Human Research Protection and the
Institutional Review Board (IRB)
2015-2016
January 12, 2016
IRB Role
• The sole mission of the IRB is the protection of
humans who participate in research.
• As part of that mission, the IRB:
– Establishes policies and procedures
– Monitors regulatory and institutional compliance
– Manages the LMU Federal Wide Assurance (FWA)
January 12, 2016
Institutional Assurance
LMU has negotiated with the Office for Human
Research Protections (OHRP) that all of the
institution’s human subject research activities,
regardless of funding, will be guided by the Belmont
Report, will comply with the Common Rule, and
other regulations as applicable.
This is referred to as a
Federal wide Assurance (FWA).
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The Belmont Report (1978)
The principles of the Belmont Report govern all
research supported by the U.S. Government and
Lincoln Memorial University. The ethical
principles outlined in the report (respect for
persons, beneficence, and justice)are the basis
for subsequent regulations designed to ensure
protection of human subjects in research.
January 12, 2016
Federal Regulations and Policy
Stemming from Belmont Principles
45 CFR 46 – DHHS Policy for Protection of Human
Research Subjects- Subpart A
Originally adopted January 13, 1981
Revised June 18, 1991
“The Common Rule” – adopted by 17 federal agencies,
including FDA-regulated research in 1991
January 12, 2016
The Common Rule (1991)
The “Common Rule” is the set of regulations
which were developed to ensure compliance
with the principles of the Belmont Report.
The regulations fall under the Department of
Health and Human Services. These
regulations have been adopted by many other
federal departments which regulate human
research.
January 12, 2016
Protective Mechanisms Established
by the Common Rule
• Institutional Assurances of compliance
• Review of research by an Institutional
Review Board (IRB) or Ethics Committee
• Informed consent of subjects
January 12, 2016
What is the IRB?
• An Institutional Review Board (IRB) is charged with
protecting the rights and welfare of people
participating in research.
• The Institutional Review Board (IRB) is comprised of
faculty and staff at Lincoln Memorial University who
have knowledge and experience in social/behavioral
and biomedical research. In addition, one local
community person serves on the board.
• The IRB reviews proposals for research involving human
subjects.
January 12, 2016
Goals of the IRB
Protect the rights and welfare of people
participating in research.
Assist investigators in conducting ethical
research that complies with the U.S. Code of
Federal Regulations, DHHS (CFR), Title 45 Part
46 (45 CFR 46).
Support the responsible conduct of research.
January 12, 2016
Activities Needing IRB Approval
• All federally-funded research projects
involving the use of Human Subjects. (Source:
45 CFR 46).
• LMU requires review for ALL research projects
involving the use of Human Subjects, federal
or not.
• Rule of Thumb: Will the research be
published or presented in a professional
setting?
January 12, 2016
Do I Really Need IRB Review?
• RESEARCH –
• A systematic investigation designed to develop or
contribute to generalizable knowledge.
• 45 CFR 46.102(d)
• HUMAN SUBJECT • A living individual about whom an
investigator…conducting research obtains
 1) data through intervention or interaction with the individual, or
 2) identifiable private information
• 45 CFR 46.102(f)
January 12, 2016
Start with “Research”
• “Systematic”: use of statistical analyses, scientific
methods – can include “nonresearch”
AND
• What about “generalizable”?
• Is the intent of this project to contribute to knowledge
in the field or discipline?
• Are there hypotheses or research questions?
• Will analysis of data lead to generalizable claims?
• Is there an intent to publish or present the project as
research?
If “yes” >>>>> the project is research
January 12, 2016
NOT “generalizable”
i.e. Not research
• Quality improvement/ assessment/ assurance
projects – designed with goal of improving
institutional/organizational practice
• Case reports, case series, anecdotal narratives –
if no systematic investigation, i.e. no statistical or
data analysis; no outcome measures; no
predictive claims
January 12, 2016
When Does an Observational Study Need
IRB Review?
• IRB approval is NOT needed if people are in public
places and the behavior they are engaging in is
public.
• However, IRB approval is needed when there is any
interaction or intervention or when children (minors)
or any other sensitive groups (e.g., institutionalized)
are involved.
January 12, 2016
Human Subjects in Research
Living individuals about whom an investigator-whether a professional or a student--conducting
research obtains data through:
• intervention ,or
• interaction with the individual, or
• identifiable private information.
Source: OHRP, 45 CFR 46
January 12, 2016
When Planning A Research Project, An
Investigator Should Consider the
Following Questions:
• Does the activity or project involve minimal
risk? —”probability and magnitude of harm or
discomfort are not greater in and of
themselves than those ordinarily encountered
in daily life or doing the performance of
routine physical or psychological examination
or tests?”
January 12, 2016
How Much Intervention is Involved?
