UW Colleges Administrative Policy #15
Guidelines for Actions by the Institutional Review Board
Formerly Senate General Institutional Policy #404
Implemented: February 1988
Revised: November, 2001
Reorganized and Renumbered March 15, 2002
Revision adopted by the Senate May 2, 2003
Revised January 16, 2008 (Prior to this date the Colleges Institutional Review Board was known as the “Colleges
Senate Research Review Committee.”)
Revised and returned to UWCAP #15, January 30, 2012
Membership of the UW Colleges Institutional Review Board is described in UW Colleges Senate Bylaws. The IRB Web
site is at found on the UW Colleges Web site.
I. Guidelines for Researchers
A. Definition of Research
Research is defined as "a systematic investigation designed to develop or contribute to
generalizable knowledge.” It is the intent to develop generalizable knowledge that makes the
activity "research." More specifically, the UW Colleges Institutional Review Board (hereafter,
IRB) defines research as data collection with the intent to disseminate the results in some
scientific or otherwise public manner—convention presentations; publication in books, journals,
newspapers or newsletters; community talks; etc. (Data utilized solely within the classroom, for
pedagogical purposes only, is exempt from this definition of research.)
What type of activity is not “research,” using the above definition? Some examples (not a
comprehensive list) include:
1. Data collected solely for the purpose of program evaluation (as when students are
given an “exit survey” before leaving a campus)
2. An activity clearly not intended to be generalizable (as when a journalist does
research into a particular individual or case study)
3. Oral histories, done by historians, may fit here – assuming the purpose of the research
is to describe individuals and not to develop generalizable knowledge about groups
B. Human Subjects
An IRB deals only with research on “human subjects.”
Human subject means a living individual about whom an investigator (whether professional or
student) conducting research obtains
1. Data through intervention or interaction with the individual, or
2. Identifiable private information.
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Intervention includes both physical procedures by which data are gathered (for example,
venipuncture) and manipulations of the subject or the subject's environment that are performed
for research purposes. Interaction includes communication or interpersonal contact between
investigator and subject.
Private information includes information about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is taking place, and
information which has been provided for specific purposes by an individual and which the
individual can reasonably expect will not be made public (for example, a medical record).
Private information must be individually identifiable (i.e., the identity of the subject is or may
readily be ascertained by the investigator or associated with the information) in order for
obtaining the information to constitute research involving human subjects.
According to this definition, what research does NOT involve “human subjects?” Some
examples (not a comprehensive list) include:
1. Library “research” which involves only historical documents, and not living persons.
2. Research which uses only data from de-identified persons (i.e., if the investigator has no
access to any identifiers. Possible “identifiers” include not only names, social security
numbers, etc. but also some demographic information. For example, if there is only one
Muslim student in a class, a data file which includes religious identification has then
“identified” that Muslim individual.)
3. A research study where the only data collected involves observations of people in a
public place and in which the investigator/s has no interaction with the persons being
observed, nor any means of identifying the individuals being observed.
If a project does not meet the definition of “research” above and/or does not involve “human
subjects” as defined above, IRB review is not required.
C. Requirement that Principal Investigators be Trained in the Rights of Research Subjects
Each educational institution is asked to ensure that persons doing research at the institution have
recent training on the rights of participants in research. Such training is currently being highly
recommended but will be required as of 1/1/2013. When submitting a proposal for review to the
IRB, researchers should attach a copy of certification of recent (within the past three years)
completion of a relevant training in the rights of human subjects in research to each proposal that
is submitted for IRB review. When students are doing research under the supervision of a
faculty member, it will be sufficient for the faculty member/s to show evidence of recent
training. Please refer to the IRB Web site for links to the National Institute of Health (NIH)
training and the CITI training.
D. Levels of IRB review: Some human subject research involves little or no risk and may not
require formal* consent from the subject. Such research is termed “exempt” but the federal
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Office for Human Research Protection suggests that an IRB member review such research to
confirm that it, in fact, meets the requirements for this category. In UW Colleges, either the IRB
Chair or the IRB Coordinator will certify that a project is “exempt.” This means that such
review need not take place at a convened meeting of the IRB. If a researcher believes a project
should be considered “exempt,” note the category of exemption which applies (found in the sixitem list (Category 1) that follows:
1.** Category I: "No apparent risks" human subject projects include the following:
(1) Research conducted in established or commonly accepted educational settings,
involving normal educational practices, such as
(i) Research on regular and special education instructional strategies, or
(ii) Research on the effectiveness of or the comparison among instructional
techniques, curricula, or classroom management methods.
