Last Revised: 10.2015
Prior Version: 7.2007
Initial Protocol Review and Approval
Definitions
Department of Health and Human Services (DHHS) is the United States government's agency
for protecting the health of all Americans and providing essential human services, especially for
those who are least able to help themselves.
Federalwide Assurance (FWA) is a written agreement that establishes standards for human
subjects’ research as approved by the Office for Human Research Protections and is executed by
the institutional official.
Human Subject (or Participant): As defined by DHHS: a human subject is 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 (45 CFR 46.102(f))
Identifiable. Federal regulations define identifiable to mean that the identity of the individual
subject is or may readily be ascertained by the investigator or may be associated with the
information.
Institutional Review Board (IRB) is an administrative body established by a local institution to
protect the rights and welfare of human subjects recruited to participate in research activities
conducted under the auspices of the institution.
Interaction: Includes communication or interpersonal contact between an Investigator or his/her
research staff and the research participant or their private identifiable information.
Intervention: Includes both physical procedures by which data are gathered (e.g., venipuncture)
and manipulations of the subjects’ environment that are performed for research purposes.
IRB of Record is a term utilized when an institution assumes the IRB responsibilities for a
human subject research protocol conducted at another institution. An IRB Authorization
Agreement signed by institutional officials at both institutions is required.
IRB Authorization Agreement is a formal agreement between CWRU and another institution
that allows the CWRU IRB to serve as the IRB of Record for protocols at that institution.
Office for Human Research Protections (OHRP) is the division of DHHS responsible for
providing leadership on human research participant protections and implementing a program of
compliance oversight for DHHS (45 CFR 46).
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Private Information: Includes information about behavior that occurs in a setting in which an
individual can reasonably expect that no observation or recording is taking place. It includes
information, which has been provided for specific purposes by an individual, and the individual
can reasonably expect will not be made public (e.g., 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 to be considered information to
constitute research involving human participants.
Research: As defined by DHHS any systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to generalizable knowledge.
Research Activities Involving Human Subjects: Activities that meet the DHHS definition of
“research” and involve “human subjects” as defined by DHHS. The definition of research and
human subjects must consistently reference the same set of regulations (i.e., DHHS) and cannot
reference the definition of research from one set of regulations, and the definition of a human
subject from the other.
Criteria by which Persons are Considered Engaged (Agents) in Research
Research under the auspices of CWRU includes research conducted at this organization,
conducted by or under the direction of any employee or agent of this organization (including
students) in connection with delegated organizational responsibilities, conducted by or under the
direction of any employee or agent of this organization using any property or facility of this
organization, or involving the use of this organization's non-public information to identify,
contact, or study human subjects.
Employee or Agent. For the purposes of this document, employees or agents refers to
individuals who: (1) act on behalf of the organization; (2) exercise organizational authority or
responsibility; or (3) perform organizationally designated activities. “Employees and agents” can
include staff, students, contractors, and volunteers, among others, regardless of whether the
individual is receiving payment or other compensation.
Engagement. The institution is considered engaged in a particular non-exempt human subject
research project when its employees or agents for the purposes of the research project obtain: (1)
data about the subjects of the research through intervention or interaction with them; (2)
identifiable private information about the subjects of the research; or (3) the informed consent of
human subjects for the research.
How to Determine Whether an Activity is Human Research
The purpose of this series of questions is to provide support for individuals in determining
whether an activity is Human Research or how it is regulated.
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1.
Research as Defined by DHHS Regulations

Is the activity an investigation?

Investigation: A searching inquiry for facts; detailed or careful
examination.

Is the investigation systematic?

Systematic: Having or involving a system, method, or plan.

Is the systematic investigation designed to develop or contribute to knowledge?

Designed: observable behaviors used to develop or contribute to
knowledge.

Develop: to form the basis for a future contribution.

Contribute: to result in. Knowledge: truths, facts, information.

Is the knowledge the systematic investigation is designed to develop or contribute
generalizable?

