WAIVER OR ALTERATION OF THE CONSENT PROCESS—PUBLIC DEMONSTRATION PROJECT

• The research is conducted by or participant to the approval of state or local government officials.
• The research or demonstration protocol is designed to study, evaluate, or otherwise examine:
• Public benefit or service programs.
• Procedures for obtaining benefits or services under those programs.
• Possible changes in or alternatives to those programs or procedures.
• Possible changes in methods or levels of payment for benefits or services under those programs.
• The research cannot practicably be carried out without the waiver or alteration.
• The research is not regulated by the US FDA.

WAIVER OR ALTERATION OF CONSENT PROCESS—OBTAINING CONSENT NOT PRACTICABLE

• The research involves no more than minimal risk to the participants.
• The research cannot practicably be carried out without the requested waiver or alteration.
• If the research involves using identifiable private information or identifiable biospecimens, the research cannot practicably be carried out without using such information or biospecimens in an identifiable format.
• The waiver or alteration will not adversely affect the rights and welfare of the participants.
• When appropriate, the participants will be provided with additional pertinent information after participation.

(See below for FDA requirements.)

WAIVER OR ALTERATION OF THE CONSENT PROCESS— SCREENING, RECRUITING, DETERIMINING ELIGIBILITY

• The investigator will obtain information through oral or written communication with the prospective participant or legally authorized representative, or 
• The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.
• The research is not regulated by the US FDA.

WAIVER OF DOCUMENTATION OF THE CONSENT PROCESS—CONFIDENTIALITY

• The only record linking the participant and the research will be the consent document.
• The principal risk will be potential harm resulting from a breach of confidentiality.
• Each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant’s wishes will govern.
• The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
• The IRB or EC will determine whether the researcher should provide participants with a written statement regarding the research.
• The research is not regulated by the US FDA.

WAIVER OF DOCUMENTATION OF THE CONSENT PROCESS—CONSENT NORMALLY NOT REQUIRED OUTSIDE THE RESEARCH CONTEXT

• The research presents no more than minimal risk of harm to participants.
• The research involves no procedures for which written document of the consent process is normally required outside of the research context.
• The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
• The IRB or EC will determine whether the researcher should provide participants with a written statement regarding the research.

WAIVER OF DOCUMENTATION OF THE CONSENT PROCESS—DISTINCT CULTURAL GROUPS

• The research presents no more than minimal risk of harm to participants.
• The participants or legally authorized representatives are members of a distinct cultural group or community in which signing consent documents is not the norm.
• There is an appropriate alternative mechanism for documenting that informed consent was obtained.
• The oral or written information provided to participants includes all required and appropriate additional elements of consent disclosure.
• The IRB or EC will determine whether the researcher should provide participants with a written statement regarding the research.
• The research is not regulated by the US FDA.

FOR WAIVER REQUIREMENTS FOR PLANNED EMERGENCY RESEARCH, SEE ELEMENT II.4.C.