(2) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public behavior,
unless:
(i) Information obtained is recorded in such a manner that human subjects can be
identified, directly or through identifiers linked to the subjects; and
(ii) Any disclosure of the human subjects' responses outside the research could
reasonably place the subjects at risk of criminal or civil liability or be damaging to
the subjects' financial standing, employability, or reputation.
(3) Research involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures, or observation of public behavior
that is not exempt under paragraph (b)(2) of this section, if:
(i) The human subjects are elected or appointed public officials or candidates for
public office; or
(ii) Federal statute(s) require(s) without exception that the confidentiality of the
personally identifiable information will be maintained throughout the research
and thereafter.
(4) Research involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are publicly available
or if the information is recorded by the investigator in such a manner that subjects cannot
be identified, directly or through identifiers linked to the subjects.
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(5) Research and demonstration projects which are conducted by or subject to the
approval of department or agency heads, and which are 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.
(6) Taste and food quality evaluation and consumer acceptance studies,
(i) If wholesome foods without additives are consumed or
(ii) If a food is consumed that contains a food ingredient at or below the level and
for a use found to be safe, or agricultural chemical or environmental contaminant
at or below the level found to be safe, by the Food and Drug Administration or
approved by the Environmental Protection Agency or the Food Safety and
Inspection Service of the U.S. Department of Agriculture.
* While “formal” consent may not be required, no one should ever be forced to participate in a research project, nor
should they be coerced to do so. Should an instructor ask that students participate in her/his research, coercion may
be implied, given the power differential within classroom settings. All research conducted under the auspices of the
UW Colleges should be careful to stress the voluntary nature of participation in research and the absence of a
punitive attitude toward or any adverse consequences for those who elect not to participate.
**This policy is currently under revision at the federal level. One suggestion is to remove any requirement that
these minimal risk projects be reviewed at all, but simply require that they “register” with the IRB. However,
HIPAA-type data-security measures may be required. For example, a data-encryption program may be required on
any data-storage device.
Some human subject research involves “minimal risk” and may undergo an “expedited” review
process. If a researcher is requesting that the review be “expedited,” the Category 2 option (F1F9) to be considered by the reviewers should be noted in the proposal.
2. ***Category II: "Minimal risk" human subject projects may undergo “expedited” review.
Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in daily life or
during the performance of routine physical or psychological examinations or tests.
In the UW Colleges, “expedited review” shall be conducted by a minimum of two experienced
members of the IRB. Normally, the two reviewers of expedited proposals will be the Chair and
the IRB Coordinator, but other members may be called to serve in this capacity as needed.
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Categories eligible for possible expedited review include the following (according to the
November 9, 1998 notice in the Federal Register (Volume 63, Number 216):
(A) Research activities that
(1) Present no more than minimal risk to human subjects, and
(2) Involve only procedures listed in one or more of the following categories,
may be reviewed by the IRB through the expedited review procedure authorized
by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed
to be of minimal risk simply because they are included on this list. Inclusion on
this list merely means that the activity is eligible for review through the expedited
review procedure when the specific circumstances of the proposed research
involve no more than minimal risk to human subjects.
(B) The categories in this list apply regardless of the age of subjects, except as noted.
(C) The expedited review procedure may not be used where identification of the subjects
and/or their responses would reasonably place them at risk of criminal or civil liability or
be damaging to the subjects' financial standing, employability, insurability, reputation, or
be stigmatizing, unless reasonable and appropriate protections will be implemented so
that risks related to invasion of privacy and breach of confidentiality are no greater than
minimal.
(D) The expedited review procedure may not be used for classified research involving
human subjects.
(E) IRBs are reminded that the standard requirements for informed consent (or its
waiver, alteration, or exception) apply regardless of the type of review--expedited or
convened--utilized by the IRB.
(F) Categories one (1) through seven (7) pertain to both initial and continuing IRB
review.
Research Categories
(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is
met.
(a) Research on drugs for which an investigational new drug application
(21 CFR Part 312) is not required. (Note: Research on marketed drugs
that significantly increases the risks or decreases the acceptability of the
risks associated with the use of the product is not eligible for expedited
review.)
(b) Research on medical devices for which
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(i) an investigational device exemption application (21 CFR Part
812) is not required; or
(ii) the medical device is cleared/approved for marketing and the
medical device is being used in accordance with its
cleared/approved labeling.