Generalizable: Universally or widely applicable. (This concept implies
that the knowledge gained will be shared with others so that it may be
applied in these other settings.)
2.
Human Subject Under DHHS Regulations

Is the investigator conducting the Research gathering data about living
individuals?
3.
Human Subject Under DHHS Regulations

Will the investigator gather that data through either of the following mechanisms?
(Which mechanism(s) apply?):

Physical procedures or manipulations of those individuals or their
environment for research purposes (“intervention”).

Communication or interpersonal contact with the individuals
("interaction”).
4.
Human Subject Under DHHS Regulations

Will the investigator gather data that is either? If yes, which category(s) apply?

The data are about behavior that occurs in a context in which an individual
can reasonably expect that no observation or recording is taking place (i.e.
“Private information”).

Individuals have provided the data for specific purposes in which the
individuals can reasonably expect that it will NOT be made public, such as
a medical record (i.e. “Private information”).

Can the individuals’ identities be readily ascertained or associated with the
information by the investigator (i.e. “Identifiable information”)?
If all items under 1, 2, and 3 or 1, 2, and 4 as listed above are “yes,” then the activity is Human
Research under DHHS regulations.
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If the activity is Human Research under DHHS regulations, it is Human Research under
organizational policy. This means that the research and this university is engaged in Human
Research
Evaluation of Proposed Research for Scientific and Scholarly Validity
The University evaluates proposed research for scientific or scholarly validity.
 The [appropriate Dean or department chair assure scientific or scholarly review and
oversee the conduct of human research in their department or school.
 Deans and Department Chairs affirm that each human research study proposed to be
conducted in their department or school can be done responsibly by the study team using
the resources described in the proposal.
 Scholarly or scientific review of proposed research addresses the following issues, at a
minimum:
o Does the research use procedures consistent with sound research design?
o Is the research design sound enough to yield the expected knowledge?
The scientific review is documented and communicated to the IRB through the sign-off process
and attestation. If the IRB has questions regarding the scientific or scholarly merit, process, etc.
these are referred back to the reviewing Dean/Chair for further input.
In order to assess the risks and benefits of the proposed research, the IRB must determine that:
 The research uses procedures consistent with sound research design; and
 The research design is sound enough to reasonably expect the research to answer its
proposed question.
In making this determination, the IRB may draw on its own knowledge and expertise, or the IRB
may draw on the knowledge and expertise of others, such as reviews by a funding agency, or
departmental review.
Policy
The CWRU IRB will be constituted and review research involving human subjects according to
federal regulations. The CWRU IRB reviews research to ensure that study participants’ rights
and welfare are adequately protected. Meetings of the IRB conform with federal regulations and
guidelines for the review of research.
Full or Convened IRB Meetings
The CWRU IRB meets monthly unless there are no protocols for review. Protocols may be
submitted to the IRB at any time; however, protocols that require review by the full board must
usually be submitted to the IRB office at least 14 days before the next convened IRB meeting.
Initial Review: The IRB office receives all protocols via the electronic IRB submission system.
Upon receipt, the full IRB is informed that there is a protocol or protocols eligible for full review
has been electronically forwarded to IRB members for review. IRB members are also informed
that said protocol(s) have been added to the meeting agenda. Primary and secondary reviewers
are assigned in order to lead discussion for the upcoming full board meeting.
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Every CWRU IRB member has access to the entire protocol application (investigator checklist
and research plan), proposed informed consent and/or assent documents, recruitment materials,
all other documents attached to the protocol (i.e., brochures, scripts, flyers, etc.), and federal
grant applications (if applicable).
All IRB members are required to review the material in enough depth to be familiar with them
and prepared to discuss them at the convened meeting as well as complete a reviewer checklist.
During the fully convened IRB meeting, the IRB can make the following determinations for
initial review:
●
To initially approve the protocol
●
To require the protocol’s investigators to submit changes/clarifications/confirmations for
full review or for confirmatory review
●
