RESEARCH ETHICS
Orientation for IRB Members
Session 1: The Regulations
and the Role of The IRB
Presented by the
Office of Sponsored Programs & Research Administration
Valdosta State University
Institutional Review Board
Historical Timeline
 1947: Nazi War Crimes Tribunal issued Nuremburg Code
 1940s: PHS Tuskegee syphilis study
 Late 1950s – Early 1960s: The thalidomide tragedy
 1963: Milgram’s obedience study published
 1964: Declaration of Helsinki/World Medical Assembly
 1974: National Research Act (IRB review for federally funded
research)
 1974: National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research established
 1979: Belmont Report issued; ethical principles defined
 1980: FDA regulations for testing of new drugs and devices codified
Valdosta State University
Institutional Review Board
Historical Timeline
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1980:
1981:
1991:
1993:
1994:
1995:
2000:
2001:
2002:
2003:
FDA regulations for testing of new drugs and devices codified
DHHS human subject protection regulations codified (45 CFR 46)
Federal Policy for the Protection of Human Subjects (“Common Rule”)
Albuquerque Tribune publicizes 1940s secret radiation experiments
National Bioethics Advisory Commission (NBAC) created
U.S. universities surveyed re: old radiation studies
U.S. Public Health Service mandates researcher education
Office of Human Research Protections (OHRP) established within DHHS
NBAC sunsets
Secretary’s Advisory Committee on Human Research Protection
established
Valdosta State University
Institutional Review Board
Belmont Principles
 Autonomy (Respect for Persons)
 Give respect, time, and opportunity to participants to make their
own decisions
 Avoid pressuring or coercing individuals to participate
 Provide special protections for potentially vulnerable populations
(children, elderly, cognitively or emotionally impaired, prisoners,
etc.)
 Be aware of the perception of inequality of roles and/or potential
for coercion in relationships
• Teacher-Student
• Counselor-Client
Valdosta State University
• Employer-Employee
• Service Provider-Service Recipient
Institutional Review Board
Belmont Principles
 Derived Rules from the Principle of Autonomy
 Securing Informed Consent
• Ongoing educational process to ensure participants’ understanding of the
research and their willingness to participate
 Respecting Privacy of the Individual
• Individual’s right to control access to him/herself and to his/her personal
information
 Protecting Confidentiality of Information
• Agreement made with research participants about how information about
the participant will be protected
Valdosta State University
Institutional Review Board
Belmont Principles
 What is private information?
 Behavior or information is considered private if it occurs in a
context in which the individual can reasonably assume that no
observation or recording is taking place or can reasonably expect
will not be made public (such as medical or educational record)
 Participants’ expectations form basis of making distinctions
between public and private behavior
 May have some expectation of privacy, even in a public setting
Valdosta State University
Institutional Review Board
Belmont Principles
 Privacy Concerns in Identification and Recruitment
 Sampling methods
• For example, “snowball sampling”
• Covert observation or video or audio taping
 Approaching in a public setting
• Safety concerns (gang member on the street; domestic violence victim)
 Recruiting via an employer’s email system
• Concerns with sensitive information
Valdosta State University
Institutional Review Board
Belmont Principles
 Thinking Through Privacy Issues
 Is it a situation in which the participant could reasonably expect privacy?
 Would reasonable people be offended by such intrusion?
 Would information gathered place the participant at risk of harm if
disclosed?
 Do benefits of the study justify the possible invasion of privacy?
 What will the participants be told after the study?
 Can the study be redesigned to avoid the intrusion?
 Are there third parties whose privacy would be invaded (for example,
asking children about parental drug use or other illegal behavior)?
Valdosta State University
Institutional Review Board
Belmont Principles
 Ensuring Confidentiality
 If possible, use a study design that assures anonymity (no true
identifiers)
 Must ensure confidentiality and communicate measures to
participants if
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Data are individually identifiable
Research topic is sensitive
Participants will be audio- or video-taped
Data will be used for purposes other than the original study
Valdosta State University
Institutional Review Board
Belmont Principles
 Confidentiality Considerations
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Is there a real need for identifiers?
