Institutional Review Board
Office of Research Integrity | Oregon State University
B308 Kerr Administration Building, Corvallis, OR 97331-2140
Telephone (541) 737-8008
irb@oregonstate.edu | http://research.oregonstate.edu/irb
Reviewer Worksheet: NON-MEMBER CONSULTANT
Study ID
Study Title
Principal Investigator
Pre-Reviewer
Consultant
(Select)
Date of Pre-review
Date of Review
REVIEWER CONFLICT OF INTEREST
As a reviewer, are you an investigator, consultant, collaborator, or study personnel on
Yes
the proposed study; do you have a financial interest in the study; or do you have any other
conflict of interest related to this study which would prevent you from providing an independent
review or which may lend itself to the perception of a COI?
Risk Determination
Risk Level: (select)
No
Category of Risk to Children
All subjects ≥ 18 y/o
§46.404
§46.405 §46.406
SECTION I. TO BE COMPLETED BY IRB OFFICE STAFF
COMMENTS/QUESTIONS RELATED TO THE REGULATORY CRITERIA FOR APPROVAL
COMMENTS/QUESTIONS UNRELATED TO THE REGULATORY CRITERIA FOR APPROVAL
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§46.407
SECTION II. TO BE COMPLETED BY CONSULTANT
In order for this research to be approved, the Board must find that the all of the regulatory criteria for
approval are satisfied. Discussion of how criteria are met, or why criteria have not been met, is the most
important component of the Consultant’s contribution. Please complete the comment section under each
criterion, even if only to explain why an item is not applicable.
Criteria for approval under 45 CFR 46 or 21 CFR 56 and OSU IRB Policies
1. Risks to subjects are minimized by using procedures which are consistent with sound research design and which do
not unnecessarily expose subjects to risk.
Criteria met
Criteria not met
Discussion:
Risks should be minimized by (a) using procedures that are consistent with sound research design and that
do not unnecessarily expose subjects to risk, (b) using procedures already being performed on the subjects
for diagnostic or treatment purposes, (c) appropriately monitoring safety, (d) using precautions to decrease
the likelihood of harm through contingencies to deal with harm if it occurs, (e) employing personnel with
the appropriate qualifications, and (f) following appropriate OSU policies and guidance.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the
knowledge that may reasonably be expected to result.
Criteria met
Criteria not met
Discussion:
In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from
the research (as distinguished from risks and benefits of therapies subjects would receive even if not
participating in the research). The IRB should not consider possible long-range effects of applying
knowledge gained in the research (for example, the possible effects of the research on public policy) as
among those research risks that fall within the purview of its responsibility.
3. Selection of subjects is equitable.
Yes
No
Discussion:
In making this assessment the IRB should take into account the purposes of the research and the setting in
which the research will be conducted and should be particularly cognizant of the special problems of
research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled
persons, or economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in
accordance with, and to the extent required by §46.116.
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Criteria met
consent §46.116(c-d)
Criteria not met
Criteria has been met for a waiver of one or more elements of
Discussion:
5. Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
Criteria met
Criteria not met
Criteria has been met for a waiver of documentation (signature)
Discussion:
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the
safety of subjects.
Criteria met
Criteria not met
Data monitoring is not necessary to ensure the safety of subjects
Discussion:
7. When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the
confidentiality of data.
Criteria met
Criteria not met
Discussion:
8. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children,
prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons,
additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Criteria met
Criteria not met
Discussion:
CONSULTATIVE NOTES TO INVESTIGATORS (NOT RELATED TO REGULATORY CRITERIA ABOVE)
COMMENTS TO IRB STAFF
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FOR REGULATORY REFERENCE – NO ACTION REQUIRED IN THIS SECTION
§46.116 - Informed Consent
Basic elements
A statement that the study involves research
An explanation of the purposes of the research
The expected duration of the subject's participation
A description of the procedures to be followed
Identification of any procedures which 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
Additional elements, as appropriate
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
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Consent Procedure that Alters or Waives one or more of the Elements of Consent
§ 46.116 - An IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements
of informed consent set forth in this section, or waive the requirements to obtain informed consent, provided the IRB
finds and documents that:
C: 1.The research or demonstration project is to be conducted by, or subject to the approval of, state or
local government officials, and is designed to study, evaluate, or otherwise examine: (i) public benefit or
service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible
changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of
payment for benefits or services under those programs; and
C: 2.The research could not practicably be carried out without the waiver or alteration.
D: 1. The research involves no more than minimal risk to the subjects;
D: 2.The waiver or alteration will not adversely affect the rights and welfare of the subjects;
D: 3.The research could not practicably be carried out without the waiver or alteration; and
D: 4.Whenever appropriate, the subjects will be provided with additional pertinent information after
participation.
Special Requirements - 45 CFR 46 Subpart D - Additional DHHS Protections for Children Involved as Subjects in
Research
Assent/
Waiver
The IRB shall determine that adequate provisions are made for soliciting the assent of the children, when in
the judgment of the IRB the children are capable of providing assent. If the IRB determines that the
capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the
intervention or procedure involved in the research holds out a prospect of direct benefit that is important to
the health or well-being of the children, and is available only in the context of the research, the assent of
the children is not a necessary condition for proceeding with the research. Even where the IRB determines
that the subjects are capable of assenting, the IRB may still waive the assent requirement under
circumstances, in which consent may be waived in accord with §46.116 of Subpart A.
Parents
The IRB may find that the permission of one parent is sufficient for research to be conducted under §46.404
or §46.405.
Where research is covered by §46.406 and §46.407, and permission is to be obtained from parents, both
parents must give their permission, unless one parent is deceased, unknown, incompetent, or not
reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
§46.408
If the IRB determines that a research protocol is designed for conditions or for a subject population, for
which parental or guardian permission is not a reasonable requirement to protect the subjects (for example,
neglected or abused children), it may waive the consent requirements in Subpart A of this part and
paragraph (b) of this section, provided an appropriate mechanism for protecting the children who will
participate as subjects in the research is substituted, and provided further that the waiver is not
inconsistent with Federal, state or local law.
§46.117 Documentation of Informed Consent
a. Except as provided in paragraph "c" of this section, informed consent shall be documented by the use of a written
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consent form approved by the IRB, and signed by the subject or the subject's legally authorized representative. A copy
shall be given to the person signing the form.
WRITTEN
The consent form may be either of the following:
1. A written consent document that embodies the elements of informed consent required by §46.116.
This form may be read to the subject or the subject's legally authorized representative, but in any event,
the investigator should give either the subject or the representative adequate opportunity to read it
before it is signed.
Non-English
speakers
are target
population
2. A short form written consent document, stating that the elements of informed consent required by
§46.116 have been presented orally to the subject or the subject's legally authorized representative.
When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a
written summary of what is to be said to the subject or the representative. Only the short form itself is
to be signed by the subject or the representative. However, the witness shall sign both the short form
and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary.
A copy of the summary shall be given to the subject or the representative, in addition to a copy of the
short form.
WAIVER of
c. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all
requirement subjects, if it finds either:
for signed
1. That the only record linking the subject and the research would be the consent document, and the
consent
principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be
form
asked whether the subject wants documentation linking the subject with the research, and the
subject's wishes will govern; or
2. That 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.
In cases in which the documentation requirement is waived, the IRB may require the investigator to
provide subjects with a written statement regarding the research.
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