To table the protocol to be considered at a later convened IRB meeting
●
To disapprove the protocol
Criteria for IRB Approval of Research
Initial Review Procedures: Except for research that is exempted or waived under 45 CFR
46.101(b) or 45 CFR 46.101(i), all non-biomedical human subject research conducted under the
auspices of CWRU will be reviewed by the IRB. For the IRB to approve research it must
determine that all of the following requirements are satisfied per 45 CFR 46.111:
●
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 subjects for diagnostic or
treatment purposes.
●
Risks are reasonable in relation to anticipated benefits, if any, and the importance of the
knowledge that may reasonably be expected to result.
●
Selection of subjects is equitable, taking into account the purposes of the research and the
setting in which it is conducted.
●
Informed consent will be sought from each prospective subject or the subject’s legally
authorized representative in accordance with 45 CFR 46.116.
●
Informed consent will be appropriately documented in accordance with 45 CFR 46.117.
●
The research plan appropriately monitors the data collected to ensure safety of subjects.
●
The subject’s privacy is appropriately protected and confidentiality of the subject’s data
is maintained.
●
Appropriate safeguards are included to protect the rights and welfare of subjects who are
likely to be vulnerable to coercion or undue influence, such as children, prisoners,
pregnant women, decisionally impaired, mentally disabled persons, or economically or
educationally disadvantaged persons.
IRB Actions
For protocols requiring approval by the Full Board, the IRB will set conditions for the approval
of research at a convened meeting. In cases where the convened IRB requests substantive
clarifications or modifications regarding the protocol or informed consent documents that are
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directly relevant to the determinations required by the IRB under HHS regulations at 45 CFR
46.111, IRB approval of the proposed research will be deferred or tabled, pending subsequent
review by the convened IRB of responsive material.
Only when the convened IRB stipulates specific revisions requiring simple concurrence by the
investigator and approves the study on the condition that the investigator concur, will the IRB
Chair, Vice Chair, another IRB member or IRB staff, subsequently approve the revised research
protocol on behalf of the IRB.
The IRB has established the following categories of actions to be taken on new protocols
reviewed at a convened IRB meeting:
Approved: The protocol is approved as submitted with no changes. Approval is usually for one
year; however, under certain circumstances (e.g., in high risk studies in which the risks and
benefits of the approved research cannot be fully anticipated), the IRB may limit the approval
interval to a shorter period of time (less than 12 months) and require that the research be
reviewed after a specific number of subjects are enrolled/studied.
Modifications Needed to Secure Approval, Pending Expedited Review: The protocol is approved
pending receipt and review of additional information, which can include minor clarification or
modification of the checklist, protocol, consent form, or supporting materials. To qualify for this
category, the requested changes must be clearly delineated and not require substantial changes to
the protocol or consent form. Written notification of required modifications will be sent to the
investigator. The investigator must provide a point-by-point response to all the issues raised by
the Board. If a consent form is modified, the new consent form must be attached. The responses
and requested modified documents will be reviewed by the Chair, Vice Chair or another IRB
member or designee, on behalf of the IRB and, if appropriate, the approval will become
effective.
Deferred or Tabled: A protocol is deferred when the changes proposed or questions raised by the
Board are significant enough to warrant re-review of the protocol at a subsequent Board meeting.
The investigator will receive notification of the issues the IRB needs addressed or changed. If a
protocol is deferred it means that it will be reconsidered by the IRB. In addition to deferring the
protocol, the IRB may ask for additional review by expert consultants outside of the IRB.
Disapproved: If the protocol is judged to be lacking in merit, if it compromises the principles as
outlined in The Belmont Report, if it raises ethical questions that cannot be resolved, or if it is
decided that the risks outweigh the benefits to the subjects, the protocol will be considered
unacceptable and disapproved. The investigator will be notified in writing by the IRB including
the reason(s) for the disapproval and give the investigator an opportunity to respond in person or
in writing. The investigator may rewrite and submit the study as a new protocol.
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Attendance and all IRB actions will be reflected in the IRB minutes. Meeting minutes will be
reviewed and approved at the next convened IRB meeting.
