IRB Basics
Presenter: Janelle Greening, M.B.A., C.I.P. Compliance Officer
Revised: April 2012
1
 Campus

www.research.missouri.edu/cirb
 Online




IRB Website:
Electronic System:
http://irb.missouri.edu/eirb
MU faculty, staff and students can login without creating
an account.
Location: 485 McReynolds Hall
2
www.citiprogram.org
 Create an Account
 Associate with UMC
 Campus SBR – User Group
 Basic Course: Select “Human Subject Research
Course”
 Refresher Course

*Do not complete the Responsible Conduct of
Research modules – it will not count towards IRB
training

Training is active for two years.
3
 Up-to-date
IRB information
 Changes to policies and procedures
 Training opportunities
 Send an e-mail to listserv@po.missouri.edu
and putting “SUBSCRIBE CIRB” in the body
of the email
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 Michele
Kennett, Director
 Janelle Greening, Compliance Officer
 Compliance Specialists:


Melissa Freeman
Denise Harrington
 Campus

IRB Phone Number: 882-9585
Heidi Mitchel
5
 IRB
Functions
 Ethical Principles
 Federal Definitions
 3 Levels of Review
 Special Categories
of Research
 Vulnerable
Subjects
 Recruitment
Process
 Informed Consent
 Investigator
Reporting
Requirements
 IRB Forms
 Criteria for Approval
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1.
2.
3.
4.
5.
Basic understanding of the federal
regulations governing human subject
research
Basic understanding the federal definition of
“human subject” and “research”
Understanding the importance of informed
consent and respect for persons
Knowing your reporting responsibilities
Maintaining appropriate oversight of your
research
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1. Safeguard human subject research participants
in accordance with the DHHS federal
regulations 45 CFR 46
2. Comply with the ethical principles outlined in
the Belmont Report, released in 1979
3. Comply with MU Institutional Policy
Chapter 410: Research Involving Humans
4. Comply with the Federalwide Assurance
Agreement
5. Comply with State or Local laws which provide
additional protections for human subjects
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 Protect
the rights and welfare of human
subjects
 Review, approve, require modifications, or
disapprove all research activities involving
human subjects
 Approve changes in previously approved
research (adding/removing components)
 Provide continuing review of all humans
subject research activities
 Any other steps necessary to protect the
human subject participants
9
1)
2)
3)
4)
5)
Belmont Report:
A statement of the basic ethical principles to
be used to resolve ethical problems that
surround the conduct of research with human
subjects
Identifies three basic principles for
conducting research with human subjects
Provides a foundation for the federal
regulations
MU must comply with the Belmont Report as
outlined in our Federalwide Assurance
Agreement
Focus on what is right or wrong
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 At
least 5 members
 Diverse membership



1 non-affiliated member
1 scientific member
1 non-scientific member
 Adequate
expertise
 Consultants, if necessary
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 Recognition
of personal dignity and autonomy
of individuals



Create a meaningful consent process
Provide subjects with all necessary information to
make a decision to participate
Allow subjects to withdraw without penalty or
adverse consequences
 Demands
that subjects enter into the research
voluntarily and with adequate information
 Persons with diminished autonomy are
entitled to protection
12
 Minimize
risks of harm and maximize the
potential benefits
 Ensure the benefits justify the risks of harm
 Risks may include:





Physical
Psychological
Legal
Social
Economic
13



Fair procedures and outcomes in the selection of research
subjects
Selection of research subjects needs to be scrutinized in
order to determine whether some classes are being
systematically selected simply because of their easy
availability, their compromised position, or their
manipulability, rather than for reasons directly related to
the problem being studied.
Participants should not be selected for research solely
because:
 they are available;
 vulnerable; or
 they cannot say no
14
 Institution
 Investigator
 IRB
 We
are all accountable for a successful local
human subject protection program
 Each is expected to play a role
15
A
contractual agreement between MU and
OHRP which guarantees this institution’s
commitment that all human subject research
complies with the regulations protecting
human subject participants.
16
 Assess
whether our institution is considered
to be engaged in the research.
http://www.hhs.gov/ohrp/policy/engage08.html
 Examples
of being engaged (requires IRB
review at MU):
Consenting participants
 Intervening or interacting with participants
 Obtaining identifiable private information or
identifiable biological specimens from any
source for the research
 MU is the lead on a contract or grant, even when
the research is conducted elsewhere

