{"id":2,"date":"2025-05-01T11:48:56","date_gmt":"2025-05-01T11:48:56","guid":{"rendered":"https:\/\/binus.ac.id\/techtransfer\/?page_id=2"},"modified":"2026-09-23T10:01:47","modified_gmt":"2026-09-23T10:01:47","slug":"ethical-clearance","status":"publish","type":"page","link":"https:\/\/binus.ac.id\/techtransfer\/ethical-clearance\/","title":{"rendered":"Research Ethical Clearance Guidelines"},"content":{"rendered":"
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Adapted from the Committee on Publication Ethics (COPE) guidance and national research ethics standards<\/em><\/p>\n

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1<\/div>\n
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Purpose and Scope<\/p>\n

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

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.<\/p>\n

1.3 They also clarify how BINUS clearance relates to the ethics requirements of journals where BINUS researchers publish.<\/p>\n<\/div>\n<\/div>\n

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2<\/div>\n
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Normative Basis<\/strong><\/p>\n

These Guidelines are based on the following instruments:<\/p>\n

a. Committee on Publication Ethics (COPE) guidance on research ethics and journal policy.
\nb. National Guidelines and Standards for Health Research and Development Ethics (KEPPKN, 2021).
\nc. International Ethical Guidelines for Health related Research Involving Humans (CIOMS, 2016) and the Declaration of Helsinki.
\nd. Law No. 27 of 2022 on Personal Data Protection (UU PDP).
\ne. Permendikbudristek No. 39 of 2021 on Academic Integrity in Producing Scientific Works.:<\/p>\n<\/div>\n<\/div>\n

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3<\/div>\n
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Definition<\/p>\n

a. Research Ethics Committee (the Committee):<\/strong> the body authorized to review research protocols and issue ethical clearance determinations, administered through RTT.
\nb. Human participant:<\/strong> 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.
\nc. Ethical clearance:<\/strong> A written determination by the Committee that a protocol has been approved, approved through expedited review, or determined to be exempt.
\nd. Minimal risk:<\/strong> 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.
\ne. Low and Negligible Risk (LNR):<\/strong> Research in which the only foreseeable risk is minor discomfort or inconvenience.<\/p>\n<\/div>\n<\/div>\n

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4<\/div>\n
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Core Principles<\/p>\n

4.1 Prior review:<\/strong> 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.<\/p>\n

4.2 Exemption is a determination, not a bypass:<\/strong> Exemption is one possible outcome of the review process. It is issued by the Committee, not decided by the researcher alone.<\/p>\n

4.3 Proportionality:<\/strong> 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.<\/p>\n

4.4 No retrospective clearance:<\/strong> 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.<\/p>\n

4.5 Respect for persons, beneficence, and justice:<\/strong> All reviews follow these principles, as reflected in the KEPPKN standards, including informed consent, privacy and data protection, and fair participant selection.<\/p>\n<\/div>\n<\/div>\n

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5<\/div>\n
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Review Tracks<\/p>\n

The Committee classifies each submission into one of the following tracks, from lightest to most rigorous.<\/p>\n

5A. Not Human Subjects Research (NHSR) Determination<\/strong><\/p>\n

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  1. Criteria:<\/strong> 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.
    \nb. Outcome:<\/strong> 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.<\/li>\n<\/ol>\n

    5B. Exempted Review<\/strong><\/p>\n

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    1. Criteria:<\/strong> 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:<\/li>\n<\/ol>\n
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      • anonymous surveys on non sensitive topics,<\/li>\n
      • research on normal educational practices in established educational settings,<\/li>\n
      • secondary analysis of deidentified data.
        \nb. Process:<\/strong> The Committee Secretariat or a designated reviewer verifies eligibility.
        \nc. Outcome:<\/strong> If eligible, an exemption determination letter is issued within 15 working days.<\/li>\n<\/ul>\n

        5C. Expedited Review<\/strong><\/p>\n

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        1. Criteria:<\/strong> 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.
          \nb. General categories:<\/strong><\/li>\n<\/ol>\n
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          • Social, behavioral, and educational research.<\/li>\n
          • Science, Technology, Engineering, and Mathematics (STEM) research.<\/li>\n<\/ul>\n
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            1. Process:<\/strong> The protocol is reviewed by one or two designated Committee members rather than the convened Committee.
              \nd. Outcome:<\/strong> Ethical clearance is issued within 30 working days.<\/li>\n<\/ol>\n

