Worksheet for Waiver of Documentation of Consent[1]
To be filled out by researcher or analyst, and made part of the eIRB study application
Study Number: Click or tap here to enter text.
PI Name: Click or tap here to enter text.
Mode of Review (IRB Use Only):☐Expedited ☐Full Board
Also known as “waiver of signature” or “verbal (oral) consent,” and often used for in-person sensitive research, and online surveys. If this waiver is granted for a verbal consent process, the IRB may require the investigator to also provide subjects with an Information Sheet containing most of the elements of a consent form but formatted appropriately (e.g., without signature lines, entitled “Information About the Study”) and a Script for Oral Consent reflecting the investigator’s side of the dialogue. Our consent template can be found at
Information Sheet Submitted? ☐Yes ☐No
Script for Oral Consent Submitted? ☐Yes ☐No
Options #1 and #2 are available. Criteria must be met for waiver to be granted. “Documentation” can mean signature or making one’s mark.
If being completed by Study Team: Please fill in “Protocol-Specific Comments”
OPTION #1 (45 CFR 46.117(c)(1)
Note: Option 1 not applicable to FDA-regulated studies; see Option 2 instead. If the subject prefers having their research information link to their medical record, investigators should follow suit.
The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all of the subjects if the IRB finds that:
☐The only record linking the subject and the research would be the consent document AND
☐The principal risk of the research would be potential harm resulting from a breach of confidentiality
(IRB Use Only)Is the study team required to provide participants with a written statement about the research (e.g., per the Sponsor or because of GCP)? ☐Yes ☐No
Protocol-specific comments: Click or tap here to enter text.
OR
OPTION#2 (45 CFR 46.117(c)(2) and 21 CFR 56.109(c)(1))
☐The research presents no more than minimal risk of harm to subjects
☐The research involves no procedures for which written consent is normally required outside of the research context.
Protocol-specific comments: Click or tap here to enter text.
Worksheet for Waiver of Documentation of HIPAAAuthorization[2]
To be completed by researcher or IRB staff, and made part of the eIRB study application, if applicable[3].
Study Number: Click or tap here to enter text.
PI Name: Click or tap here to enter text.
Mode of Review (IRB Use Only):☐Expedited ☐Full Board
If this waiver is granted, the IRB usually requires the investigator to include to theInformation Sheet, containing the required HIPAA authorization but formatted appropriately. Our consent template can be found at
The PHI requested: Click or tap here to enter text.
The IRB, sitting as a privacy board, must determine that the waiver of documentation of HIPAA authorization satisfies ALL of the following criteria (may refer to protocol and eIRB submission):
(A)That the use or disclosure of PHI involves no more than a minimal risk to the privacy of individuals, based on, at least, the presence of the following elements:
- An adequate plan to protect the identifiers from improper use and disclosure;
- An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law; and
- Adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, or for authorized oversight of the research study, or for other research for which the use or disclosure of PHI would be permitted by this subpart;
How the request meets this criterion:Click or tap here to enter text.
(B)That the research could not practicably be conducted without the waiver or alteration
How the request meets this criterion: Click or tap here to enter text.
(C)That the research could not practicably be conducted without access to and use of the protected health information.
How the request meets this criterion: Click or tap here to enter text.
Version Date: 9/7/2017
[1]45 CFR 46.117 (c); FDA Guidance: IRB Waiver or Alteration of Informed Consent for Clinical Investigations Involving No More Than Minimal Risk to Human Subjects
[2]Title 45, Subchapter C, Part 164 (E)
[3]If the study is not a chart review or HIPAA does not apply, this worksheet is not necessary.