In order to approve research in which the IRB considers provisions for monitoring data to ensure
the safety of subjects to be appropriate, the IRB determines that the research plan makes
adequate provisions. The IRB might consider provisions such as:
 What safety information will be collected, including serious adverse events.
 How safety information will be collected (e.g., with case report forms, at study visits, by
telephone calls with subjects).
 The frequency of data collection, including when safety data collection starts.
 The frequency or periodicity of review of cumulative safety data.
 Conditions that would trigger an immediate suspension of the research, if applicable.
Special Determinations by the IRB
At Board meetings, special determinations will be made, if appropriate, regarding conflict of
interest, special populations (e.g., prisoners and children), pediatric risk, waiver of assent, waiver
of informed consent, and waiver of written consent.
Conflict(s) of Interest:
Conflicting Interest or Conflict of Interest means the existence of one or more concerns that
might influence an IRB member in the performance of their Board responsibilities. Conflicting
interests are factors that can cloud judgment, such as personal relationships between an IRB
member and an investigator, and financial relationships with sponsor companies. An IRB
member or an IRB staff member will inform the meeting attendees of conflict and will leave for
the discussion and recuse him or herself from the convened IRB vote.
Prisoners in Research: For all new protocols that proposed to recruit prisoners as research
subjects, or propose to include individuals who subsequently become incarcerated during the
course of an active research trial, the IRB will review the protocols to determine if the inclusion
is appropriate in accordance with OHRP 45 CFR 46 Subpart C. The IRB will also review the
current research protocol in which the subject is enrolled, taking into special consideration the
additional ethical and regulatory concerns for prisoners.
Minimal Risk for Prisoners is the probability and magnitude of physical or
psychological harm that is normally encountered in the daily lives, or in the routine
medical, dental, or psychological examinations of healthy persons.
Pregnant Women in Research: Pregnancy encompasses the period of time from implantation
until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent
presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are
negative or until delivery (45 CFR 46.202, Subpart B). A research protocol is considered to
include pregnant women when pregnancy occurs during the course of a research study and
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information about the pregnancy, fetus and/or neonate will be obtained as part of the research
study.
The research protocol must provide sufficient justification for inclusion of pregnant women.
Prior to inclusion of pregnant minors in research, parental permission must be obtained or the
IRB must approve a waiver of the requirement for parental permission in accordance with 45
CFR 46.116 or 45 CFR 46.117.
Pediatric Risk: All studies involving children require IRB review in accordance with the
provisions of 45 CFR 46, Subpart D. The IRB will determine the pediatric risk level of a
protocol and document its determination by the appropriate federal regulation citation number in
the minutes of the IRB meeting.
Waiver of Assent: The assent plan and documentation of assent for children must be recorded in
the meeting minutes. The IRB will determine if the assent is necessary for all or some of the
population, based on the justification provided by the investigator, and according to federal
regulations (45 CFR 46.408). This determination will be documented using the federal regulation
citation number in the minutes of the Board meeting.
Alteration or Waiver of Consent:
a)
Alteration/Waiver of Consent Approved under 45 CFR 46.116(c) - 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 the research could not practicably be carried out without waiver or
alteration.
b)
Alteration/Waiver of Consent Approved under 45 CFR 46 116(d) - Involves no more
than minimal risk, does not adversely affect rights and welfare of subjects, research could
not be carried out without waiver or alteration, and subjects may be provided with
information regarding the study.
Waiver of Signed Consent:
a)
Waiver of Signed Informed Consent Approved under 45 CFR 46.117(c)(1) - The only
record linking the subject and the research would be the consent document and the
principal risk would be a breach of confidentiality.
b)
Waiver of Signed Informed Consent Approved under 45 CFR 46.117(c)(2) - Research
presents no more than minimal risk and involves no procedures for which written consent
is normally required outside of the research context.
Additional Information Available to IRB Members
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Before, after or during a convened IRB meeting, IRB members may ask the IRB office provide
them with additional protocol information and any other information about any protocol. IRB
