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

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

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

Consists of 10 members Internal and External

2 Co-chairman 8 members

1 Secretarial support

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

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

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.

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.

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.

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

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

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

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

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

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.

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.

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.

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.

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.

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.

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.

SP ERC SecretarialTechnology Transfer and Enterprise

CentreWebsite: www.sp.edu.sg/ercEmail: tiffany@sp.edu.sg