IRB committee members, and reviewers using the expedited procedure, must determine that appropriate provisions are made to document informed consent, unless waived or altered. The following examples illustrate when to use different options for documenting consent, and examples of alteration or waiver of consent.

Long form consent

Long form consent is the "standard" or "default" form of consent. Written, long form consent is used in the following kinds of studies:

• clinical investigation of a new drug or device, like a new HIV medication compared with standard of care
• greater than minimal risk behavioral trials, like HIV prevention trials studying the role of condoms in HIV prevention

Short form consent

• Short forms consent may be used with an oral explanation of consent form information to obtain consent from non-English speaking subjects in a study when the majority of subjects are English speakers as an alternative to translated consent forms (see 45 CFR 46.117(b)(2)).
• These forms cannot be used as a substitute for a translated consent form when the primary population of a study will be non-English speakers. In that instance, fully translated consent forms should be provided for IRB review with an English Language Version.
• For example, consider a study of a new anti-tuberculosis drug at A. G. Holley State Hospital, where the IRB has approved consent in English, Spanish, and Creole. A patient might present to A. G. Holley who came to Florida on vacation, who needs treatment, but does not speak any of the langauges in the IRB-approved consent. In that case, researchers could use a short form consent on conjunction with certified medical translation service that provides a verbal translation. Normally, when non-English speaking participants are enrolled in research, the DOH IRB will require approval of a translated consent document.

Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #1)

When the primary risk to participants would be violation of confidentiality, researchers may request a waiver of written documentation of consent.

• For example, if a researcher were studying behaviors such as drug use, commercial sex work, or prostitution, where the only identifiers linking the participant to the researcher would be the consent document itself, the IRB should consider a waiver of documentation.
• In such a case, the researcher will need to ask each participant whether they want documentation; the participant's wishes will govern.
• Option #1 does not apply to FDA-regulated research
• The IRB needs to review a script and determine how the researcher will discuss all required elements of consent with participants

Waiver of the Requirement to Obtain Written Documentation of the Consent Process (Option #2)

When research presents not greater than minimal risk, and involves procedures where written documentation of consent is normally required outside of research, then researchers may request a waiver under option 2.

• For example, phone interviews or in-person surveys in a shopping center or on a beach might qualify, provided that the research is not greater than minimal risk, and provided the research procedures do not normally require written consent outside the research context.
• The reviewer needs to verify a script that required elements of consent will be provided
• The IRB needs to consider whether the investigator is to provide written information to the participant that includes all required and appropriate additional elements of consent disclosure.
• Like in option #1, consider this option only for research where there is interaction with a research participant (this does not apply to records research).

Alteration of Elements of Informed Consent (Option #1)

• Consider this when reviewing research or demonstration projects conducted by the Department or other government officials.
• In order to grant an alteration, the IRB must find that the research cannot practicably be conducted without the waiver or alteration

Alteration of Elements of Informed Consent (Option #2)

The IRB may approve an alteration of some or all elements of informed consent provided it finds:

(1) The research involves no more than minimal risk to the participants.
(2) The waiver or alteration does not adversely affect the rights and welfare of the participants.
(3) The research cannot practicably be carried out without the waiver or alteration.
(4) When appropriate, the participants will be provided with additional pertinent information after participation.
(5) The research is not FDA-regulated.

This option may be applied to registry research involving secondary analysis of large data sets, where the research cannot practicably be carried out without the waiver or alteration. Key considerations for reviewers include when research "adversely affects the rights and welfare of participants" and when research "cannot practicably be carried out." Look for this help page to be updated as staff identifies good examples.

Alteration of Elements of Informed Consent (Option #3)

Consider this option only for laboratory analysis of specimens when research is regulated by the FDA.