Can code lists or participant-created identifiers be used?
Can identifiers or code lists be destroyed after data collection?
Who will have access to the data, now and in the future?
How will data be reported (aggregate, pseudonyms, real names?)
What will become of video or audio tapes (destruction, used for teaching,
shown at meetings, saved for future research)?
 Protection of data from inadvertent disclosure (authorized staff, computer
passwords, locked file cabinets)?
 Are the data destruction methods appropriate?
 Federal regulations require retention of data for at least three years
Valdosta State University
Institutional Review Board
Belmont Principles
 Beneficence
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Secure the well-being of research participants
Minimize harm to participants
Maximize benefits to participants and to society
Carefully balance risks and benefits to the participants
Valdosta State University
Institutional Review Board
Belmont Principles
 Derived Rules from the Principle of Beneficence
 Use the best possible research design
 Ensure that the researcher is qualified to perform the
procedures and handle the risks
 Refrain from the conduct of research that is without a
favorable risk-benefit balance if risk is greater than
minimal
Valdosta State University
Institutional Review Board
Belmont Principles
 Justice
 Distribute benefits and burdens of the research fairly
and without bias
• Do not select or restrict participants based on gender, class,
ethnicity, socioeconomic status, or language ability (unless
justified by study objectives)
 Avoid selection of participants based on
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Convenience of researcher
Participant availability
Compromised position of participants
Ability to manipulate participants
Valdosta State University
Institutional Review Board
The DHHS Regulations (45 CFR 46)
 Underpinned by the Belmont Report principles
 Establishes oversight of federally funded human research
 Establishes Institutional Review Boards (IRBs) for the
protection of human research participants
 Establishes institutional assurance mechanism
Valdosta State University
Institutional Review Board
FederalWide Assurance (FWA) Program
 Federal policy requires that institutions engaged in
federally-supported research involving human
participants file an Assurance
 The Assurance formalizes the institution’s commitment
to protect human subjects
 The Assurance includes both “awardee” and
collaborating “performance site” institutions
Valdosta State University
Institutional Review Board
VSU’s FWA
 VSU has assured DHHS that it:
 Accepts the ethical principles of the Belmont Report
 Complies with the Federal Policy for Protection of Human Subjects
(the Common Rule)
 Has adopted all subparts of the regulations (45 CFR 46)
 Verifies exemptions from the Common Rule
 Maintains an IRB in accordance with the regulations
 Requires assurance training of IRB members and staff
 Requires education of all researchers
 Applies protections to all participants, regardless of funding source
Valdosta State University
Institutional Review Board
VSU’s FWA
 VSU has assured DHHS that it maintains written procedures for:
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Conducting IRB initial and continuing reviews
Approving research involving human participants
Ensuring documentation of informed consent
Ensuring that proposed protocol changes are reported, reviewed,
and approved prior to implementation
 Reporting findings to the IRB and institution
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Initial and continuing reviews
Adverse events and unanticipated problems
Serious or continuing non-compliance with regulations or IRB policies
Suspension or termination of protocols
Valdosta State University
Institutional Review Board
The Institutional Review Board (IRB)
 Mandated to safeguard the rights and welfare of
research participants by
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Reviewing research protocols
Requiring protocol modifications as necessary
Approving or disapproving protocols
Ensuring or waiving informed consent and/or
documentation of informed consent
 Conduct continuing review of research
Valdosta State University
Institutional Review Board
Constitution of IRB
 At least five members with varying backgrounds
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Different professions
At least one scientist and one non-scientist
At least one non-affiliated (community) member
Prisoner or prisoner representative if institution engages in prisoner research
 Diversity in gender, ethnicity, and cultural background
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Sensitivity to community attitudes
Knowledgeable in standards of professional conduct and practice
Outside consultants may be used
Alternate members may serve as proxies for designated voting
members at convened meetings (but not as expediters)
 Members with conflicting interests may not participate in protocol
reviews.
