Form 95 CIRB WoC Supp

CIRB COMBINED WAIVER OF ELEMENTS OF INFORMED CONSENT AND WAIVER OF
DOCUMENTATION OF CONSENT REQUEST SUPPLEMENTAL FORM

OMB #0925-0753 Expiration Date: 05/31/2024
The purpose of the information collection is to conduct reviews of clinical trial studies. NCI guidelines mandate the participation of institutions in the CIRB
for Network group studies. You are being requested to complete this instrument so that we can conduct activities involved with the operations of the NCI
CIRB Initiative. Although your participation in Network group research and completion of the forms is voluntary, if you wish to participate in the CIRB, you
must complete all questions on the form. The information you provide will be combined for all participants and reported as summaries. It will be kept
private to the extent provided by law.
NOTIFICATION TO RESPONDENT OF ESTIMATED BURDEN
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not
conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send
comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH,
Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0753). Do not return the completed form to this
address.

This application has been designed to meet the regulatory requirements for review, so answer each question as
completely as possible.
• All answers must be in lay language.
• If an answer to any question cannot be provided, provide an explanation for the missing answer.
• If you have any questions regarding the completion of this application, contact the CIRB Helpdesk at
[email protected] or 888-657-3711.
STUDY ID:
STUDY TITLE:
PROTOCOL VERSION DATE:
INITIAL APPROVAL DATE:
A study must meet specific criteria in order to qualify for a waiver or alteration of the regulatory elements of informed
consent or a waiver of documentation of informed consent.
The questions below are designed to assist the CIRB in making either or both of these determinations. If you are
requesting a waiver or alteration of the regulatory elements of informed consent or a waiver of documentation of informed
consent, please complete this supplemental form, providing your assessment below along with the requested rationales.
INSTRUCTIONS: Answer the following questions. You may cite the protocol section and page number that includes
this information:

Waiver or Alteration of Regulatory Elements of Informed Consent. Only complete this section if you are
requesting a full waiver of consent or a waiver or alteration of the required elements of consent.
1. Type of waiver or alteration requested:
Full waiver of consent (Select only when there is no intent to obtain informed consent prior to participation in
the research. Typically used for projects involving the secondary analysis of existing data or projects involving
deception).
Provide the details of the research activities and rationale for requesting a full waiver of informed consent:

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Waiver or alteration of required elements of consent. Check the elements of consent you are requesting to
waive or alter:
Basic Elements (Unless a waiver is granted, basic elements of consent are required) [45 CFR 46.116(b)]:
A Statement that the study involves research, an explanation of the purposes of the research and the
expected duration of the subject’s participation, a description of the procedures to be followed, and
identification of any procedures that are experimental
A description of any reasonably foreseeable risks or discomforts to the subject
A description of any benefits to the subject or to others which may reasonably be expected from the
research
A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be
advantageous to the subject
A statement describing the extent, if any, to which confidentiality of records identifying the subject
will be maintained
For research involving more than minimal risk, an explanation as to whether any compensation, and
an explanation as to whether any medical treatments are available, if injury occurs and, if so, what
they consist of, or where further information may be obtained
An explanation of whom to contact for answers to pertinent questions about the research and research
subjects’ rights, and whom to contact in the event of a research-related injury to the subject
A statement that participation is voluntary, refusal to participate will involve no penalty or loss of
benefits to which the subject is otherwise entitled, and the subject may discontinue participation at
any time without penalty or loss of benefits, to which the subject is otherwise entitled
One of the following statements about any research that involves the collection of identifiable private
information or identifiable biospecimens:
• A statement that identifiers might be removed from the identifiable private information or
identifiable biospecimens and that, after such removal, the information or biospecimens could be
used for future research studies or distributed to another investigator for future research studies
without additional informed consent from the subject or the legally authorized representative, if
this might be a possibility
• A statement that the subject’s information or biospecimens collected as part of the research, even
if identifiers are removed, will not be used or distributed for future research studies.
Additional Elements as Appropriate (A waiver for these elements is only needed if the elements are
applicable to your study. More information can be found here: [45 CFR 46.116(c)]:
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 or legally authorized representative’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 that 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
A statement that the subject’s biospecimens (even if identifiers are removed) may be used for
commercial profit and whether the subject will or will not share in this commercial profit
A statement regarding whether clinically relevant research results, including individual research
results, will be disclosed to subjects, and if so, under what conditions

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For research involving biospecimens, whether the research will (if known) or might include whole
genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to
generate the genome or exome sequence of that specimen)
Provide the details of the research activities and rationale for waiving or altering the elements of consent
checked above:

2. The study involves only research activities that are no more than minimal risk to the subjects [46.116(d)(1) /
46.116(f)(3)(i)]
Yes

No

Provide the details of the research activities and rationale for response:

3. The research activities could not be practicably carried out without the requested waiver or alteration. [46.116(d)(3) /
46.116(f)(3)(ii)]
Yes

No

Provide rationale for this response:

4. If the research involves using identifiable private information or identifiable biospecimens, the research could not
practicably be carried out without using such information or biospecimens in an identifiable format. [46.116(d)(3) /
46.116(f)(3)(iii)]
Yes

No

N/A

Provide a rationale for this response:

5. The waiver or alteration will not adversely affect the rights and welfare of the subjects. [46.116(d)(2) /
46.116(f)(3)(iv)]
Yes

No

Provide procedures for how subjects rights and welfare will be protected:

6. Whenever appropriate, subjects or legally authorized representatives will be provided with additional pertinent
information after participation. [46.116(d)(4) / 46.116(f)(3)(v)]
Yes

No

N/A

Provide a rationale for this response, including a description of how participants or legally authorized
representatives will be informed:

Waiver of Documentation of Informed Consent. Only complete this section if you are requesting a waiver of
documentation of informed consent (waiver of the signature requirement).

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1. The only record linking the subject and the research would be the informed consent form and the principal risk would
be the potential harm resulting from a breach of confidentiality. [NOTE: If ‘Yes”, each subject (or legally authorized
representative) should be asked whether the subject wants documentation linking the subject with the research, and
the subject’s wishes will govern]. [46.117(c)(1)(i)]
Yes

No

Provide the details of the activity and rationale for response:

2. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written
consent is normally required outside of the research context. [ 46.117(c)(1)(ii)]
Yes

No

Provide the details of the activity and rationale for response:

3. If the subjects or legally authorized representatives are members of a distinct cultural group or community in which
signing forms is not the norm, the research presents no more than minimal risk of harm to subjects and there is an
appropriate alternative mechanism for documenting that informed consent was obtained. [46.117(c)(1)(iii)]
Yes

No

N/A

Provide rationale for response:

4. Subjects or legally authorized representatives will be provided with a written statement regarding the research.
[NOTE: A “Yes” response is not required but the IRB has the authority to require that a written statement be provided
to subjects or legally authorized representatives.] [ 46.117(c)(2)]
Yes

No

Provide rationale for response:

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