of Information Sheets must be easy to read and/or understand, be in lay language that is suitable for the participant, and capture pertinent information.
Minimum Requirements:
- Title of Study or the UAB IRB Project Number (IPN) assigned to the study
- Purpose of the research and procedures of the research
- Participation is voluntary
- That the activities involve research
- Confidentiality of the responses and/or anonymity of the process
- Costs and payment, only if applicable
- Alternatives, if needed (e.g., students not participating may be doing something else while others complete the study)
- Employee or student language from UAB IRB’s Sample Consent, if applicable.
- Approximate time of participation
- Contact information for the Principal Investigator, including phone number
- Contact information for the UAB IRB, as follows: If you have questions about your rights as a research participant, or concerns or complaints about the research, you may contact the UAB Office of the IRB (OIRB) at (205) 934-3789 or toll free at 1-855-860-3789. Regular hours for the OIRB are 8:00 a.m. to 5:00 p.m. CT, Monday through Friday.
In some cases (e.g., research involving FERPA), written documentation of agreement to participate is required.
NOTE: Except for the last item, this list is not intended as the text you should use in your document. Rather, these are the consent items that should be addressed, using language appropriate to your specific research, setting, and participants.
There is no need to utilize the UAB IRB’s Sample Consent form for consent processes in exempt research. Your consent process should be clear and contain full sentences that are in no more than 8th grade reading level. Examples of consent documents or processes that are appropriate are:
- An email containing a link to a survey
- An Information Sheet handed out at the beginning of an interview session
- A phone script for a phone survey
- An Information Sheet sent home to parents regarding an educational intervention
- The landing page to an online survey that provides the required research information
- A letter sent to participants asking if they’d like to attend a focus group