17
 Examples
of activities that would not require
review by MU’s IRB:







Inform subjects about the availability of the research;
Provide subjects with information about the research but do not
obtain subjects’ consent or act as representatives of the
investigators;
Provide subjects with information about contacting investigators
for information or enrollment; and/or
Seek or obtain the subjects’ permission for investigators to
contact them.
Permit use of our facilities.
Release to investigators at another institution identifiable
private information or identifiable biological specimens
pertaining to the subjects of the research.
Obtain coded private information or human biological
specimens from another institution , but cannot readily
ascertain the identity of the subjects.
18
Research
2) Human Subject
3) Minimal Risk
1)
19

A systematic investigation, including research development,
testing and evaluation, designed to develop or contribute to
generalizable knowledge
Internal MU Definitions:
 Systematic Investigation: A "systematic investigation" is an
activity that involves a prospective plan that incorporates
data collection, either quantitative or qualitative, and data
analysis to answer a question.
 Generalizable Knowledge: Investigations designed to
develop or contribute to generalizable knowledge are those
designed to draw general conclusions, inform policy, or
generalize findings beyond a single individual or an internal
program (e.g., publications or presentations.) However,
research results do not have to be published or presented to
qualify the experiment or data gathering as research. The
intent to contribute to "generalizable (scholarly) knowledge"
makes an experiment or data collection research, regardless
of publication.
20
A
living individual about whom an
investigator obtains:


Data through intervention or interactions with the
individual; OR
Identifiable private information
21
 Intervention:
Includes both physical
procedures by which data are gathered and
manipulations of the subject or the
subject’s environment that are performed
for research purposes
 Interaction:
Includes communication or
interpersonal contact between investigator
and subject
22

Includes information about behavior that occurs
in a context in which:

An individual can reasonably expect:


That no observation or recording is taking place, AND
The information will not be made public.
 Private
information must be individually
identifiable (i.e. the identity of the subject is
or may readily be ascertained by the
investigator or associated with the
information) in order for obtaining the
information to constitute research involving
human subjects.
23
 The
probability and magnitude of harm or
discomfort anticipated in the research are not
greater in and of themselves than those
encountered in daily life or during the
performance of routine physical or
psychological examinations or tests.
24
1.
2.
3.
Exempt
Expedited
Full Board
25
 Determination
must come from the IRB
 Projects involving minimal risk
 Must fall under 1 of the 6 categories in the
federal regulations 45 CFR 46
 Cannot involve prisoners or children
 Investigators
must complete the Exempt
Application for initial review



