Mountain State University

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Mountain State University Institutional Review
Board (IRB)
Presentation Created by Mark Miller
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Presentation Outline Part I - General Background
Information Part II - IRB Review Process Part
III - Special Considerations and Requirements
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Section I
General Background Information
What is an IRB?
Why do we have IRBs?
What do IRBs do?
IRB Jurisdiction
Basis of IRB Authority
Who serves on an IRB?
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What is an IRB? An Institutional Review Board
(IRB) is a committee, or board, of volunteers
including scientists, non-scientists, community
members, and health care professionals that
ensures research protocols involving human
subjects are ethical and that the rights of
participants are protected.
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Why do we have IRBs? In the past, some
individual researchers have valued the
acquisition of scientific knowledge more highly
than the protection of human subjects rights and
well-being.
Radiation Experiments
The Tuskegee Syphilis Study
Nazi War Experiments
Thalidomide Studies
JCDH Cancer Research
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Why do we have IRBs? (continued) Significant
harm to and death of subjects has occurred when
scientists failed to adhere to basic moral
standards/rules such as
Concern for the well-being of others Respect
for the autonomy of others Trustworthiness
honesty Willing compliance with the law (with
the exception of civil disobedience) Basic
justice being fair Refusing to take unfair
advantage Benevolence doing good Preventing
harm
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What do IRBs do? To ensure that research
protocols involving human subjects are ethical
and that the rights of participants are
protected, IRBs evaluate the following
1. The nature and purpose of the research
2. Proposed procedures involving human subjects
3. Risks or harms to the subjects
(including physical, psychological, sociological,
economic, and legal) 4. Benefits 5.
Risk/benefit relationship 6. Subject
population 7. Subject recruitment 8.
Process of obtaining informed consent 9.
Research data processing and storage and 10.
Need and frameframe for IRB follow-up.
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IRB Jurisdiction IRBs Review and Evaluate --
? All research involving human subjects conducted
at the University including all Schools,
Campuses, and Centers. ? All research conducted
by students, faculty or staff associated with any
of those institutions. ? If a MSU person is a
Principal Investigator (PI) or a Co-Investigator
(Co-I) on research conducted at another
institution anywhere in the world, that
protocol and consent must be reviewed and
approved by the MSU IRB.
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Key Definitions What is Research? Research is
defined as a systematic investigation, including
research and evaluation, designed to develop or
contribute to generalizable knowledge (45 CFR
46.102d). This is generally interpreted to mean
that if the results of the work are meant to be
published or disseminated to an unrestricted
audience, it is considered as regulated human
subjects research. However, the benchmark / goal
of 'publishing' is not a part of the federal
code. If an activity follows a deliberate plan
whose purpose is to develop or contribute to
generalizable knowledge, such as an exploratory
study or the collection of data to test a
hypothesis, it is research. What is a Human
Subject? A human subject is a living individual
about whom a researcher obtains either (1) data
through intervention with the individual or (2)
identifiable private information.
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Basis of IRB Authority Ethical Codes Governing
Research Involving Human Subjects Prior to 1906,
with the passage of the Pure Food and Drug Act,
there were no governmental regulations regarding
the ethical use of human subjects in research.
There were no consumer regulatory agencies, no
Food and Drug Administration (FDA), no Common
Rule, and no Institutional Review Boards (IRB).
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Basis of IRB Authority (continued) The harm and
injury associated with the Tuskegee Syphilis
Study, Nazi War Experiments, Radiation
Experiments, the Thalidomide Studies, JHCD Cancer
Research, and other events resulted in the
development of several ethical codes with the
goal of protecting human research subjects.
The Nuremburg Code (1947)