• Intervention means manipulations of subjects
or subjects’ environment that are performed
for research purposes.
• Interaction includes communication or
interpersonal contact between investigator or
subjects.
• Private information includes information
about behavior that occurs in a context in
which an individual can reasonably expect
that no observation or recording is taking
place, and …..privacy
January 12, 2016
Privacy
• Private information is information which has
been provided for specific purposes by an
individual and which the individual can
reasonably expect will not be made public
(e.g., academic record). Private information
must be individually identifiable in order for it
to constitute “research” involving human
subjects.
January 12, 2016
Does the Research Involve a Vulnerable
Population?
• Vulnerable populations include:
• Children (all minors younger than 18 years of age
must also have parental consent)
• Pregnant women
• Institutionalized individuals (e.g., prisoners,
individuals in group homes, nursing homes,
mental institutions)
• Cognitively impaired individuals
January 12, 2016
Populations Specifically Protected in
Federal Regulations
45CFR46
–Pregnant women - Subpart B
–Prisoners – Subpart C
–Children – Subpart D
January 12, 2016
Other Considerations May
Also Count as “Vulnerable”
• Language
• Culture
• Current Events or
Incidents
• Age (elderly)
• Age (adolescents)
• Educationally,
economically
disadvantaged
• Transient Cognitive
Impairment
• Substance Use
• Health Status
• Students
• Employees
January 12, 2016
IRB Training Requirement
Principal Investigator and Co-PI (including
students) named on the application must
complete online IRB training and submit proof
of completion along with their IRB application.
January 12, 2016
LMU IRB Application
Submission and Review
Process
January 12, 2016
Path to LMU IRB Application
Submission
• lmunet.edu
(Main LMU website)
– Administration
– Office of Research, Grants, and Sponsored
Programs (ORGSP)
– Institutional Review Board
All the information and forms needed to submit an IRB
application are on the ORGSP webpage.
January 12, 2016
January 12, 2016
Things to consider when completing
your application
• Is the proposal
• Have I addressed
– Clear
– Concise
– Consistent
– Why
– Who
– What
– Where
– When
– How
January 12, 2016
Basic Steps to IRB Application Process
• Get the current application from the webpage.
http://www.lmunet.edu/administration/office-ofresearch-grants-and-sponsored-programsorgsp/institutional-review-board-irb/forms
• Make sure you have the required signatures.
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Principal Investigator
Chair
Dean
Any Co-Investigator
January 12, 2016
Basic Steps to IRB Application Process
Continued
• Include the following items with your protocol when submitted if
applicable:
– Consent form(s)
– Data collections instruments (with permission to use or proof of purchase if
not developed by the investigator) to be used (e.g. surveys, questionnaires,
tests, etc.)
– Recruitment flyers
– Letters of permission
– CITI Training certificate
– Debriefing statements
– Media clips
•
All the above documents should be emailed to (teresa.creech@lmunet.edu),
then a copy should be hand delivered or sent through the mail to the ORGSP
attention, Teresa Creech, Duke room 304.
January 12, 2016
Application Form
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Project Title
Type of review—IRB makes final decision
Project dates—approval date by IRB vs. researcher’s planned dates
Principal Investigator, co-investigators, faculty sponsor, with signatures
IRB Training and Certification date
Student/Outside researcher information - Signature of a university sponsor
Funding
Research statement: purpose of study and/or research question(s)
Participants—subjects, number of subjects, method of solicitation
Informed consent (consent and assent forms), method to obtain
Data & Consent collection methods—data with identifiers, how confidentiality/anonymity will be
protected, how will/where the data is to be stored
Methodology details—specifics regarding contact, selection and exclusion, consent and assent process,
data instruments (permission or purchase issues), distribution and collection of instruments, location with
permission to distribute at school, agency, company
Risk factors
Submission of all materials—recruitment flyers, informed consent, data collection instrument(s), letters of
permission, debriefing, media to show to participants
Certification statement – signatures have been completed from PI, chair, dean (if applicable) and co-PI’s
NOTE: IRB Processing may be delayed due to missing information, incomplete information,
inconsistencies, or the need for clarification of statements describing processes
January 12, 2016
The Review Process
Once the chair receives the application, all research
projects are categorized into one of three categories
for the IRB review process.
• Exempt
• Expedited
• Full
Each category is different in the level of review it
receives from the IRB. The IRB is responsible for
making the final decision of which category a
research project falls under.
January 12, 2016
• The basic differences in the review categories are:
– Exempt (Minimal risk for the study participants –
reviewed by the chair, quick turnaround time--allow 12 weeks.) Exempt does not mean exempt from review.
– Expedited (No more than minimal risk, reviewed
by the chair and at least 1 IRB member, turnaround
time--allow 2-3 weeks.)
