SUBMISSION >>> REVIEW >>> DECISION
Step 1. Submission of documents to the REO
Research studies that involve either human participants/human subjects or the use of animals require evidence of scientific merit before they can be considered for approval by the XA REB or the XA IACUC, respectively.
Basic documents (must be submitted for initial review):
- Full protocol
◻Formatted with Line numbers added (restarting each page) only on the textual parts of the protocol (chapters and sections), including attached sample Informed Consent Forms and Assent Forms but excluding the title and preliminary pages, other attachments in the Appendix, e.g., scanned or photo images, sample survey or questionnaires, CVs of investigators, etc. To add line numbers on a Word document, highlight the page/s to add line numbers, and on the Layout tab, in the Page Setup group, click Line Numbers, and select Restart Each Page.
- Document checklist form (REC Form No. 2020-02C or IACUC Form No. 2020-02B)
- Document receipt form (REC Form No. 2020-02D or IACUC Form No. 2020-02C)
- Ethical risk filter form (REC Form No. 2020-02A)
- Application form for protocol review (REC Form No. 2020-02B or IACUC Form No. 2020-02A)
- Study protocol assessment form (REC Form No. 2020-02E) or Protocol Risk Assessment form (IACUC Form No. 2020-04A)
- Informed consent assessment form (REC Form No. 2020-02G)
- Curriculum vitae of principal investigator and study team members
- Declaration of Conflict of Interest (COI) signed by the principal investigator (REC Form No. 2020-02B)
Study-specific documents (to be submitted as needed)
- Questionnaire/Online Survey Screenshots, Interview question/Focus Group guide, and other Data collection forms, including Case Report Forms (CRFs)
- Participant Information Sheet (for studies with human participants)
- Participant Consent Form (in English and in local language)( for studies with human participants)
- Participant Debrief (for studies involving deception)
- All recruitment advertisements (as needed by the study protocol)
- Assent Form (in English and in local language)(for studies involving minors and relevant populations deemed incompetent to sign an informed consent form)
- Copies of letters to parents/guardians/children (for studies involving children or educational institutions)
- Material transfer agreement or Terms of reference (for research involving transfer of biological specimen)
- Memorandum of agreement (MOA) or Memorandum of understanding (MOU) (for collaborative studies)
- Data Management Plan (DMP) (where available and only when required by funder)
- External permission forms/emails (for research requiring permission for access to land or building, participants, data, or other aspects)
- Ethical approval documents (in full) from an external review body (for students/personnel of foreign universities researching in the University or those with prior ethical review)
- National Commission for Indigenous People (NCIP) clearance (for studies with indigenous populations; can be processed while XU REB review is ongoing)
- Clearance or permit from respective regulatory authorities (such as FDA approval for clinical trials and DENR local transport permit, as applicable)
Step 2. Initial review
The REO staff screens, manages, and process the study protocol package submission. Only when all required documentation (listed below) has been duly submitted, will the REO staff forward the study for review by the XU REB or XU IACUC.
Each research project submitted to the REO is referred as a "package". Each package has its own unique package number. REO will be using this number to refer to your research project.
A study protocol is submitted for one of the following types of review:
- Exemption from full-board review
- Expedited review
- Full-committee review
EXEMPTION FROM FULL-BOARD REVIEW
Proposals are exempt from REB review when there is negligible risk arising as a result of the conduct of the research project or when the information being collected is available from the public domain.
The determination of whether or not a particular research is exempt from review is made by the XU REB, not the researcher. A Letter of Exemption from Ethical Review is communicated to the Principal Investigator within seven (7) working days from receipt of complete package.
A proposal is circulated for expedited review when the research procedures present no more than minimal risk to the research participants or communities. “Minimal risk” would be defined as one which may be anticipated as harm or discomfort not greater than that encountered in routine daily life activities of general population or during the performance of routine physical or psychological examinations or tests. The REO Administrative Staff forwards the complete package submission to primary reviewers.
Protocols presenting more than minimal risk, those which do not qualify for exemption or expedited review, and projects that involve vulnerable population and special groups will be subjected to full committee review.
A full-committee review entails a formal meeting among the five (5) Research Ethics Committee (REC) members who present their findings to the REC followed by a general discussion and a consensus decision. The REC may request for the proponent/s to attend the Full REC Review meeting.
- Procedures of low or mild severity
- Procedures of medium or moderate severity o Procedures of high or substantial severity
PROCEDURES OF LOW OR MILD SEVERITY
These include the taking of small or infrequent blood samples; skin irritation tests with substances expected to be only mildly irritant; conventional minor surgical procedures under anaesthesia such as laparoscopy, small superficial tissue biopsies or cannulation of peripheral blood vessels; other procedure which will be terminated before the animal shows more than minor changes from normal behavior. Proposals under this category are for expedited review by the XU IACUC Chairperson.
PROCEDURES OF MEDIUM OR MODERATE SEVERITY
These include much of the screening and development of potential pharmacological agents, toxicity tests avoiding lethal endpoints, and most surgical procedures, provided that suffering can be controlled by reliable post-operative analgesia and care. Proposals under this category are for expedited review by the XU IACUC Chairperson and 1 or 2 other members of the committee assigned by the Chairperson.
PROCEDURES OF HIGH OR SUBSTANTIAL SEVERITY
These include procedures that result in a major departure from the animal’s usual state of health or well-being. These include acute toxicity procedures where significant morbidity or death is an endpoint; some efficacy tests or anti-microbial agents and vaccine; some models of disease and major surgery where significant post-operative suffering may result. Proposals under this category are for full review by a quorum of the XU IACUC.
For expedited review study protocols, the primary reviewers accomplish the Study protocol assessment form (REC Form No. 2020-02E) or the Protocol Risk Assessment form (IACUC Form No. 2020-04A), completely signed and dated, forwards the electronic forms through e-mail, or returns the signed paper-based review to the REO Administrative Staff within fourteen (14) working days from receipt of package.
Step 3. Decision
The REB or IACUC may give any of the following recommendations on a study protocol submitted to it for consideration:
- Minor modifications required
- Major modifications required
The REO Administrative Staff notifies the principal investigator through email regarding committee decision through a certificate of approval, or a notice of action indicating committee recommendations at least fourteen (14) working days from the date the submission package was received by the REO. For full committee review protocols, the REO Administrative Staff notifies the principal investigator through email within seven (7) working days after the committee meeting. The principal investigator may be requested to provide additional information or submit additional documents.
Proposals are disapproved when there are aspects of the study that are deemed unethical or when the ethical issues cannot be resolved. The respective committee will provide a rationale for this decision, which will be similarly communicated to the proponent. The proponent(s) has/have the option of either (1) revising and resubmitting their research proposal, or (2) appeal the committee decision.
Failure to obtain ethics approval when it is required, to deviate from or failure to adhere to approved research protocol, and failure to comply with the policies established by the University, may constitute research misconduct and may warrant disciplinary action following standard University procedures.