Transcript Ethics Review Committee Information Sheet

SINGAPORE POLYTECHNIC
ETHICS REVIEW COMMITTEE
INFORMATION SHEET
SP ETHICS REVIEW COMMITTEE (ERC)
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About SP ERC
Role of SP ERC
SP ERC Members
ERC Operations
 Definition of Research
 Definition of Principal Investigator (PI), Co-PI, Collaborator
 Knowledge on Ethics Review
 Workflow
 Categories of Review
 Submission Requirements
 Guidelines for Application
 Processing Time
Reporting Requirements
 Protocol Amendments
 Half yearly/Final report
ABOUT SP ERC
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Singapore Polytechnic is committed to promote a
vibrant Research & Development (R&D) culture
through the Technology & Innovation Centres (TICs),
school laboratories and collaboration with industries.
As our research and development work gain
momentum, there is a need for the research
community within SP to look into the ethical issues of
research work
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SP establishes an ERC to provide policy and operative
oversight of the research activities within the campus
ROLE OF SP ERC
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The ERC is a vehicle for SP to implement its
system of ethics governance of research carried
out within the institution
To ensure adequate protection of potential and
actual human subjects, through the review of
research proposals
 To conduct independent reviews of the ethical merits
of research projects that involve human subjects or
human tissues as proposed by SP staff
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SP ERC MEMBERS
Consists of 10 members
 Internal and External
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2
Co-chairman
 8 members
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1 Secretarial support
ERC OPERATIONS
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Definition of Research
Definition of Principal Investigator (PI), Co-PI, Collaborator
Workflow of New Protocol
Categories of Review
 Exempt Category
 Expedited Category
 Full Board Category
Submission Requirements
Guidelines for Application
 Subject Selection
 Informed Consent & Confidentiality
 Risks
Processing Time
DEFINITION OF RESEARCH
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Research is broadly defined as activities that:
 Involve
systematic investigation; and
 Designed to contribute to generalisable
knowledge
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Reserach projects involving humans require
review and approval by the SP ERC
DEFINITION OF PRINCIPAL INVESTIGATOR
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The Principal Investigator is the overall responsible
person for the proper conduct of research. In general,
each study can have only one Principal Investigator
who is responsible for the conduct of the clinical
study.
DEFINITION OF CO-INVESTIGATOR
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Co-investigator means an individual assigned by the
institution along with one or more other coinvestigators to direct a project or activity supported
by external funding.
Co-investigators have equal authority and
responsibility for the conduct of the sponsored project.
All co-investigators are responsible and accountable
for the proper conduct of the project or activity, to the
institution and sponsor of the project or activity.
DEFINITION OF COLLABORATOR
Associates in the project/research
 Can be a person/s, a company, an institution, a
department.
 All data results collected to be shared with the
collaborator MUST NOT contain personal
identifiers of the participants.
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KNOWLEDGE ON ETHICS REVIEW
SP is a member of CITI Program
 CITI Program is a subscription service providing
research ethics education to all members of
the research community
 All Principal Investigators are required to go
through CITI Program via online (approximately
half a day) and submit the certificate together
with the application
 www.citiprogram.org
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WORKFLOW OF NEW PROTOCOL
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All applications shall undergo full board review
unless criteria for an exempt or an expedited review
are met
CATEGORIES OF REVIEW
1 ERC Application
Chairpersons to decide and distribute into
3 Categories
Exempt
- Anonymous surveys, samples
and data
Expedited
- Research involving no more
than minimal risk
Full Board
- Neither Exempt Nor Expedited;
more than minimal risk
EXEMPT CATEGORY
Surveys where no identifying data is recorded
 No potential risk to subject if data were to
become known outside of research
 Not applicable for sensitive data collection
(relating to HIV, sexual behavior, drug use,
illegal conduct, use of alcohol)
 Reviewed and Approved by the Chairperson
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EXPEDITED CATEGORY
RESEARCH that involves minimal risk (i.e risk
encountered in daily life)
 Collection of biological samples by non invasive
means
 Collection of data through non invasive
procedures routinely employed in clinical practice
 Retrospective record review
 Research employing identifiable survey, interview
 Reviewed and Approved by the Chairperson and
the relevant Cluster ERC
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FULL BOARD CATEGORY
All proposals that do not fall into Exempt or
Expedited category
 Reviewed and Approved by the whole
committee
 Submission dates and review dates are listed
in www.sp.edu.sg/erc
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SUBMISSION REQUIREMENTS
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A complete application consists of 1 scanned copy of ERC
Application Form, Participant Information & Consent Form, CITI
Certificate, data collection sheet/survey form, approved/awarded
research proposal, and any supporting documents.
All relevant sections of the application form must be filled out
completely, including signature from your school/centre Director.
Please note that only completed application will be reviewed.
The Secretariat may at times requests from the Principal Investigator
original documents to be furnished for verification purposes.
Always download the latest version of the forms from
http://www.sp.edu.sg/erc.
GUIDELINES FOR APPLICATION
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Subject Selection
 Selection
of participants is Equitable.
 SP ERC is unable to review study/research that
involves Vulnerable participants such as prisoners,
mentally disabled persons or economically or
educationally disadvantaged persons.
GUIDELINES FOR APPLICATION
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Informed Consent & Confidentiality
 Informed
consent must be sought from each
prospective Participant of the participant’s legally
acceptable representative and must be properly
documented.
 When appropriate, the research plan must have
adequate provisions to protect the privacy of
participants and to maintain the confidentiality of
data.
GUIDELINES FOR APPLICATION
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Risks
 Risks
to participants are minimized by using
procedures which are consistent with sound
research design and do not unnecessarily expose
subjects to risk.
 Risks to participants are reasonable in relation to
anticipated benefits, if any, to subjects, and the
importance of the knowledge that may reasonably
be expected to result.
PROCESSING TIME
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The minimum review time is 3 weeks
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The processing time for ERC in reviewing an application from the date of receipt
of the submission by the Secretariat to the Principal Investigator being informed
of approval or disapproval of the proposed project.
Dependent on factors such as the complexity of the research, rounds of
amendments (modification) to the application in response to the issues raised
by the Committee.
Approval will be given when applicant has satisfactorily replied all queries.
The Principal Investigator will be kept informed at all times of
the ERC's comments including decision of approval or
disapproval.
Principal Investigator will be notified by email of the ERC's
decision of approval of the ERC application, the email will serve
as the approval letter from the ERC. There will be no further
official letter of approval to follow.
REPORTING REQUIREMENTS
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ERC Protocol Amendment Review Comment Form
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the principal investigator is obliged to notify the ERC in any
event such as:
 A deviation or changes (eg. experimental designs) from
that disclosed in the documents reviewed and approved
by the ERC during the course of the research. An
approval on such change must be sought with the ERC.
 Any adverse events and apparent risks beyond those
predicted in the approved proposal must be reported
within 7 days of first notice.
 Any new information that may alter the ethical basis of
the research programme.
 OR Premature termination of the research.
REPORTING REQUIREMENTS
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Half-yearly Report
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Principal Investigator should keep the ERC
informed of the progress of the project by
submitting a Reporting Form every 6 months
following the approval of the proposed project.
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Final Report
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Principal Investigator should inform the ERC as
soon as the project is completed with the
submission of the Reporting Form.
CONTACT
SP ERC Secretarial
Technology Transfer and Enterprise Centre
Website: www.sp.edu.sg/erc
Email: [email protected]