(2) Collection of blood samples by finger stick, heel-stick, ear stick, or
venipuncture as follows:
(a) From healthy, non-pregnant adults who weigh at least 110 pounds. For
these subjects, the amounts drawn may not exceed 550 ml in an 8 week
period and collection may not occur more frequently than 2 times per
week; or
(b) From other adults and children,2 considering the age, weight, and health
of the subjects, the collection procedure, the amount of blood to be
collected, the frequency with which it will be collected. For these
subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml
per kg in an 8 week period and collection may not occur more frequently
than 2 times per week.
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Children are defined in the HHS regulations as ``persons who have
not attained the legal age for consent to treatments or procedures
involved in the research, under the applicable law of the jurisdiction in
which the research will be conducted.'' 45 CFR 46.402(a).
(3) Prospective collection of biological specimens for research purposes by
noninvasive means. Examples:
(a) Hair and nail clippings in a non-disfiguring manner;
(b) Deciduous teeth at time of exfoliation or if routine patient care
indicates a need for extraction;
(c) Permanent teeth if routine patient care indicates a need for extraction;
(d) Excreta and external secretions (including sweat);
(e) Uncannulated saliva collected either in an un-stimulated fashion or
stimulated by chewing gum-base or wax or by applying a dilute citric
solution to the tongue;
(f) Placenta removed at delivery;
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(g) Amniotic fluid obtained at the time of rupture of the membrane prior
to or during labor;
(h) Supra- and sub-gingival dental plaque and calculus, provided the
collection procedure is not more invasive than routine prophylactic scaling
of the teeth and the process is accomplished in accordance with accepted
prophylactic techniques;
(i) Mucosal and skin cells collected by buccal scraping or swab, skin
swab, or mouth washings;
(j) Sputum collected after saline mist nebulization.
(4) Collection of data through noninvasive procedures (not involving general
anesthesia or sedation) routinely employed in clinical practice, excluding
procedures involving x-rays or microwaves. Where medical devices are
employed, they must be cleared/approved for marketing. (Studies intended to
evaluate the safety and effectiveness of the medical device are not generally
eligible for expedited review, including studies of cleared medical devices for
new indications.) Examples:
(a) Physical sensors that are applied either to the surface of the body or at
a distance and do not involve input of significant amounts of energy into
the subject or an invasion of the subject's privacy;
(b) Weighing or testing sensory acuity;
(c) Magnetic resonance imaging;
(d) Electrocardiography, electroencephalography, thermography,
detection of naturally occurring radioactivity, electroretinography,
ultrasound, diagnostic infrared imaging, Doppler blood flow, and
echocardiography;
(e) Moderate exercise, muscular strength testing, body composition
assessment, and flexibility testing where appropriate given the age,
weight, and health of the individual.
(5) Research involving materials (data, documents, records, or specimens) that
have been collected or will be collected solely for non-research purposes (such as
medical treatment or diagnosis). (Note: Some research in this category may be
exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.101(b)(4). This listing refers only to research that is not exempt.)
(6) Collection of data from voice, video, digital, or image recordings made for
research purposes.
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(7) Research on individual or group characteristics or behavior (including, but
not limited to, research on perception, cognition, motivation, identity, language,
communication, cultural beliefs or practices, and social behavior) or research
employing survey, interview, oral history, focus group, program evaluation,
human factors evaluation, or quality assurance methodologies. (Note: Some
research in this category may be exempt from the HHS regulations for the
protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers
only to research that is not exempt.)
(8) Continuing review of research previously approved by the convened IRB as
follows:
(a) Where
(i) The research is permanently closed to the enrollment of new
subjects;
(ii) All subjects have completed all research-related interventions;
and
(iii) The research remains active only for long-term follow-up of
subjects; or
(b) Where no subjects have been enrolled and no additional risks have
been identified; or
(c) Where the remaining research activities are limited to data analysis.
(9) Continuing review of research, not conducted under an investigational new
drug application or investigational device exemption where categories two (2)
through eight (8) do not apply but the IRB has determined and documented at a
convened meeting that the research involves no greater than minimal risk and no
additional risks have been identified.
*** The listing of the types of projects eligible for expedited review is also currently under revision at the federal
level. It may change substantially sometime in 2012.
3. Standard review (by the full committee), at a convened meeting.
II. Types of Proposal Review
A proposal may receive an Exempt Review, Expedited Review or a Standard (full committee)
Review.