              5D. Full Board Review<\/strong><\/p>\n

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              1. Criteria:<\/strong> 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).
                \nb. Process:<\/strong> The protocol is reviewed at a convened meeting of the full Committee.
                \nc. Outcome:<\/strong> Ethical clearance is issued within 15 working days after the meeting.<\/li>\n<\/ol>\n<\/div>\n<\/div>\n
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                6<\/div>\n
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                Journal Policies and Self Assessment Exemptions<\/strong><\/p>\n

                6.1 COPE’s position:<\/strong> 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.<\/p>\n

                6.2 Self assessment models:<\/strong> 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:<\/p>\n

                – 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.<\/p>\n

                – 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.<\/p>\n

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

                6.3 BINUS requirement:<\/strong> 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.<\/p>\n

                6.4 Stricter standard prevails:<\/strong> Where BINUS requirements and a journal’s requirements differ, researchers must meet whichever is stricter.<\/p>\n

                7<\/div>\n
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                Procedure for Researchers<\/strong><\/p>\n

                a. Identify the participants:<\/strong> Determine whether the study involves human participants, human data or materials, or animals.
                \nb. Assess the risk:<\/strong> Make a preliminary classification of the risk level as negligible, minimal, or greater than minimal. Then identify the likely review track under Section 5.
                \nc. Check the target journal’s policy:<\/strong> Confirm what ethics documentation the journal requires.
                \nd. Prepare the submission:<\/strong> Complete the ethical clearance form, conflict of interest, and attach the required documents. These include:<\/p>\n

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                • the research protocol,<\/li>\n
                • the instruments,<\/li>\n
                • informed consent materials,<\/li>\n
                • a data management plan consistent with UU PDP,<\/li>\n
                • a supervisor endorsement (for student research).<\/li>\n<\/ul>\n

                  e. Submit through [submission system\/channel]:<\/strong> The Committee makes the final track determination and may reclassify the study.
                  \nf. Wait for the determination:<\/strong> Do not begin recruitment or data collection until you receive written clearance.
                  \ng. Report accurately:<\/strong> State the clearance number and determination type in the manuscript’s ethics statement.<\/p>\n<\/div>\n

                  8<\/div>\n
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                  Responsibilities<\/strong><\/p>\n

                  a. Researchers:<\/strong> Researchers must:<\/p>\n

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                  • submit complete and truthful applications,<\/li>\n
                  • conduct the study as approved,<\/li>\n
                  • protect participant data,<\/li>\n
                  • keep clearance documentation.<\/li>\n<\/ul>\n

                    b. Supervisors:<\/strong> Supervisors of student research must review applications before submission and oversee compliance throughout the study.<\/p>\n

                    c. The Committee and RTT:<\/strong> The Committee and RTT are responsible for:<\/p>\n

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                    • conducting reviews independently and consistently,<\/li>\n
                    • keeping review records,<\/li>\n
                    • issuing determinations within the stated timelines,<\/li>\n
                    • providing guidance to researchers.<\/li>\n<\/ul>\n<\/div>\n
                      9<\/div>\n
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                      Journal Policies and Self Assessment Exemptions<\/strong><\/p>\n

                      a. Validity:<\/strong> Ethical clearance is valid for 12 months from the date of issue. It may be extended on request before it expires.<\/p>\n

                      b. Amendments:<\/strong> Any change to the protocol, instruments, participant population, or data handling must be approved before it is implemented. Examples include adding a new instrument or recruiting from a new population.<\/p>\n

                      c. Adverse events:<\/strong> Unanticipated problems or harm to participants must be reported to the Committee within as soon as possible.<\/p>\n

                      d. Completion:<\/strong> Researchers must submit a brief closure report when the study ends.<\/p>\n

                      10<\/div>\n
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                      Journal Policies and Self Assessment Exemptions<\/strong><\/p>\n

                      Research conducted without the required clearance, or in a way that departs from the approved protocol, may be treated as a violation of academic integrity. Such cases are handled under University Regulation and the applicable procedures of the University. BINUS may also inform the relevant journal where publication is involved.<\/p>\n

                      11<\/div>\n
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                      References<\/strong><\/p>\n

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                      1. Committee on Publication Ethics (COPE). Guidance on research ethics and ethical oversight. publicationethics.org<\/li>\n
                      2. Harvard University Area IRB. Guidance on “Not Human Subjects” and exempt determinations.<\/li>\n
                      3. National University of Singapore Institutional Review Board. Expedited review categories.<\/li>\n
                      4. KEPPKN. (2021). Pedoman dan Standar Etik Penelitian dan Pengembangan Kesehatan Nasional<\/em>. Kementerian Kesehatan RI.<\/li>\n
                      5. CIOMS. (2016). International Ethical Guidelines for Health related Research Involving Humans<\/em>.<\/li>\n<\/ol>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n
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                        Key Component<\/p>\n