Modifications: Exempt Amendment Form
Continuing Review: Annual Exempt Certification
Form
Complete Applications: ~1 business day turnaround time
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1.
2.
Research conducted in established or commonly
accepted educational settings, involving normal
educational practices, such as (i) research on regular
and special education instructional strategies, or (ii)
research on the effectiveness of or the comparison
among instructional techniques, curricula, or classroom
management methods.
Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures or
observation of public behavior, unless: (i)
information obtained is recorded in such a manner that
human subjects can be identified, directly or through
identifiers linked to the subjects; and (ii) any disclosure
of the human subjects' responses outside the research
could reasonably place the subjects at risk of criminal or
civil liability or be damaging to the subjects' financial
standing, employability, or reputation.
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3.
4.
Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement), survey
procedures, interview procedures, or observation of
public behavior that is not exempt under paragraph
(b)(2) of this section, if: (i) the human subjects are
elected or appointed public officials or
candidates for public office; or (ii) federal
statute(s) require(s) without exception that the
confidentiality of the personally identifiable
information will be maintained throughout the
research and thereafter.
Research involving the collection or study of
existing data, documents, records, pathological
specimens, or diagnostic specimens, if these
sources are publicly available or if the information is
recorded by the investigator in such a manner that
subjects cannot be identified, directly or through
identifiers linked to the subjects.
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5.
6.
Research and demonstration projects which are
conducted by or subject to the approval of
department or agency heads, and which are designed
to study, evaluate, or otherwise examine: (i) Public
benefit or service programs; (ii) procedures for
obtaining benefits or services under those programs; (iii)
possible changes in or alternatives to those programs or
procedures; or (iv) possible changes in methods or levels
of payment for benefits or services under those programs.
Taste and food quality evaluation and consumer
acceptance studies, (i) if wholesome foods without
additives are consumed or (ii) if a food is consumed that
contains a food ingredient at or below the level and for a
use found to be safe, or agricultural chemical or
environmental contaminant at or below the level found to
be safe, by the Food and Drug Administration or approved
by the Environmental Protection Agency or the Food
Safety and Inspection Service of the U.S. Department of
Agriculture.
29
 Projects
involving minimal risk
 Minor changes to approved research
 Must fall under 1 of the 7 categories of initial
review or 1 of the 2 categories of continuing
review
 Investigators must complete the
Expedited/Full Board Application for initial
review



Modifications: Amendment Form
Continuing Review: Continuing Review Status
Report
Complete Applications: ~5-10 business day turnaround time
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 Projects
not meeting the criteria for Exempt
or Expedited review
 Projects involving greater than minimal risk
 Investigators
must complete the
Expedited/Full Board Application for initial
review



Modifications: Amendment Form
Continuing Review: Continuing Review Status
Report
Deadline: 1st of every month or the following business day
31
An IRB shall conduct continuing review of
research covered by this policy at intervals
appropriate to the degree of risk, but not less than
once per year.
 PURPOSE: Ensure the research remains justified
and the rights and welfare of the participants
continue to be fully protected.
 Failure to provide the annual report could lead to
study suspension, a loss of funding and/or
publication possibilities, or reporting of
noncompliance to sponsors or funding agencies.

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 Internet
Research
 International Research
 Ethnographic Research
 Survey Research
 Qualitative Research
 Collaborative Research
 Deception Studies
 Any
others you would like to discuss?
33
 Research
using de-identified secondary datasets
 Quality improvement/program evaluation only
studies
 Classroom research only submitted for a grade
– not disseminated outside the classroom
34
 Vulnerable




Pregnant Women: 45 CFR 46.201
Prisoners: 45 CFR 46.301
Children: 45 CFR 46.401
Wards: 45 CFR 46.409
 Possible




as defined by the federal regulations
other vulnerable subjects
Students
Low-Income
Employees
Elderly
35
 Constraints
could affect their ability to make a
truly voluntary and uncoerced decision
whether or not to participate
 Prisoner representative will review the study
 Must fall under one of the categories for
research involving prisoners
 Parole boards will not take into account a
prisoner’s participation in research
 Additional duties of IRBs where prisoners are
involved
36
 Research
must fall under
one of the four categories
for research involving
children
 Cannot be Exempt
 Child assent and parental
permission must be
obtained unless waived
 Describe for the IRB how
child assent will be
documented if not written
37
 Greater
than minimal risk studies where there
is no direct benefit:


Research is related to their status as wards; or
Conducted in schools, camps, hospitals,
institutions, or similar settings in which the
majority of children involved as subjects are not
wards.
38
 Students:
Extra/Course Credit, Instructor
initiated studies (Undue Influence)
 Non-English Speaking: Comprehension
 Low-Income: Monetary incentives
 Elderly: Comprehension, Capability to
consent
 Employees: Employability risks
39
The four Cs of Recruitment from an IRB perspective
1.
2.
3.
4.
Consent (ongoing)
Coercion
Confidentiality and Privacy
Completeness (accuracy as well as truthfulness
versus deception)
40