Conflict of Interest Statement: No IRB member may participate in the review of a project
(whether initial review or continuing review) in which the member has a conflicting interest,
except to provide information required by the IRB. Except when requested to provide
information, IRB members with a conflict of interest shall absent themselves from the meeting
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room/teleconference during the review of the proposal, and such shall be noted in the IRB
meeting minutes. In the case of Exempt or Expedited reviews, the IRB member/staff person
with a conflict of interest shall be replaced by another experienced reviewer for the duration of
the deliberations on the relevant protocol.
A. Exempt review: Either the IRB Chair or the IRB Coordinator will review the proposal and
verify that the requirements for exemption are met. Such proposals can be submitted to the
IRB at any time. If it is not clear that the project is exempt, it may be recommended for
Expedited or Standard Review. The reviewer can approve the project or refer it to the full
IRB for review. (S/he cannot reject a proposal.) All projects approved at this level shall be
reported to the full IRB at the next convened meeting.
B. Expedited Review: Research that appears to involve minimal risk as defined above can be
submitted and reviewed in an expedited fashion. Such proposals can be submitted to the IRB
at any time. Expedited reviewers (the IRB Chair and the IRB Coordinator or, in the absence
of the preceding, another experienced reviewer(s) so designated) will generally respond to
the investigator within seven business days. See III.E.2 for actions that may be taken by the
subcommittee performing an Expedited Review. The subcommittee can approve the project
or refer it to the full IRB for review. (They cannot reject a proposal.) All projects approved
at this level shall be reported to the full IRB at the next convened meeting.
C. Standard Review: For a Standard Review, protocols must be received before each
announced (via email) deadline, to be considered at the next convened meeting of the IRB.
This timeline should be taken into account in cases where an IRB approval is needed for an
internal or external grant. Note also that proposals are often deferred due to inadequate
information, requests for modifications, etc. See III.E.3 for actions that may be taken by the
IRB. A simple majority shall be sufficient to approve a proposal.
III. Procedures
A. Step 1: Preparation of Protocol by Principal Investigator
To facilitate review, protocols and consent forms shall be prepared carefully and completely
according to these guidelines. The pages of the protocol should be numbered consecutively.
The protocols become part of the permanent records maintained by the IRB and are subject to
periodic audits and inspection by various federal government agencies. Protocol forms may be
found under the IRB section of the UW Colleges Web site.
1. Cover Sheet: Please provide all information requested. Students must have a faculty
sponsor. The proposal must be sent by the faculty sponsor; proposals received directly
from students will not be considered.
2. Sections B through I: Answer all questions, noting “not applicable” if a question is not
relevant to a particular proposal.
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B. Step 2: Committee Consult (optional)
To facilitate the review process, the investigator may consult with an IRB member prior to
submitting a proposal. The main purpose is to save time for the investigator and the IRB by
assuring that the protocol provides information of sufficient quality and quantity to allow an
informed decision at the IRB meeting. The investigator may wish to select a IRB member as
consultant whose field of expertise is closest to the research design. The consultant's suggestions
are not binding, nor does this preliminary review insure immediate approval by the IRB.
C. Step 3: Submission of Protocol to IRB
Scheduled meetings of the IRB will be announced via email, including a deadline for receipt of
proposals for consideration at the next meeting. Protocols that require full committee review and
are received after the deadline will be held until the next scheduled meeting of the IRB.
Protocols will be placed on the agenda according to the order received. The IRB meets roughly
once per month during the academic year. Proposals may be sent in electronic form to the IRB
Coordinator or to the entire IRB via [email protected].
Investigators may wish to be available (via telephone) to the IRB at the time of the meeting to
provide additional information or answer questions that may arise. The IRB Coordinator should
be contacted if an investigator wishes to attend the meeting. All deliberations of the IRB are
conducted in “open” session, in accordance with Wisconsin state statutes.
Members of the IRB shall be elected by the UW Colleges Senate, for staggered three-year terms.
Voting members of the IRB shall elect the IRB Chair at the first convened meeting of the
academic year. Membership must also satisfy the U.S. Department of Health and Human
Services (HHS) regulations at 45 CFR 46.107.
D. Step 4: Initial Review/Action by IRB
1. All IRB actions will be based upon the following criteria:
a. Value of the potential contribution of the project, particularly its relationship
to the institutional mission;
b. Clarity of the proposal;
i. Coherence of the proposed project;
ii. Completeness of the application (including copies of all
questionnaires, other instruments, etc.)
c. The “Protocol Forms for Review by the UWC IRB” document, the proposed
consent form or script, any relevant grant application(s), any recruitment
materials, and proposed questionnaires/tests/other relevant instruments shall
be reviewed. If full committee review is required, these documents shall be
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distributed to IRB members at least five business days in advance of each
scheduled meeting.
d. Meetings of the IRB may be held either in person or via teleconference.