The Declaration of Helsinki (1962)
National Research Act (1974)
The Belmont Report (1979)
CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC
WELFARE DEPARTMENT OF HEALTH AND HUMAN
SERVICES NATIONAL INSTITUTES OF HEALTH OFFICE FOR
PROTECTION FROM RESEARCH RISKS PART 46 PROTECTION
OF HUMAN SUBJECTS
The Common Rule (1991) 45 CFR 46, Subpart A
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Basis of IRB Authority (continued)
Federal Laws, Guidelines, Policies - 45 CFR
46 A uniform policy was created for protecting
the rights and welfare of human research
subjects, providing for shared responsibilities
between the federal Government and institutions.
Those regulations were based upon the ethical
principles set forth in the Belmont Report. All
research that includes the use of human subjects
and/or private information about humans must
comply with all of the regulations in the US Code
of Federal Regulations (CFR) at 45 CFR 46. The
basic components of the federal regulations at
45CFR46 are ? Subpart A (Basic DHHS Policy) ?
Subpart B (Pregnant Women, Fetuses, Human In
Vitro Fertilization) ? Subpart C (Prisoners) ?
Subpart D (Children)
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Basis of IRB Authority (continued) The Common
Rule (45 CFR 46, subpart A) The Belmont Report
is the basis for all current laws, regulations,
and policies governing the use of human subjects.
The three fundamental ethical principles of this
report are respect for persons, beneficence and
justice.
Respect for Persons ? Individuals should be
treated as autonomous agents. ? Individuals with
diminished autonomy are entitled to protection.
Respect for Persons is the basis for the focus
on Informed Consent Beneficence ? Human subjects
should not be harmed. ? Research should maximize
possible benefits and minimize possible harms.
Beneficence is the basis for the focus on the
Assessment of Risks and Benefits Justice ? The
benefits and risks of research must be
distributed fairly. Justice is the basis for
focus on the Selection of Subjects
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Who serves on an IRB? Mandated Background
Requirements for IRB Members An IRB must have at
least five members, with varying backgrounds to
promote complete and adequate review of research
activities commonly conducted by the institution.
The following categories must be represented on
the Board
? At least one scientist ? At least one
non-scientist ? At least one community member
who (or his/her immediate family) has no
employment or contractual relationships with the
institution and ? At least one health care
professional.
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Section II
IRB Review Process
Types of IRB Review Exempt Expedited Full
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Types of IRB Review Exempt exempt from full
or partial board IRB review, but still requires
filing an application for approval with the Chair
of the IRB. The Chair of the IRB then determines
and confirms the exempt status of the research.
Expedited requires review by the Chair of
the IRB and at least one other member of the
committee having expertise in the area of the
study. After initial evaluation, the reviewers
may require review by the entire IRB (full
board). Full requires review by the full
membership of the IRB.
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Exempt Review
? Exempt human subject research projects may be
reviewed by the IRB Chair or designee, and do not
require full Board review. ? There are no
deadlines for IRB applications qualifying for
Exempt Review. ? IRB approval does not expire
therefore, continuing review is not required.
? Obtaining written, signed consent from
research participants is not required by federal
regulations however, certain departments (e.g.,
psychology) may require written consent even for
exempt research, or the IRB may require written
consent for certain studies.
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Exempt Review (continued) What Qualifies for
Exempt Review? Research must meet all of the
following criteria
? Must not involve pregnant women, prisoners or
mentally impaired persons ? Must not include
survey research with minors unless involving
standard educational activities (e.g.,
educational tests) within the particular
education system ? Must not include
observation of a minors public behavior unless
there is no researcher interaction ? Research
must not involve video or audio recording of
subjects and ? Must be in one or more of the
following categories (next slide)
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Exempt Research Categories - 45 CFR 46.101(b)

