2.  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

3.  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

4.  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

5.  Consists of 10 members  Internal and External  2 Co-chairman  8 members  1 Secretarial support

6.  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

7.  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

8.  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.

9.  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.

10.  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.

11.  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

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

13. 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

14.  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

15.  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

16.  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

17.  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.

18.  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.

19.  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.

20.  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.

21.  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.

22.  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.

23.  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.

24. SP ERC Secretarial Technology Transfer and Enterprise Centre Website: www.sp.edu.sg/erc Email: tiffany@sp.edu.sg