The advertisement is limited to the information
the prospective subjects need to determine their
eligibility and interest, such as:






The name and address of the investigator or research
facility
The condition under study or the purpose of the research
In summary form, the criteria that will be used to
determine eligibility for the study
A brief list of participation benefits, if any
The time or other commitment required of the subjects
The location of the research and the person or office to
contact for further information
41
Describe the amount, method, and timing of
disbursement
 Compensation is not contingent upon completing
the entire study
 Any amount of compensation as a bonus for
completion is reasonable and not so large as to
unduly induce subjects to stay in the study when
they would otherwise have withdrawn
 Course/Extra Credit: The alternative assignment
is comparable in time and effort
 Accounting Services Approval is required when
the investigator proposes to use internal or
external funding, and offering cash or non-cash
items to their subjects

42
Informed consent is a process that enables
persons to voluntarily decide whether or not to
participate as a research subject
43
 Consent
is a fundamental mechanism to ensure
the basic ethical principle of respect for persons is
met through a provisional process of thoughtful
consent for a voluntary act.

Consent is a procedure designed to educate the
subject population in terms that they can
understand.
44
Who is obtaining consent and do they have proper
training and oversight?
 Is it coercive?
 Is it voluntary?
 Does the subject have time to consider participation?
 Does the subject understand the alternatives?
 Do they have the legal and mental capacity to consent
or is a Legally Authorized Representative required to
consent on their behalf?

45

(1) A statement that the study involves research, an explanation of the
purposes of the research and the expected duration of the subject's
participation, a description of the procedures to be followed, and
identification of any procedures which are experimental;

(2) A description of any reasonably foreseeable risks or discomforts to the
subject;

(3) A description of any benefits to the subject or to others which may
reasonably be expected from the research;

(4) A disclosure of appropriate alternative procedures or courses of
treatment, if any, that might be advantageous to the subject;

(5) A statement describing the extent, if any, to which confidentiality of
records identifying the subject will be maintained;

(6) For research involving more than minimal risk, an explanation as to
whether any compensation and an explanation as to whether any medical
treatments are available if injury occurs and, if so, what they consist of, or
where further information may be obtained;

(7) An explanation of whom to contact for answers to pertinent questions
about the research and research subjects' rights, and whom to contact in the
event of a research-related injury to the subject; and

(8) A statement that participation is voluntary, refusal to participate will
involve no penalty or loss of benefits to which the subject is otherwise
entitled, and the subject may discontinue participation at any time without
penalty or loss of benefits to which the subject is otherwise entitled.
46






(1) A statement that the particular treatment or
procedure may involve risks to the subject (or to the
embryo or fetus, if the subject is or may become
pregnant) which are currently unforeseeable;
(2) Anticipated circumstances under which the
subject's participation may be terminated by the
investigator without regard to the subject's consent;
(3) Any additional costs to the subject that may result
from participation in the research;
(4) The consequences of a subject's decision to
withdraw from the research and procedures for orderly
termination of participation by the subject;
(5) A statement that significant new findings
developed during the course of the research which may
relate to the subject's willingness to continue
participation will be provided to the subject; and
(6) The approximate number of subjects involved in
the study.
47
 Written
Consent
 Short Form
 Waiver of Documentation (no signature)
 Waiver of Consent
A
copy of the consent document must be
provided to the subject unless waived by the
IRB
48






For the occasional and unanticipated non-English-speaking
subject, an alternative "short form" method is allowed
Used because no consent form in the subject's language was
prepared
Routine use of the "short form" for obtaining informed
consent is strongly discouraged
The short form consent process cannot be used for
vulnerable subject populations
There will be a witness to the oral presentation
Contact the IRB for additional requirements
49
Waiver or Alteration of
Consent
No more than minimal risk to
subjects
 Would not adversely affect the
rights and welfare of subjects
 Could not practicably be
carried out without the waiver
or alteration; and
 When appropriate, debriefing
session is available
Waiver of Documentation



