Table 2.

Options for consent/waiver of consent.

Option	Characteristics	Examples
Complete waiver	No attempt is made to notify or request permission from research subjects prior to participation.	Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC)28
		Lumbar Image Reporting with Epidemiology (LIRE)29
		Active Bathing to Eliminate Infection (ABATE)30
Broadcast information	Waiver of consent is allowed, but there is widespread public notification of the research process at the institution or in the community. The notice may consist of a general statement that the institution engages in clinical research and that individual patients may be enrolled in research as part of their care, or it may be more specific (for example, a given category of patients may be notified they could be participating in research).	–
Integrated consent	The question of research participation is discussed as part of the consent process for clinical care, and permission obtained for both in a manner consistent with the consent for clinical care. The process may involve opting in or out, and giving oral or written consent as described in the following options. All 8 required elements from 45 CFR 46.116(a) would not need to be included in the consent process.	—
Simple opt-out	Potential participants are told they will be included in the research process unless they decide not to participate. Usually potential participants are able to opt out orally and are not required to document this decision in writing.	Time to Reduce Mortality in End-Stage Renal Disease (TiME).27  In the TiME trial, potential participants receive written information about the trial and have access to research personnel to have questions answered and/or to opt-out.
Simple opt-In – oral	Potential participants are asked if they would like to participate in the research and may provide oral consent. Investigative staff would generally document that consent in the medical and/or research record (similar to Integrated Consent model).	Collaborative Care for Chronic Pain in Primary Care/Pain Program for Active Coping and Training (PPACT)31
Simple opt-In - written	Potential participants are asked if they would like to participate in the research and provide written consent via a simplified consent form.	—
“Short form”	A short form is a standardized, regulation-defined approach to informed consent that is based on 45 CFR 46.117 (b)(2) and may be used in situations in which a translator is required.32 Although the document that the research subject signs is shorter, the defined consent process is often longer than the use of a standard form.	—
Electronic consent	Options include electronic tablets and Internet applications using a web browser and a laptop or desktop computer. The electronic consent may or may not emulate a standard 8-required-element informed consent document.	—
Standard informed consent	The consent process is conducted in person and a written informed consent form is signed by the participant. The informed consent form contains all 8 required elements from 45 CFR 46.116(a).	—