                        What Is Informed Consent?<\/h2>\n

                        An Informed Consent<\/strong> form ensures every research participant fully understands and voluntarily agrees to their involvement in the study. It is the ethical heart of participant protection: without valid informed consent, no research is ethically or legally defensible, regardless of how valuable the findings are.<\/p>\n

                        8 mandatory elements in a BINUS Informed Consent (per 21 CFR \u00a750.25 & GDPR Art. 7):<\/p>\n

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                        1.<\/strong> Research title & institution name<\/div>\n
                        2.<\/strong> Purpose of the study & data collection methods<\/div>\n
                        3.<\/strong> Estimated duration of participation<\/div>\n
                        4.<\/strong> Guarantee of confidentiality of identity<\/div>\n
                        5.<\/strong> Right to withdraw at any time without consequence<\/div>\n
                        6.<\/strong> Foreseeable risks and expected benefits<\/div>\n
                        7.<\/strong> Researcher’s contact for questions<\/div>\n
                        8.<\/strong> BINUS Ethics Committee contact for complaints<\/div>\n<\/div>\n<\/div>\n
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                        Legal Framework<\/p>\n

                        Regulations That Require Ethical Clearance<\/h2>\n

                        Ethical clearance at BINUS is not just an internal policy, it is backed by interlocking national regulations and internationally adopted standards:<\/p>\n\n\n\n\n\n\n\n\n\n\n
                        Regulation<\/th>\nScope<\/th>\nRelevance<\/th>\n<\/tr>\n<\/thead>\n
                        Law No.11\/2019 Sisnas Iptek Art.39<\/td>\nIndonesia<\/td>\nMandates an Ethical Committee at every research institution<\/td>\n<\/tr>\n
                        BRIN Regulation No.22\/2022<\/td>\nIndonesia<\/td>\nNational ethical clearance mechanism; prerequisite for foreign researcher permits<\/td>\n<\/tr>\n
                        PDP Law No.27\/2022<\/td>\nIndonesia<\/td>\nCriminal sanctions for data collection without valid consent; fully enforced since Oct 2024<\/td>\n<\/tr>\n
                        Declaration of Helsinki (WMA 2024)<\/td>\nInternational<\/td>\nGlobal standard for medical and social research ethics; adopted by international journals<\/td>\n<\/tr>\n
                        21 CFR Part 50 (US FDA)<\/td>\nInternational<\/td>\nBenchmark for informed consent in clinical and behavioural research<\/td>\n<\/tr>\n
                        EU GDPR & APPI (Japan)<\/td>\nInternational<\/td>\nLeading data protection benchmarks \u2014 increasingly relevant for international research collaborations<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n
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                        Practical Tips<\/p>\n

                        Make Your Application Go Smoothly<\/h2>\n
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                        \ud83d\uddd3\ufe0f Start 4 weeks early<\/p>\n

                        The full process can take 3\u20134 weeks. Never apply when your data collection window is just around the corner.<\/p>\n<\/div>\n

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                        \ud83d\udccb Finalise instruments before submitting<\/p>\n

                        Revising a questionnaire after submission triggers a formal amendment, adding at least 1 extra week to your timeline.<\/p>\n<\/div>\n

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                        \u2705 Be honest in self assessment<\/p>\n

                        Use the 10 question self assessment in BINUS Panduan Edisi 1 to determine your review type. Don’t underestimate the risk profile of your study.<\/p>\n<\/div>\n

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                        \ud83d\udcbe Archive all correspondence<\/p>\n

                        Keep all emails from the Ethics Committee. If a journal reviewer or grant body questions your clearance, this is your evidence trail.<\/p>\n<\/div>\n<\/div>\n<\/div>\n

                        <\/p>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

                        Adapted from the Committee on Publication Ethics (COPE) guidance and national research ethics standards 1 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 […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"open","template":"","meta":{"footnotes":""},"class_list":["post-2","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/binus.ac.id\/techtransfer\/wp-json\/wp\/v2\/pages\/2","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/binus.ac.id\/techtransfer\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/binus.ac.id\/techtransfer\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/binus.ac.id\/techtransfer\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/binus.ac.id\/techtransfer\/wp-json\/wp\/v2\/comments?post=2"}],"version-history":[{"count":8,"href":"https:\/\/binus.ac.id\/techtransfer\/wp-json\/wp\/v2\/pages\/2\/revisions"}],"predecessor-version":[{"id":746,"href":"https:\/\/binus.ac.id\/techtransfer\/wp-json\/wp\/v2\/pages\/2\/revisions\/746"}],"wp:attachment":[{"href":"https:\/\/binus.ac.id\/techtransfer\/wp-json\/wp\/v2\/media?parent=2"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}