Frequently Asked Questions
What type of studies should be submitted to CEU-IERB?
All research studies involving human participants should be submitted to CEU-IERB. The Board shall require the submission of a set of pertinent documents for an application for ethical review to be accepted. A preliminary evaluation shall determine whether a research proposal is exempted from or needs to undergo ethical review based on the NEGHHR 2017 The Research Ethics Review Process Guideline 3.1.
When should I seek ethical review?
You should seek an ethical review before you make contact with human participants as part of your research.
Will every modification of my research instruments and/ methodology
require a further review process?
All relevant research instruments and elements of the research which differ from those that are written wherein clearance has been given, should be ethically reviewed by IERB.
How do I submit my research protocols to the IERB?
All research protocols must be submitted online. Kindly use the link embedded inyour CEU-LEAPS for submission.
What is initial submission?
Initial Submission refers to a set of documents consisting of the full proposal and other study-related documents that need to be submitted so that review can be conducted.
What are study documents?
Study Documents include all materials (protocol, forms, certificates, research tools) pertinent to a research proposal that have to be submitted to the REC for review.
What is initial review?
Initial Review refers to the ethical and technical review conducted on the initially- submitted study documents. It may be expedited or full.
How is ethics review done?
All reviews are facilitated online. Result of review from the panel are communicated through e-mail.
What types of research may be exempted from review?
Exempt from Review is a decision made by the IERB Chair or designated member of the committee regarding a submitted study proposal based on criteria in the NEGHHR 2017 The Research Ethics Review Process Guideline 3.1. This means that the protocol will not undergo an expedited nor a full review.
These include:
Protocols that neither involve human participants nor identifiable human tissue, biological samples, and data (e.g., meta-analysis protocols)
Protocols for institutional quality assurance purposes, evaluation of public service programs, public health surveillance, educational evaluation activities, and consumer acceptability tests.
Research that only includes interactions involving survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording)
Protocols that involve the use of publicly available data or information
What is an expedited review?
An expedited review shall be conducted for study protocols that:
(1) do not entail more than minimal risk to the study participants,
(2) do not have study participants belonging to a vulnerable group, and (3) the
study procedures do not generate vulnerability.
The results of the initial review shall be released to the principal investigator
within four weeks after the submission of all the required documents.
What is a full review?
Full Review is the ethical evaluation of a research proposal and other protocol-related documents, a resubmission and after-approval submissions, conducted by the IERB en banc, in the presence of a quorum, using established technical and ethical criteria.
A full review shall be conducted when a proposed study entails more than minimal risk to study participants or when study participants belong to vulnerable groups or when a study generates vulnerability to participants.
Who are considered vulnerable groups?
Vulnerable Groups are participants or potential participants of a research study who may not have the full capacity to protect their interests and may be relatively or absolutely incapable of deciding for themselves whether or not to
participate in the research. They may also be at a higher risk of being harmed or to be taken advantage.
What is the meaning of Minimal Risk?
Minimal Risk is the term used when the probability and magnitude of harm or discomfort anticipated in a research are not greater, in and of themselves, than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.
What is the meaning of More than Minimal Risk?
More than Minimal Risk is the term used when the probability and magnitude of harm or discomfort anticipated in a research are greater, in and of themselves, than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.
What are the possible actions of IERB after the ethical review?
The primary reviewers signify their decision by marking the appropriate section of the aforementioned forms and affixing their signature in the space provided.
Decision points are:
APPROVE
MAJOR MODIFICATIONS
MINOR MODIFICATIONS
DISAPPROVE
PENDING
Who are the Primary Reviewers?
Primary Reviewers are members of the Institutional Ethics Review Board
(usually a scientist and a non-scientist) assigned to do an in-depth evaluation of
the research-related documents using technical and ethical criteria established
by the board.
The non-scientist member shall focus on the review of the Informed Consent
process and form and reflect on community values, culture, and tradition to
recommend acceptance, non-acceptance or improvement of the informed
consent process and form.
The primary reviewers shall present their findings and recommendations during
the meeting for discussion.
What is Major Modification?
Major Modification is a recommended revision of significant aspects/s of the
study (e.g., study objectives, recruitment of participants, exclusion/inclusion
criteria, collection of data statistical analysis, mitigation of risks, protection of
vulnerability, etc.) that impact on potential risks/harms to participants and on the
integrity of the research.
What is Minor Modification?
The primary reviewers signify their decision by marking the appropriate section of the aforementioned forms and affixing their signature in the space provided.
Decision points are:
APPROVE
MAJOR MODIFICATIONS
MINOR MODIFICATIONS
DISAPPROVE
PENDING
What are resubmissions?
Resubmissions are revised study proposals that are submitted after the initial review.
The CEU IERB shall require a resubmission of a protocol that requires either minor or major modification/s not later than 4 weeks after receipt of the Decision Letter. Minor modifications shall undergo expedited review while major
modifications shall undergo full review.