Informed consent may be “documented” in research protocols by requiring participants to click on a link or image that
- indicates acceptance of the consent form (i.e. a button that says “I accept” or “I agree”),
and
2. advances participants to an online study web page that is otherwise inaccessible.
The consent form for web-based studies must:
- contain all the elements ordinarily required in a “regular” or “paper” consent form
- information about the study itself with “key “information about the study
- state the name and email address of the principal investigator (and/or faculty supervisor if the study is a student project)
- provide information for participants who wish to discuss their rights as participants in the study (i.e., contact information for the Office of Research Protections and Compliance)
- inform participants that responses transmitted over the World Wide Web may not be secure (unless the study is using a secure server with “https” rather than “http”)
Consent forms are provided to participants at the time the consent conversation begins by the person actually administering consent, attesting to the informed consent conversation. The UMBC Office of Research Protections and Compliance assigns an IRB protocol number as well a “valid through” (or “end”) date indicating the end of the IRB approval period; this will appear at the bottom of all pages of the UMBC assent form.
Obtaining and documenting informed consent is required for all participants in a research project. As a general rule, investigators must:
- Provide “key information”to participants essential to decision making;
- Present informed consent information in sufficient detail and in a way that helps with participant comprehension, not just running down a list of risks and procedures;
- Provide a copy of the consent form to the participant and/or legal representative;
- Keep a copy of the consent form for the approved protocol file
- Seek consent only if the potential participant has the decisional capacity to give consent; if not, consent must be obtained by a legal representative;
- Obtain parental permission for minor participants;
- Provide sufficient opportunity to the potential participant or legal representative to consider whether or not to participate;
- Ensure that the possibility of coercion or undue influence is absent;
- Enhance each participant’s comprehension of the information; and
- Utilize a consent form appropriate to the age level.
Choose the below to submit with your IRB application:
Waivers of consent
Investigators may request a “waiver of consent” that waives certain requirements of consent documentation. The IRB will expect you to document how and when consent was obtained. This may be in the form of a consent tracking log (paper based, spreadsheet, etc.) that tracks the consent conversation and is used as part of protocol file.
Include the appropriate consent waiver document with this template in the application for IRB review.