Valdosta State University
Institutional Review Board
IRB Jurisdiction
 The IRB has jurisdiction over research conducted by VSU
 Faculty members
 Staff
 Students
 in any location
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On the VSU campus
At another institution or organization
In a community setting
In a foreign country
Valdosta State University
Institutional Review Board
IRB Authority
The IRB’s decision to deny approval of a
protocol cannot be overridden by the President,
any member of the administration, or the Board
of Regents.
The IRB’s decision is final.
Valdosta State University
Institutional Review Board
CITIProgram.org Training for Researchers
 Basic Course
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6.
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9.
Introduction
History and Ethical Principles – SBR
Defining Research with Human Subjects – SBR
The Regulations and the Social and Behavioral Sciences – SBR
Basic Institutional Review Board (IRB) Regulations and Review Process
Assessing Risk in Social and Behavioral Sciences – SBR
Informed Consent – SBR
Privacy and Confidentiality – SBR
VSU Module
(SBR = Social and Behavioral Research)
Valdosta State University
Institutional Review Board
CITIProgram.org Training for Researchers
 Additional Required (?) Modules Based on Research Design
1. Research with Children - SBR
2. Research in Public Elementary and Secondary Schools - SBR
3. Vulnerable Subjects – Research Involving Pregnant Women and Fetuses in utero
4. Research with Prisoners - SBR
5. Research with Protected Populations – Vulnerable Subjects: An Overview
6. International Research
7. Group Harms: Research with Culturally or Medically Vulnerable Groups
8. Records-Based Research
9. Genetic Research in Human Populations
10. HIPAA and Human Subjects Research (personal medical information)
11. Internet Research - SBR
12. Workers as Research Subjects – A Vulnerable Population
Valdosta State University
Institutional Review Board
Additional Training for IRB Members
 CITIProgram.org IRB Reference Resource (all IRB modules)
 OHRP Human Subjects Assurance Training
 Module 1 - HHS Regulations & Institutional Responsibilities
 Module 2 - Investigator Responsibilities & Informed Consent
 Module 3 - Human Research Protections Program
Module 1 is strongly recommended for the Institutional Official. All three
modules are required for the IRB Chair and the IRB Administrator. All IRB
members are invited to complete the modules.
http://ohrp-ed.od.nih.gov/CBTs/Assurance/login.asp
Valdosta State University
Institutional Review Board
Other Resources for IRB Members
 OHRP (http://www.hhs.gov/ohrp/)
 Institutional Review Board (IRB) Guidebook On-Line
• http://www.hhs.gov/ohrp/irb/irb_guidebook.htm
 Policy and Guidance
• http://www.hhs.gov/ohrp/policy/index.html
 Frequently Asked Questions (FAQs)
• http://www.hhs.gov/ohrp/faq.html
 VSU IRB Website
 Policy and procedures, guidance, forms, membership, meeting dates
• http://www.valdosta.edu/ospra/HumanResearchParticipants.shtml
Valdosta State University
Institutional Review Board
Federal Definitions
 Research is a systematic investigation intended to develop or
contribute to generalizable knowledge
 The regulations do not define “systematic” or “generalizable
knowledge”
• Systematic: adj. “Methodical in procedure or plan (a systematic
approach) (a systematic scholar); marked by thoroughness and
regularity (systematic efforts)” – Merriam-Webster Dictionary
• Generalizable Knowledge infers a quantitative methodology which
allows generalization of research findings to a larger population.
 For VSU IRB purposes, a systematic investigation intended to
advance disciplinary knowledge is also included in the definition of
research
• Includes qualitative research
See handout on qualitative and quantitative research.
