Transcript What Is the Institutional Review Board and What Are My

Protecting Human
Participants
in Research
http://orip.syr.edu/humanresearch.html
Office of Research Integrity and
Protections
Tracy Cromp
Director
Jeanne Diederich
IRB Administrator
What Is the Institutional
Review Board and what
is it’s role?
The Institutional Review Board is designated to protect
the rights and welfare of human subjects participating
in research conducted at or sponsored by an
institution.
The SU IRB is comprised of 9 members from relevant
and diverse academic backgrounds and 2 non-affiliated
community members, with one IRB Chair and three CoChairs.
How do we do this?
Federal Wide Assurance
Because SU receives federal funds, we are
obligated to have a FWA with the government.
As part of the FWA SU pledges to follow the
ethical principles outlined in the Belmont
Report AND federal regulations 45 CFR 46-Part
A-also known as the Common Rule when
reviewing Human Subjects protocols.
The Belmont Report
Basic Ethical Principles
1.
2.
3.
Respect for Persons
Beneficence-(1) do not harm and (2)
maximize possible benefits and
minimize possible harms
Justice- fair procedures and outcomes
in the selection of research subjects
Federal Policy for the Protection of
Human Subjects
Common Rule 45 CFR 46 (Part A)
Regulations for:
The roles and responsibilities of the IRB
The definition of research
IRB review of research
Criteria for IRB review/approval of research
General requirements for informed consent
The IRB at SU reviews all research
studies involving Human Subjects
conducted at the university for
compliance with federal, state, and
local laws as well as institutional policy
whether or not they are funded .
Where do I begin?
Is it Research?
Definition of Human Subjects
Research as defined in 45 CFR 46
Research means a systematic
investigation, including research
development, testing and evaluation,
designed to develop or contribute to
generalizable knowledge.
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Systematic investigation-attempts to answer a
research question; is methodically driven-collects
data in an organized and consistent way; attempts to
analyze data or information in some manner; and
intends to draw conclusions from the result.
Generalizable knowledge-contributes to a theoretical
framework of an established body of knowledge;
publication; presentation; workshop; conference;
results are intended to inform the field of study; web
based publications, etc.
Is it Human Subjects
Research?
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Is the data being obtained about living
individuals?
Is the data collected through
interaction/intervention with
individuals?
Is identifiable private information being
obtained?
Categories of IRB Review
Exempt
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Expedited
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Full Board
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What determines which category
for my research?
The category of research is determined
by the level of risk to the participant.
Exempt Review
Exempt research studies present risks so
benign, that the federal regulations
determine these types of studies to be
exempt from review.
At SU the IRB must make this
determination.
Exempt Review
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The research must qualify for exemption under one or
more of the 6 categories as defined by the federal
regulations.
Examples-anonymous surveys, existing data that is
already in existence and publicly available, research
conducted in established or commonly accepted
educational settings involving normal educational
practices.
Exempt Review Process
Exempt applications are reviewed by the
ORIP Director, Tracy Cromp.
Turn around time for review is approximately
5-7 business days. There are no deadlines for
exempt applications. Allow a minimum of 4
weeks for the review process.
Exempt studies are authorized for a period of
5 years.
Your research is not exempt when:
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Any part of the research requires that subjects be deceived.
Involvement in the research exposes Human Subjects to
discomfort or harassment beyond levels encountered in daily
life.
Disclosure of the subject’s responses outside of the research
could place them at risk of criminal/civil liability, be damaging to
their social and/or financial standing, employability or
reputation.
Data analysis on data that will come into existence after the
research begins.
The research involves prisoners/legally restricted persons as
participants.
Expedited Review
Expedited research activities present
no more than minimal risks to
participants– no greater than those
encountered in daily life
Expedited Review
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The research procedures must be listed in one or
more the 9 categories defined by the federal
regulations.
Examples-research on individual or group
characteristics or behaviors; research employing the
use of surveys, interviews, focus groups, program
evaluation and/or the collection of data through nonevasive procedures (moderate exercise, BP
screening, muscular strength, flexibility testing, body
composition assessment).
Expedited Review Process
Expedited applications are reviewed by the IRB Chair or one
of the three IRB Co-Chairs. If deemed necessary expert
consultant may also be asked to review-e.g.-disabilities
expert.
Turn around time for review is approximately 7-10 business
days. There are no deadlines for expedited applications.
Allow a minimum of 4-6 weeks for the review process.
Expedited studies are approved for a period of one year,
(unless the IRB determines more frequent review is
necessary) and are renewable for up to 7 years.
Your research is not Expedited when:
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Involvement in the research exposes Human
Subjects to discomfort or harassment beyond
levels encountered in daily life.
Disclosure of the subject’s responses outside of
the research could place them at risk of
criminal/civil liability, be damaging to their social
and/or financial standing, employability or
reputation.
The research involves prisoners/legally restricted
persons as participants.
Full Board Review
Full board research activities
involve greater than minimal
risks to participants.
