Alterations or Waiver of Informed Consentversion February 2025

IRBNet ID Number and full study title*

Principal Investigator*

contact email address*

Enter email address of PI or knowledgeable designee

Essential ICF elements to waive*

select all that apply

• All

• Statement that the study involves research

• Explanation of the purposes of the research

• Expected duration of participation

• Description of the procedures

• Identification of experimental procedures

• Description of any reasonably foreseeable risks or discomforts

• Description of any benefits

• Disclosure of appropriate alternative procedures

• Statement describing how the confidentiality of records identifying the subject will be maintained

• If more than minimal risk, an explanation as to whether any compensation, or medical treatments are available, if injury occurs

• Who to contact for answers to pertinent questions about the research and research subjects' rights, and who to contact in the event of a research-related injury to the subject

• A statement that participation is voluntary

Additional Elements as Appropriate (listed later on form)

Justifications*

Provide rationale for requesting waiver (per above)

Attestations*

NOTE: You must be able to attest to all of the above (and the IRB must agree) in order for a waiver or alteration to

be granted.

*The research involves no more than minimal risk to the subjects;

*The waiver or alteration will not adversely affect the rights and welfare of the subjects;

*The research could not practicably be carried out without the waiver or alteration; and

*Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Additional ICF elements

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable

• Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent

• Any additional costs to the subject that may result from participation in the research

• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject

• A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject

• The approximate number of subjects involved in the study

Send me a copy of my responses