– Full (More than Minimal Risk or vulnerable
populations (children, pregnant women, prisoners);
longer turnaround time, must be reviewed by full
committee and discussed at monthly meeting--allow
6-8 weeks, may take longer if application is not
complete.)
January 12, 2016
Examples of social science projects that will
likely require IRB submission
• Interviews – quantitative or qualitative
approaches
• Focus groups
• Pretest – intervention – posttest (eg., analysis of
writing samples)
• Surveys, including Internet-based surveys
• Randomized intervention and control group
• Data analysis of primary or secondary data that
contain identifiers or codes
• School-based research
January 12, 2016
Most research projects conducted
by students and faculty are:
• Exempt (poses minimal risk to human subjects) and
is reviewed the chair of the IRB,
OR
• Expedited (poses potential risk) and is reviewed by
at least 2 members of the IRB (including the chair).
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January 12, 2016
IRB Review
Continuum
Level of potential risk determines
route of review for biomedical and social-behavioral research
Exempt
Low
Expedited
Risk
January 12, 2016
Full
High
Risk/Benefit Assessment
IRB considers the risk
of criminal/civil liability,
financial risk,
employment risk,
stigmatization,
insurability, and
embarrassment
in deciding if risk
is truly minimal.
January 12, 2016
Privacy and Confidentiality
• “When appropriate, there are adequate
provisions to protect the privacy of subjects
and to maintain the
confidentiality of data” 45 CFR 46.111(a)
• Breaches of privacy and/or confidentiality are
the main risk in socialbehavioral research or
research that is no greater
than minimal risk
January 12, 2016
Exempt Review
• Exempt Certification: Research may be eligible if it
meets the criteria specified in one or more of 6 allowable
categories. In general, projects involving public
observation, taste tests, and some surveys or interviews
with adults may be eligible.
– The six categories of research eligible for exemption
are available on the IRB website.
– The IRB Chair reviews all claims of exemption.
– An Exempt Checklist is available for your use in
determining if your proposal is exempt on the IRB
website.
January 12, 2016
Expedited Review
• Expedited Review: Research may be eligible if it
involves no more than minimal risks, and meets the
criteria specified in one or more of 9 allowable
categories. In general, projects involving interventions,
surveys of a sensitive nature, and/or child participants
may be eligible.
– Expedited review is performed by the chair and 1
board members.
– The categories of expedited review are available on
the IRB website.
– The categories of research eligible for expedited
review or exemption are specified by federal
regulations.
January 12, 2016
Full Review
Full Board: According to 45 CFR 46.110(b), full board
review is required of all research studies that are
neither exempt, nor subject to expedited review.
– IRB Committee must review and vote at a fully
convened meeting.
– Meeting held once a month.
– Submissions must be processed at least one week prior.
–Needs to be reviewed annually under 45 CFR 46.109 (e).
–Deception/ Non disclosure of information to subjects.
–Studies with greater than minimal risk.
–Special/ Vulnerable Populations.
January 12, 2016
Upon Review
• IRB certifies that protocol conforms to Federal
Regulations.
• If necessary, conditions are given to investigator for
REVISIONS before approval.
• The ORGSP administrative assistant will notify an
investigator of the decision first with an email,
followed with an official letter of approval to be kept
by the investigator for their records.
January 12, 2016
Required elements of informed consent –
BASIC ELEMENTS 45 CFR 46.116(a)
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Statement that the study involves research
Reasonably foreseeable risks/discomforts
Reasonably expected benefits
Disclosure of appropriate alternative procedures
Confidentiality of identifiable records
For high risk, what happens if injured in research
Whom to contact about research, problems, or
concerns
• Participation is voluntary, refuse to participate
without penalty, and discontinue participation at any
time
January 12, 2016
Revising your study based on the
conditions set forth by the IRB
The study may receive:
• Approval with Recommendations
• Approved Pending Revisions.
• The ORGSP administrative assistant will
email the Investigator.
• The investigator must submit any revisions
and the revised application back to the IRB
office.
• The study does not have approval.
• Study cannot begin.
January 12, 2016
Protocol Revisions and Continuations
• Any changes to the protocol including, but not
limited to instrument revision and data collection
methods (group administration of surveys to
email distribution, focus groups to individual
interviews, etc.) require submittal of the revisions
to the IRB; these revisions will be reviewed at the
same level as the proposal
• Expiration of the IRB approval occurs on the 365th
day from the date on the approval letter—all
activities stop including recruitment, consent,
data collection, or data analysis
January 12, 2016
• Also see the US Office for Human Research
Protections for more information about these
levels of risk and the federal regulations in
place to protect human research participants
from risk.
http://www.hhs.gov/ohrp/
January 12, 2016