Information for Investigators - Office of Research Integrity and

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Protecting Human Participants
in Research
http://orip.syr.edu/humanresearch.html
Office of Research Integrity and
Protections
(ORIP)
Jeanne Diederich
IRB Administrator
What Is the Institutional
Review Board and what is
it’s role?
Composition of the IRB
The IRB at Syracuse University is
currently comprised of 10 members
from relevant academic disciplines
and includes one non-affiliated
community member.
Role of the IRB
The role of the IRB is to protect human
subjects participating in research.
Because Syracuse University receives
federal funds. SU is obligated to review
ALL projects involving human subjects for
compliance with institutional, state, local
and federal laws.
Federal Wide Assurance
In the Federal Wide Assurance
(FWA), SU pledges to follow
certain ethical principles outlined
in the Belmont Report and
federal regulations 45 CFR 46Part A.
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 definition of research
IRB membership
IRB functions and operations
IRB review of research
Criteria for IRB approval of research
IRB’s authority to suspend or terminate approval of
research
IRB records
General requirements for informed consent
Documentation of informed consent
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.
Human subject means a living individual about
whom an investigator (whether professional or
student) conducting research obtains:
 (1) Data through intervention or interaction with
the individual, or
 (2) Identifiable private information.
Categories of IRB Review
Exempt

Expedited

Full Board

Exempt Review

Exempt



Some studies meet the definition of human subjects research
but may qualify for exemption under one or more of the 6
categories defined by the Federal Regulations.
Examples include anonymous surveys, existing data that is
publicly available, and research conducted in established or
commonly accepted educational settings involving normal
educational practices.
Exemption must be determined by the IRB, not the
investigator (must submit and exempt application).
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.
Expedited Review

Expedited


Research activities that (1) present no more
than minimal risk to human subjects, and
(2) involve only procedures listed in one or
more of the 9 categories defined by the Federal
Regulations
May be reviewed by one member of the IRB,
usually the IRB Chair unless additional
expertise is needed
Expedited Review-con’t

Common examples of expedited research include:
 Research on individual or group characteristics or
behavior
 Research employing survey, interview, oral history,
focus group, program evaluation, human factors
evaluation, or quality assurance methodologies
 Collection of data through noninvasive procedures
routinely employed in clinical practice (moderate
exercise, blood pressure screening, muscular strength
and flexibility testing, and body composition
assessment)
Expedited Review Process
Turn around time for review is approximately 710 business days. There are no deadlines for
expedited applications. Allow a minimum of 4
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.
Full Board Review

The research involves greater than minimal risk:
Harm or discomfort > those encountered in daily life



Potential illegal behavior
 Under age drinking
 Child abuse or neglect
Sensitive topics that could be damaging to participants
 Disclosure of medical status
 Sexual Behavior
The research involves a population requiring FBR

Legally restricted participants
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-con’t
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
 Purpose of Research (Rationale or research question)
 Approach/Method –What are you going to do and what is
going to happen to the subject?
 Qualifications of the Researchers
 Characteristics of the Subject population to be Recruited
 Special Groups Involved in Research
 Type of Informed Consent to Be Obtained
 Precautions to Ensure Privacy and Confidentiality
 Risks to Subjects (physical, psychological, financial, etc.) and
how the risks will be managed.
 Benefits to Subjects and Society at Large - How Do the
Benefits Outweigh the Risks?
Application Content-con’t
 All applications should be completed under
the guidance of the student’s faculty advisor
and reviewed by the faculty advisor prior to
submission.
 The application must be signed by the
faculty advisor and the student.
Informed Consent
Required elements include (are not limited to):
 Statement – that the study involves “research”
 Purpose of Research
 Procedures involved in the Research
 Duration of Involvement in the Research
 Participation is Voluntary-Right to withdraw at anytime without
Penalty
 Right to confidentiality
 Risks and Benefits
 Who to Contact for More Information or Questions
 Who to Contact if a Participant is Harmed or Has Concerns
Informed Consent-con’t






Use everyday language appropriate to potential
participant (readable and clear)
On SU Letterhead
Title of Research
Signature lines
Sample available at
http://orip.syr.edu/IRBInstructions.htm
Keep signed documents for at least 3 years after
the study has closed
Outcomes of Review

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 con’t
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 con’t


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



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”)
 Cannot implement change to the protocol without
prior 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.
 Collaborative IRB Training Initiative (CITI) is
required by all individuals actively engaged in the
research (not required for exempt research).
 Full board and expedited applications can be approved
for up to 365 days (unless IRB determines more
frequent review is necessary).
 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]
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