Valdosta State University
Institutional Review Board
Federal Definitions
 Human Participant is a living individual about whom the
investigator obtains
 Data through intervention or interaction with the individual
and/or
 Identifiable private information
Valdosta State University
Institutional Review Board
Federal Definitions
 Intervention includes
 Physical procedures such as specimen collection and
physical measurements
 Manipulation of the participant
 Manipulation of the participant’s environment
 Interaction includes
 Direct communication with the participant (such as
interviewing or conducting a focus group)
 Interpersonal contact with the participant (such as
surveying)
Valdosta State University
Institutional Review Board
Federal Definitions
 Private Information is
 Information about behavior that the participant can reasonably
expect is not being observed or recorded (for example,
restroom habits)
 Information provided by the participant that he/she
reasonably expects will not be made public (such as a medical,
personnel, or academic record)
 Identifiable means
 The participant’s identity can be readily ascertained by
investigator or
 The participant’s identity can be associated with the
information directly or through the use of identifiers
Valdosta State University
Institutional Review Board
Federal Definitions
 Minimal Risk - Risk is considered minimal when 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 performance of
routine physical or psychological examinations or tests
The concept of risk goes beyond physical risk and includes
psychological, emotional, or behavioral risk as well as risks to
employability, economic well being, and social standing and risks of
civil and criminal liability.
Valdosta State University
Institutional Review Board
Other Important Definitions
 Anonymous means that no one, including the researcher, can
identify the participant directly, through demographic or
other identifiers, through a voice recording, or through a
code list that links the participant’s identity with his/her data
 Confidential means that identifiable information from or
about a participant that is maintained by the researcher is
protected from unauthorized or accidental disclosure
Valdosta State University
Institutional Review Board
Other Important Definitions
 De-identification means removing personal identifiers from
confidential data after collection, allowing the data to be
maintained indefinitely without risk of breach of
confidentiality. De-identification techniques include:
 Destruction of the code list that links the participant identities with
their data
 Removal and destruction of the portions of written data collection
tools that include identifiers
 Destruction of audiotapes after transcription in which pseudonyms
that are not linked to participant identity through a code list are used
 Destruction of videotapes after recorded behaviors are coded if there
is no code list that links coded behaviors to participants’ identities
Valdosta State University
Institutional Review Board
When 45 CFR 46 Doesn’t Apply
 When the proposed project does not involve research as defined by
Federal regulations and the VSU IRB
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Oral history projects
“Action research” to improve teaching of College of Education students
Use of de-identified or publicly available archival data
Most student projects completed as class assignments to learn methods
 When the subjects of the research are deceased
…but consider possible third party protection
 When there is no intervention or interaction with the individual and
no private data or information will be obtained or recorded in such
a manner that it can be associated with the individual (includes
observation of public behavior)
…but consider expectation of privacy
No application required.
Valdosta State University
Institutional Review Board
Student Research Not Subject to IRB Oversight
 Projects that are conducted and presented solely within the confines of the
college classroom or departmental “subject pool” that are
• A general course requirement;
• Intended solely to develop the student’s research skills; and
• Will be overseen by a faculty member
 Projects intended primarily to teaching research methods that are conducted
outside the college classroom or subject pool, provided they do not
• Involve minors; target vulnerable populations; or pose risk of physical harm to
pregnant women or fetuses;
• Deal with a personal or sensitive nature unless data are collected anonymously; or
• Involve any activity that would place participants at more than minimal risk
 “Action research” conducted by College of Education students in their own
PK-12 classrooms for the purpose of improving teacher practice
Valdosta State University
Institutional Review Board
Student Research Subject to IRB Oversight
 Investigative activities that meet the IRB’s definition of research
(“systematic investigation…designed to develop or contribute to generalizable knowledge”)
 Other investigative activities involving humans if they
• Are undertaken with the intent to produce results that will be submitted for
peer-reviewed publication or presentation;
• Include minors, target a vulnerable population, or place pregnant women
and/or fetuses at risk of physical harm;
• Deal with a topic of a sensitive or personal nature in a way in which anonymity
cannot be sustained and the examination or reporting of participant responses
or behavior may be potentially stigmatizing or may place the participant at
more than minimal risk physically, psychologically, socially, or economically or
for civil or criminal liability;
• Involve any other type of activity that places the participants at more than
minimal risk, considering both the probability and the magnitude of harm.