2. An affirmative vote by a simple majority of IRB members in attendance shall be
sufficient to approve a proposal (assuming that a quorum is present and at least one
non-science member is present). Should the quorum fail during a meeting (due, e.g.,
to early departures or recusals), the IRB shall not take further actions or votes unless
the quorum can be restored. Detailed minutes shall be kept of each meeting, and
votes recorded for all motions. Separate deliberations and votes shall be made and
recorded for each proposal, whether initial or continuing review. Before approving a
protocol, the IRB will insure that each of the following requirements (45 CFR
46.111) is met:
a. Risks to subjects are minimized:
i. By using procedures which are consistent with sound research design
and which do not unnecessarily expose subjects to risk, and
ii. Whenever appropriate, by using procedures already being performed
on the subjects for diagnostic or treatment purposes.
b. 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. 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.
c. Selection of subjects is equitable. 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.
d. 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.
e. Informed consent will be appropriately documented, in accordance with, and
to the extent required by §46.117.
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f. When appropriate, the research plan makes adequate provision for monitoring
the data collected to ensure the safety of subjects.
g. When appropriate, there are adequate provisions to protect the privacy of
subjects and to maintain the confidentiality of data.\
h. 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.
3. In an Expedited Review, the subcommittee can take one of three actions:
a.
Approve the proposal as submitted;
b.
Ask the investigator for more information, orally or in writing, to resolve any
questions the subcommittee might have, and then approve the proposal; or
c. Refer the protocol to the full IRB for discussion. The subcommittee
recommendations can be discussed at the next convened meeting of the full
IRB and could result in straight approval, approval with modifications, or
deferral for further information.
d. No IRB member may participate in the review of a project in which the
member has a conflicting interest, except to provide information required by
the IRB. A member of this subcommittee who has a conflict of interest shall
be replaced by another experienced member of the IRB for said deliberations.
4. In a Standard Review, the IRB can take one of five actions:
a. Approve the protocol as submitted;
b. Approve the protocol with suggestions for modification; the investigator is not
obliged to accept suggestions;
c. Approve the protocol with required modifications;
d. Defer the protocol for further discussion, to obtain more information, or to
give the investigator an opportunity to respond to questions. The IRB may
consult with outside experts, as needed. The initial response from the IRB
should normally be expected within three business days of the meeting. If the
project is approved pending required modifications, the investigator will not
receive final approval notice until said modifications are returned to the IRB.
If the investigator disagrees with the required modifications, the protocol
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should be resubmitted with a response that can be in writing or by attending
the next meeting. The IRB procedure for original submissions will also be
followed for re-submission.
If the protocol is deferred, the investigator will receive a written
summary of the reasons for deferral.
e. Rejection of the protocol would occur only if the IRB and the investigator
cannot reach a compromise and the investigator refuses to comply with
required modifications.
E. Step 5: Documentation of Findings in Special Cases
1. If the IRB elects to waive the requirement for documentation of signed consent,
the reasons for doing so shall be included in the minutes of the meeting.
2. If the IRB approves research involving pregnant women, human fetuses or
neonates, protocol-specific information about the potential risks and benefits shall
be fully documented in the minutes of the meeting.
3. If the IRB approves research involving prisoners, protocol-specific information
about the potential risks and benefits shall be fully-documented in the minutes of
the meeting.
4. If the IRB approves research involving children, protocol-specific information
about the potential risks and benefits shall be fully-documented in the minutes of
the meeting.
5. If the IRB elects to require review more often than annually, the reasons for this
decision shall be documented in the minutes of the meeting.
F. Step 6: Reporting of Findings to Investigators and the Institution
1. Investigators will be promptly (within 3 business days of a convened meeting)
informed in writing of any of the above actions regarding submitted protocols.
2. If minor changes are required to the original protocol, these may be approved by
the IRB Chair or IRB Coordinator (if so specified by a motion supported by a
majority of voting members during the meeting). If substantive changes are
required, action on the protocol will be deferred for review by the full committee
at their next meeting (again, as specified by a vote of IRB members). In the
former case, investigators should expect a written response from the IRB Chair or
IRB Coordinator within five business days of submitting the required revisions.