staff will make these items available upon request.
Reviewer System
The IRB staff will assign a primary reviewer to each protocol. The IRB Office is responsible to
ensure that at least one reviewer has the required scientific and scholarly expertise required to
review the protocol. If the research involves prisoners, the IRB staff will assign a prisoner
representative as the primary reviewer. If a primary or secondary reviewer with the appropriate
scientific, scholarly, or cultural expertise and background is not available, the IRB office will
seek out a qualified individual within or outside of CWRU to serve as a consultant and as the
IRB reviewer(s).
The review process ensures that at least one person with appropriate scientific or scholarly
expertise conducts an in-depth review of the protocol through the assignment of a qualified
primary reviewer who is responsible for such review for each protocol.
The primary reviewer is responsible to review all materials in depth and present the research
proposal at the convened meeting of the IRB. A secondary reviewer is responsible to review all
materials in depth, substitutes for the primary reviewer if the latter is absent at the meeting, and
otherwise provides an additional level of review and discussion. After the primary and
secondary reviewers have presented their comments, all Board members discuss the documents
received for review and add their comments.
Notification of Action and Review of Responses
The results of IRB actions are conveyed in writing usually within one week of a convened IRB
meeting at which the protocol was considered. Furthermore, when a primary reviewer (either
through Full Board or expedited review) determines that additional modifications or
clarifications are required, these are also forwarded in writing to the Responsible/Principal
Investigator. All communications are sent by the IRB Administrative staff.
The investigator must respond to all IRB requests and enquiries in writing. When an investigator
responds to the IRB actions, the correspondence is reviewed by the IRB members to determine
whether the information provided satisfies the Board’s requests and the criteria for IRB approval.
The information can be reviewed administratively (when the investigator has agreed to the
changes requested by the IRB or the protocol is eligible for review using the expedited
procedure). Otherwise, the modifications are reviewed by the convened IRB.
When the IRB disapproves a protocol, the Principal Investigator/Responsible Investigator is
provided with written notification for the reason(s) for the disapproval and is given the
opportunity to respond in person or in writing; however, a detailed critique of the protocol is not
provided. The investigator is instructed to contact the IRB office with any questions. An
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investigator may rewrite and submit the study as a new protocol if they wish, but must take into
account the Board’s concerns and reason(s) for the disapproval of the protocol.
Communication of IRB Reviews
All IRB determinations are communicated to the investigator, or designated contact person for
the research study, in writing, for initial review, continuing review, and review of proposed
modifications to previously approved research. Letters to investigators are maintained in the
electronic protocol submission system by the IRB. In addition to supplying the agenda for each
meeting, the IRB reports its findings and actions to the organization in the form of its minutes,
which are distributed by the IRB Manager to the CWRU Institutional Official. The IO may
request further clarification from the IRB or may disapprove a study that the IRB has approved,
but may not approve a study that has been disapproved.
Required Steps Prior to Commencement of Research
Study-Specific Coordination: In addition to IRB approval, the investigator must obtain and
document the approval, support, or permission of other individuals and departments or entities
affected by the research as well as approval by other oversight committees, including, but not
limited to:
 Dean/Chair scientific/scholarly review/approval
 Conflict of Interest Committee
 Letters of Cooperation from the site:
 Permission to enter classrooms or hospital units
 Permission from external research locations (sites)
 Database access permissions (e.g., Educational/Medical Records)
For any that are indicated, a letter of support, collaboration, permission, or approval from the
designated authority will be reviewed in the IRB Office to ensure that all necessary letters are
included. The IRB may request review or consultation with any of the above listed or other
organizational committees or components even when such review or consultation is not
technically required by policy.
Other committees and officials may not approve research involving human subjects to
commence that has not been approved or has been disapproved by the IRB.
The CWRU IRB provides information in its training sessions for investigators and study staff