Valdosta State University
Institutional Review Board
Exemptions from 45 CFR 46
 Some research involving human participants is exempt from IRB
review
 Risk must be minimal and
 Research must meet at least one exemption criterion listed in 45
CFR 46
 IRB has delegated exemption authority to the IRB Administrator
(Director of Office of Sponsored Programs & Research
Administration)
 Except exemption of IRB members’ protocols which are determined
by the Chair
 Questionable protocols are referred to the IRB Chair for
determination
Valdosta State University
Institutional Review Board
Exemption Categories
 Category 1: Research conducted in established or
commonly accepted educational settings, involving
educational practices, such as
 Research on regular and special education instructional
strategies
 Research on effectiveness of, or comparison among,
• Instructional techniques
• Curricula
• Classroom management methods
Valdosta State University
Institutional Review Board
Exemption Categories
 Category 2: Research involving
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Educational tests (cognitive, diagnostic, aptitude, achievement)
Survey procedures
Interview procedures or
Observation of public behavior
unless
 Information is recorded in such a way that participants can be
identified directly or through identifiers and
 Disclosure could reasonably
• Place participant at risk of criminal or civil liability or
• Be damaging to financial standing, employability, or reputation
Valdosta State University
Institutional Review Board
Exemption Categories
 Special notes on Category 2
 Exemption for survey and interview procedures does not
apply to research involving children
 Exemption for observation of public behavior does not
apply to research involving children except when the
investigator does not participate in the activities being
observed
Valdosta State University
Institutional Review Board
Exemption Categories
 Category 3: Research involving
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Educational tests (cognitive, diagnostic, aptitude, achievement)
Survey procedures
Interview procedures or
Observation of public behavior
that is not exempt under Category 2 if
 Participants are elected or appointed public officials or candidates for
public office or
 Federal statute requires without exception that confidentiality of the
personally identifiable information be maintained throughout the
research and thereafter
Valdosta State University
Institutional Review Board
Exemption Categories
 Category 4: Research involving collection or study of
existing
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Data
Documents
Records
Pathological or diagnostic specimens
if
 The sources are publicly available or
 Information is recorded by the investigator in such a manner that
participants cannot be identified directly or through identifiers linked to
the participants
Valdosta State University
Institutional Review Board
Exemption Categories
 Category 5: Research and demonstration projects that are
mandated by federal statute and are designed to study,
evaluate, or otherwise examine:
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public benefit or service programs;
procedures for obtaining benefits or services under those programs;
possible changes in or alternatives to these programs or procedures; or
possible changes in methods or levels of payment for benefits or services
under those programs, unless there is a specific requirement for IRB
review in the statute and provided the project does not involve significant
physical invasions or intrusion upon the privacy of the participants.
(Note: This category is not applicable to evaluation of most federally funded
programs, nor is it applicable to any state or local government funded programs
or those supported by a non-profit organization.)