In the latter case, investigators should expect a written response from the Chair or
Coordinator within 3 business days of the next convened meeting of the IRB.
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3. Institutional officials will be informed of all actions taken both via copies of each
meeting’s minutes and via the annual report to the UW Colleges Senate.
4. All IRB records and correspondence shall be retained for at least three years after
the completion of the research. All records shall be accessible for inspection and
copying by an authorized representative of the U.S. Department of Health and
Human Services.
5. The IRB shall affix approval and expiration dates to all approved informed
consent documents and stipulate that copies of these dated documents must be
used in obtaining consent. This procedure helps to insure that only current, IRBapproved documents are presented to subjects and also serves as a reminder to
investigators of the need for continuing review.
G. Step 7: Continuing Review of Research
1. Continuing, non-exempt research needs to be re-approved at least annually as
long as the study is active.
2. If concerns are raised based on a likelihood of serious harm to subjects and/or a
history of noncompliance by this investigator and/or a record of adverse events in
this laboratory, the IRB can vote to require review at more frequent intervals
(assuming that a simple majority is in agreement with the motion).
3. Unless adverse events and/or noncompliance have been reported, continuing
review will generally be at the same level (exempt, expedited or full) as the initial
review.
4. The “Continuing Review of Research/Changes to Protocol” form and an attached
current consent form shall be reviewed when continuing review is required; the
original research protocol need not be reviewed but shall be made available if
needed to answer questions.
H. Other Possible Actions
1. Possible Suspension or termination of IRB approval of research. The IRB shall
have authority to suspend or terminate approval of research that is not being
conducted in accordance with the IRB's requirements or that has been associated
with unexpected serious harm to subjects. Any suspension or termination of
approval shall include a statement of the reasons for the IRB's action and shall be
reported promptly (within 3 business days) by the IRB Chair or the IRB
Coordinator to the investigator, appropriate institutional officials, the department
or agency head, and the federal Office of Human Research Protection (OHRP).
2. Reporting of Adverse Events/Reporting of Noncompliance
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a. Adverse events brought to the attention of the IRB shall be reported
promptly by the IRB Chair or the IRB Coordinator (within three business
days) to the OHRP, the UW Colleges Office of Academic Affairs,
Provost, and Chancellor.
b. Serious or continuing noncompliance with this policy and/or the
requirements or determinations of the IRB shall be reported promptly
(within three business days) by the IRB Chair or the IRB Coordinator to
the investigator, department or agency head, appropriate institutional
officials, and OHRP.
=
c. Serious adverse events and/or serious and/or continuing noncompliance
shall prompt a reconsideration of the original research protocol by the IRB
at its next meeting, including a thorough re-assessment of the risks and
benefits of the project.
3. Additional monitoring of research by the IRB
a. Projects involving investigators with a history of noncompliance and/or
adverse events may be required to be monitored (by someone other than
the investigator) to verify that no material changes have occurred since the
last IRB review.
b. If the majority of the IRB votes to require such monitoring, the
correspondence to the investigator shall detail the types of monitoring that
shall be required, who shall do the monitoring, and at what intervals the
monitoring shall occur.
c. Said correspondence shall be copied to appropriate department heads and
institutional officials.
4.
Action on protocol changes
a. Investigators shall notify the IRB of any substantive changes to the
research protocol, using the “Continuing Research Review/Changes to
Protocol” form. The IRB Coordinator and the IRB Chair (or his/her
designee) shall review the changes and the current consent form to
determine if said changes require review at a different level than the initial
protocol.
b. The protocol will be referred to the necessary procedure as detailed above
(exempt or expedited or full committee review).
c.
The original research protocol need not be reviewed but shall be made
available, if needed to answer questions.
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d. Each revision to a research protocol shall be incorporated into the written
protocol, with revision dates noted. This practice ensures that there is only
one complete, current research protocol, should a copy be requested for
audit purposes.
I. Appeal or Other Institutional Review of IRB Actions
1. Appeal. If the investigator is in disagreement with the final decision of the IRB,
after submitting a rebuttal in writing or by appearing at the IRB meeting, the
Chancellor may be requested to review the IRB’s decision.
2. Further institutional review of IRB actions
a. In accordance with HHS regulation 45 CFR 46.112, no other institutional
office or official may approve research that has not been approved by the
IRB
b. The Chancellor or Provost may, at his/her discretion, further review any
project that has been approved by the IRB (including, but not limited to
those with significant adverse events).
c. The Chancellor or Provost may elect to disapprove research that has
previously been approved by the IRB.
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