• Tests, surveys, interviews, focus groups (see
  next chart)
• Research in educational settings (e.g.,
  classrooms)
• Existing data, documents or records (see next
  chart)
• Existing data Retrospective Medical Record
  Reviews
• Analysis of tissue, blood or other specimens
• NOTE Ordinarily identifiers should not be
  recorded unless the information is benign.
• ltlt For more detailed information on please see
  the MSU IRB web site. gtgt

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Exempt Review / Common Exemptions Exemption 45
CFR 46.101(b) (2) Research will involve the use
of educational tests (cognitive, diagnostic,
aptitude, achievement), survey procedures,
interview procedures or observation of public
behavior, unless the subjects can be identified
directly or through identifiers linked to the
subjects and disclosure of responses could
reasonably place the subjects at risk or criminal
or civil liability or be damaging to the
subjects financial standing, employability or
reputation. Exemption 45 CFR 46.101(b)
(4) Research will involve 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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Expedited Review
? Expedited human subject research projects may
be reviewed by the IRB Chair, and do not require
full Board review. ? There are no deadlines for
IRB applications qualifying for Expedited Review.
? IRB approval will be granted for a determined
length of time not to exceed one year. ? The
IRB approval expiration date will be specified in
the approval letter. ? Continuing review is
required for re-approval if the research is to
continue beyond the expiration date. ? Signed
consent is required unless the IRB grants a
waiver.
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Expedited Review What Qualifies for Expedited
Review? To qualify for Expedited Review, the
research must meet all of the following criteria
? Be of minimal risk (see definitions) to the
subjects ? Must not involve pregnant women,
prisoners or mentally impaired persons
? Involve only procedures listed in one or more
of the following categories (following slides).
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Definitions of Risk 45 CFR 46.102 (i) Risk The
probability of harm or injury (physical,
psychological, social, or economic) occurring as
a result of participation in a research
study. Minimal Risk Minimal risk means that the
probability and magnitude of the 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.
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Expedited Research Categories 45 CFR 46.110 (a)
(b)

• ? Research on individual or group characteristics
  or behavior
• ? Collection of data through non-invasive means
  (excluding X rays, but including MRI and EEG)
• ? Materials collected initially for non-research
  purposes (e.g., medical diagnosis school
  performance)
• ? Collection of blood samples
• Prospective collection of biological specimens by
  non-invasive means
• http//www.hhs.gov/ohrp/humansubjects/guidance/exp
  edited98.htm

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Full Review
? A project that involves greater than minimal
risk requires approval by an IRB panel, the
Board, composed of members qualified to review
research in that field. ? There are deadlines
for IRB applications requiring Full IRB Review.
Required materials / documents should be
submitted a minimum of two (2) weeks prior to its
next scheduled meeting. ? IRB approval will be
granted for a determined length of time not to
exceed one year. ? The IRB approval expiration
date will be specified in the approval letter.
? Continuing review is required for re-approval
if the research is to continue beyond the
expiration date.

• The continuing review request must be reviewed by
  the Full IRB at its scheduled meeting unless one
  of the following applies

1) the research is permanently closed to the
enrollment of new subjects all subjects have
completed all research related interventions and
the research remains active only for long-term
follow-up of subjects or 2) where no subjects
have been enrolled and no additional risks have
been identified or 3) where the remaining
research activities are limited to data analysis
or 4) continuing review of research, not
conducted under an investigational new drug
application or investigational device exemption
where categories for expedited approval 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.
? Signed consent is required unless the IRB
grants a waiver.
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Full Review What Types of Research Require Full
IRB Review? Research includes one or more of the
following Prisoners Pregnant Women
Fetuses Human in Vitro Fertilization
Mentally Disabled Persons Microwaves or
X-Rays General Anesthesia or Sedation
Greater than Minimal Risks (than those
anticipated under exempt expedited research,
e.g., questions about abuse, illegal activities).
Vulnerable Populations (see definitions,
below)
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IRB Review Process
Required Forms Documentation

• Forms
• ? MSU IRB Research Protocol Application Form
• ? Amendment of Research Protocol Request Form
• ? Continuation of Review Request Form
• ? Participant Informed Consent Form
• ? Notification of Adverse Event Form
• Documents
• ? Copy Information Letter to Participants for
  Informed Consent
• ? Copy of Survey Instrument
• ? Copy of Subject Recruitment Materials (printed
  material and hard copies of oral scripts)
• ? Security Statement addressing data access and
  storage
• ? Security Statement addressing the protection of
  participant anonymity and privacy
• ? Verification of human subject protection
  training (copy of training certification from
  NIH, Office of Extramural Research, "Protecting
  Human Research Participants" (PHRP) training
  course http//phrp.nihtraining.com/users/login.ph
  p, or other equivalent training.

