The goal of the consent process is to facilitate a prospective participant’s or legally authorized representative’s understanding of the reasons why an individual might or might not want to participate in a research study. The responsibility for the investigator in the consent process is to:
- Provide more information when requested by subjects
- Make sufficient time and opportunity to discuss the research
- Answer questions to improve a subject’s understanding
However, the method of delivery may not be appropriate for all participants. An investigator provides information about the study “orally” using an oral consent script. But, an information sheet is left with the participant as a reference to review to contact investigators in case they have further questions The use of an information sheet meets the requirements of providing all of the necessary information to the participant about a study before obtaining their consent.
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 protocol 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.