That the only record linking the
subject and the research would be
the consent document and the
principal risk would be potential
harm resulting from a breach of
confidentiality. Each subject will
be asked whether the subject
wants documentation linking the
subject with the research, and the
subject's wishes will govern; or
That the research presents no
more than minimal risk of harm
to subjects and involves no
procedures for which written
consent is normally required
outside of the research context.
50
 Does
the subject understand the information
provided?
 It is your responsibility to enhance each
subject’s comprehension of the information
 Avoid complex terms and sentences
 No exculpatory language (waiving legal rights)

The investigator must consider:




The nature of the subject population
The type of information conveyed
The circumstances under which the consent process will
take place
The primary language of the participant
51
 Contact






our office for template language:
Certificates of confidentiality
Use of electrodes
Studies involving alcohol consumption
IRB contact information
Injury statement (greater than minimal risk
studies)
Etc.
52
Translated documents shall be prepared after IRB
review and approval of the English version
 Minimal Risk Studies: The qualifications of
the individual performing the translation will be
assessed by the IRB. A letter from the translator
describing their qualifications must be provided
with the translation documents.
 Greater than Minimal Risk Studies: A
certified translation is one that has been formally
verified by a licensed translator or translation
company for use in official purposes.

53
 The
parental consent process must contain all
elements of consent unless a waiver is
approved by the IRB
 Consent may need to be obtained from one or
two parents (greater than minimal risk studies
with no direct benefit)
 The IRB shall determine that adequate
provisions are made for soliciting the assent of
children.



Are the children capable of providing assent?
Is a waiver appropriate?
Take into consideration age, maturity, and
psychological state
54
 The
Campus IRB will save a revised copy of
your consent document(s) to the document
storage of eIRB. We will place a footer in the
document with the approval date and IRB
number.
 You must use this copy when obtaining
consent.
55
56
Changes
 Deviations
 Unanticipated Problems
 Conflicts of Interest
 Subject Complaints
 Known or suspected noncompliance
 Funding Source / Personnel changes
 Suspension or closure of approved projects


Any issue that arises that could impact the
adequate protection of human subjects involved in
research
57
Located at: http://irb.missouri.edu/eirb
58
 Exempt
Application
 Expedited/Full Board Application
 Exempt Amendment
 Amendment Form (Expedited/Full Board)
 Annual Exempt Certification Form
 Continuing Review Status Report
 Event Report
 Site Additions Form
 Project Personnel Change Form
 Completion/Withdrawal Report
59
 Exempt





Permission Letters
Accounting Services
Cover Letter
Funding Proposal
Instruments




Research:
Interview Questions
Survey Questions
Focus Group
Questions
Information
provided to subjects
about the research
 Expedited
& Full
Board Research:
Permission Letters
 Recruitment
Materials
 Consent Documents
 Accounting Services
 Instruments
 Funding Proposals
 Any other
documents to
support the research
application

60
 The
IRB now marks approved documents.
 You must use the documents we mark
approved in document storage.
 Go to the upper right hand corner and select
approved documents from the drop-down list.
 Use the IRB approved consent documents
stamped with our approval footer
61
 The
research plan makes adequate provision
for monitoring the data collected to ensure the
safety of the subjects
 There also must be adequate provisions to
protect the privacy of subjects and to maintain
the confidentiality of the data.
 All research records must be retained for at
least seven years after completion of the
research – including audio, video, and
photographs


Inspection
Copying
 Records
must be retained at MU
62
1.
2.
3.
4.
5.
6.
7.
Risks to subjects are minimized
Risks to subjects are reasonable in relation to
anticipated benefits
Selection of subjects is equitable
Informed consent will be sought from each
prospective subjects
Informed consent will be appropriately
documented
When appropriate, the research plan makes
adequate provisions for monitoring the data
collected to ensure the safety of the subject
When appropriate, the research plan makes
adequate provisions to protect the privacy of
subjects and to maintain confidentiality
63
Every effort must be made to protect
human subjects from harm.
64