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Section III
Special Considerations and Requirements From the
Belmont Report and the Common Rule (45 CRR 46,
subpart A)
Informed Consent Recruitment of
Participants Protecting Confidentiality and
Anonymity
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Special Considerations and Requirements

• Informed Consent
• There are three elements to the informed consent
  process
• Information
• Comprehension
• 3. Voluntariness

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Special Considerations and Requirements
Informed Consent - Information Subjects must be
given adequate information to properly make an
informed decision regarding participation. At a
minimum, federal regulations require the
following information to be included in the
consent process and consent document
Brief description of the research procedures,
including length of procedures Statement that
the study involves research Purpose of the
research Risks and anticipated
benefits Alternative procedures (if therapy
clinical/surgical treatment involved) Descriptio
n of confidentiality/anonymity provided Explanat
ion of compensation provided, if any Statement
indicating that subject is free to withdraw at
any time from the research project without
penalty Statement that questions can be asked,
and names and addresses / telephone numbers of PI
and IRB Chair provided
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Special Considerations and Requirements
Informed Consent - Comprehension Subjects must
be able to adequately understand the project,
his/her role, and the risks involved. As the
risks become more serious, the obligation to
ensure subject comprehension greatly increases.
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Special Considerations and Requirements
Informed Consent - Voluntariness Voluntary
recruitment involves the free-will choice of
individuals in conditions free of extreme
urgency, with little time to ponder choices and
undue influence / coercion. Recruitment not free
of these conditions invalidates any consent that
may be given.
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Special Considerations and Requirements
Recruitment - Vulnerable Populations Researchers
must also provide compelling justification for
the use of vulnerable populations within
research. Individuals within vulnerable
populations may have limited autonomy. In other
words, they may not be able to provide sufficient
informed consent. This may be because they cannot
fully understand the research or are within a
coercive environment.
Examples of vulnerable populations Children
Cognitively (Decisionally) impaired Comatose
patients Prisoners Pregnant women
fetuses (clinical studies) Students Employee
s Terminally ill Economically
disadvantaged Educationally disadvantaged
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Special Considerations and Requirements
Protecting Confidentiality Anonymity Researcher
s need to be creative to ensure that the utmost
confidentiality or anonymity is provided to their
research participants. Do not collect
identifying information from participants unless
it is absolutely necessary to the research. If
identifying information is collected, keep this
information separate from subjects responses
(e.g., responses to questionnaires / interviews,
biological specimens, lab information, etc.).
To do so, use a study code / ID to link
identifying information to study responses. Keep
the document linking study ID with identifying
information in a separate locked area and limit
access to head researchers.
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Special Considerations and Requirements
Protecting Confidentiality Anonymity
(Cont.) Examples of Identifying
information Names Addresses Employers
names or addresses Relatives names or
addresses Dates (e.g., birth date, date of
death) Phone/fax numbers Email
addresses Social Security Number Member
account numbers Voiceprints Fingerprints
Full face photos comparable images
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MSU IRB Mission Statement The Mountain State
University Institutional Review Board will
assure highest quality human subject research
for all research studies conducted under the
auspices of the University. The IRB is guided by
ethical principles outlined in the Belmont Report
(1979) and legal mandates outlined in the Code of
Federal Regulations Title 45 Part 46 (1994).
The IRBs main purpose is to ensure protection
of human subjects through the review, approval,
modification, or disapproval of research
applications submitted by faculty, staff,
students, and/or external investigators. The IRB
is responsible for communication, record keeping,
reporting, monitoring, and education of the MSU
community . Responsibilities cover ethical
issues and oversight of all research activity
involving human subjects.