Full Board Review
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Involvement in the research exposes Human Subjects to
discomfort or harassment beyond levels encountered in daily
life.
Disclosure of the subject’s responses outside of the research
could place them at risk of criminal/civil liability, be damaging to
their social and/or financial standing, employability or
reputation.
The research involves legally restricted/prisoners as
participants.
Examples-illegal behaviors-underage drinking, illegal drug use;
situations of abuse-child/spousal abuse; disclosure of medical
status, etc.
Full Board Review Process
Full board applications must be reviewed at a
convened meeting of the IRB with a majority of IRB
members in attendance.
There is a hard deadline for full board applications.
Full board applications must be received two weeks
prior to the scheduled IRB meeting.
The IRB meets monthly except during the month of
July. The meeting schedule is posted on our website.
Full Board Review Process
Allow a minimum of 8 weeks for the full
board review approval process.
Full board applications can be approved
for up to 365 days from the date of
review (unless the IRB determines more
frequent review is necessary) and are
renewable for up to 7 years.
Application Content
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What is the purpose of the research-what is your research
question/rationale for the research?
What is your approach/what methods will you employ -what you
will do to answer your research question-what will participants be
asked to do?
What are the characteristics of the participants-special populations?
Additional form may be required.
What are the risks-physical, psychological, financial, etc. How will
risks be mitigated?
What are the benefits of the knowledge gained-to the participant,
society at large?
How will you ensure the privacy of the participant and
confidentiality of the data?
What type of informed consent will you obtain?
Application Information
Student researchers cannot be Principal Investigators on
Human Subjects research projects that require IRB review
and oversight at SU. It is Institutional Policy that the
Principal Investigator be a member of the SU faculty at
one of the following positions/levels: Assistant, Associate,
Full Professor; Academic, Research, or Professor-of
Practice, Department Dean/Chair; or Administrative Staff
with the position of Director of higher.
All applications should be completed under the guidance
of the faculty mentor/person listed as PI on the protocol.
Informed Consent
Avoid the use of technical terminology. Should be written using
explanations or definitions at the reading level appropriate for the
targeted population (Suggested reading level-8th grade).
The Informed Consent must include:
 A statement that the study involves research
 A description of the purpose for the study
 A description of the procedures
 A description of the time commitment
 A statement that participation is voluntary
 A description of how Confidentiality/Privacy will be protected
 A description of the Risks/Benefits
 The contact information-PI/Researcher and SU IRB
 When appropriate-incentive-permission to
record/photograph/videotape
Completed Application Packet
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The fully completed and signed application.
All research instruments-questionnaires/surveys/interview
questions, focus group topics, etc.
All recruitment tools, oral scripts for direct-in-person
recruitment, ads-placed in newspapers-on the internetsocial media sites, flyers, emails, letters, etc.
All informed consent documents and/or assent documents
for children when appropriate
Any additional forms that may be necessary as indicated
in the application-special populations, international
research, research conducted in schools, genetic research,
etc.
Outcomes of Review
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Once your application has been submitted,
the IRB can:
 Approve
 Request modification(s) or additional
information
 Disapprove
 Re-Categorize the research as Exempt,
Expedited or Full
Student Projects
Student projects (including Capstone projects)
involving human participants that are conducted
solely to fulfill course requirements do not
require IRB review.
Master’s or doctoral theses involving human
participants must be submitted for IRB review.
Student Projects
IRB review is not required for research projects conducted
solely to fulfill course requirements and the results of the
classroom assignment are only used and shared as follows:
 In the classroom; and/or,
 If the project involves gathering data from or about a
company, agency, or organization, the data/results are
shared only with the company, agency, or organization;
and/or
 Project results are presented at departmental or
interdepartmental seminars designed to exhibit
coursework, or to continue the learning process related to
presentations.
Student Projects
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HOWEVER: If data will be shared beyond the
circumstances described above (e.g. for publication,
presentation at academic conferences/workshops, in
thesis/dissertation, etc.) then the project must receive
IRB approval prior to initiation.
Even if the project stays within the class and IRB review is not
required, the instructor of the class should be aware of the
types of questions being asked and all ethical principles
regarding teaching should be followed in addition to the ethical
standards regarding privacy and confidentiality.
Training Requirements
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CITI Training is required for all Expedited and
Full Board Applications.
All persons listed in the protocol application that
will have direct contact with participants and or
identifiable human participant data are required
to complete the CITI training appropriate to their
role in the research.
No Expedited or Full Board studies will be
approved until CITI training requirements are
satisfied.
Amendments
Needed whenever anything changes in materials
originally submitted (the “protocol”)
 Changes to the protocol cannot be implemented
prior to IRB review/approval
- Exception: if the change is essential to protect
human participants from harm
Reminders….
 No human subjects research can be
conducted without IRB approval or
exemption.
 Allow enough time for your application to be
approved, it can take up to two months if
revisions are needed.
Where do I go for help?
The Office of Research Integrity and
Protections
121 Bowne Hall
Phone Number: 443-3013
Email: [email protected]