Valdosta State University
Institutional Review Board
Exemption Categories
 Category 6: Taste and food quality evaluation and
consumer acceptance studies if the food to be
consumed
 Is wholesome and additive-free
 Contains an ingredient at or below the level, and for a use,
found to be safe or
 Contains an agricultural chemical or environmental
contaminant at or below the level found to safe by the FDA or
approved by the EPA or the USDA
Valdosta State University
Institutional Review Board
Notes About Exemption
 Written informed consent is generally not required or
recommended for exempt protocols
 If written consent is desired by the investigator to meet
professional standards, the IRB provides specific language
for inclusion regarding participants’ rights
 The IRB may recommend a consent script to be read to
participants being interviewed
 The IRB may recommend a written explanation including
consent elements to accompany written surveys
Valdosta State University
Institutional Review Board
Research Requiring IRB Review
 Research involving receipt, possession, or release of private
information that is individually identifiable, either directly or
through coding systems
 Research involving manipulation of the participant’s
environment
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Controlling light, sound, or temperature
Presenting sensory stimuli
Orchestrating environmental events or social interactions
Making voice, digital, or image recordings
Valdosta State University
Institutional Review Board
Research Requiring IRB Review
 Research involving invasive or non-invasive procedures
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Collecting biological specimens
Taking physical measurements
Utilizing physical sensors
Dispensing drugs
Administering treatments
Employing medical technologies
Valdosta State University
Institutional Review Board
Types of IRB Review
 Some research qualifies for “Expedited Review”
 Must be minimal risk research and
 Must meet federal criteria for expediting
 Remaining research must receive a “Convened Review”
Valdosta State University
Institutional Review Board
Expedited Review
 Review is done by two-member expediting team (IRB
Chair or Vice-Chair may individually expedite in
emergency)
 Approval is subject to full IRB concurrence at next
convened meeting
 Expediters may recommend convened review
Valdosta State University
Institutional Review Board
Expedited Review Process
 IRB Administrator conducts pre-review of application and consults
with researcher regarding suggested revisions
 Application is sent to expediting team for review
 Team members communicate with each other via email (with cc: to
IRB staff) while conducting review
 Team takes action, with team leader responsible for
communication with IRB Administrator
 Requests revisions as necessary
 Approves protocol and completes approval report
 Refers for convened review
Team members should not correspond directly with researchers. All
requests for information/clarification should be made through the IRB
Administrator to keep the identity of reviewers confidential.
Valdosta State University
Institutional Review Board
Expedited Review Categories
 Categories that are not often used at VSU
 Category 1: Clinical studies of approved drugs and devices that are
used as approved
 Category 2: Collection of blood samples (limited amounts)
 Category 3: Non-invasive collection of biological specimens (hair,
nail clippings, etc.)
Valdosta State University
Institutional Review Board
Expedited Review Categories
 Category 4: Collection of data through non-invasive procedures
(not involving general anesthesia or sedation) routinely
employed in clinical practice, excluding procedures involving xrays or microwaves. Such procedures include, but are not
limited to:
 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 participant or an invasion of the participant's
privacy;
 Weighing or testing sensory acuity;
 Magnetic resonance imaging;
Valdosta State University
Institutional Review Board
Expedited Review Categories
 Category 4: Collection of data through non-invasive procedures
(continued):
 Electrocardiography, electroencephalography, thermography,
detection of naturally occurring radioactivity,
electroretinography, ultrasound, diagnostic infrared imaging,
doppler blood flow, and echocardiography; and
 Moderate exercise, muscular strength testing, body composition
assessment, and flexibility testing where appropriate given the
age, weight, and health of the individual.
(Note: Medical devices employed must be cleared/approved for marketing.)
Valdosta State University
Institutional Review Board
Expedited Review Categories
 Category 5: Research involving materials such as
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Data
Documents
Records
Specimens
that have been collected, or will be collected, solely
for non-research purposes, such as
 Medical diagnosis and/or treatment
 Education
 Employment
Valdosta State University
Institutional Review Board
Expedited Review Categories
 Category 6: Collection of data from
 Voice recordings
 Video recordings
 Digital recordings
 Image recordings
made for research purposes
Valdosta State University
Institutional Review Board
Expedited Review Categories
 Category 7: Research on individual or group characteristics
or behavior, including, but not limited to, research on
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Perception
Cognition
 Motivation
 Identity
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Language
 Communication
 Cultural beliefs or practices
 Social behavior
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or research employing the following methods:
Survey
 Interview
 Oral history
 Focus group
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Valdosta State University
