When must written informed consent be obtained?

The Department of Health and Human Services regulations for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized representative, unless the research is determined to be exempt or the IRB finds and documents that informed consent can be waived as stated below.

Federal guidelines allow for the waiver or alteration of the requirements for obtaining informed consent from adult subjects under certain conditions. An IRB may waive the requirement for the investigator to obtain a signed consent form if it finds either that the:

1. only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality; or
2. that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.

An IRB may also waive or alter the requirement of informed consent, provided that the IRB finds and documents that all of the following four conditions are met:

1. the research involves no more than minimal risk to the subjects;
2. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
3. the research could not practicably be carried out without the waiver or alteration; and
4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

For research involving children, an IRB may waive the requirements for obtaining parental or guardian permission under any of the following provisions:

1. the research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs;
2. the research could not practicably be carried out without the waiver or alteration.
3. research where all of the following four conditions are met:
   1. the research involves no more than minimal risk to the subjects;
   2. the waiver or alteration will not adversely affect the rights and welfare of the subjects;
   3. the research could not practicably be carried out without the waiver or alteration; and
   4. whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Exempt Studies and Informed Consent

For most exempt studies, consent is not necessary. Anonymous archival data, for example, does not require consent, though it usually requires permission from the data’s owner to access the data. Anonymous data collection such as using a blind survey does not require consent, but the IRB may require that you provide an informational document (consent document) explaining the purpose of the study, how the data will be used, and stating that the data are anonymous. This consent document would include the same elements required for a consent form with the exception of the page initials and signature line. Collecting consent documentation in this case would hamper the benefits of collecting the data anonymously. However, providing basic information about the study in the consent document may make the participants feel more comfortable about participating. Anonymous questionnaires or surveys, including online surveys, in which no identifying information is present are also required to add the statement below to the beginning of the questionnaire or survey.

The return of your completed questionnaire constitutes your informed consent to act as a participant in this research.

Spanish version: El regresar su encuesta contestada constituye su consentimiento informado para participar en este estudio.

Page last updated 8:55 AM, January 14, 2019