Research Ethical Clearance Guidelines

Purpose and Scope

1.1 These Guidelines set out how research conducted by BINUS University faculty, researchers, and students obtains ethical clearance before data collection begins.

1.2 They apply to all research involving human participants, human data or biological materials, or animals. This covers research conducted under the BINUS University affiliation, whether funded internally or externally, and whether carried out on or off campus.

1.3 They also clarify how BINUS clearance relates to the ethics requirements of journals where BINUS researchers publish.

Normative Basis

These Guidelines are based on the following instruments:

a. Committee on Publication Ethics (COPE) guidance on research ethics and journal policy.
b. National Guidelines and Standards for Health Research and Development Ethics (KEPPKN, 2021).
c. International Ethical Guidelines for Health related Research Involving Humans (CIOMS, 2016) and the Declaration of Helsinki.
d. Law No. 27 of 2022 on Personal Data Protection (UU PDP).
e. Permendikbudristek No. 39 of 2021 on Academic Integrity in Producing Scientific Works.:

Definition

a. Research Ethics Committee (the Committee): the body authorized to review research protocols and issue ethical clearance determinations, administered through RTT.
b. Human participant: A living individual about whom a researcher obtains information or biological material through interaction or intervention, or whose identifiable private information is used, studied, or analyzed.
c. Ethical clearance: A written determination by the Committee that a protocol has been approved, approved through expedited review, or determined to be exempt.
d. Minimal risk: The probability and magnitude of harm or discomfort anticipated in the research are no greater than those ordinarily encountered in daily life or during routine physical or psychological examinations.
e. Low and Negligible Risk (LNR): Research in which the only foreseeable risk is minor discomfort or inconvenience.

Core Principles

4.1 Prior review: All research within the scope of Section 1.2 must be submitted to the Committee before participant recruitment or data collection begins. This applies even when the researcher believes the study carries only minimal risk.

4.2 Exemption is a determination, not a bypass: Exemption is one possible outcome of the review process. It is issued by the Committee, not decided by the researcher alone.

4.3 Proportionality: The level of review is proportional to the level of risk. Low risk studies go through simpler tracks, and higher-risk studies receive fuller scrutiny.

4.4 No retrospective clearance: The Committee does not issue ethical clearance for data that has already been collected. Researchers with this situation should consult RTT on available options, such as a secondary use review where applicable.

4.5 Respect for persons, beneficence, and justice: All reviews follow these principles, as reflected in the KEPPKN standards, including informed consent, privacy and data protection, and fair participant selection.

Review Tracks

The Committee classifies each submission into one of the following tracks, from lightest to most rigorous.

5A. Not Human Subjects Research (NHSR) Determination

3. Criteria: The activity does not involve human participants or animals as defined in Section 3. Examples include analysis of fully anonymized, publicly available datasets or research on institutions rather than individuals.
   b. Outcome: On request, the Committee issues an NHSR determination letter. This letter is often useful when a journal asks for proof that ethical review was not required.

5B. Exempted Review

1. Criteria: The study involves human participants but presents no more than minimal risk and fits within one or more exemption categories set by the Committee, for example:

• anonymous surveys on non sensitive topics,
• research on normal educational practices in established educational settings,
• secondary analysis of deidentified data.
  b. Process: The Committee Secretariat or a designated reviewer verifies eligibility.
  c. Outcome: If eligible, an exemption determination letter is issued within 15 working days.

5C. Expedited Review

1. Criteria: The study presents no more than minimal risk but does not qualify for exemption. Examples include studies that collect identifiable data, involve sensitive topics, or use non invasive physical measurements.
   b. General categories:

• Social, behavioral, and educational research.
• Science, Technology, Engineering, and Mathematics (STEM) research.

1. Process: The protocol is reviewed by one or two designated Committee members rather than the convened Committee.
   d. Outcome: Ethical clearance is issued within 30 working days.

5D. Full Board Review

1. Criteria: The study presents more than minimal risk. Examples include invasive procedures, clinical interventions, animal experimentation, deception, or the involvement of vulnerable populations (such as minors, patients, or people with limited capacity to consent).
   b. Process: The protocol is reviewed at a convened meeting of the full Committee.
   c. Outcome: Ethical clearance is issued within 15 working days after the meeting.

Journal Policies and Self Assessment Exemptions

6.1 COPE’s position: COPE holds that ethical approval is generally required for research involving human or animal participants. It also recognizes that requirements vary by country and that each journal may set its own policy.

6.2 Self assessment models: Some journals accept a signed Low and Negligible Risk (LNR) self assessment checklist instead of a formal ethics certificate. These categories are defined as follows:

– Low Risk: Research where discomfort is the maximum foreseeable risk. Any study with the potential to cause harm beyond discomfort cannot be categorized as low risk.

– Negligible Risk: Research involving no foreseeable risk of harm or discomfort, with potential impacts limited strictly to inconvenience. If the risk could reasonably exceed inconvenience, the study must not be classified as negligible risk.

(Source: https://research-support.uq.edu.au/resources-and-support/ethics-integrity-and-compliance/human-ethics/ethics-application/lower-risk-research)

6.3 BINUS requirement: Even when a target journal accepts a self-assessment checklist, BINUS researchers must still register the study with the Committee and obtain the appropriate determination under Section 5. The journal’s checklist may be submitted in addition to that determination, but not as a replacement for it.

6.4 Stricter standard prevails: Where BINUS requirements and a journal’s requirements differ, researchers must meet whichever is stricter.