SINGAPORE POLYTECHNIC Ethics Review Committee Information Sheet

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SINGAPORE POLYTECHNICEthics Review
CommitteeInformation Sheet
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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

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About SP ERC

• Singapore Polytechnic is committed to promote a
  vibrant Research Development (RD) 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

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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
  

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Sp erc members

• Consists of 10 members
• Internal and External
• 2 Co-chairman
• 8 members
• 1 Secretarial support

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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

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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

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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.

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Definition of co-investigator

• Co-investigator means an individual assigned by
  the institution along with one or more other
  co-investigators 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.

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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

• All applications shall undergo full board review
  unless criteria for an exempt or an expedited
  review are met

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Categories of review
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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

• 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.

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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.

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Guidelines for application

• Informed Consent Confidentiality
• Informed consent must be sought from each
  prospective Participant of the participants
  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.

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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.

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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.

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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.

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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.

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Contact

• SP ERC Secretarial
• Technology Transfer and Enterprise Centre
• Website www.sp.edu.sg/erc
• Email tiffany_at_sp.edu.sg