Program evaluation
 Human factors evaluation
 Quality assurance
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Institutional Review Board
Expedited Review Categories
 Category 8: Continuing review of research approved in
convened IRB meeting if
 Enrollment is permanently closed
 All research-related interventions are completed and
 The research remains active only for long-term follow-up of
participants
or
 No participants have been enrolled and no additional risks have
been identified
or
 Only data analysis remains
Valdosta State University
Institutional Review Board
Expedited Review Categories
 Category 9: Continuing review of research to which Expedited
Review Categories 2 through 8 do not apply if the IRB has
documented at a convened meeting that risk is minimal and no
new risks have been identified
Valdosta State University
Institutional Review Board
Convened Review
 Initiated when research is not exempt or cannot be expedited
(e.g., when risk is more than minimal or the research involves prisoners)
 Requires review by a quorum of IRB members in a face-to-face
meeting
 Majority of members must be present
(Alternate members may serve as specifically assigned proxies)
 A non-scientist must be present
 For research involving prisoners, the Prisoner Representative member
must be present and special review criteria are considered
 A majority of those present must approve the protocol
 OHRP now allows review via teleconferencing or other electronic
means provided all members have opportunity for input and
exchange
Valdosta State University
Institutional Review Board
Protocol Modification Requests
 For modifications only during the current protocol approval
period
 Expedited review by team if
 Original review was expedited and no changes are proposed
that
• Will increase the level of risk to “more than minimal” or
• Will make expedited review categories no longer applicable
 Original review was convened but
• The IRB has documented at a convened meeting that risk is minimal and
no new risks have been identified
Valdosta State University
Institutional Review Board
Continuation Requests
 For continuation of protocol approval without any proposed
changes for up to twelve additional months
 Expedited by Chair or Vice-Chair if
 Original review was expedited or
 Original review was convened but
• Enrollment is permanently closed; all research-related interventions are
completed, and the research remains active only for long-term follow-up
of participants; or
• No participants have been enrolled and no additional risks have been
identified; or
• Only data analysis remains
 Referred for Convened Review if
 Original review was convened and
 Criteria for expedited review not met
Valdosta State University
Institutional Review Board
Combo Mod and Continuation Requests
 For combination of protocol modification request and continuation
review
 Handled like a Protocol Modification Request
Valdosta State University
Institutional Review Board
Is this research subject
to IRB oversight?
Thoroughly Confused?
Who reviews this protocol
modification request?
Is this research exempt
from IRB review?
Does this research qualify
for expedited review?
Aaaagggghhh!!!
What do I do?
Relax! The IRB Administrator routes applications
and requests according to federal criteria.
Valdosta State University
Institutional Review Board
IRB Review Criteria
 Risks to participants are minimized
 Risks to participants are reasonable in relation to
anticipated benefits to the individual and/or society
 Selection of participants is equitable
 Adequate preparation is taken to protect privacy
and confidentiality of participants
Valdosta State University
Institutional Review Board
IRB Review Criteria
 Informed consent
 is sought from each prospective participant or legally
authorized representative
 is documented (unless research is exempt or waiver of
documentation of consent is granted by IRB)
 Adequate provisions are made for ongoing monitoring
of participants’ welfare
Valdosta State University
Institutional Review Board
Required Elements of Consent
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Identification and affiliation of the researcher
A statement that study involves research
An explanation of purpose of research
The expected duration of participant’s involvement in the study
A description of study procedures
Identification of the experimental procedures
A description of reasonably foreseeable risks or discomforts to
participant—those that are minimal and/or those that are more
than minimal
 A description of any benefits which may reasonably be expected
for the participant or for society
Valdosta State University
Institutional Review Board
Required Elements of Consent
 Disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the participant
 Statement describing the extent, if any, to which confidentiality
of records identifying the participant will be maintained
 An explanation of any costs associated with participation
 An explanation of any compensation for participation
 For research involving more than minimal risk, an explanation of
any medical treatments available if injury occurs, what
treatments consist of, and where to obtain further information
Valdosta State University
Institutional Review Board
Required Elements of Consent
 Statement that
 Participation is voluntary
 Refusal to participate will involve no penalty or loss of benefits to
which the participant is otherwise entitled
 Participant may discontinue his/her participation at any time
without penalty or loss of benefits to which he/she is otherwise
entitled
 Name of contact persons to ask questions about the research, to
ask questions about research participants’ rights, and to report
research-related injuries or other adverse events
All these elements are included in the IRB’s Model Consent Form.
