Ethics Review Committee Information Sheet
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Transcript Ethics Review Committee Information Sheet
SINGAPORE POLYTECHNIC
ETHICS REVIEW COMMITTEE
INFORMATION SHEET
SP ETHICS REVIEW COMMITTEE (ERC)
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
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
SP establishes an ERC to provide policy and operative
oversight of the research activities within the campus
ROLE OF SP ERC
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
SP ERC MEMBERS
Consists of 10 members
Internal and External
2
Co-chairman
8 members
1 Secretarial support
ERC OPERATIONS
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
Research is broadly defined as activities that:
Involve
systematic investigation; and
Designed to contribute to generalisable
knowledge
Reserach projects involving humans require
review and approval by the SP ERC
DEFINITION OF PRINCIPAL INVESTIGATOR
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
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.
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
WORKFLOW OF NEW PROTOCOL
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
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
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
SUBMISSION REQUIREMENTS
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
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
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
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
The minimum review time is 3 weeks
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
ERC Protocol Amendment Review Comment Form
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
Half-yearly Report
The
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.
Final Report
The
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]