Human Research Ethics

All complete and fully-endorsed applications must be submitted to SJREC through [email protected].

Reach out to SJREC via email for the following documents:

 

APPLICATION FORM

1. SIDC Human Research Ethics Application Form (for reciprocal approval)
2. SIDC Human Research Ethics Exemption Form (for project assumed exemption from human research ethics review)

 

OTHER DOCUMENTS

1. SIDC Sample Consent Form (Standard Research Project)
2. SIDC Sample Consent Form (The Minors)
3. SIDC Sample Consent Form (Surveys or Interview)
4. SIDC Sample Study Information Card
5. SIDC Sample Safety Information Sheet

 

GUIDELINES AND STANDARD OPERATING PROCEDURES (SOP)

1. Human Research Guidelines for Researchers
2. Managing Approved Projects
   • Amendment
     A formal amendment application must be completed for changes to approved projects. This application requires detailing the proposed changes and providing justification for their necessity.
     The majority of amendments are swiftly processed and approved within a few working days. However, complex or contentious amendments will need to undergo a thorough, full review by the SJREC.Contact SJREC via email at [email protected]. SJREC will then advise on the formalities pertaining to the amendment.

• • Annual Progress
    Researchers are required to submit a concise annual progress report detailing the progress of the research. A reminder will be issued to researchers approximately two weeks prior to the report’s due date. The annual progress report serves as a vital document to provide an overview of the progress and outcomes of research conducted with human participants. Failure to submit this report may prompt the SJREC to reconsider the approval status of the research project, potentially leading to suspension or cancellation of ethics approval.If the research project is anticipated to extend beyond four years, an extension of up to one additional year may be granted. However, if the research extends beyond five years, a more formal review of the project’s ethics will be conducted by the SJREC toward the end of the fifth year. This requires submitting a new, updated application.

• • Project Closure
    It is an essential compliance obligation that the project must be formally closed through the submission of a closure report to the SJREC upon completion of all communication with participants, including the provision of feedback.The closure report can be submitted even if the publications or thesis are still in progress, provided there is no further contact with participants as part of the research project.

• • Adverse Incident
    All adverse events must be documented by researchers using a standard form (CIOMS form), then submitted and reported to the SJREC.
    For local serious adverse events, the researcher must provide SJREC with verbal and written reports from within the following stipulated timeline:
    1. For serious local adverse events, verbal reports are to be submitted to SIEC within 48 hours, with a written report due within SEVEN (7) calendar days of awareness. An updated written report is required within an additional THIRTY (30) calendar days.
    2. For foreign serious adverse events vary, with fatal or life-threatening events, it requires reporting within SEVEN (7) calendar days, and other serious adverse events reported within FIFTEEN (15) calendar days upon receipt from the funding provider or Contract Research Organization (CRO).
    3. For overseas suspected/unexpected serious adverse reactions (SUSAR), reports are to be submitted within THIRTY (30) calendar days upon receipt from the sponsor or CRO.

National Governance and Policies

Other Relevant Information