Valdosta State University
Institutional Review Board
Additional Elements of Consent
As appropriate (usually for greater than minimal risk
research)…
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Statement regarding possibility of unforeseeable risks
Any additional costs to the participant
Circumstances that may require participant’s termination
Consequences of a decision to withdraw
Procedures for orderly termination
Statement that significant new findings that may influence the
participant’s willingness to continue in the study will be provided
Valdosta State University
Institutional Review Board
Written Consent Requirements
 Researcher must follow IRB Model Consent format
 Form must contain all elements or must indicate that
all elements were given orally with witness present
 From must include IRB approval stamp
 Form must be signed by participant or his/her legally
authorized representative
 Participant must receive a copy
 IRB may audit a research project to determine
compliance with informed consent requirements
Valdosta State University
Institutional Review Board
Documentation of Consent
 If research participant is a minor…
 And the child is too young to agree or refuse to participate
in the research, secure parent/guardian permission
 And the child is old enough to agree or refuse to
participate, secure parent/guardian permission and the
child’s assent (written or verbal)
• A signature line for the child may be added to the
parent/guardian permission form
Note: Even very young children have some capacity to give assent
verbally or through their actions.
Valdosta State University
Institutional Review Board
A Note on Terms
 Consent is sought from adults who have the capacity to
understand and act for themselves
 Permission is sought from parents or guardians of
minors or other adults who do not have the legal
standing or capacity to understand and act for
themselves
 Written Assent is sought from older children (usually
cognitive age of 12-14 years)
The IRB also provides model permission and assent forms for researchers.
Valdosta State University
Institutional Review Board
Waiver of Written Consent
 The IRB may waive the requirement for written (signed)
consent
 When the consent form is the only record linking the
participant to the research and potential harm could result
from breach of confidentiality
 When the research presents no more than minimal risk and
involves no procedures for which written consent is normally
required outside the research context
An application attachment form for request for waiver of documentation
of informed consent is in development.
Valdosta State University
Institutional Review Board
Waiver of Written Consent
 In lieu of written consent, the IRB may require
 Presentation of a written statement that includes the
elements of consent but does not have a signature line to
participants
 Oral explanation of consent elements using an approved script
Valdosta State University
Institutional Review Board
Other IRB Consent Options
 May approve consent procedure which alters or waives some or all of
the elements of informed consent if
 The study is government sponsored and examines a public service/benefit
program
 The research could not practicably be carried out without alteration or waiver of
informed consent
 The research involves no more than minimal risk
 The alteration or waiver will not adversely affect participants’ rights or welfare
 Pertinent information is provided to participants after their participation, if
appropriate
 The alteration or waiver does not conflict with other federal, state, or local laws
An application attachment form for request for alteration or waiver of
informed consent is in development.
Valdosta State University
Institutional Review Board
Consent Process Approval
 When written informed consent is required, the IRB will place a
dated approval stamp on the consent form. This form is returned
to the researcher to be used as a copy master.
 When a written explanation of consent elements or a script to be
delivered orally is approved by the IRB, the researcher may not
make changes to the approved procedure without IRB
authorization.
 When written consent is not required and the participant has
been fully informed with a witness present, his/her willingness to
participate implies consent.
Valdosta State University
Institutional Review Board
Additional Protections for Prisoners
45 CFR 46, Subpart C: Additional Protections
Pertaining to Biomedical and Behavioral
Research Involving Prisoners as Subjects
 Recognizes that prisoners may be under constraints
because of their incarceration which could affect
their ability to make a truly voluntary and uncoerced
decision whether or not to participate in research
 Provides additional safeguards for the protection of
prisoners
Valdosta State University
Institutional Review Board
Targeted Processing Time
(Assuming complete request or application)
 Exemption Request: 1-5 working days
 Expedited Review: 5-10 working days
 Convened Review:
• Must be submitted by posted deadline (10 days before meeting)
• Will be reviewed at next regular meeting
(IRB meets monthly except in December, June, and July)
• Notification of approval or request for revisions provided in 1-5
working days after IRB meeting
• Special meetings possible but discouraged
Valdosta State University
Institutional Review Board