that researching involving human subjects may not commence until the research has received all
approves required by the University. The IRB sends an electronic correspondence containing the
IRB approval letter to the Investigators and study contact (if applicable).
The IRB website has language stating IRB approval must be obtained prior to beginning a
research project involving human subject: http://www.case.edu/research/facultystaff/compliance/irb/irb_members/
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Study Closure for Lack of Response
If a protocol has been given contingent approval with a request for minor changes; or has been
deferred, a written letter outlining the required changes or reasons given for the action will be
sent to the investigator. The investigator has 90 days from the time of the IRB meeting at which
the protocol was considered to respond in writing to the changes requested by of the IRB. If the
investigator does not respond in writing within 60 days from the time of the IRB meeting, a
reminder letter will be sent. If the investigator does not respond in writing in 90 days, the
protocol will be closed by the IRB office staff. A written notice of study application closure for
lack of response will be sent to the investigator and placed in the study file. If the investigator
wishes to seek approval for the study, a new protocol must be submitted and approved. If there
are unusual circumstances that prevent a timely response to requested changes, the principal
investigator can request an extension of time to respond.
Length of Time of Approvals
The DHHS regulations require reevaluation of approved research at intervals that are appropriate
to the degree of risk, but not less than once a year 45 CFR 46.109(e). The CWRU IRB’s
maximum approval period for new protocols and the re-approval of studies at continuing review,
is one year minus one day. It is important to note, that IRB approval is a temporary authority
and may be withdrawn at any time if warranted by the conduct of the research activities.
When determining the approval period of protocols at initial and continuing review, the Board
determines whether the estimate of the investigator’s assessment of the anticipated results, risks
and procedures are reasonable; whether the risk/benefit ratio is appropriate and accurate; and
whether there is an adequate plan for monitoring the data collected to ensure subjects safety.
The IRB recognizes that protecting the rights and welfare of subjects sometimes requires that
research be reviewed more often than annually. For example, when a highly vulnerable subject
population is being researched, the risks may not be completely known at initial review. The IRB
shall monitor the research project closely, and require more frequent than annual review. The
IRB shall consider the following factors in determining the criteria for which studies require
more frequent review and what the timeframes generally will be:
●
Probability and magnitude of anticipated risks to subjects.
●
Likely psychological condition of the proposed subjects.
●
Overall qualifications of the Responsible Investigator and other members of the research
team.
●
Specific experience of the Responsible Investigator and other members of the research
team in conducting similar research.
●
Nature and frequency of adverse events observed in similar research at this and other
facilities.
●
Vulnerability of the population being studied.
●
Other factors that the IRB deems relevant.
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In specifying an approval period of less than one year, the IRB may define the period with either
a time interval or a maximum number of subjects (e.g., after 3 months or after three subjects
enrolled, but not longer than 6 months). The IRB minutes will clearly reflect these
determinations regarding risk and approval period.
The approval date is determined by the date which the research was reviewed and approved by
the full Board. If the full Board requests modifications to secure approval which can be
administratively approved, the approval date is calculated from the date that the protocol was
reviewed at full Board approval, and not the date the changes were administratively approved.
The expiration date is one day less than the period of approval, e.g., if the approval period is for
one year starting April 14, 2016 then the study will expire at midnight on April 13, 2017.
For protocols approved by expedited review, the expiration date is also one day less than the date
of approval. When amendments are approved, the expiration date of the study does not change.
The approved consent form will have the IRB approval stamp stating the expiration date showing
the last day it may be used.
Attendance and all IRB actions will be reflected in the IRB minutes. Meeting minutes will be
reviewed and approved at the next convened IRB meeting.
References and/or Regulatory Citations:
45 CFR 46
Belmont Report
CWRU Website for Federalwide Assurance
OHRP Assurance Information
OHRP IRB Registration
OHRP Policy Guidance
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