The researcher has a legal and ethical obligation to ensure that prospective study participants have sufficient knowledge and understand all aspects of the research prior to obtaining informed consent. This means the prospective research participant must be able to make an informed decision as to whether or not to participate in research. Valid informed consent should be obtained by using a simple, but complete consent form written at an appropriate educational level for the participant population. As part of the process for obtaining informed consent, each element of consent should be carefully and simply explained to the prospective participant. In addition, the researcher should periodically assess the prospective participant's understanding by asking appropriate questions. The researcher bears full responsibility for obtaining valid informed consent from the participant.
Investigators should be sensitive to the possible need of an interpreter/translator for participants who do not speak English as a first language or who are hearing impaired. Follow the Process for Obtaining Informed Consent, and make sure that you have included all of the components required in the consent form. This link explains each of these components.
The requirements for informed consent are less rigorous for Exempt reviews and for research that poses “less than minimal risk” as opposed to “minimal risk or greater.”
Legally, children cannot give consent on their own behalf. The consent of their parent(s) or legal guardian is required before children can participate in research projects. In addition to obtaining parental/legal guardian consent, researchers must also obtain assent of children between the ages of 5 and 18. If a subject is age 5 or younger, consent from a parental/legal guardian is required. View the procedures for obtaining parental/legal guardian consent and assent of children to participate in research.
There are some situations in which obtaining a signature of informed consent can be waived and an alternative mechanism for documenting informed consent can be used. If the research is no more than minimal risk and involves a procedure for which written consent is not normally required outside the research setting, obtaining a signature is not required. Obtaining a signature can also be waived if the signature is the only record linking the subject to the research and there is a potential risk of a breach of confidentiality. In addition, if the research is of no more than minimal risk and it is not the cultural norm for subjects to sign such documents, obtaining a signature is not necessary as long as an alternate mechanism of documenting consent is used.
If the research involves using identifiable private information, and the research could not practicably be carried out without using such information in an identifiable format, waiver of signature or alternation of consent can be granted. To qualify the research must involve no more than minimal risk and could not be practicably carried out otherwise. In addition, the waiver or alteration cannot adversely affect the rights and welfare of the subjects.